- Symptomatic treatment of pruritus of different origin, such as urticaria, food allergy, drug allergy, eczema, varicella, insect bites, senile pruritus. - Symptomatic treatment of allergic rhinitis, such as hay fever or perennial rhinitis.
Fenistil coated tablets.
Dimetindeni maleas 1 mg - Lactos. - Amyl. - Magnes. stearas - Talc. - Colophon. - Térébenthine. - Lacca - Sandarac - Accac. gum. - Calc. Carbonas - Titan. dioxide. - Macrogol. - Sacchar. pro compr. obduct.
Fenistil oral drops, solution.
Dimetindeni maleas 1 mg - Natr. dihydrogenophosphas. dihydricus - Ethanol. 96% v / v - Methyl. parahydroxybenzoas - sorbitol liq. (Non-Crystall) - Aqua purificata 1 ml (1 ml = approx 20 gutti).
Posology and method of use:
Posology to be 3 times a day.
Children under 1 years: 0.15 - 0, 5 mg (see 'special precautions') - from 1-3 years: 0.5 to 0.75 mg - 3-12 years : 0.75 to 1 mg - a dole cents and adults: 1 to 2 mg.
Fenistil coated tablets.
Adults and adolescents: 1-2-coated tablets, 3 times a day.
In susceptible patients with a tendency to sedation is recommended 2 coated tablets at bedtime and 1 coated tablet at breakfast to prescribe.
Fenistil oral drops, solution.
Children under 1 years: 3 to 10 drops, 3 ; x per day (see 'special precautions'), - from 1 to 3 years: 10 to 15 drops, 3 times a day - older than 3 years : 15 to 20 drops, 3 times a day - adolescents and adults: 20 to 40 drops, 3 times a day. 20 drops = 1 ml = 1 mg dimetindeenmaleaat. The treaties do not Fenistil drops high temperatures. The drops at the last moment add the lukewarm bottle. For babies who are already eating with the spoon, the drops blended into a coffee spoon are administered, because the drops have a pleasant taste. Regarding the sensitivity, large individual variations. If the patient after 3 days of treatment shows no improvement, it is unlikely that the patient can be helped by this therapy.
This is a medicine, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
Hypersensitivity to any component of the product. - Premature infants and children younger than 1 Mon - Hypertrophy of the prostate. - Bladder Obstruction. - Cardiac Arrhythmias.
As with all antihistamines, caution is required if administered to patients with Fenistil: - glaucoma - bladder neck obstruction (eg prostatic hypertrophy) - peptic ulcer - pyloroduodenal obstruction - cardiovascular disease - severe hypertension - hyperthyroidism - asthma.
Caution is also required in children younger than 1 years.
In young children, antihistamines may cause some excitement.
Caution is recommended in case of administration of antihistamines to children younger than 1 years. The sedative effect of antihistamines may be associated with episodes of sleep apnea.
Fenistil drops will be administered only on medical advice to children younger than 1 years, and for the strict indications of a treatment with antihistamines. The recommended dose will not be exceeded.
The oral drops, solution, containing ethanol: 50 mg per ml of ethanol solution, ethanol or 2.5 mg per drop. This is important for patients with liver disorders, alcoholism, epilepsy, disorders or injuries to the brains, and for pregnant women and children. The presence of ethanol, the effect of other medicines or increase.
Pregnancy and lactation:
mutagenicity and reproduction studies have shown that dimetindeenmaleaat no mutagenic activity. In studies in animals showed that dimetindeenmaleaat no teratogenic effect or a detrimental effect of exercise on the embryo and / or fetus. The safe use of Fenistil during pregnancy has not been evaluated in studies in humans. Fenistil should be administered during pregnancy only in cases of absolute necessity and only if the desired effect considering the potential risks.
In studies in animals showed that a very small amount dimetindeenmaleaat and / or its metabolites are excreted in human milk . The use of Fenistil during lactation is therefore not recommended.
Immune: since the marketing of Fenistil were isolated cases of angioneurotic edema, possibly associated with administration of the product, perceived .
central nervous system: a sedative effect, which varies according to individual susceptibility, occurs only at high doses.
in clinical trials were drowsiness sometimes observed, particularly in the early treatment .
Came in rare cases: dizziness, headache and agitation.
Cardiovascular disorders: palpitations.
Respiratory Disorders: isolated cases of respiratory disorders.
Gastro-intestinal disorders: were in rare cases: gastralgie, anorexia, diarrhea, nausea, dry mouth or throat.
Skin Disorders: isolated cases of skin erythema and rash .
Muscular disorders: isolated cases of muscle spasms.
driving and using machines:
Fenistil Like other antihistamines can cause drowsiness and to reduce the reflexes. Caution is required in case of driving a vehicle or perform work requiring action (eg using machines).
In case of overdose, as with most H 1 antihistamines, the following symptoms occur: suppression of the central nervous system sedation (especially in adults), stimulation of the central nervous system with antimuscarinic effects (especially in children) to include: agitation, ataxia, hallucinations, tremors, convulsions, fever or urinary retention. Hypotension, coma and cardiovascular collapse may follow.
Up to now no cases of fatal overdose with Fenistil known.
There is no specific antidote for overdose with antihistamines: the usual emergency measures should be used, including administration of activated charcoal, zoutlaxativa administration, and the usual supportive measures of the cardiovascular system. Stimulants should not be used, vasopressors may be used to treat hypotension.
It means that the sedative effect of central nervous system depressants such as tranquilizers, hypnotics and alcohol, can be strengthened. Concomitant intake of alcohol and Fenistil may lead to a further reduction reflex. Concomitant intake of monoamine oxidase inhibitors, the antimuscarinic effect and the central nervous system suppressant effects of antihistamines increase. The combination of these agents should be avoided. Tricyclic antidepressants or anticholinergics can be combined with an additive antimuscarinic effects of antihistamines lead, with a possible worsening of diseases like glaucoma or urinary retention.
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