TAVEGIL Tablet Ref.[27502] Active ingredients: Clemastine

Antihistamines should be used with caution in patients with:

• narrow-angle glaucoma
• stenosing peptic ulcer
• pyloroduodenal obstruction
• prostatic hypertrophy with urinary retention and bladder neck obstruction.
• children due to the risk of excitability in this special population (see section 4.8)
• epilepsy or history of seizures
• in the elderly, who are more likely to experience adverse effects such as paradoxical excitation. Avoid use in elderly patients with confusion. Do not exceed recommended dosage and duration of use without consulting a health care provider (See Dosage and Administration).

Tavegyl tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

Antihistamines potentiate the sedative effects of Central Nervous System (CNS) depressants including hypnotics, monoamine-oxidase inhibitors (MAOI’s), antidepressants, anxiolytics, opioid analgesics and alcohol.

Patients should be advised to avoid alcoholic drinks.

As clemastine has some anticholinergic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated.

TAVEGIL should not be given during pregnancy and breast-feeding.

TAVEGYL has moderate influence on the ability to drive and use machines, due to the antihistamine sedative effect of clemastine, however, patients should be warned not to take charge of vehicles or machinery until the effect of TAVEGIL treatment on the individual is known.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000) or not known (can not to beestimated from available data). Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be rare or very rare.

Reporting of suspected adverse reactions

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 via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.