Fenistil ®

Antipruritic, antihistaminic, antiallergic

Fenistil contains:
Syrup:
100ml contain: Active principle: Dimethindene maleate (DCI) 0.01g; Excip. q.s.
Drops:
100ml contain: Active principle: Dimethindene maleate (DCI) 0.1g; Conserv.: Excip. q.s.
Coated tablets:
1 tablet contains: Active principle: Dimethindene maleate (DCI) 1mg; Excip. q.s. ad compr. obd.
1 capsule contains:
Active principle: Dimethindene maleate (DCI) 4mg; Acidum glutamicum, Excip.
Once daily
What is Fenistil used for?

Fenistil is a potent antipruritic antihistamine, characterized by the small size of its effective dose and its rapidity of action. Its effect sets in after 20 to 60 minutes and lasts several hours. Fenistil drops as well as Fenistil syrup is particularly indicated in paediatric practice.
Fenistil is indicated as symptomatic treatment of allergic reactions: urticaria, allergies of the upper respiratory tract such as hey fever and perennial rhinitis, food and drug allergies; pruritus of various origins, except pruritus due to cholestasis; insect bites. Fenistil is also indicated for pruritus in eruptive skin diseases such as chicken-pox.
Fenistil can be as an adjuvant in eczema and other pruriginous dermatoses of allergic origin.

When must Fenistil not be used?
When the patient is hypersensitive to the active substance.
What precautions are required when using Fenistil?
Observe the customary precautions in case of narrow-angle glaucoma, of urinary retention linked with urethroprostatic disorders and of chronic obstructive pulmonary disorders.
Antihistamines can cause excitation in young children.
Caution is recommended in case of administration of the syrup to children below the age of 1 year: the sedative effect can be associated with episodes of sleep apnea. The administration of Fenistil can impair wakefulness; for concerned patients, caution is recommended in case of car driving or tasks requiring alertness (such as for instance the operation of machines).
Medicines should be kept out of reach of children.
Can Fenistil be used during pregnancy or when breast feeding?
Reproduction studies in animals have not shown any risk for the fetus, but there are no controlled studies in pregnant women. Fenistil should only be used during pregnancy if the treatment is essential and if the expected benefits outweigh the potential hazards.
A study performed in animals has shown that very small amounts of dimethinedene and/or of its metabolites are secreted in the mother،¯s milk. The use of Fenistil is not recommended during breast feeding.

What undesirable side effects can Fenistil have?
Information on undesirable side effects was gathered during clinical trials and from post-marketing surveillance. In clinical trials, the following undesirable side effects were observed:
Frequently: drowsiness, especially at the beginning of treatment and at high dosages (approximately 8% of treated cases).
Occasionally: gastrointestinal disturbances (among them nausea), dryness of the mouth or throat, vertigo, excitation, headaches.
Post-marketing surveillance has reported rare cases of oedema, cutaneous eruptions, muscular spasms and respiratory disturbances which could be linked with the administration of the product.
What else needs to be taken into account?

Dosage:
Average daily dosage (in three doses spread over the day):
Drops:
Infants up to 1 year, 10-30 drops;
Infants of 1 to 3 years, 30-45 drops;
Children over 3 years, 45-60 drops;
Adults, 60-120 drops.
Syrup:

Infants up to 1 year, 1-3 teaspoons;
Infants of 1 to 3 years, 3-4 teaspoons;
Children over 3 years, 4-6 teaspoons;
Adults, 6-12 teaspoons.
Coated tablets:

Adults, 3-6 tablets.

Capsule:
Once Daily

Fenistil = 1 coated tablet
1 teasponful Fenistil syrup = 5ml = 0.5mg
The doctor should determine the optimum dose. In sensitive patients presenting apathy during the day, prescribe 2 coated tablets (or 40 drops) before retiring; 1 tablet (or 20 drops) before breakfast.
Overdosage:

As with other antihistaminic drugs, overdosage can produce the following symptoms: CNS depression accompanied by drowsiness (especially in adults), CNS stimulation and antimuscarinic effects (especially in children) including the following: excitation, ataxia, hallucinations, tonic or clonic spasms, mydriasis, dryness of the mouth, redness of the face, urine retention, fever and tachycardia. Blood hypotension is also possible. In its terminal phase, coma can be aggravated by cardiorespiratory colapse and death.
There has been no report of a fatal outcome of Fenistil overdosage.
There is no specific antidote in case of overdosage with antihistamines. The customary emergency measures should be taken: provocation of vomiting, gastric lavage if vomiting is inefficacious, administration of activated charcoal, saline laxative drugs as well as the usual cardio-respratory assistance. Stimulants should not be used. Vasopressors can be administered to treat hypotension.
Drug Interaction:
The sedative effect of central nervous system depressants, such as that of tranquillizers, hypnotic drugs and alcohol, can be enhanced. The simultaneous ingestion of alcohol can result in a more marked slowing down of reflexes.
The concomitant administration of MAO inhibitors can increase the antimuscarinic and the CNS depressor effect of antihistaminics; the simultaneous use is not recommended. Tricyclic antidepressants and anticholinergic drugs can have an antimuscarinic effect additional to that of antihistaminics, thus increasing the risk of decompensation glaucoma or of urine retention.
Remarks:

Coated tablets: protect from light.
Syrup and drops: protect from light and heat (store below 25°C ).
Packaging:

Coated tablets: 10 coated tablets per pack
Syrup: 100ml bottle
Drops: 15ml bottle