Composition, form of production and packaging
? The gel for external use is homogeneous, colorless, transparent or slightly opalescent, practically odorless.
100 g
dimethindene maleate 100 mg
Excipients: disodium edetate - 50 mg, carbomer - about 900 mg, sodium hydroxide (30% solution) - about 1 g, benzalkonium chloride - 5 mg, propylene glycol - 15 g, purified water - about 82.9 g.
30 g - aluminum tubes (1) - cardboard packs.
50 g - aluminum tubes (1) - packs of cardboard.
? Emulsion for external use is whitish, homogeneous, semi-liquid, with a slight smell of benzyl alcohol.
1 g
dimethindene maleate 1 mg
Excipients: Benzalkonium chloride 0.1 mg, benzyl alcohol 5 mg, butyl hydroxytoluene 0.2 mg, disodium edetate 0.5 mg, cocoyl caprylcaprate 25 mg, paraffin liquid 25 mg, cetostearmacrogol 20 mg, carbomer about 4 mg sodium hydroxide solution 30% m / m - about 4 mg, propylene glycol - 150 mg, water - about 765.2 mg.
8 ml - glass bottles (1) with ball applicator - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The blocker of histamine H 1 -receptors. Has antiallergic and antipruritic effect. Reduces the increased permeability of capillaries, associated with allergic reactions.When applied to the skin, it reduces itching and irritation caused by skin-allergic reactions.
The drug also has a pronounced local anesthetic effect.
It blocks the action of kinins, has a weak anticholinergic effect.
With external application due to the gel basis, the action with a slight cooling effect begins in a few minutes and reaches a maximum after 1-4 hours.
PHARMACOKINETICS
When applied externally, it penetrates well into the skin. Systemic bioavailability of the active substance is 10%.
INDICATIONS
Itching of various origin (except for those associated with cholestasis) with:
- itching dermatoses;
- eczema;
- hives;
- bites of insects.
Sun burns, household and industrial burns (mild).
DOSING MODE
Apply externally. The drug should be applied to the affected skin 2-4 times / day. In cases of severe itching or common skin lesions, the simultaneous use of oral forms is recommended.
SIDE EFFECT
Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1 / 1000), very rarely (<1/10 000), including individual messages and reactions with unknown frequency (it is impossible to estimate on the basis of available data).
From the skin and subcutaneous tissues: infrequently - dry skin, burning sensation of the skin.
Allergic reactions: very rarely (post-registration data) - allergic dermatitis, including skin rash, itching.
If any of the above side effects are aggravated, or any other side effects occur, the patient should notify the doctor.
CONTRAINDICATIONS
- an angle-closure glaucoma;
- hyperplasia of the prostate;
- Children's age up to 1 month (especially premature);
- hypersensitivity to dimethindene and other components that make up the drug.
With caution should appoint Fenistil В® in the first trimester of pregnancy and lactation (breastfeeding).
PREGNANCY AND LACTATION
Use of the drug Fenistil В® in the first trimester of pregnancy is possible only after consulting a doctor.
In the II and III trimesters of pregnancy and during lactation, the gel should not be used on large areas of the skin, especially if inflammation and bleeding occur.
Nursing mothers should not apply the drug to the nipples of the mammary glands.
APPLICATION FOR CHILDREN
Contraindicated in childhood up to 1 month (especially in premature babies).
In infants and young children, the drug should not be used on large areas of the skin, especially if inflammation or bleeding occurs.
SPECIAL INSTRUCTIONS
If the itching is severe or if extensive areas of the skin are affected, the drug can be used only after consulting a doctor.
When using Fenistil В® on large areas of the skin, exposure to sunlight should be avoided.
If during the period of using the drug Fenistil В® the severity of the symptoms of the disease does not decrease or increase, it is necessary to consult a doctor.
The drug is ineffective when itching, associated with cholestasis.
The drug contains propylene glycol and benzalkonium chloride. The emulsion also contains butylhydroxytoluene. The listed excipients can cause local allergic reactions (contact dermatitis). Butylhydroxytoluene can also cause irritation of the eyes and mucous membranes.
Use in Pediatrics
In children from 1 month to 2 years of age, the drug should be used only after consulting a doctor.
In infants and young children, the drug should not be used on large areas of the skin, especially if inflammation or bleeding occurs.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect.
OVERDOSE
Symptoms: In case of accidental ingestion of a large amount of the drug, symptoms characteristic of histamine H 1 -receptor blockers can occur - CNS depression and drowsiness (mainly in adults), CNS stimulation and m-cholinoblocking effects (especially in children), including. excitation, ataxia, tachycardia, hallucinations, tonic or clonic convulsions, mydriasis, dry mouth, flushing to the face, urinary retention, fever. This may be followed by a decrease in blood pressure.
Treatment: a specific antidote is unknown. It should be assigned activated charcoal, salt laxative; carry out activities to maintain the function of the cardiovascular and respiratory systems. To treat arterial hypotension, vasoconstrictors can be used.
In case of accidental overdose, the patient should consult a doctor.
DRUG INTERACTION
The drug interaction of the drug Fenistil В® is not described.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, the gel at a temperature of no higher than 25 В° C, emulsion - no higher than 30 В° C. Shelf life - 3 years.
