Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pentazocine hydrochloride
DE Pharmaceuticals
N02AD01
Pentazocine hydrochloride
25mg
Oral tablet
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04070200
130x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Pentazocine, Tablets, 25 mg, 28s - UK 130x210 (Reel Fed) 50985590 Leaflet for Bottles 7184 RH 16-12-19 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GTIN 13 (Belgium & Slovenia): EU-Artwork-Support@accord-healthcare.com PENTAZOCINE HYDROCHLORIDE 25MG 28 TABLETS PIL - UK Black Profile BBBA7195 S.Anson 03.01.20 07.01.20 S.Anson 130 x 210 7pt Accord Barnstaple n/a n/a 2 Version 6 12.12.2019 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) PENTAZOCINE 25MG TABLETS (Pentazocine Hydrochloride) PACKAGE LEAFLET: INFORMATION FOR THE PATIENT THIS MEDICINE CONTAINS PENTAZOCINE HYDROCHLORIDE WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT PENTAZOCINE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PENTAZOCINE TABLETS 3 HOW TO TAKE PENTAZOCINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PENTAZOCINE T Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PENTAZOCINE TABLETS BP 25mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg Pentazocine Hydrochloride BP. Excipient(s) with known effect: Each tablet contains 200.00mg lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM White uncoated tablets. White, circular, biconvex uncoated tablets impressed “C” and the identifying letters “PZ” on one face. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of moderate to severe pain. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with pentazocine hydrochloride in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). Posology The dosage is usually tailored to the individual patient and to the severity of the pain. _ _ _Adults_ The usual initial dosage is two 25 mg tablets (50mg) every four hours after meals followed by 25mg to 100mg of pentozocine every three to four hours. _ _ _Elderly _ Since impaired renal or hepatic function is often associated with ageing, elderly patients may require smaller doses of pentazocine. _ _ _Paediatric population _ _6-12 years:_ One 25mg tablet every three to four hours as necessary. Pentazocine tablets are not recommended for children under 6 years of age. No data are available. Method of administration For oral use. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Pentazocine should not be administered to patients with established respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion - Acute alcoholism - Acute bronchial asthma - Heart failure secondary to chronic lung disease - Porphyria - Raised intracranial pressure, head injuries or pathological brain conditions where clouding of the sensorium is undesirable. 4.4. SPECIA Đọc toàn bộ tài liệu