Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydroxyzine hydrochloride
UCB Pharma Ltd
N05BB01
Hydroxyzine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5024091737251
Note: Artwork Studio checks and approves technical accuracy and pre-press suitability of this artwork only. Ensure the artwork has been thoroughly checked for textual accuracy and has been approved as such! Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Straße 10 40789 Monheim, Germany Artwork Studio Date Operator Approver PT Approval Dispatched to Tonnellier Manufacturing Site BRA Artwork Information Fontsize Bodytext 9 pt Linespacing 10 pt Technical Changes Remarks: Product Name Ucerax Print Colours Techn. Colours Aesica Id.-No. black techn. info external Id.-No. CIA74251D / GB-IE Dimensions 180 x 315 mm Operator Nagler Creation Date 03.08.2015 Amended by Nagler Modific. Date 26.08.2015 Edition No. 04 VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011 R 25 mg film-coated tablets Hydroxyzine dihydrochloride PATIENT INFORMATION LEAFLET_ _ UCERAX ® 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 25 mg film-coated tablets are called Ucerax. IN THIS LEAFLET: 1. What Ucerax is for 2. Before you take Ucerax 3. How to take Ucerax 4. Possible side effects 5. How to store Ucerax 6. Further information. 1. WHAT UCERAX IS FOR Ucerax belongs to the group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain. Ucerax is used to treat: • Anxiety in adults • Itching (pruritus) caused by allergic reactions in adults and children. 2. BEFORE YOU TAKE UCERAX DO NOT TAKE UCERAX IF: • You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Ucerax (listed in section 6) • You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine • You are pre Đọc toàn bộ tài liệu
OBJECT 1 UCERAX 25 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 02-Dec-2015 | UCB Pharma Limited 1. Name of the medicinal product Ucerax 25 mg film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 25 mg of hydroxyzine dihydrochloride For the full list of excipients, see 6.1. 3. Pharmaceutical form White oblong, film-coated tablet with a bisect line 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 H Đọc toàn bộ tài liệu