FAST RELIEF OF ALLERGIES
24hr CONTROL
Cetrine Allergy 10mg Film-Coated Tablets available in packs of 7s and 30s. Always read the leaflet. ABBREVIATED PRESCRIBING INFORMATION Product Name: Cetrine Allergy 10mg film-coated tablets & 1 mg/ml oral solution. Composition(s): Each tablet contains 10 mg cetirizine dihydrochloride. One ml of the oral solution contains 1 mg cetirizine dihydrochloride. Description(s): White, oblong film-coated tablets, scored on one side. Can be divided into equal halves. Clear, colourless liquid with banana flavour. Indication(s): Tablets: Adults and paediatric patients 6 years and above. Oral solution: Adults and children 2 years and above. Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis (hay fever); relief of symptoms of chronic idiopathic urticaria. Dosage: Tablets: Adults, elderly and children aged 12 years and over: 10 mg once daily. Children from 6 years to 12 years: 5 mg (half a tablet) twice daily. Moderate renal insufficiency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insufficiency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. Children under 6 years: Not recommended. Oral solution: Children aged from 2 to 6 years: 2.5 mg twice daily (2.5 ml oral solution twice daily (half a measuring spoon twice daily)). Children aged from 6 to 12 years: 5 mg twice daily (5 ml oral solution (a full measuring spoon twice daily)). Adults and adolescents over 12 years of age: 10 mg once daily (10 ml oral solution (2 full measuring spoons)). Not recommended in children aged less than 2 years. Moderate renal insufficiency (creatinine clearance CrCl 30-49 ml/min): 5 mg once daily. Severe renal insufficiency (creatinine clearance ≤30 ml/min): 5 mg once every 2 days. In paediatric patients suffering from renal impairment: Adjust dose on an individual basis taking into account the renal clearance of the patient, his age and his body weight. Contraindications: History of hypersensitivity to the active substance, to any of the excipients, piperazine derivatives or hydroxyzine. Severe renal impairment < 10 ml/min creatinine clearance. Warnings and Precautions for Use: Cetirizine may increase risk of urinary retention, therefore caution in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Caution in epileptic patients and patients at risk of convulsions. Discontinue use of cetirizine three days before allergy testing. Pruritis and/or urticaria may occur when cetirizine is stopped, even if the symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. Tablets contain lactose. Oral solution contains sorbitol, propylene glycol, sodium (essentially ‘sodium free’), methyl - & propyl-parahydroxybenzoate. Interactions: Caution is advised when taken concomitantly with alcohol or other CNS depressants. Cetirizine does not potentiate the effect of alcohol (0.5 g/l blood levels). The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. Pregnancy and Lactation: Caution during pregnancy and breast-feeding. Ability to Drive and Use Machinery: Usually non-sedative, patients should take their response to the product into account. In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance. Undesirable Effects: Cetirizine at the recommended dosage has minor adverse effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported which resolves on discontinuation of the drug. Uncommon: Agitation, diarrhoea, pruritus, rash, asthenia, malaise, paraesthesia. See SPC for all adverse reactions. Marketing Authorisation Holder: Rowex Ltd, Bantry, Co. Cork. Marketing Authorisation Number: PA0711/075/002-003. Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: rowex@rowa-pharma.ie Legal Category: Not subject to medical prescription. Date of Preparation: March 2021 Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie
Date of preparation: (04-22) CCF: 24955
Supply status: Supply through pharmacies only.
