Fenistil oral drops 1mg / ml, 20ml

• Allergic diseases: urticaria hay fever perennial allergic rhinitis angioedema food and drug allergies.

• Itching of various origins (eczema, pruritic dermatoses: including atopic dermatitis; measles, rubella, chickenpox, insect bites).

• Prevention of allergic reactions during hyposensitization therapy.

Inside.

Children aged 1 month to 12 years: the recommended daily dose is 01 mg / kg of body weight, which is equivalent to 2 drops per kg of body weight. The daily dose must be divided into 3 doses. Children aged 1 month to 1 year should take the drug only as directed by a doctor and if there are indications for the use of H1-histamine receptor blockers.

Children over 12 years old and adults: the recommended daily dose is 3-6 mg of dimetindene (60-120 drops) divided into 3 doses, that is, 20-40 drops 3 times a day. 20 drops = 1 ml = 1 mg dimethinsna.

For elderly patients (over 65 years of age), dose adjustment is not required. Patients prone to drowsiness are advised to apply 40 drops at bedtime and 20 drops in the morning.

Active substance: dimethindene maleate.

1 ml of oral drops contains 1 mg of dimethindene maleate

Excipients:

Sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, benzoic acid, disodium edetate, sodium saccharinate, propylene glycol, purified water.

• Hypersensitivity to dimstinden and other components that make up the drug

• angle-closure glaucoma

• bronchial asthma

• hyperplasia of the prostate

• children's age up to 1 month

• pregnancy I trimester

• period of breastfeeding.

Carefully:

In chronic obstructive pulmonary diseases of epilepsy. In children aged 1 month to 1 year, since sedation may be accompanied by episodes of sleep apnea.

Trade name of the drug

FenistilЃ

International non-proprietary name

Dimethindene

Dosage form

oral drops

Composition

Active substance: dimethindene maleate.

1 ml of oral drops contains 1 mg of dimethindene maleate

Excipients:

Sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, benzoic acid, disodium edetate, sodium saccharinate, propylene glycol, purified water.

Description

colorless, transparent liquid, practically odorless.

Pharmacotherapeutic group

Antiallergic agent - H1-histamine receptor blocker

ATX code

R06AB03

Pharmacodynamics:

Antihistamine antiallergic and antipruritic agent. The histamine H1 receptor blocker is a competitive histamine antagonist.

The drug reduces the increased capillary permeability associated with allergic reactions.

It also has an anti-bradykinin and weak m-anticholinergic effect. When taking the drug during the day, there may be a slight sedation.

Pharmacokinetics:

It is quickly and completely absorbed when taken orally. Bioavailability is about 70%. The antihistamine affect begins to manifest itself 30 minutes after ingestion, reaching its maximum severity within 5 hours. The time to reach the maximum concentration of dimetindene in the blood plasma after oral administration of drops is 2 hours. Communication with plasma proteins - 90%. Penetrates well into tissues. It is metabolized in the liver by hydroxylation and methoxylation. The half-life is 6 hours. It is excreted in the bile and urine (90% as a metabolite and 10% unchanged).

Indications:

• Allergic diseases: urticaria hay fever perennial allergic rhinitis angioedema food and drug allergies.

• Itching of various origins (eczema, pruritic dermatoses: including atopic dermatitis; measles, rubella, chickenpox, insect bites).

• Prevention of allergic reactions during hyposensitization therapy.

Contraindications:

• Hypersensitivity to dimstinden and other components that make up the drug

• angle-closure glaucoma

• bronchial asthma

• hyperplasia of the prostate

• children's age up to 1 month

• pregnancy I trimester

• period of breastfeeding.

Carefully:

In chronic obstructive pulmonary diseases of epilepsy. In children aged 1 month to 1 year, since sedation may be accompanied by episodes of sleep apnea.

Pregnancy and lactation:

The use of FenistilЃ during pregnancy (II-III trimester) is possible under medical supervision only if the expected benefit to the mother outweighs the potential risk to the fetus. The use of the drug FenistilЃ during breastfeeding is contraindicated.

Method of administration and dosage:

Inside.

Children aged 1 month to 12 years: the recommended daily dose is 01 mg / kg of body weight, which is equivalent to 2 drops per kg of body weight. The daily dose must be divided into 3 doses. Children aged 1 month to 1 year should take the drug only as directed by a doctor and if there are indications for the use of H1-histamine receptor blockers.

Children over 12 years old and adults: the recommended daily dose is 3-6 mg of dimetindene (60-120 drops) divided into 3 doses, that is, 20-40 drops 3 times a day. 20 drops = 1 ml = 1 mg dimethinsna.

For elderly patients (over 65 years of age), dose adjustment is not required. Patients prone to drowsiness are advised to apply 40 drops at bedtime and 20 drops in the morning.

Side effects:

Immune system disorders:

Very rare: anaphylactoid reactions including facial edema, pharyngeal edema, rash, muscle spasms and shortness of breath.

Mental disorders:

Rarely: anxiety.

Nervous system disorders:

Very often: fatigue.

Often: drowsiness, nervousness.

Rare: headache, dizziness.

Gastrointestinal disorders:

Rare: gastrointestinal disorders nausea dry mouth dry larynx.

If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not indicated in the instructions, inform your doctor.

Interaction:

Enhances the effect of anxiolytics, hypnotics and other drugs that inhibit the function of the central nervous system (opioid analgesics, anticonvulsants, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine ethanol). Tricyclic antidepressants and m-anticholinergics (bronchodilators, gastrointestinal antispasmodics, etc.) increase the risk of increased intraocular pressure or urinary retention. It is also necessary to avoid the combined use of antihistamines and procarbazine.

Special instructions:

In young children, in particular those under 6 years of age, antihistamines can cause irritability.

FenistilЃ drops should not be exposed to high temperatures; when administered to infants, they should be added to a bottle of warm baby food immediately prior to feeding. If the child is already spoon-fed, drops can be given undiluted. The drops taste good. Do not exceed the recommended dose. Ineffective for pruritus associated with cholestasis.

Impact on the ability to drive vehicles. Wed and fur .:

Like other antihistamines, FenistilЃ can weaken attention, therefore it should be taken with caution when driving, working with mechanisms or other types of work where increased attention is required.

Release form / dosage:

Oral drops 1 mg / ml.

Packaging:

20 ml in a dark glass bottle equipped with a low density polyethylene dropper-dispenser and a polypropylene cap. The bottle together with the instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ? C.

Store the bottle in its own carton. Out of the reach of children.

Shelf life:

3 years. The drug should not be used after the expiration date.

Vacation conditions

Without recipe

Manufacturer

Novartis Consumer Health S.A., Route de l`Etraz, 1260 Nyon, Switzerland, Switzerland