Fenistil^® 24 (Capsules) Instructions for Use

Marketing Authorization Holder

Novartis Consumer Health S.A. (Switzerland)

Manufactured By

Famar Italia, S.p.A. (Italy)

ATC Code

R06AB03 (Dimetindene)

Active Substance

Dimetindene (Rec.INN registered by WHO)

Dosage Form

Fenistil® 24

Extended-release capsules 4 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Excipients: lactose, microcrystalline cellulose, pregelatinized starch, glutamic acid, silicone emulsion E-2, methylhydroxypropylcellulose, titanium dioxide, talc, Eudragit ECD-30, ECD-30 water-soluble coating, red iron oxide, yellow iron oxide, gelatin.

10 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker. It has antiallergic and antipruritic effects. It significantly reduces the increased capillary permeability associated with allergic reactions.

It blocks the action of kinins, has a weak anticholinergic effect, and may cause a slight sedative effect. It does not have an antiemetic effect.

When taken prophylactically, the drug reduces the severity of hay fever symptoms.

Pharmacokinetics

Absorption

After a single oral administration of 1 extended-release capsule, the C_max of the active substance in blood plasma is reached within 7-12 hours.

Distribution

In the concentration range of dimetindene in plasma of 0.09-2 µg/ml, its binding to plasma proteins is about 90%.

With a course of application of 1 capsule once/day, the kinetics of dimetindene is linear. No accumulation is observed.

Metabolism

Metabolic reactions include hydroxylation and methoxylation.

Elimination

After a single oral administration of 1 capsule, T_1/2 is about 11 hours. Dimetindene and its metabolites are excreted by the kidneys and with bile.

Indications

• Symptomatic treatment of allergic skin reactions (including urticaria);
• Symptomatic treatment of seasonal (hay fever) and perennial allergic rhinitis;
• Itching associated with pruritic dermatoses (including eczema);
• Food and drug allergy;
• Prophylactic hyposensitizing therapy.

ICD codes

Dosage Regimen

Administer one capsule once daily to adults and children aged 12 years and older.

Take the capsule in the evening. For individuals on a shift work schedule, take the dose before going to bed.

Swallow the extended-release capsule whole; do not chew or crush it.

The maximum recommended duration of continuous treatment is 25 days.

Do not exceed the stated dose. This product is not recommended for children under 12 years of age.

Exercise caution in patients with glaucoma, bronchial asthma, prostatic hyperplasia, or pyloric obstruction.

Avoid concurrent use with MAO inhibitors and central nervous system depressants, including alcohol.

Adverse Reactions

From the central nervous system sometimes – feeling of fatigue, transient drowsiness, headache, dizziness; in rare cases – excitation.

From the digestive system sometimes – gastrointestinal disorders (including nausea), dry mouth.

Other rarely – edema, skin rash, muscle spasm, respiratory disorders.

Contraindications

• Hypersensitivity to dimetindene and other components of the drug.

With caution, the drug should be used in cases of increased intraocular pressure, bronchial asthma, hyperthyroidism, diseases of the cardiovascular system (including arterial hypertension).

Special caution should be exercised when using the drug in cases of stenosing gastric ulcer, pyloroduodenal obstruction, obstruction of the bladder neck, prostatic hyperplasia accompanied by urinary retention.

Use in Pregnancy and Lactation

The use of Fenistil 24 during pregnancy is possible only for vital indications and under medical supervision.

It is not recommended to prescribe the drug to a nursing mother during lactation.

Pediatric Use

Fenistil^® 24 is not recommended for children under 12 years of age. Dimetindene in the form of drops is indicated for this category of patients.

Special Precautions

The use of Fenistil 24 in patients with bronchial asthma is not recommended.

Fenistil^® 24 should not be used simultaneously with MAO inhibitor antidepressants (including nialamide).

Use in pediatrics

Fenistil^® 24 is not recommended for children under 12 years of age. Dimetindene in the form of drops is indicated for this category of patients.

Effect on the ability to drive vehicles and operate machinery

It is not recommended to prescribe the drug to patients whose activities require increased concentration and rapid psychomotor reactions (driving a car, working with machinery).

Overdose

In case of an overdose of Fenistil 24, as with an overdose of other histamine H₁-receptor blockers, the following symptoms are possible: CNS depression and drowsiness (mainly in adults), CNS stimulation and anticholinergic effects (especially in children), including excitation, ataxia, tachycardia, hallucinations, tonic-clonic convulsions, mydriasis, dry mouth, facial flushing, urinary retention, fever. Arterial hypotension is also possible. In advanced cases, deepening of coma with depression of the vasomotor and respiratory centers and a fatal outcome is possible.

No cases of fatal outcome with an overdose of Fenistil 24 have been reported.

Treatment: usual emergency measures should be taken: induce vomiting; if this fails – perform gastric lavage, prescribe activated charcoal, saline laxative; carry out measures to maintain the function of the cardiovascular and respiratory systems (analeptic agents should not be used). Vasoconstrictor agents can be used to treat arterial hypotension.

There is no specific antidote for dimetindene overdose.

Drug Interactions

With the simultaneous administration of Fenistil 24 and drugs that depress the central nervous system, such as tranquilizers, hypnotics, anesthetics, the sedative effect of these drugs may be enhanced.

With the simultaneous use of Fenistil 24 and MAO inhibitor antidepressants (including nialamide), their anticholinergic effect and inhibitory effect on the central nervous system may be enhanced.

With the simultaneous use of Fenistil 24 and tricyclic antidepressants (including amitriptyline, imipramine), as well as anticholinergic agents (including atropine, scopolamine), the anticholinergic effect may be enhanced.

With the simultaneous use of ethanol and dimetindene, the inhibitory effect on the central nervous system is enhanced.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.