Drospyrenon, ethinyl estradiol, calcium Levomefolynat | Jess Plus tablets coated. 84 pcs.
Special Price
$75.46
Regular Price
$84.00
In stock
SKU
BID605146
Latin name
YAZ PLUS
YAZ PLUS
Latin name
YAZ PLUS
Release form
Film-coated tablets (active combination) pink, round, biconvex, on one side with Z + embossing in the right hexagon
Pharmacological action
Jess® Plus is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug, which includes active tablets and auxiliary tablets containing calcium levomefolate.
The contraceptive effect of Jess® Plus is mainly achieved by suppressing ovulation and increasing the viscosity of the cervical secretion.
In women taking combined oral contraceptives, the cycle becomes more regular, pain is reduced, the intensity and duration of menstrual bleeding, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduction in the risk of endometrial and ovarian cancer.
Drospirenone, which is part of Jess® Plus, has antimineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps to reduce acne (acne), oily skin and hair (seborrhea). These features of drospirenone should be considered when choosing a contraceptive for women with hormone-dependent fluid retention, as well as for women with acne and seborrhea. In its characteristics, drospirenone is similar to the natural progesterone produced by the female body. With proper use, the Pearl index (an indicator that reflects the number of pregnancies in 100 women who use contraceptives during the year) is less than 1. If the pill is missed or if it is used incorrectly, the Pearl index can increase.
The acidic form of calcium of levomefolate is identical in structure to the natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration of L-5-methyltetrahydrofolate in the blood plasma of people who do not use folic acid-rich foods is about 15 nmol / L.
Levomefolate, unlike folic acid, is a biologically active form of folate. Due to this, it is absorbed better than folic acid. Levomefolate is indicated for women during pregnancy and during breastfeeding to meet the increased need for folates. The introduction of calcium levomefolate in the composition of an oral contraceptive reduces the risk of developing a fetal neural tube defect if a woman becomes pregnant unexpectedly, immediately after stopping contraception (or, in very rare cases, when using oral contraception).
Indications
- contraception, intended primarily for women with symptoms of hormone-dependent fluid retention
- contraception and treatment of moderate forms of acne (acne vulgaris)
- contraception in women with folate deficiency
- contraception and treatment of severe premenstrual syndrome.
Contraindications
JessВ® Plus is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time during administration, the drug should be discontinued immediately.
- thrombosis (venous and arterial) and thromboembolism currently or in an anamnesis (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders
- conditions preceding thrombosis (i.e. transient ischemic attacks, angina pectoris) currently or in the history of
- a detected acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant)
- the presence of a high risk of venous or arterial thrombosis
- a migraine with focal neurological symptoms at present or in the history of
- pancreatitis with severe hypertriglyceridemia at present or in the history of diabetes mellitus - severe liver diseases (before normalization of liver tests)
- currently or in the history of
liver tumors (benign or malignant) - severe and / or acute renal
deficiency - identified hormone-dependent malignant neoplasms (including genital organs or mammary glands) or suspected
- vaginal bleeding of unknown origin
- pregnancy or suspected
- breastfeeding period
- rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the content)
- Hypersensitivity or intolerance to any of the components of JessВ® Plus.
Caution
The potential risk and expected benefit of using JessВ® Plus should be evaluated in each individual case with the following diseases / conditions and risk factors:
- risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, a hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin)
- other diseases in which peripheral circulation disorders may occur: diabetes mellitus without vascular complications, systemic red lupus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins
- hereditary angioneurotic
edema - hypertriglyceridemia
- liver disease, non-
Contraindications - diseases caused or aggravated first time during pregnancy, or on the background of the previous use of sex hormones (eg, jaundice and / or pruritus related to cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes pregnant, Sydenham chorea)
- the postpartum period (not earlier than 21-28 days after birth, in the absence of breastfeeding).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy. If pregnancy is detected during the use of Jess® Plus, the drug should be discontinued immediately. Data on the results of using Jess® Plus during pregnancy are limited, and do not allow any conclusions to be drawn about the negative effects of the drug on pregnancy, the health of the fetus and the newborn. At the same time, extensive epidemiological studies did not reveal an increased risk of developmental defects in children born to women who took combined oral contraceptives before pregnancy, or teratogenic effects in cases of taking combined oral contraceptives through negligence in the early stages of pregnancy. No specific epidemiological studies have been conducted with Jess® Plus.
The drug is contraindicated during lactation. Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so the use of Jess® Plus is contraindicated until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the health of the baby.
Composition
1 tab. - ethinyl estradiol (micronized, in the form of betadex clathrate) 20 ?g
drospirenone (micronized) - 3 mg
calcium levomefolate (micronized) - 451 ?g.
Excipients:
lactose monohydrate - 45.329 mg,
microcrystalline cellulose - 24.8 mg, croscarmellose sodium
- 3.2 mg, hyprolose
(5 cP) - 1.6 mg, magnesium
stearate - 1.6 mg.
Shell composition:
pink varnish - 2 mg or (alternatively):
hypromellose (5 cP) - 1.0112 mg,
macrogol 6000 - 202.4 ?g,
talcum powder - 202.4 ?g,
titanium dioxide - 558 ?g,
red dye iron - 26 mcg.
Dosing and Administration
Tablets should be taken orally in the order indicated on the package, every day at the same time, without chewing, with a little water. Take 1 tablet / day continuously for 28 days. Reception of tablets from the following packaging begins immediately after completion of the previous one.
Withdrawal bleeding usually begins 2–3 days after the start of taking inactive tablets and may not end before taking the tablets from the next pack.
Instructions for handling the packaging of Jess® Plus
A blister containing 24 active (pink) tablets and 4 auxiliary (light orange) tablets (bottom row) is glued into the folding packaging of Jess® Plus. The package also contains a sticker block, consisting of 7 self-adhesive strips with the names of the days of the week marked on them, necessary for the design of the reception calendar.
You must select the strip where the day of the week on which the pill begins is indicated first. For example, if you start taking the pills on Wednesday, you should use a strip that starts with Wed. . A strip is glued along the upper part of the package so that the first day designation is above the tablet to which the arrow with the inscription Start is directed. Thus, it becomes clear on which day of the week each tablet should be taken.
Starting to take
If you are not taking any hormonal contraceptives in the previous month,
Taking Jess® Plus begins on the 1st day of your menstrual cycle (i.e., on the 1st day of your menstrual bleeding). On this day, you must take one pink (active) tablet, which is marked with the corresponding day of the week. Then you should take the pills in order. Jess® Plus begins to act immediately, so there is no need to use additional barrier methods of contraception.
It is allowed to start taking the drug on the 2nd-5th day of the menstrual cycle, but in this case it is necessary to additionally use the barrier method of contraception (for example, a condom) during the first 7 days of taking pink (active) tablets from the first package.
When switching from other combined oral contraceptives, a vaginal ring or contraceptive patch
It is preferable to start taking Jess® Plus the day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package). Jess® Plus should be started on the day the vaginal ring or patch is removed, but no later than the day the new ring is inserted or a new patch is pasted.
When switching from contraceptives containing only gestagens (mini-pill, injection, implant), or from an intrauterine therapeutic system with the release of gestagen
You can switch from mini-pill to Jess® Plus any day (without interruption), from the implant or an IUD with gestagen - on the day of their removal, from an injection contraceptive - on the day when the next injection is to be made. In all cases, during the first 7 days of taking Jess® Plus, you must additionally use a barrier method of contraception (for example, a condom).
After an abortion (including spontaneous) in the first trimester of pregnancy
You can start taking the drug immediately. Subject to this condition, additional contraceptive measures are not required.
After childbirth (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy
It is recommended to start taking the drug on the 21-28th day after childbirth or abortion (including spontaneous) in the II trimester pregnancy. If you start taking the drug later, you must use the additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual contact has occurred, pregnancy should be excluded before taking Jess® Plus.
Acceptance of Missed Pills
Skipping ancillary light orange pills can be ignored. However, missed tablets should be discarded so as not to accidentally extend the period of taking the auxiliary tablets. The following recommendations apply only to skipping active pink tablets (1-24 tablets per pack).
If the delay in taking any pink (active) pill was less than 24 hours, contraceptive protection does not decrease. A woman should take the missed pill as soon as possible, and take the next at the usual time.
If the delay in taking any pink (active) pill is more than 24 hours, contraceptive protection may be reduced. The more tablets missed and the closer the tablet passes to the phase of taking light orange (auxiliary) tablets, the higher the chance of pregnancy.
In this case, it must be remembered:
- the drug should never be interrupted for more than 7 days (you should pay attention to the fact that the recommended interval for taking light orange (auxiliary) tablets is 4 days)
- to achieve adequate suppression of the hypothalamic the pituitary-ovarian system requires 7 days of continuous intake of active (pink) tablets.
Accordingly, if the delay in taking active (pink) tablets was more than 24 hours, you can recommend the following:
From the 1st to the 7th day
A woman should take the last missed tablet as soon as she remembers this, even if it means taking two tablets at the same time. The following tablets should be taken at the usual time. In addition, over the next 7 days, it is necessary to additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping a pill, you should consider the possibility of pregnancy.
From the 8th to the 14th day
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets at the usual time.
Subject to compliance with the regimen of tablets within 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception (for example, a condom) for the next 7 days.
From the 15th to the 24th day
The risk of a decrease in contraceptive reliability is inevitable due to the approaching phase of taking light orange (auxiliary) tablets. In this case, it is necessary to adhere to the following algorithms:
- if during the 7 days preceding the first missed pill, all tablets were taken correctly, there is no need to use additional contraceptive methods. When taking missed tablets, you should be guided by points 1 or 2
- if, during the 7 days preceding the first missed tablet, the tablets were taken incorrectly, then, over the next 7 days, it is necessary to additionally use the barrier method of contraception (for example, a condom) and in this case, paragraph 1 should be followed for taking the missed tablets.
1. Take the missed pill as soon as possible, as soon as the woman remembers this (even if it means taking two tablets at the same time). The following tablets are taken at the usual time until the pink (active) tablets in the package run out. Four light-orange (auxiliary) tablets should be discarded and you should immediately start taking the pink (active) tablets from the new package. Until the pink (active) tablets from the second package run out, withdrawal bleeding is unlikely, however, spotting and / or breakthrough bleeding may occur.
2. Stop taking pink (active) tablets from the current package, then take a break for 4 or less days (including days of skipping tablets), and then start taking the drug from a new package.
If a woman has missed taking pink (active) tablets, and while taking light orange (auxiliary) tablets, the withdrawal bleeding has not occurred, it is necessary to make sure that there is no pregnancy.
It is allowed to take no more than two tablets in one day.
Recommendations for gastrointestinal disorders
In severe gastrointestinal disorders, absorption of the drug may be incomplete, therefore, additional contraceptive measures should be taken.
If vomiting or diarrhea occurs within 3-4 hours after taking the pink (active) tablet, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, an additional pink (active) tablet should be taken from another package.
Stopping Jess® Plus
You can stop taking Jess® Plus anytime. If a woman does not plan a pregnancy, you should take care of other methods of contraception. If you are planning a pregnancy, you should simply stop taking Jess® Plus, wait for the natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the gestational age and time of birth.
Delaying the onset of menstrual bleeding
To delay the onset of withdrawal bleeding, skip taking 4 light orange (auxiliary) tablets from the current package and start taking pink (active) tablets from the next package of Jess® Plus. If you have taken all 24 pink tablets from the second package, then 4 light orange tablets should also be taken. Only then can you start taking pills from a new package. Thus, the cycle can be extended, if desired, for any period, up to 3 weeks, including until all pink tablets from the second package are taken. If a woman wants the menstrual bleeding to begin earlier, you should stop taking pink tablets from the second package, throw it away and take a break in taking all the tablets for no more than 4 days, and then start taking pills from a new package. In this case, menstrual bleeding will begin approximately 2-3 days after taking the last pink pill from the second package. While taking Jess® Plus from the second package, spotting and / or breakthrough bleeding may occur on the days of taking the tablets.
Change in the day onset of menstrual bleeding
If tablets are taken as recommended, menstrual bleeding will occur on approximately the same day every 4 weeks. If a woman wants to change the day the menstrual bleeding begins, stop taking light orange tablets for as many days as the woman wants to change the start of menstrual bleeding. For example, if a cycle usually starts on Friday, and in the future, a woman wants him to start on Tuesday (3 days earlier), taking the tablets from the next package should start 3 days earlier than usual, that is, do not use the last 3 light orange tablets from the current package and start taking tablets from next packing. The fewer light-orange tablets a woman takes, the higher the likelihood that menstrual bleeding will not occur. When taking Jess® Plus from the next pack, spotting and / or breakthrough bleeding may occur.
The efficacy and safety of Jess® Plus as a contraceptive have been studied in women of reproductive age. The use of the drug in children and adolescents is contraindicated until regular menstrual cycles are established.
Jess® Plus is not used after menopause.
The drug is contraindicated in women with severely impaired liver function.
The drug is contraindicated in women with severe impaired renal function and in acute renal failure.
Side effects
The most common adverse reactions reported in connection with the use of the drug are the following: nausea, pain in the mammary glands, irregular uterine bleeding, genital bleeding of unspecified origin (more than 3% of women using the drug as indicated Contraception and Contraception and treatment of moderate forms of acne (acne vulgaris)) nausea, pain in the mammary glands, irregular uterine bleeding (more than 10% of women using the drug as indicated by contraception and treated e severe form of premenstrual syndrome (PMS)).
Serious adverse reactions are arterial and venous thromboembolism.
The following is the frequency of adverse reactions reported during clinical trials of Jess® and Jess® Plus for contraception, as well as for contraception and moderate acne (acne vulgaris) (n = 3565) and severe contraception and treatment premenstrual syndrome (PMS) (n = 289) for Jess®. Within each group identified depending on the frequency of occurrence, adverse reactions are presented in order of decreasing severity. By frequency they are divided as follows: often (? 1/100 and
Infectious and parasitic diseases: rarely - candidiasis.
From the side of metabolism and nutrition: infrequently - weight gain rarely - weight loss, increased appetite, anorexia, hyperkalemia, hyponatremia.
From the psyche: often - mood swings infrequently - decrease or loss of libido2, drowsiness, depression / depressed mood rarely - anorgasmia, insomnia.
From the nervous system: often - headache infrequently - dizziness, paresthesia.
From the cardiovascular system: infrequently - increased blood pressure, migraine rarely - tachycardia, venous and arterial thromboembolism *, fainting, nosebleeds.
From the side of the organ of vision: rarely - conjunctivitis, dry mucous membranes of the eyes, visual impairment.
From the gastrointestinal tract: often - nausea1 infrequently - abdominal pain, vomiting, gastritis, diarrhea, dyspepsia, flatulence rarely - bloating, constipation, dry mouth.
From the liver and biliary tract: rarely - pain in the right hypochondrium.
On the part of the immune system: rarely - allergic reactions frequency unknown - hypersensitivity.
From the skin and subcutaneous tissues: infrequently - acne, itching, rash rarely - alopecia, hypertrichosis, eczema, dry skin, contact dermatitis, acneform dermatosis, frequency is unknown - erythema multiforme.
From the musculoskeletal system: infrequently - back pain, pain in the limbs, muscle cramps.
From the genitals and mammary gland: often - pain in the mammary glands1, soreness of the mammary glands, acyclic spotting / bleeding from the vagina1, bleeding from the genital tract of unspecified origin, lack of menstrual bleeding infrequently - pain in the pelvic area, hot flashes, fibro cystic mastopathy, candidal vulvovaginitis, vaginal discharge, heavy menstrual bleeding, scanty menstrual-like spotting, rare menstrual-like bleeding, painful menstrual-like bleeding, dry vaginal mucosa, pathological Pap test results rarely — breast hyperplasia, cervical polyp, ovarian cyst, endometrial atrophy.
From the hemopoietic system: rarely - anemia, thrombocythemia.
Other: infrequently - asthenia, increased sweating, generalized or peripheral edema rarely - malaise.
Adverse events were classified using the MedDRA Dictionary. Different MedDRA terms reflecting the same symptom have been grouped together and presented as the only adverse reaction to avoid weakening or blurring the true effect.
* Estimated frequency based on epidemiological studies, covering a group of combined oral contraceptives. The frequency was very rare.
- Venous or arterial thromboembolism includes the following nosological units: peripheral deep vein occlusion, thrombosis and embolism / pulmonary vascular occlusion, thrombosis, embolism and heart attack / myocardial infarction / cerebral infarction and hemorrhagic stroke.
1 Frequency of cases in studies evaluating ICP was very frequent> 10/100
2 Frequency of cases in studies evaluating ICP was frequent? 1/100
Additional information
Adverse reactions with a very rare occurrence rate or with delayed symptoms, which are believed to be associated with taking drugs from the combined oral contraceptive group.
Tumors
- in women, using combined oral contraceptives, the incidence of breast cancer is very slightly increased. Because breast cancer is rare in women under the age of 40, an increase in the incidence of cancer in women using combined oral contraceptives is not significant in relation to the overall risk of breast cancer. A causal relationship with the use of combined oral contraceptives is unknown
- liver tumors (benign and malignant).
Other conditions
- erythema nodosum
- hypertriglyceridemia (increased risk of pancreatitis during the use of combined oral contraceptives)
- increased blood pressure
- conditions that develop or worsen during the use of combined oral contraceptives, but their relationship has not been proven (jaundice and / or itching associated with cholestasis gallbladder stones epilepsy porphyria systemic lupus erythematosus hemolytic uremic chorea Sydenham herpes during pregnancy hearing loss associated with otosclerosis)
- in women with hereditary angioedema taking estrogens can cause or aggravate its symptoms
- impaired liver function
- changes in glucose tolerance or an effect on insulin resistance
- Crohn's disease, ulcerative colitis
- chloasma
- hypersensitivity (including symptoms such as rash, urticaria).
Interactions
Interactions of oral contraceptives with other drugs (enzyme inducers) can lead to breakthrough bleeding and / or decreased contraceptive effectiveness.
Drug interactions
Influence of other drugs on Jess® Plus
It is possible to interact with drugs that induce microsomal liver enzymes, resulting in increased clearance of sex hormones, which, in turn, can lead to breakthrough uterine bleeding and / or decrease in contraceptive effect.
Women who receive treatment with these drugs in addition to Jess® Plus are advised to use the barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their cancellation. If the period of application of the barrier method of contraception ends later than the pink (active) tablets in the package of Jess® Plus, you should skip taking the orange-colored (auxiliary) tablets and start taking the tablets from the new package of Jess® Plus.
Products that increase the clearance of Jess® Plus (weakening effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, possibly, oxcarbazepine, topiramate, felbamate, griseofulvin, as well as preparations containing St. John's wort.
Means with various effects on the clearance of Jess® Plus: when used together with Jess® Plus, many HIV protease inhibitors or hepatitis C virus and non-nucleoside reverse transcriptase inhibitors can both increase and decrease the concentration of estrogen or progestin in the blood plasma. In some cases, this effect can be clinically expressed.
Drugs that reduce the effectiveness of calcium levomefolate: some drugs reduce the concentration of folate in blood plasma and reduce the effectiveness of folates by inhibiting the enzyme dihydrofolate reductase (e.g. methotrexate, trimethoprim, sulfasalazine and triamteren) or by decreasing the absorption of folates (e.g., colestyramine) unknown mechanisms (e.g. antiepileptic drugs - carbamazepine, phenytoin, phenobarbital, primidone, and valproic acid).
Tools, lowering the clearance of combined oral contraceptives (enzyme inhibitors): strong and moderate CYP3A4 inhibitors, such as antifungal drugs of the azole group (for example, itraconazole, voriconazole, fluconazole), verapamil, macrolide antibiotics (for example, clarithromycin, erythromycin and erythromycin) increase plasma concentrations of estrogen or progestin, or both.
It was shown that etoricoxib at doses of 60 and 120 mg / day when taken together with combined oral contraceptives containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively.
Effect of combined oral contraceptives or levomefolate calcium on other drugs
Combined oral contraceptives can affect the metabolism of other drugs, leading to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.
In vitro drospirenone is able to slightly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
Based on in vivo interaction studies in female volunteers taking omeprazole, simvastatin, or midazolam as marker substrates, it can be concluded that the clinically significant effect of 3 mg of drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely.
In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical trials, the administration of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only led to a slight increase in plasma concentrations of CYP3A4 substrates (e.g., midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (e.g., theophylline ) or moderately (e.g., melatonin and tizanidine).
Folates can alter the pharmacokinetics or pharmacodynamics of certain drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (mostly reversible, subject to an increase in the dose of the drug influencing the metabolism of folates) of their therapeutic effect. The appointment of folates during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.
Other forms of interaction
In patients with undisturbed renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Jess®Plus with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be controlled during the first cycle of administration.
Overdose
There have been no reports of overdoses with the drug Jess® Plus.
Symptoms, which may be noted with overdose: nausea, vomiting, spotting vaginal discharge or metrorrhagia (more commonly in young women).
Treatment: no specific antidote, symptomatic treatment should be performed. Calcium levomefolate and its metabolites are identical to folates that are part of natural products, the daily intake of which does not harm the body. The intake of levomefolate calcium at a dose of 17 mg / day (dose 37 times higher than contained in 1 tablet of the drug Jess® Plus) within 12 weeks was well tolerated.
Storage Conditions
The product should be stored out of reach of children at a temperature not exceeding 25 РC.
Shelf life
3 years.
active substance
drospi enone, Эtinilэstradiol, Kalytsiya Levomefolinat
Terms and conditions
prescription
Dosage PMA
Prescribing
Prescribing
For women of childbearing age, for prescribing sdl45p prescribing sdl45 For women of childbearing age, For women
YAZ PLUS
Release form
Film-coated tablets (active combination) pink, round, biconvex, on one side with Z + embossing in the right hexagon
Pharmacological action
Jess® Plus is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug, which includes active tablets and auxiliary tablets containing calcium levomefolate.
The contraceptive effect of Jess® Plus is mainly achieved by suppressing ovulation and increasing the viscosity of the cervical secretion.
In women taking combined oral contraceptives, the cycle becomes more regular, pain is reduced, the intensity and duration of menstrual bleeding, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduction in the risk of endometrial and ovarian cancer.
Drospirenone, which is part of Jess® Plus, has antimineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps to reduce acne (acne), oily skin and hair (seborrhea). These features of drospirenone should be considered when choosing a contraceptive for women with hormone-dependent fluid retention, as well as for women with acne and seborrhea. In its characteristics, drospirenone is similar to the natural progesterone produced by the female body. With proper use, the Pearl index (an indicator that reflects the number of pregnancies in 100 women who use contraceptives during the year) is less than 1. If the pill is missed or if it is used incorrectly, the Pearl index can increase.
The acidic form of calcium of levomefolate is identical in structure to the natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration of L-5-methyltetrahydrofolate in the blood plasma of people who do not use folic acid-rich foods is about 15 nmol / L.
Levomefolate, unlike folic acid, is a biologically active form of folate. Due to this, it is absorbed better than folic acid. Levomefolate is indicated for women during pregnancy and during breastfeeding to meet the increased need for folates. The introduction of calcium levomefolate in the composition of an oral contraceptive reduces the risk of developing a fetal neural tube defect if a woman becomes pregnant unexpectedly, immediately after stopping contraception (or, in very rare cases, when using oral contraception).
Indications
- contraception, intended primarily for women with symptoms of hormone-dependent fluid retention
- contraception and treatment of moderate forms of acne (acne vulgaris)
- contraception in women with folate deficiency
- contraception and treatment of severe premenstrual syndrome.
Contraindications
JessВ® Plus is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time during administration, the drug should be discontinued immediately.
- thrombosis (venous and arterial) and thromboembolism currently or in an anamnesis (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders
- conditions preceding thrombosis (i.e. transient ischemic attacks, angina pectoris) currently or in the history of
- a detected acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant)
- the presence of a high risk of venous or arterial thrombosis
- a migraine with focal neurological symptoms at present or in the history of
- pancreatitis with severe hypertriglyceridemia at present or in the history of diabetes mellitus - severe liver diseases (before normalization of liver tests)
- currently or in the history of
liver tumors (benign or malignant) - severe and / or acute renal
deficiency - identified hormone-dependent malignant neoplasms (including genital organs or mammary glands) or suspected
- vaginal bleeding of unknown origin
- pregnancy or suspected
- breastfeeding period
- rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the content)
- Hypersensitivity or intolerance to any of the components of JessВ® Plus.
Caution
The potential risk and expected benefit of using JessВ® Plus should be evaluated in each individual case with the following diseases / conditions and risk factors:
- risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, a hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin)
- other diseases in which peripheral circulation disorders may occur: diabetes mellitus without vascular complications, systemic red lupus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins
- hereditary angioneurotic
edema - hypertriglyceridemia
- liver disease, non-
Contraindications - diseases caused or aggravated first time during pregnancy, or on the background of the previous use of sex hormones (eg, jaundice and / or pruritus related to cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes pregnant, Sydenham chorea)
- the postpartum period (not earlier than 21-28 days after birth, in the absence of breastfeeding).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy. If pregnancy is detected during the use of Jess® Plus, the drug should be discontinued immediately. Data on the results of using Jess® Plus during pregnancy are limited, and do not allow any conclusions to be drawn about the negative effects of the drug on pregnancy, the health of the fetus and the newborn. At the same time, extensive epidemiological studies did not reveal an increased risk of developmental defects in children born to women who took combined oral contraceptives before pregnancy, or teratogenic effects in cases of taking combined oral contraceptives through negligence in the early stages of pregnancy. No specific epidemiological studies have been conducted with Jess® Plus.
The drug is contraindicated during lactation. Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so the use of Jess® Plus is contraindicated until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the health of the baby.
Composition
1 tab. - ethinyl estradiol (micronized, in the form of betadex clathrate) 20 ?g
drospirenone (micronized) - 3 mg
calcium levomefolate (micronized) - 451 ?g.
Excipients:
lactose monohydrate - 45.329 mg,
microcrystalline cellulose - 24.8 mg, croscarmellose sodium
- 3.2 mg, hyprolose
(5 cP) - 1.6 mg, magnesium
stearate - 1.6 mg.
Shell composition:
pink varnish - 2 mg or (alternatively):
hypromellose (5 cP) - 1.0112 mg,
macrogol 6000 - 202.4 ?g,
talcum powder - 202.4 ?g,
titanium dioxide - 558 ?g,
red dye iron - 26 mcg.
Dosing and Administration
Tablets should be taken orally in the order indicated on the package, every day at the same time, without chewing, with a little water. Take 1 tablet / day continuously for 28 days. Reception of tablets from the following packaging begins immediately after completion of the previous one.
Withdrawal bleeding usually begins 2–3 days after the start of taking inactive tablets and may not end before taking the tablets from the next pack.
Instructions for handling the packaging of Jess® Plus
A blister containing 24 active (pink) tablets and 4 auxiliary (light orange) tablets (bottom row) is glued into the folding packaging of Jess® Plus. The package also contains a sticker block, consisting of 7 self-adhesive strips with the names of the days of the week marked on them, necessary for the design of the reception calendar.
You must select the strip where the day of the week on which the pill begins is indicated first. For example, if you start taking the pills on Wednesday, you should use a strip that starts with Wed. . A strip is glued along the upper part of the package so that the first day designation is above the tablet to which the arrow with the inscription Start is directed. Thus, it becomes clear on which day of the week each tablet should be taken.
Starting to take
If you are not taking any hormonal contraceptives in the previous month,
Taking Jess® Plus begins on the 1st day of your menstrual cycle (i.e., on the 1st day of your menstrual bleeding). On this day, you must take one pink (active) tablet, which is marked with the corresponding day of the week. Then you should take the pills in order. Jess® Plus begins to act immediately, so there is no need to use additional barrier methods of contraception.
It is allowed to start taking the drug on the 2nd-5th day of the menstrual cycle, but in this case it is necessary to additionally use the barrier method of contraception (for example, a condom) during the first 7 days of taking pink (active) tablets from the first package.
When switching from other combined oral contraceptives, a vaginal ring or contraceptive patch
It is preferable to start taking Jess® Plus the day after taking the last active pill from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package). Jess® Plus should be started on the day the vaginal ring or patch is removed, but no later than the day the new ring is inserted or a new patch is pasted.
When switching from contraceptives containing only gestagens (mini-pill, injection, implant), or from an intrauterine therapeutic system with the release of gestagen
You can switch from mini-pill to Jess® Plus any day (without interruption), from the implant or an IUD with gestagen - on the day of their removal, from an injection contraceptive - on the day when the next injection is to be made. In all cases, during the first 7 days of taking Jess® Plus, you must additionally use a barrier method of contraception (for example, a condom).
After an abortion (including spontaneous) in the first trimester of pregnancy
You can start taking the drug immediately. Subject to this condition, additional contraceptive measures are not required.
After childbirth (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy
It is recommended to start taking the drug on the 21-28th day after childbirth or abortion (including spontaneous) in the II trimester pregnancy. If you start taking the drug later, you must use the additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual contact has occurred, pregnancy should be excluded before taking Jess® Plus.
Acceptance of Missed Pills
Skipping ancillary light orange pills can be ignored. However, missed tablets should be discarded so as not to accidentally extend the period of taking the auxiliary tablets. The following recommendations apply only to skipping active pink tablets (1-24 tablets per pack).
If the delay in taking any pink (active) pill was less than 24 hours, contraceptive protection does not decrease. A woman should take the missed pill as soon as possible, and take the next at the usual time.
If the delay in taking any pink (active) pill is more than 24 hours, contraceptive protection may be reduced. The more tablets missed and the closer the tablet passes to the phase of taking light orange (auxiliary) tablets, the higher the chance of pregnancy.
In this case, it must be remembered:
- the drug should never be interrupted for more than 7 days (you should pay attention to the fact that the recommended interval for taking light orange (auxiliary) tablets is 4 days)
- to achieve adequate suppression of the hypothalamic the pituitary-ovarian system requires 7 days of continuous intake of active (pink) tablets.
Accordingly, if the delay in taking active (pink) tablets was more than 24 hours, you can recommend the following:
From the 1st to the 7th day
A woman should take the last missed tablet as soon as she remembers this, even if it means taking two tablets at the same time. The following tablets should be taken at the usual time. In addition, over the next 7 days, it is necessary to additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping a pill, you should consider the possibility of pregnancy.
From the 8th to the 14th day
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets at the usual time.
Subject to compliance with the regimen of tablets within 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception (for example, a condom) for the next 7 days.
From the 15th to the 24th day
The risk of a decrease in contraceptive reliability is inevitable due to the approaching phase of taking light orange (auxiliary) tablets. In this case, it is necessary to adhere to the following algorithms:
- if during the 7 days preceding the first missed pill, all tablets were taken correctly, there is no need to use additional contraceptive methods. When taking missed tablets, you should be guided by points 1 or 2
- if, during the 7 days preceding the first missed tablet, the tablets were taken incorrectly, then, over the next 7 days, it is necessary to additionally use the barrier method of contraception (for example, a condom) and in this case, paragraph 1 should be followed for taking the missed tablets.
1. Take the missed pill as soon as possible, as soon as the woman remembers this (even if it means taking two tablets at the same time). The following tablets are taken at the usual time until the pink (active) tablets in the package run out. Four light-orange (auxiliary) tablets should be discarded and you should immediately start taking the pink (active) tablets from the new package. Until the pink (active) tablets from the second package run out, withdrawal bleeding is unlikely, however, spotting and / or breakthrough bleeding may occur.
2. Stop taking pink (active) tablets from the current package, then take a break for 4 or less days (including days of skipping tablets), and then start taking the drug from a new package.
If a woman has missed taking pink (active) tablets, and while taking light orange (auxiliary) tablets, the withdrawal bleeding has not occurred, it is necessary to make sure that there is no pregnancy.
It is allowed to take no more than two tablets in one day.
Recommendations for gastrointestinal disorders
In severe gastrointestinal disorders, absorption of the drug may be incomplete, therefore, additional contraceptive measures should be taken.
If vomiting or diarrhea occurs within 3-4 hours after taking the pink (active) tablet, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, an additional pink (active) tablet should be taken from another package.
Stopping Jess® Plus
You can stop taking Jess® Plus anytime. If a woman does not plan a pregnancy, you should take care of other methods of contraception. If you are planning a pregnancy, you should simply stop taking Jess® Plus, wait for the natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the gestational age and time of birth.
Delaying the onset of menstrual bleeding
To delay the onset of withdrawal bleeding, skip taking 4 light orange (auxiliary) tablets from the current package and start taking pink (active) tablets from the next package of Jess® Plus. If you have taken all 24 pink tablets from the second package, then 4 light orange tablets should also be taken. Only then can you start taking pills from a new package. Thus, the cycle can be extended, if desired, for any period, up to 3 weeks, including until all pink tablets from the second package are taken. If a woman wants the menstrual bleeding to begin earlier, you should stop taking pink tablets from the second package, throw it away and take a break in taking all the tablets for no more than 4 days, and then start taking pills from a new package. In this case, menstrual bleeding will begin approximately 2-3 days after taking the last pink pill from the second package. While taking Jess® Plus from the second package, spotting and / or breakthrough bleeding may occur on the days of taking the tablets.
Change in the day onset of menstrual bleeding
If tablets are taken as recommended, menstrual bleeding will occur on approximately the same day every 4 weeks. If a woman wants to change the day the menstrual bleeding begins, stop taking light orange tablets for as many days as the woman wants to change the start of menstrual bleeding. For example, if a cycle usually starts on Friday, and in the future, a woman wants him to start on Tuesday (3 days earlier), taking the tablets from the next package should start 3 days earlier than usual, that is, do not use the last 3 light orange tablets from the current package and start taking tablets from next packing. The fewer light-orange tablets a woman takes, the higher the likelihood that menstrual bleeding will not occur. When taking Jess® Plus from the next pack, spotting and / or breakthrough bleeding may occur.
The efficacy and safety of Jess® Plus as a contraceptive have been studied in women of reproductive age. The use of the drug in children and adolescents is contraindicated until regular menstrual cycles are established.
Jess® Plus is not used after menopause.
The drug is contraindicated in women with severely impaired liver function.
The drug is contraindicated in women with severe impaired renal function and in acute renal failure.
Side effects
The most common adverse reactions reported in connection with the use of the drug are the following: nausea, pain in the mammary glands, irregular uterine bleeding, genital bleeding of unspecified origin (more than 3% of women using the drug as indicated Contraception and Contraception and treatment of moderate forms of acne (acne vulgaris)) nausea, pain in the mammary glands, irregular uterine bleeding (more than 10% of women using the drug as indicated by contraception and treated e severe form of premenstrual syndrome (PMS)).
Serious adverse reactions are arterial and venous thromboembolism.
The following is the frequency of adverse reactions reported during clinical trials of Jess® and Jess® Plus for contraception, as well as for contraception and moderate acne (acne vulgaris) (n = 3565) and severe contraception and treatment premenstrual syndrome (PMS) (n = 289) for Jess®. Within each group identified depending on the frequency of occurrence, adverse reactions are presented in order of decreasing severity. By frequency they are divided as follows: often (? 1/100 and
Infectious and parasitic diseases: rarely - candidiasis.
From the side of metabolism and nutrition: infrequently - weight gain rarely - weight loss, increased appetite, anorexia, hyperkalemia, hyponatremia.
From the psyche: often - mood swings infrequently - decrease or loss of libido2, drowsiness, depression / depressed mood rarely - anorgasmia, insomnia.
From the nervous system: often - headache infrequently - dizziness, paresthesia.
From the cardiovascular system: infrequently - increased blood pressure, migraine rarely - tachycardia, venous and arterial thromboembolism *, fainting, nosebleeds.
From the side of the organ of vision: rarely - conjunctivitis, dry mucous membranes of the eyes, visual impairment.
From the gastrointestinal tract: often - nausea1 infrequently - abdominal pain, vomiting, gastritis, diarrhea, dyspepsia, flatulence rarely - bloating, constipation, dry mouth.
From the liver and biliary tract: rarely - pain in the right hypochondrium.
On the part of the immune system: rarely - allergic reactions frequency unknown - hypersensitivity.
From the skin and subcutaneous tissues: infrequently - acne, itching, rash rarely - alopecia, hypertrichosis, eczema, dry skin, contact dermatitis, acneform dermatosis, frequency is unknown - erythema multiforme.
From the musculoskeletal system: infrequently - back pain, pain in the limbs, muscle cramps.
From the genitals and mammary gland: often - pain in the mammary glands1, soreness of the mammary glands, acyclic spotting / bleeding from the vagina1, bleeding from the genital tract of unspecified origin, lack of menstrual bleeding infrequently - pain in the pelvic area, hot flashes, fibro cystic mastopathy, candidal vulvovaginitis, vaginal discharge, heavy menstrual bleeding, scanty menstrual-like spotting, rare menstrual-like bleeding, painful menstrual-like bleeding, dry vaginal mucosa, pathological Pap test results rarely — breast hyperplasia, cervical polyp, ovarian cyst, endometrial atrophy.
From the hemopoietic system: rarely - anemia, thrombocythemia.
Other: infrequently - asthenia, increased sweating, generalized or peripheral edema rarely - malaise.
Adverse events were classified using the MedDRA Dictionary. Different MedDRA terms reflecting the same symptom have been grouped together and presented as the only adverse reaction to avoid weakening or blurring the true effect.
* Estimated frequency based on epidemiological studies, covering a group of combined oral contraceptives. The frequency was very rare.
- Venous or arterial thromboembolism includes the following nosological units: peripheral deep vein occlusion, thrombosis and embolism / pulmonary vascular occlusion, thrombosis, embolism and heart attack / myocardial infarction / cerebral infarction and hemorrhagic stroke.
1 Frequency of cases in studies evaluating ICP was very frequent> 10/100
2 Frequency of cases in studies evaluating ICP was frequent? 1/100
Additional information
Adverse reactions with a very rare occurrence rate or with delayed symptoms, which are believed to be associated with taking drugs from the combined oral contraceptive group.
Tumors
- in women, using combined oral contraceptives, the incidence of breast cancer is very slightly increased. Because breast cancer is rare in women under the age of 40, an increase in the incidence of cancer in women using combined oral contraceptives is not significant in relation to the overall risk of breast cancer. A causal relationship with the use of combined oral contraceptives is unknown
- liver tumors (benign and malignant).
Other conditions
- erythema nodosum
- hypertriglyceridemia (increased risk of pancreatitis during the use of combined oral contraceptives)
- increased blood pressure
- conditions that develop or worsen during the use of combined oral contraceptives, but their relationship has not been proven (jaundice and / or itching associated with cholestasis gallbladder stones epilepsy porphyria systemic lupus erythematosus hemolytic uremic chorea Sydenham herpes during pregnancy hearing loss associated with otosclerosis)
- in women with hereditary angioedema taking estrogens can cause or aggravate its symptoms
- impaired liver function
- changes in glucose tolerance or an effect on insulin resistance
- Crohn's disease, ulcerative colitis
- chloasma
- hypersensitivity (including symptoms such as rash, urticaria).
Interactions
Interactions of oral contraceptives with other drugs (enzyme inducers) can lead to breakthrough bleeding and / or decreased contraceptive effectiveness.
Drug interactions
Influence of other drugs on Jess® Plus
It is possible to interact with drugs that induce microsomal liver enzymes, resulting in increased clearance of sex hormones, which, in turn, can lead to breakthrough uterine bleeding and / or decrease in contraceptive effect.
Women who receive treatment with these drugs in addition to Jess® Plus are advised to use the barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their cancellation. If the period of application of the barrier method of contraception ends later than the pink (active) tablets in the package of Jess® Plus, you should skip taking the orange-colored (auxiliary) tablets and start taking the tablets from the new package of Jess® Plus.
Products that increase the clearance of Jess® Plus (weakening effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, possibly, oxcarbazepine, topiramate, felbamate, griseofulvin, as well as preparations containing St. John's wort.
Means with various effects on the clearance of Jess® Plus: when used together with Jess® Plus, many HIV protease inhibitors or hepatitis C virus and non-nucleoside reverse transcriptase inhibitors can both increase and decrease the concentration of estrogen or progestin in the blood plasma. In some cases, this effect can be clinically expressed.
Drugs that reduce the effectiveness of calcium levomefolate: some drugs reduce the concentration of folate in blood plasma and reduce the effectiveness of folates by inhibiting the enzyme dihydrofolate reductase (e.g. methotrexate, trimethoprim, sulfasalazine and triamteren) or by decreasing the absorption of folates (e.g., colestyramine) unknown mechanisms (e.g. antiepileptic drugs - carbamazepine, phenytoin, phenobarbital, primidone, and valproic acid).
Tools, lowering the clearance of combined oral contraceptives (enzyme inhibitors): strong and moderate CYP3A4 inhibitors, such as antifungal drugs of the azole group (for example, itraconazole, voriconazole, fluconazole), verapamil, macrolide antibiotics (for example, clarithromycin, erythromycin and erythromycin) increase plasma concentrations of estrogen or progestin, or both.
It was shown that etoricoxib at doses of 60 and 120 mg / day when taken together with combined oral contraceptives containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively.
Effect of combined oral contraceptives or levomefolate calcium on other drugs
Combined oral contraceptives can affect the metabolism of other drugs, leading to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.
In vitro drospirenone is able to slightly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
Based on in vivo interaction studies in female volunteers taking omeprazole, simvastatin, or midazolam as marker substrates, it can be concluded that the clinically significant effect of 3 mg of drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely.
In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical trials, the administration of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only led to a slight increase in plasma concentrations of CYP3A4 substrates (e.g., midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (e.g., theophylline ) or moderately (e.g., melatonin and tizanidine).
Folates can alter the pharmacokinetics or pharmacodynamics of certain drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, which may be accompanied by a decrease (mostly reversible, subject to an increase in the dose of the drug influencing the metabolism of folates) of their therapeutic effect. The appointment of folates during treatment with such drugs is recommended mainly to reduce the toxicity of the latter.
Other forms of interaction
In patients with undisturbed renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Jess®Plus with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be controlled during the first cycle of administration.
Overdose
There have been no reports of overdoses with the drug Jess® Plus.
Symptoms, which may be noted with overdose: nausea, vomiting, spotting vaginal discharge or metrorrhagia (more commonly in young women).
Treatment: no specific antidote, symptomatic treatment should be performed. Calcium levomefolate and its metabolites are identical to folates that are part of natural products, the daily intake of which does not harm the body. The intake of levomefolate calcium at a dose of 17 mg / day (dose 37 times higher than contained in 1 tablet of the drug Jess® Plus) within 12 weeks was well tolerated.
Storage Conditions
The product should be stored out of reach of children at a temperature not exceeding 25 РC.
Shelf life
3 years.
active substance
drospi enone, Эtinilэstradiol, Kalytsiya Levomefolinat
Terms and conditions
prescription
Dosage PMA
Prescribing
Prescribing
For women of childbearing age, for prescribing sdl45p prescribing sdl45 For women of childbearing age, For women
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