País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydroxyzine hydrochloride
UCB Pharma Ltd
N05BB01
Hydroxyzine hydrochloride
2mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5024091737206
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • In this leaflet Ucerax Syrup 10 mg/5 ml is called Ucerax Syrup. IN THIS LEAFLET: 1. What Ucerax Syrup is for 2. Before you take Ucerax Syrup 3. How to take Ucerax Syrup 4. Possible side effects 5. How to store Ucerax Syrup 6. Further information. 1. WHAT UCERAX SYRUP IS FOR Ucerax Syrup belongs to a group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain. Ucerax Syrup is used to treat: • Anxiety in adults • Itching (pruritus) caused by allergic reactions in adults and children. 2. BEFORE YOU TAKE UCERAX SYRUP DO NOT TAKE UCERAX SYRUP IF: • You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Ucerax Syrup (listed in Section 6) • You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine • You are pregnant or breastfeeding • You have a condition called porphyria. (A blood disease that can cause stomach pain, vomiting and mental disturbances such as depression.) • You have a condition known as prolonged QT interval causing irregular heart beat and/or palpitations. • Your ECG (electrocardiogram) shows a heart rhythm problem called “QT interval prolongation” • You have or had a cardiovascular disease or if your heart rate is very low • You have low salt levels in your body (e.g. low level of potassium or of magnesium) • You are taking certain medicines for heart rhythm problems or medicines that may affect the heart rhythm (see “Other medicines and Ucerax Syrup”) • Anyone in your close family has died suddenly of heart problems If any of the above applies to you talk to your doctor or pharmacist. WARNINGS AND PRECAUTIONS Ucerax Syrup m Leia o documento completo
OBJECT 1 UCERAX SYRUP 10MG/5ML Summary of Product Characteristics Updated 02-Dec-2015 | UCB Pharma Limited 1. Name of the medicinal product Ucerax 10 mg/5 ml Syrup 2. Qualitative and quantitative composition Each ml contains 2 mg of hydroxyzine dihydrochloride For the full list of excipients, see 6.1. 3. Pharmaceutical form Syrup. Clear, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Ucerax is indicated to assist in the management of anxiety in adults. Ucerax is indicated to assist in the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and in atopic and contact dermatosis in adults and children. 4.2 Posology and method of administration Posology Ucerax should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day. Anxiety. 50 mg/day in 3 separate administrations of 12.5-12.5-25mg. In more severe cases, doses up to 100mg/day can be used. Pruritus. Starting dose of 25 mg at night, increasing as necessary to 25 mg three or four times daily. Special populations The dosage should be adjusted according to the patient's response to therapy. Older People In the elderly, it is advised to start with half the recommended dose due to the prolonged action. In the elderly, the maximum daily dose is 50 mg per day (see section 4.4). Patients with hepatic impairment In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%. Patients with Renal impairment Dosage should be reduced in patients with moderate or severe renal impairment due to decreased excretion of its metabolite cetirizine. Paediatric population: In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day. In children over 40 kg in weight, the maximum daily dose is 100 mg per day. Children aged from 12 months: 1mg/kg/day up to 2mg/kg/day in divided doses. 4.3 Contraindications Hypersensitivity to the active substance or to any of th Leia o documento completo