Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tramadol hydrochloride
NorthStar Healthcare Unlimited Company
N02AX02
Tramadol hydrochloride
50mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04070200; GTIN: 5051089990657 5051089990664
350x210 Leaflet Reel Fed Profile Landscape (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Tramadol Hydrochloride Capsules 50mg x 30, 100 (UK) 350x210 (Reel Fed) 50988803 Leaflet for Blisters 3737 T. Hull 28/02/20 * 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. EU-Artwork-Support@accord-healthcare.com TRAMADOL 50MG CAPSULES BLISTER PACK PIL - UK Black Profile BBBA7635 NM 02/03/2020 22/04/2020 NM 350 x 210 (Reel Fed) 9 pts Accord Barnstaple NA 05 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): NA Cartons and label leaflets only (labels only when specified) page 1 page 4 50988803 BBBA7635 THIS MEDICINE CONTAINS TRAMADOL 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in the leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT TRAMADOL CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL CAPSULES 3 HOW TO TAKE TRAMADOL CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE TRAMADOL CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT TRAMA Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol Hydrochloride 50mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg tramadol hydrochloride (equivalent to 43.9 mg of tramadol base) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol capsules are indicated for the management (treatment and prevention) of moderate to severe pain. _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Posology As with all analgesic drugs, the dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. A total daily oral dose of 400 mg should not be exceeded, except in special circumstances. Unless otherwise prescribed, tramadol should be administered as follows: Adults and children aged 12 years and over _Acute pain: _ An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 or 100 mg at 4 – 6 hourly, intervals, and the duration of treatment should be matched to clinical need (see section 5.1). _Pain associated with Chronic Conditions: _ An initial dose of 50 mg is advised and then titrate dose according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (see section 4.4). Paediatric population Tramadol capsules are not suitable for children below the age of 12 years. Older people A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirement. _Renal insufficiency/dialysis and hepatic impairment _ In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage int Izlasiet visu dokumentu