Instructions for use Fenimax oral 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; citric acid monohydrate; benzoic acid (E 210); disodium edetate; sodium saccharin; propylene glycol; 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 level of H1 receptors. 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.
During preclinical studies, no risk was identified when using the drug in recommended doses. Dimethindene maleate did not show mutagenic and clastogenic properties.
Indication
For the symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and perennial allergic rhinitis, allergies to medicines and foods.
Itching of various origins, except that associated with cholestasis. Itching in diseases with skin rashes, such as chickenpox. Insect bites.
As an adjuvant 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 babies.
Interaction with other medicinal products and other types of interactions
In the case of concomitant use of drugs that depress the central nervous system (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 may occur, which may lead to undesirable effects or even life-threatening effects.
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 of the drug's effects, the concomitant use of procarbazine and antihistamines should be carried out with caution.
Application features
Caution should be exercised when using antihistamines, in particular Fenimax, in patients with glaucoma, in patients with bladder neck contracture and/or urinary incontinence, including prostatic hypertrophy, and in patients 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.
It is recommended to use the drug with caution in elderly patients, in whom the risk of adverse reactions, in particular agitation and increased fatigue, is increased. Misuse of the drug by elderly patients should be avoided. The recommended dosage and duration of use should not be exceeded without the advice of a doctor.
Fenimax 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.
This medicinal product contains 0.05 mmol (or 1.15 mg)/ml sodium. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Pregnancy. There are no clinical data on the use of dimethindene maleate 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 drug can be used 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
While taking Fenimax, 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.
Method of administration and doses
The duration of use of Fenimax 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.
Children. Taking the drug is recommended 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 kilogram of body weight per day, divided into 3 doses.
20 drops = 1 ml = 1 mg of dimethindene maleate.
Fenimax 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 baby is spoon-fed, 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.
Fenimax 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
Overdose of Fenimax oral drops, as with other antihistamines, may cause the following symptoms: central nervous system (CNS) depression and drowsiness (predominantly 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 occur.
In case of overdose, it is necessary to take measures recommended by the medical institution, according to the symptoms that occur.
Adverse reactions
The frequency of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), and frequency unknown.
The main side effect of dimethindene maleate is drowsiness, especially at the beginning of treatment. In very rare cases, allergic reactions may occur.
Possible side effects.
On the part of 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.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
2 years.
Storage conditions
Keep out of reach of children.
Packaging
20 ml in a bottle, 1 bottle in a cardboard pack.
Vacation category
Without a prescription.
Manufacturer/Applicant
"Ternofarm" LLC.
Location of the manufacturer and address of the place of business / location of the applicant. Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
