Instructions for Fenistil drops 1 mg/ml bottle 20 ml
Composition
active ingredient: dimethindene maleate;
1 ml contains 1 mg of dimethindene maleate;
excipients: sodium hydrogen phosphate, dodecahydrate; propylene glycol; benzoic acid E 210; disodium edetate; citric acid, monohydrate; sodium saccharin; purified water.
Dosage form
Oral drops.
Main physicochemical properties: transparent solution, colorless or slightly brownish-yellowish in color.
Pharmacotherapeutic group
Antihistamines for systemic use. ATX code R06A B03.
Pharmacological properties
Pharmacodynamics
Dimethindene maleate is a histamine antagonist at the H1 receptor level. At low concentrations, it has a stimulating effect on histamine methyltransferase, which leads to the inactivation of histamine. It exhibits high affinity for H1 receptors and is a mast cell stabilizer. Dimethindene maleate does not affect H2 receptors. It also has local anesthetic properties.
Dimethindene maleate is an antagonist of bradykinin, serotonin, and acetylcholine. It exists as a racemic mixture with R-(-)-dimethindene, which has more pronounced H1-antihistamine activity.
Dimethindene maleate significantly reduces capillary hyperpermeability, which is associated with immediate-type hypersensitivity reactions.
In combination with histamine H2 receptor antagonists, it inhibits almost all types of histamine effects on the bloodstream.
Studies have shown that the effect of a single dose of 4 mg of dimethindene in the form of drops on skin reactions is determined up to 24 hours after administration of the drug.
Pharmacokinetics
The systemic bioavailability of dimethindene in the form of drops is approximately 70%. After taking the drops, the maximum concentration of dimethindene in the blood plasma is reached within 2 hours.
At concentrations of 0.09 to 2 μg/ml, the binding of dimethindene to plasma proteins is approximately 90%. Metabolic reactions of dimethindene include hydroxylation and methoxylation.
The half-life of dimethindene is almost 6 hours. Dimethindene and its metabolites are excreted by the liver and kidneys.
Preclinical studies have not revealed any risk when using the drug in recommended doses. Dimethindene maleate has not shown mutagenic and clastogenic properties.
Indication
Symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and perennial allergic rhinitis, allergies to drugs and food products. Itching of various origins, except those associated with cholestasis. Itching in diseases with skin rashes, such as chickenpox. Insect bites. An auxiliary remedy for eczema and other itchy dermatoses of allergic origin.
Contraindication
Hypersensitivity to dimethindene maleate or to any other component of the drug. Duodenal/pyloric stenosis. Contraindicated in children under 1 month of age, especially premature infants.
Interaction with other medicinal products and other types of interactions
With the parallel use of drugs that depress the CNS, such as opioid analgesics, anticonvulsants, antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors), other antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, scopolamine and ethyl alcohol, increased CNS depression is possible, which can lead to undesirable effects or even life-threatening consequences.
Tricyclic antidepressants and anticholinergic drugs, such as bronchodilators, gastrointestinal antispasmodics, mydriatics, urological antimuscarinics may cause an additive antimuscarinic effect when taken with antihistamines, thereby increasing the risk of worsening glaucoma and urinary retention.
In order to minimize the risk of CNS depression or possible potentiation, the concomitant administration of procarbazine and antihistamines should be carried out with caution.
Application features
As with other antihistamines, caution should be exercised when using Fenistil in patients with glaucoma, patients with bladder neck contracture and/or urinary incontinence, including prostatic hypertrophy, and those with chronic obstructive pulmonary disease.
As with all H1-receptor antagonists and some H2-receptor antagonists, this drug should be used with caution in patients with epilepsy. Antihistamines may cause agitation in young children.
The drug should be used with caution in elderly patients, who are at increased risk of adverse reactions, including agitation and fatigue. Avoid misuse of the drug in elderly patients. Do not exceed the recommended dosage and duration of use without medical advice.
Fenistil oral drops can be used in children aged 1 month to 1 year only on the recommendation of a doctor and in the presence of clear indications for treatment with antihistamines. The recommended dose should not be exceeded.
Ability to influence reaction speed when driving vehicles or other mechanisms
When taking Fenistil, a slowdown in the speed of psychomotor reactions, drowsiness, and dizziness may occur, so you should refrain from driving a car and working with mechanical devices.
Use during pregnancy or breastfeeding
Pregnancy. There are no clinical data on the use of the drug in pregnant women. The use of the drug during pregnancy in animal studies did not cause any harmful effects (either direct or indirect) on the course of pregnancy, fetal development, or the further development of the offspring. However, the drug is not recommended for use during pregnancy, except in cases where the benefit of use outweighs the potential risk to the fetus. In this case, the use of the drug is possible only as prescribed by a doctor.
Breastfeeding. It is likely that dimethindene maleate passes into breast milk. It is not recommended to take the drug during breastfeeding. If necessary, breastfeeding should be discontinued for the period of treatment.
Method of administration and doses
The duration of use of the drug without consulting a doctor should not exceed 14 days.
Adults, children over 12 years of age and elderly patients.
The recommended daily dose is 3–6 mg, divided into 3 doses of 20–40 drops 3 times a day. Patients prone to drowsiness are recommended to take 40 drops before bedtime and 20 drops in the morning, during breakfast.
No dose adjustment is necessary for elderly patients.
For children.
The drug is recommended to be taken after prior consultation with a doctor, children aged 1 month to 1 year can be used only on the recommendation of a doctor. The recommended daily dose is 0.1 mg (i.e. 2 drops) per kg of body weight per day, divided into 3 doses.
20 drops = 1 ml = 1 mg of dimethindene maleate.
Fenistil oral drops should not be exposed to high temperatures. They should be added to a bottle of warm baby food immediately before feeding. If the child is fed from a spoon, the drops can be used undiluted, in a teaspoon. The drops have a pleasant taste.
Children
Do not administer to children under 1 month of age, especially premature infants. Use caution when administering oral drops to children under 1 year of age: sedation may be associated with episodes of sleep apnea. Antihistamines may cause agitation in younger children.
Fenistil oral drops can be used in children aged 1 month to 1 year only on the recommendation of a doctor and in the presence of clear indications for treatment with antihistamines. The recommended dose should not be exceeded.
Overdose
In case of overdose with Fenistil, oral drops, as with other antihistamines, the following symptoms may occur: central nervous system (CNS) depression and drowsiness (mainly in adults), CNS stimulation and antimuscarinic effects (especially in children and the elderly), including agitation, ataxia, tachycardia, hallucinations, convulsions, tremor, mydriasis, dry mouth, flushing, urinary retention and fever. Hypotension, coma and cardiorespiratory collapse may also develop.
In case of overdose, it is necessary to take measures recommended by the medical institution, according to the symptoms that occur.
Adverse reactions
The main side effect of the drug is drowsiness, especially at the beginning of treatment. In very rare cases, allergic reactions may occur.
Possible side effects
From the immune system.
Rare: anaphylactic reactions including facial edema, pharyngeal edema, rash; muscle spasms and shortness of breath.
Mental disorders.
Isolated: agitation.
From the nervous system.
Very common: increased fatigue.
Common: drowsiness, nervousness.
Rare: headache, dizziness.
From the digestive tract.
Rare: gastrointestinal disorders, nausea, dry mouth and throat.
Expiration date
2 years.
Storage conditions
Store out of the reach of children in the outer cardboard packaging at a temperature below 25 °C.
Packaging
20 ml in a bottle with a dropper.
Vacation category
Without a prescription.
Producer
GSK Consumer Helsker S.A./ GSK Consumer Healthcare SA
Location of the manufacturer and its business address
Route de l'Etraz, 1260 Nyon, Switzerland.
