Zylofen Ketotifen 20mg/100ml syrup 1. NAME OF THE MEDICINAL PRODUCT Zylofen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100ml contains: Ketotifen fumarate 27.6 mg Eq.to ketotifen base 20 mg 3. PHARMACEUTICAL FORM Syrup. Clear colorless solution with sweet taste and fruity odour. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Symptomatic treatment of allergic rhinoconjunctivitis in adults, adolescents and children over 4 years old. 4.2. Dosage and method of administration Reserved for adults and children over 4 years old (over 12 kg) 1 scoop of solution (5 ml = 1 mg of ketotifen) morning and evening. Because of the risk of drowsiness at the start of treatment, an adjustment period of a few days at ½ dose is necessary, administered only in the evening. Specific populations: Elderly patients (65 years and over): There is a priori no need to adjust the dosage in the elderly. Renal failure: No studies have been performed in patients with renal impairment. Given its predominantly urinary elimination (60 to 70%), it is preferable to avoid the use of ketotifen in patients with renal impairment (see section 5.2). Hepatic impairment: No studies have been performed in patients with hepatic impairment. Due to the hepatic metabolism of ketotifen, it is preferable to avoid the use of ketotifen in severe hepatic impairment (see section 5.2). 4.3. Contraindications -Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; -History of epilepsy or seizures -Combination with oral antidiabetics (see sections 4.4. and 4.5.) -Breastfeeding
