Fenicap (Drops) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

ATC Code

R06AB03 (Dimetindene)

Active Substance

Dimetindene (Rec.INN registered by WHO)

Dosage Form

Fenicap

Oral drops 1 mg/1 ml: 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, or 100 ml bottle or dropper bottle.

Dosage Form, Packaging, and Composition

Oral drops in the form of a colorless, transparent liquid, practically odorless.

Excipients: sodium phosphate dibasic dodecahydrate, citric acid monohydrate, benzoic acid, disodium edetate, sodium saccharin, propylene glycol, purified water.

10 ml – bottles or dropper bottles – cardboard packs.
15 ml – bottles or dropper bottles – cardboard packs.
20 ml – bottles or dropper bottles – cardboard packs.
25 ml – bottles or dropper bottles – cardboard packs.
30 ml – bottles or dropper bottles – cardboard packs.
40 ml – bottles or dropper bottles – cardboard packs.
50 ml – bottles or dropper bottles – cardboard packs.
60 ml – bottles or dropper bottles – cardboard packs.
70 ml – bottles or dropper bottles – cardboard packs.
80 ml – bottles or dropper bottles – cardboard packs.
90 ml – bottles or dropper bottles – cardboard packs.
100 ml – bottles or dropper bottles – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Systemic antihistamines; substituted alkylamines

Pharmacological Action

Histamine H₁-receptor blocker, an alkylamine derivative. It has an antiallergic, antipruritic, and weak anticholinergic effect. It also has a pronounced local anesthetic effect. It causes a weakly expressed central genesis sedative effect.

Pharmacokinetics

It is rapidly and sufficiently completely absorbed after oral administration. Bioavailability is about 70%. Plasma protein binding is 90%. It penetrates tissues well and passes through the BBB. It is metabolized in the liver by hydroxylation and methoxylation. It is excreted in bile and urine (90% as a metabolite and 10% unchanged).

With topical application, Dimetindene rapidly penetrates the skin; systemic bioavailability is 10%.

Indications

For oral administration: urticaria, hay fever, vasomotor rhinitis, food and drug allergy, angioedema; as an auxiliary agent in the treatment of anaphylactic reactions and serum sickness; itching from insect bites, eczema, dermatoses of allergic and non-allergic origin, with measles, rubella, chickenpox. Prophylactic hyposensitizing therapy in patients prone to allergic reactions.

For topical application: itchy skin lesions in dermatoses, urticaria, insect bites, as well as in mild burns.

ICD codes

Dosage Regimen

Orally. For adults and children over 12 years old the recommended daily dose is 3-6 mg, divided into 3 doses. Children aged from 1 month to 12 years are prescribed a daily dose based on 0.1 mg/kg of body weight. The daily dose must be divided into 3 doses.

Topically. Apply to the affected area of skin 2-4 times/day.

In cases of severe itching or widespread skin lesions, simultaneous use of oral forms is recommended.

Adverse Reactions

From the immune system: when taken orally very rarely – anaphylactoid reactions, including facial edema, pharyngeal edema, rash, muscle spasms, and shortness of breath.

From the nervous system when taken orally – fatigue, drowsiness (especially at the beginning of treatment), nervousness, state of excitation, muscle spasm; rarely – headache, dizziness, anxiety.

From the digestive system when taken orally, nausea, dry mouth or throat are possible.

Others when taken orally – edema; rarely – skin rash; in isolated cases – disorders of the respiratory system.

With topical application rarely – dryness and burning sensation at the application site, skin allergic reactions.

Contraindications

Hypersensitivity to dimetindene; angle-closure glaucoma, urination disorders (including with prostatic hyperplasia), children under 1 month of age (especially in case of premature birth).

For oral administration: bronchial asthma; first trimester of pregnancy; breastfeeding period.

Use in Pregnancy and Lactation

Oral administration. Dimetindene is contraindicated for oral administration in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible under medical supervision, only if the expected benefit to the mother outweighs the potential risk to the fetus. Use during breastfeeding is contraindicated.

Topical application. Use in the first trimester of pregnancy is possible only after consultation with a doctor. In the second and third trimesters of pregnancy, as well as during breastfeeding, it should not be applied to large areas of the skin, especially in the presence of inflammation or bleeding. Nursing mothers should not apply the product to the nipples of the mammary glands.

Pediatric Use

Oral administration. Contraindicated for use in children under 1 month of age (especially in case of premature birth). In children aged from 1 month to 1 year, the product should be used only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, while the recommended doses should not be exceeded.

Topical application. In children from 1 month to 2 years, Dimetindene is used only after consultation with a doctor.
In infants and young children, the product should not be applied to large areas of the skin (especially with weeping and inflammation).

Geriatric Use

Use in elderly patients is permitted according to indications in recommended doses.

Special Precautions

Oral administration. In children aged from 1 month to 1 year, the product should be used only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, while the recommended doses should not be exceeded.

Effect on the ability to drive vehicles and mechanisms

During treatment, one should not engage in activities requiring increased attention and rapid psychomotor reactions.

Topical application. In children from 1 month to 2 years, Dimetindene is used only after consultation with a doctor.
In infants and young children, the product should not be applied to large areas of the skin (especially with weeping and inflammation). In case of severe itching or when large areas of the skin are affected, Dimetindene should be used only after consultation with a doctor. When Dimetindene is applied topically to large areas of the skin, insolation should be avoided.
It is not effective for itching associated with cholestasis.

Drug Interactions

With simultaneous use with agents that have a depressant effect on the myocardium, it is possible to enhance the effect of the latter.

With simultaneous use with tricyclic antidepressants or anticholinergic agents, the risk of increased intraocular pressure increases.

MAO inhibitors may cause an increase in the anticholinergic and sedative effects of dimetindene.

With simultaneous use, Dimetindene enhances the effect of anxiolytics and hypnotics.

With simultaneous consumption of ethanol, a slowdown in the speed of reactions is observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.