Composition, form of production and packaging
? Capsules of prolonged action 1 caps.
dimethindene maleate 4 mg
Excipients: lactose, microcrystalline cellulose, pregelatinized starch, glutamic acid, silicone emulsion E-2, methylhydroxypropylcellulose, titanium dioxide, talc, eudragit ECD-30, water-soluble coating ECD-30, iron oxide red, iron oxide yellow, gelatin.
10 pieces. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
The blocker of histamine H 1 -receptors. Has antiallergic and antipruritic effect. Significantly reduces the increased permeability of capillaries, associated with allergic reactions. It blocks the action of kinins, has a weak anticholinergic effect, can cause a small sedative effect. Antiemetic effect does not.
With the preventive intake of the drug, there is a decrease in the severity of the symptoms of hay fever.
PHARMACOKINETICS
Suction
After a single intake of 1 capsule prolonged action of Cmax active substance in blood plasma is achieved within 7-12 hours.
Distribution
In the range of dimethindene concentrations in plasma 0.09-2 Ојg / ml, its binding to plasma proteins is about 90%.
With the course application of 1 capsule 1 time / day the kinetics of dimethindene has a linear character. Cumulation is not observed.
Metabolism
Metabolic reactions include hydroxylation and methoxylation.
Excretion
After a single intake of 1 capsule, T 1/2 is about 11 hours. Dimethindene 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 all-the-year-round allergic rhinitis;
- itching associated with itching dermatoses (including eczema);
- food and drug allergies;
- preventive hyposensitizing therapy.
DOSING MODE
Adults and children aged 12 years and older are prescribed 1 capsule 1 time / day. The capsule should be taken in the evening. Swallow whole, without chewing.With a replacement schedule, the drug should be taken before bedtime. The duration of treatment should not exceed 25 days.
SIDE EFFECT
From the side of the central nervous system: sometimes - a feeling of fatigue, transient drowsiness, headache, dizziness; in rare cases - arousal.
From the digestive system: sometimes - gastrointestinal disorders (including nausea), dry mouth.
Other: rarely - swelling, skin rash, muscle spasm, breathing disorders.
CONTRAINDICATIONS
- hypersensitivity to dimethindene and other components that make up the drug.
With caution should apply the drug with increased intraocular pressure, bronchial asthma, hyperthyroidism, diseases of the cardiovascular system (including arterial hypertension).
Special care should be taken when using the drug in stenosing gastric ulcer, pyloroduodenal obstruction, obstruction of the neck of the bladder, prostatic hypertrophy accompanied by a delay in urine.
PREGNANCY AND LACTATION
The use of Fenistil 24 during pregnancy is possible only for life indications and under the supervision of a doctor.
It is not recommended to prescribe a lactating mother during lactation.
APPLICATION FOR CHILDREN
Fenistil 24 is not recommended for children younger than 12 years . This category of patients shows dimethindene in the form of drops.
SPECIAL INSTRUCTIONS
It is not recommended to use Fenistil 24 in patients with bronchial asthma.
Do not use Fenistil 24 concurrently with antidepressant MAO inhibitors (including nialamide).
Use in Pediatrics
Fenistil 24 is not recommended for children younger than 12 years . This category of patients shows dimethindene in the form of drops.
Impact on the ability to drive vehicles and manage mechanisms
It is not recommended to prescribe the drug to patients whose activities require increased concentration of attention and rapid psychomotor reactions (driving, working with mechanisms).
OVERDOSE
In case of an overdose of Fenistil 24, as in the case of an overdose of other histamine H 1 -receptor blockers, the following symptoms are possible : CNS depression and drowsiness (mainly in adults), CNS stimulation and anticholinergic effects (especially in children), incl. excitation, ataxia, tachycardia, hallucinations, tonic-clonic convulsions, mydriasis, dry mouth, red face, urinary retention, fever. Arterial hypotension is also possible. In far-reaching cases it is possible to deepen the coma with suppression of the vasomotor and respiratory centers and death.
No cases of death were reported with an overdose of Fenistil 24.
Treatment: usual first aid measures should be taken: induce vomiting; if it is not possible - to wash the stomach, prescribe activated charcoal, salt laxative; carry out activities to maintain the function of the cardiovascular and respiratory systems (analeptic drugs should not be used). To treat arterial hypotension, vasoconstrictors can be used. .
Specific antidote in the case of an overdose of dimethindene is not present.
DRUG INTERACTION
With the simultaneous administration of Fenistil 24 and drugs depressing the central nervous system, such as tranquilizers, hypnotics, anesthesia drugs, it is possible to increase the sedative effect of these drugs.
With the simultaneous use of Fenistil 24 and antidepressants - MAO inhibitors (including nialamide), it is possible to enhance their anticholinergic action and inhibitory effect on the central nervous system.
With the simultaneous use of Fenistil 24 and tricyclic antidepressants (including amitriptyline, imipramine), as well as anticholinergics (including atropine, scopolamine), an anticholinergic effect may be enhanced.
With the simultaneous use of ethanol and dimethindene, the inhibitory effect on the central nervous system increases.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored dry, protected from light, inaccessible to children at a temperature of no higher than 30 В° C. Shelf life - 5 years.
