TAVEGIL

Adults 1mg clemastine base (one tablet) night and morning. In individual cases the dose may be increased to 6mg clemastine base daily if necessary (six tablets). Children 1 to 3 years: 250 microgrammes to 500 microgrammes clemastine base (¼ - ½ tablet night and morning.

3 to 6 years: 500 microgrammes clemastine base (½ tablet) night and morning. 6 to 12 years: 500 microgrammes to 1000 microgrammes clemastine base (½ - 1 tablet) night and morning. Use in the elderly No evidence exists that elderly patients require different dosages or show different side effects from younger patients.

Oral administration only.

Maximum duration of use:

Clemastine fumarate should not be used for more than 14 days without consulting a doctor. Do not exceed the recommended dose

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 MedDRA SOC Adverse Reaction Frequency Anaphylactic shock RareImmune system disorders Hypersensitivity reactions Rare Psychiatric disorders Excitability, especially in children Rare Sedation Common Dizziness Uncommon Headache Rare Nervous system disorders Fatigue Common Tachycardia Very rareCardiac disorder Palpitations Very rare Respiratory, thoracic and mediastinal disorders Dyspnoea Rare Abdominal pain Rare Nausea Rare Dry mouth Rare Gastrointestinal disorder Constipation Very rare Skin and Subcutaneous tissue disorders Skin rash Rare General system disorders Asthenia 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. 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). Excipient Warning Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose -galactose malabsorption should not take this medicine.

TAVEGIL is contraindicated in patients with a known hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients. TAVEGIL should not be given to porphyric patients. TAVEGIL should not be given to children below one year of age.