MYLAN Cetirizine, Cetirizina 10 mg 7 MYLAN

“Composition:
One film-coated tablet contains cetirizine dihydrochloride 10 mg. Contains lactose monohydrate. For a full list of excipients, see section 6.1.
Excipients
Tablet core: lactose monohydrate, pregelatinized corn starch, povidone K29/32, magnesium stearate. Tablet shell: Talc Opadry Y-1-7000, titanium dioxide (E171), hypromellose 5cP (E464), macrogol 400,

Therapeutic indications
Adults and adolescents over 12 years of age: symptomatic treatment of allergic rhinitis (seasonal and perennial) associated with allergic conjunctivitis and chronic idiopathic urticaria. Children aged 6-12 years: symptomatic treatment of allergic rhinitis (seasonal and perennial) and chronic idiopathic urticaria.

Contraindications
Hypersensitivity to cetirizine or any of the excipients of the drug, as well as to other piperazine derivatives. Cetirizine 10 mg tablets are contraindicated in children under six years of age. Patients with severe renal insufficiency.

Dosage
Generic Cetirizine Milan should be taken with liquid, without chewing, preferably in the evening. Adults and adolescents over 12 years: one tablet per day. Children aged 6-12 years weighing less than 30 kg: ½ tablet (5 mg) once a day. Children aged 6–12 years weighing 30 kg or more: 1 tablet (10 mg) once daily or ½ tablet (5 mg) twice daily (morning and evening). The duration of treatment in children is 2–4 weeks. Clinical studies in children did not exceed 4 weeks. Cetirizine is contraindicated in patients with severe renal impairment. In patients with moderate renal impairment, the dose should be increased to 5 mg (½ tablet daily). Caution is advised in patients with mild to moderate renal impairment or liver impairment. (See section 4.4). There is no evidence that dosage adjustment is necessary in healthy elderly individuals. The duration of treatment may vary depending on symptoms. 3–6 weeks are usually sufficient for the treatment of hay fever. Clinical experience with cetirizine dihydrochloride in chronic urticaria or chronic allergic rhinitis is 1 year.”