Dicloran Plus gel, 30 g

-Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);

- Pain in joints (joints of fingers, knees, etc.) with osteoarthritis;

-Muscle pain (due to sprains, overexertion, bruises, injuries);

-Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, damage to periarticular tissues, wrist syndrome).

Outwardly. For adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and rubbed lightly. The required amount of the drug depends on the size of the painful area. A single dose of the drug is 2 - 4 g (by volume comparable to the size of a cherry or walnut), which is sufficient to treat an area of ??400 - 800 cm2. The total daily dose of the drug should not be exceeded 16 g per day. If the hands are not the area of ??pain localization, then after applying the drug, they must be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic soft tissue diseases without a doctor's recommendation. If after 7 days of use, the therapeutic effect is not observed or the condition worsens, you should consult a doctor.

Gel for external use

1 g

active substances:

diclofenac diethylamine 11.61 mg

which is equivalent to diclofenac sodium 10 mg

flax seed oil 30 mg levomenthol 50 mg

methyl salicylate 100 mg

excipients: butylhydroxyanisole - 0.2 mg; butylhydroxytoluene - 2 mg; benzyl alcohol - 10 ?l; disodium edetate - 1 mg; diethylamine - 7.1 ?l; carbomer 980 - 10.8 mg; citric acid monohydrate - 1 mg; macrogol glyceryl hydroxystearate (Cremophor RH-40) - 35 mg; propylene glycol - 100 mg; water - sc. required up to 1 g

• Hypersensitivity to diclofenac, methyl salicylate or other components that make up the drug;

• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);

• pregnancy (III trimester);

• lactation period (breastfeeding);

• children's age (up to 6 years old);

• violation of the integrity of the skin.

With caution: the drug should be prescribed for severe violations of liver and kidney function, bronchial asthma, in the I and II trimesters of pregnancy, in elderly patients.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID).

Pharmacological properties

Non-steroidal anti-inflammatory drug (NSAID) for external use. It has a local analgesic, anti-inflammatory and anti-exudative effect. Diclofenac sodium and methyl salicylate are NSAIDs, the mechanism of action of which is due to the suppression of prostaglandin synthesis. When applied topically, they reduce pain and inflammation in the joints, morning stiffness and swelling of the joints, and increase the range of motion. The main ingredient in flaxseed oil is? - linolenic acid, which also has an anti-inflammatory effect. Levomenthol causes irritation of the nerve endings, has a local distracting and mild analgesic effect, and causes a feeling of coolness at the site of application of the drug.

Pharmacokinetics

When applied topically, diclofenac sodium, methyl salicylate and flaxseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and joint capsule.

Application during pregnancy and during breastfeeding

Due to the lack of data on the use in pregnant women, the use of the drug in the first and second trimesters of pregnancy is recommended only as directed by a doctor, comparing the benefits to the mother and the risk to the fetus. The drug is contraindicated in the third trimester of pregnancy due to the possibility of a decrease in the tone of the uterus, impaired renal function of the fetus, followed by the development of oligohydramnios and / or premature closure of the fetal arterial flow. Due to the lack of data on penetration into breast milk, the drug is not recommended for use during breastfeeding. If it is nevertheless necessary to use the drug, then it should not be applied to the mammary glands or on a large surface of the skin and should not be used for a long time. There are no data on the use and its effect on fertility in humans.

Side effect

Reactions at the site of application . Very rare: eczema, photosensitivity, paresthesia, contact dermatitis, itching, redness, irritation, swelling of the treated skin area, papules, vesicles, peeling, burns, pain, rashes.

Skin and subcutaneous tissue disorders. Rare: bullous dermatitis.

Systemic reactions. Very rare: hypersensitivity reactions (including urticaria), angioedema, bronchospastic reactions.

From the respiratory system . Very rare: shortness of breath.

Infectious and parasitic diseases. Very rare: pustular rash.

Overdose

When applied externally in recommended doses, the extremely low systemic absorption of the active components of the drug makes an overdose almost impossible. In case of accidental ingestion, systemic side effects may develop. Ingestion treatment: gastric lavage, induction of vomiting, intake of activated carbon, forced diuresis, symptomatic therapy. Dialysis is ineffective due to the high degree of binding of diclofenac to blood plasma proteins (about 99%).

Interaction with other medicinal products

Diclofenac may increase the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.

special instructions

For external use only.

DIKLORAN a PLUS should only be applied to intact skin, avoiding contact with open wounds. After applying the gel, do not apply an occlusive dressing. With prolonged application to open surfaces, systemic side effects may develop due to the resorptive effect. Do not allow the drug to come into contact with the eyes and mucous membranes.

NSAIDs can cause gastrointestinal bleeding. The risk may increase with increasing dose and duration of use and may be higher in elderly patients with a history of gastric ulcer, patients with coagulopathies taking anticoagulants, glucocorticoids, or other NSAIDs, and alcohol consumption. NSAIDs can increase the risk of serious cardiovascular thrombosis, myocardial infarction, and stroke. This risk may increase with increasing dose and duration of use. Patients with cardiovascular disease or cardiovascular risk factors may be at greater risk. NSAIDs should be used with caution in patients with hypertension, fluid retention, cardiovascular disease, or in patients taking diuretics or coumarin anticoagulants.

The use of salicylates can provoke Reye's syndrome. If excessive skin irritation occurs, discontinue use.

Exposure of treated areas to natural or artificial sunlight should be minimized or avoided.

If symptoms persist or worsen, or new symptoms appear, discontinue use and consult a doctor.

If a medicinal product has become unusable or the expiration date has expired, do not throw it into wastewater or outside! Place the medicine in a bag and put it in the trash can. These measures will help protect the environment!

Influence on the ability to drive vehicles and other mechanisms

The drug does not affect the ability to drive and maintain moving mechanical equipment.