Guttasil oral drops 7.5mg / ml, 30ml

• Constipation or cases requiring relief of bowel movements (hemorrhoids, proctitis, cracks in the anus, preparation for surgery, instrumental and X-ray examinations).

Inside.
The drug is dosed with the manufacturer's dispenser.

The following reception mode is recommended:

Adults and children over 10 years old: 13-27 drops (corresponding to 5-10 mg of sodium picosulfate).

Children from 4 to 10 years old (only as prescribed by a doctor) : 7-13 drops (which corresponds to 2.5-5 mg of sodium picosulfate).

Use the drug in children aged 4 years and older only after consulting a doctor.

It is recommended to start with the lowest dose.

In order to achieve regular bowel movements, the dose may be increased to the maximum recommended.

To obtain a laxative effect in the morning hours, the drug Guttasil must be taken at night.

After using the drug Guttasil, bowel emptying occurs after 10-12 hours.

The drug can be used with or without liquid.

Guttasil should not be taken daily without consulting a doctor for more than 10 days.

1 ml of the drug contains:

active substance:
sodium picosulfate in terms of 100% anhydrous substance - 7.5 mg;

excipients:
sorbitol - 460 mg, sodium methyl parahydroxybenzoate - 2.0 mg, 1 M hydrochloric acid solution to pH 6.0-7.0, purified water up to 1 ml.

• Intestinal obstruction or obstructive bowel disease;

• acute inflammatory bowel diseases and acute diseases of the abdominal organs (including acute appendicitis, ulcerative colitis, peritonitis);

• severe abdominal pain, accompanied by nausea, vomiting and fever, which may indicate acute inflammatory diseases, severe dehydration;

• hypersensitivity to sodium picosulfate and other components of the drug;

• intolerance to sucrose, sucrase / isomaltase deficiency, glucose-galactose malabsorption (contains sorbitol).

• Pregnancy.

• Children under 4 years of age.

Carefully

Use with caution in elderly people, with hypokalemia, increased concentration of magnesium in the blood, patients with asthenia.
The use of the drug in patients with severe renal failure (in accordance with the section 'Special instructions') only under the supervision of a physician.

Tradename:

Guttasil

International non-proprietary name:

Sodium picosulfate.

Dosage form:

Drops for oral administration.

Composition:

1 ml of the drug contains:

active substance:
sodium picosulfate in terms of 100% anhydrous substance - 7.5 mg;

excipients:
sorbitol - 460 mg, sodium methyl parahydroxybenzoate - 2.0 mg, 1 M hydrochloric acid solution to pH 6.0-7.0, purified water up to 1 ml.

Description:

transparent colorless or light yellow liquid.

Pharmacotherapeutic group:

laxative.

Pharmacological properties

Pharmacodynamics

Contact laxative of the triarylmethane group, activated in the large intestine by bacterial sulfatases; the substance that is released in this case - stimulates the sensitive nerve endings of the intestinal mucosa, enhances its motility. The use of the drug is not accompanied by tenesmus and intestinal spasms.
During the course of treatment, Guttasil stimulates the growth and metabolic activity of normal intestinal microflora.

Pharmacokinetics

After ingestion, it reaches the large intestine without significant absorption, where, under the action of the bacterial flora, it breaks down to form the active form - bis- (p-hydroxyphenyl) -pyridyl-2-methane. The laxative effect develops 6-12 hours after ingestion, the severity of the laxative effect does not correlate with the level of active bis- (p-hydroxyphenyl) -pyridyl-2-methane in the blood plasma. Does not undergo hepatic-intestinal recirculation.

Indications for use

• Constipation or cases requiring relief of bowel movements (hemorrhoids, proctitis, cracks in the anus, preparation for surgery, instrumental and X-ray examinations).

Contraindications

• Intestinal obstruction or obstructive bowel disease;

• acute inflammatory bowel diseases and acute diseases of the abdominal organs (including acute appendicitis, ulcerative colitis, peritonitis);

• severe abdominal pain, accompanied by nausea, vomiting and fever, which may indicate acute inflammatory diseases, severe dehydration;

• hypersensitivity to sodium picosulfate and other components of the drug;

• intolerance to sucrose, sucrase / isomaltase deficiency, glucose-galactose malabsorption (contains sorbitol).

• Pregnancy.

• Children under 4 years of age.

Carefully

Use with caution in elderly people, with hypokalemia, increased concentration of magnesium in the blood, patients with asthenia.
The use of the drug in patients with severe renal failure (in accordance with the section 'Special instructions') only under the supervision of a physician.

Application during pregnancy and during breastfeeding

Due to the lack of sufficient clinical studies, the use of the drug Guttasil during pregnancy is not recommended.

Clinical data show that neither the active metabolite bis- (p-hydroxyphenyl) -pyridyl-2-methane (BGPM) nor its glucuronides pass into breast milk. Thus, the drug Guttasil can be used during breastfeeding.

Method of administration and dosage

Inside.
The drug is dosed with the manufacturer's dispenser.

The following reception mode is recommended:

Adults and children over 10 years old: 13-27 drops (corresponding to 5-10 mg of sodium picosulfate).

Children from 4 to 10 years old (only as prescribed by a doctor) : 7-13 drops (which corresponds to 2.5-5 mg of sodium picosulfate).

Use the drug in children aged 4 years and older only after consulting a doctor.

It is recommended to start with the lowest dose.

In order to achieve regular bowel movements, the dose may be increased to the maximum recommended.

To obtain a laxative effect in the morning hours, the drug Guttasil must be taken at night.

After using the drug Guttasil, bowel emptying occurs after 10-12 hours.

The drug can be used with or without liquid.

Guttasil should not be taken daily without consulting a doctor for more than 10 days.

Side effect

With short-term use of the drug, side effects are rare.
Possible side effects are classified by frequency of occurrence as follows: very common (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to 1/10000 to <1/1000), very rarely (<1/10000), the frequency is unknown (currently, there are no data on the prevalence of adverse reactions).

With prolonged use of the drug in significantly increased doses, violations are possible:

on the part of the skin and subcutaneous tissues, the
frequency is unknown: skin rash, urticaria, itching.

on the part of metabolism and nutrition, the
frequency is unknown: increased excretion of potassium, sodium and other electrolytes, possibly the development of dehydration.

from the gastrointestinal tract
very often: diarrhea.
often: dyspeptic symptoms, cramps and pain in the abdomen, flatulence.
infrequently: vomiting, nausea.
the frequency is unknown: pain in the stomach and anus, increased intestinal motility, which disappear with a decrease in the dose of the drug.

on the part of the immune system, the
frequency is unknown: allergic reactions, angioedema, allergic dermatitis.

from the nervous system
infrequently: dizziness.
frequency unknown: headache, fatigue, drowsiness, convulsions, fainting.
The likelihood of dizziness and fainting may be associated with a vasovagal reaction (such as cramping abdominal pain or straining to defecate).

Overdose

Symptoms: high doses of Guttasil can cause liquid bowel movements, abdominal cramps (colic) and clinically significant disturbances in water and electrolyte balance (hypokalemia, loss of other electrolytes and fluids), ischemia of the thick mucosa. intestines. Long-term overdose leads to the development of chronic diarrhea and pain in the abdomen, hypokalemia, secondary hyperaldosteronism, possibly kidney damage and the development of nephrolithiasis, metabolic alkalosis, hypokalemia and muscle weakness as a result of hypokalemia.

Treatment: gastric lavage, intake of enterosorbents (activated carbon), symptomatic treatment (correction of water and electrolyte balance, use of antispasmodics).

Interaction with other medicinal products

Electrolyte imbalances can lead to decreased tolerance to cardiac glycosides. Diuretics or glucocorticosteroids can increase the severity of hypokalemia caused by the use of Guttasil in high doses; antibiotic treatment can reduce the laxative effect of the drug.

special instructions

Like other laxatives, Guttasil should not be taken daily without consulting a doctor for more than 10 days. If it is necessary to take laxatives daily, the cause of the constipation should be investigated.

Long-term use of laxatives can lead to water and electrolyte imbalance and hypokalemia, as well as cause addiction and constipation due to the rebound effect. Guttasil should be taken under medical supervision for conditions associated with imbalance in water and electrolyte balance (for example, with severe renal impairment).

Cases of dizziness and / or fainting have been reported that coincided with the use of sodium picosulfate. Case studies have shown that these conditions are associated with fainting during bowel movements (or fainting caused by straining during bowel movements) or associated with a vasovagal response to abdominal pain, which may be due to constipation. and is not necessarily associated with taking the drug. Guttasil is effective in relieving constipation in cancer patients receiving high doses of opioids.

Fertility studies have not been conducted.

The drug contains sorbitol, so patients with rare hereditary fructose intolerance are not recommended to take it.

Influence on the ability to drive vehicles and work with mechanisms
Studies of the effect on the ability to drive vehicles and work with other mechanisms have not been conducted.
However, patients should be warned about the possibility of the development due to a vasovagal reaction (in particular, abdominal spasm) of such adverse reactions as dizziness and / or syncope.
In the event of an abdominal spasm, the patient should avoid potentially hazardous activities such as driving or working with other mechanisms.

Release form

Oral drops 7.5 mg / ml.
15 ml or 30 ml each in polyethylene bottles with dispensers, sealed with lids with seals (first opening control) or in polyethylene bottles, sealed with dropper caps and caps.
Each bottle, along with instructions for medical use, is placed in a cardboard box.

Storage conditions

In its original packaging at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use the drug after the expiration date

Vacation conditions

Available without a prescription.