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 ...
Hypersensitivity to any of the excipients or to alkylamines Breastfeeding mothers. Children less than one year of age.
Contraindicated in patients taking MAO inhibitors or who have narrow angle glaucoma, stenosis of the pylorus or duodenum, symptomatic prostatic hypertrophy or bladder neck obstruction.
Caution is recommended in patients with increased intraocular pressure, hyperthyroidism, hypertension, cardiovascular disease, asthma.
In young children, antihistamines have been reported to possibly produce excitability.
In case of administration of any antihistamine in infants aged less than 1 year: the sedative effect may be associated with episodes of sleep apnoea.
The sedative effect of dimetindene maleate increases with the simultaneous administration of alcohol or other CNS depressants. Dimetindene maleate increases the activity of epinephrine.
The anticholinergic activity of dimetindene maleate increases with the simultaneous administration of MAO inhibitors, tricyclic antidepressants and anticholinergics. Concurrent use is not recommended.
Animal studies with orally administrated dimetindene maleate indicate no teratogenicity or other adverse effects on the fetus.
No safety data for use during human pregnancy have been established, especially during the first trimester and therefore not recommended for use. The medicine is only administrated when treatment is necessary and the expected benefit outweighs the potential risk to the fetus.
A study in animals has shown that very small amounts of dimethindene and/or its metabolites are excreted in breast milk. The use of Fenistil is nevertheless not recommended during breast feeding.
In general, dimetindene carries suppressive effect on the CNS. Fenistil may cause somnolence or slow reflexes. There is a risk because of decreased reaction to people who drive vehicles or operate machinery, and must be careful.
The most commonly reported side effects are: somnolence, CNS depression, dry mouth, nose and throat, drainage of bronchial secretions, dizziness, impaired mobility, and gastrointestinal upset.
The following side effects may also occur: weakness, irritability, confusion, insomnia, restlessness, hallucinations, hysteria, blurred vision, diplopia, vertigo, convulsions, peripheral neuritis, headache, palpitations, tachycardia, pressure drop, loss of appetite, weight gain, nausea, vomiting, diarrhoea, constipation, thrombocytopenia, leukopenia, agranulocytosis, pancytopenia. Also, urinary frequency, urinary retention, decreased sexual activity, impotence, rash, photosensitivity, anaphylactic reaction, haemolytic anemia. Overdose, especially in children, can cause the clinical syndrome condition of atropinism.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs or Fax: +357 22608649.
Not applicable.
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