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20 ml X 1 mg/ml (0.05 mg/drop)
Adults and adolescents over 12 years of age: The daily recommended dose is 3 to 6 mg of dimethindene maleate divided into 3 doses; this corresponds to: 20-40 drops, 3x per day.
In patients with a tendency to drowsiness, it is recommended to prescribe 40 drops before bedtime, and 20 drops in the morning at breakfast.
Children: In small children from 1 month to 1 year of age, Fenistil Drops should only be used according to a doctor’s recommendations and upon strict medical indication for antihistamines. The recommended dose should not be exceeded.
Caution should be used when administering drops to children under 1 year of age. The sedative effect may be associated with episodes of sleep apnoea.
The recommended daily dose is 0.1 mg/kg of body weight per day (this corresponds to 2 drops per kg of body weight per day, divided into 3 doses).
The usual daily doses for children from 1 month to 12 years of age and based on body weight, are therefore the following: See prescribing information for full details.
Fenistil Drops cannot withstand high temperatures; before feeding pour them directly into a warm feeding bottle. If the baby is already eating with a spoon, give the drops in a teaspoon.
Antipruritic, antihistaminic and antiallergic.
Hypersensitivity to the active substance or to one of the excipients in the composition.
Neonates under 1 month old, in particular premature babies.
Follow the usual precautions in case of glaucoma, urinary retention, for example
associated with prostatic hypertrophy, chronic obstructive pulmonary disease.
Like all H1 and H2 receptor agonists, caution should be used in patients with epilepsy.
Antihistamines may cause excitation in young children.
Use in young children from 1 month to 1 year of age: Caution should be used when administering drops to children under 1 year of age: the sedative effect may be associated with episodes of sleep apnoea.
In small children from 1 month to 1 year of age, Fenistil Drops should only be
administered after a medical consultation and upon strict medical indication for
antihistamines. The recommended dose should not be exceeded.
Undesirable effects are, in particular, drowsiness occurring in particular at the start of treatment. Allergic reactions occur very rarely.
See prescribing information for full details.
It is expected that the concomitant use of two or more medicinal products with a sedative effect on the central nervous system leads to increased depression of the CNS. This may have adverse, even fatal consequences. These medicinal products are, in particular, analgesics (opioids), anticonvulsants, antidepressants (tricyclic antidepressants and MAO inhibitors), antihistamines, anti-emetics, antipsychotics, anxiolytics, hypnotics, scopolamine and alcohol.
Tricyclic antidepressants and anticholinergics (for example, bronchodilators,
gastrointestinal spasmolytics, mydriatics, urological antimuscarinics) may cause an additional antimuscarinic effect with antihistamines, and increase the risk of exacerbation of glaucoma or urinary retention.
In order to reduce the risks of CNS depression or possible potentiation, procarbazine and antihistamines should only be administered concomitantly.
Pregnancy and Lactation
Pregnancy: In animal studies with dimethindene maleate, no teratogenic potential and no direct or indirect toxicity with an impact on pregnancy, embryonic development, the development of the fetus, and/or postnatal development was revealed.
There are no available clinical data concerning use in pregnant women. During
pregnancy, Fenistil Drops should only be used under a strict indication.
Lactation: It is likely that dimethindene maleate is excreted in human milk. Taking Fenistil Drops is not recommended while breastfeeding.
The signs and symptoms of overdose by H1 antihistamines include: depression of the central nervous system accompanied by drowsiness (primarily in adults), stimulation of the central nervous system and antimuscarinic effects (in particular in children) including excitation, tachycardia, ataxia, hallucinations, tonic or clonic seizures, mydriasis, dry mouth, facial redness, urinary retention and fever. Later, hypotension, coma and cardiorespiratory collapse may occur.
There is no specific antidote in case of overdose by antihistamines. The usual
emergency measures should be undertaken: administration of activated charcoal, saline laxatives, as well as the usual cardio-respiratory assistance measures. Stimulants should not be used. Vasopressors may be used to treat hypertension.
Storage: Store away from light and at room temperature (15-25°C).