FENISTIL Oral drops, solution Ref.[51023] Active ingredients: Dimetindene

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: GlaxoSmithKline Καταναλωτικά Προϊόντα Υγείας Ελλάς Μονοπρόσωπη Ανώνυμη Εταιρεία, διακριτικός τίτλος «GSK CH Ελλάς Μονοπρόσωπη Α.Ε.», 274 Kifissias Ave. , Halandri, 152 32 Athens, Greece Tel.: 210 6882100 ...

4.1. Therapeutic indications

To relieve the symptoms of seasonal and perennial allergic rhinitis, vasomotor rhinitis and allergic conjunctivitis, skin reactions, urticaria, angioedema, dermografism.

4.2. Posology and method of administration

 Posology
mg
Syrup
(1,0mg/1ml = approximately 20 drops)
Administration
Frequency
3 times a day 3 times a day
Children aged 1-3 years 0,5mg-0,75mg 10-15 drops
Children aged 3-12 years 0,75mg-1,00mg 15-20 drops
Adolescents and
Adults
1,0 mg-2,0mg 20-40 drops

4.9. Overdose

In case of overdose poisoning, the clinical condition of the patient indicates three phases: depression, agitation and coma with impaired cardiopulmonary function. CNS stimulation and anticholinergic reactions occur more often in children than in adults, while CNS depression with somnolence, occur mainly in adults.

The following symptoms may also occur: depression, fatigue, dizziness, headache, tinnitus, paleness and erythema with face edema.

Dry mouth, hypotension or hypertension, tonic clonic spasms, mydriasis, hallucinations, ataxia, blurred vision, diplopia.

With very large doses: coma and impaired cardiovascular operation.

There is no specific antidote for overdose with antihistamines. The usual emergency assistance must be undertaken, including activated charcoal, saline laxative and usual cardio-respiratory supportive measures. Stimulants should not be used; vasopressors may be used to treat hypotension.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 25°C. After use to be kept in the initial package.

6.5. Nature and contents of container

Amber glass bottle with a polyethylene dropper and a polypropylene guarantee cap, which contains 10 or 20 ml.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

It must not be exposed to high temperatures. The dose is administrated insoluble with the spoon. It has a pleasant taste.

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