Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Eumedica Pharmaceuticals AG
N02AE01
Buprenorphine hydrochloride
200microgram
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04070200; GTIN: 5054792000378
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER TEMGESIC 200 MICROGRAM Buprenorphine hydrochloride 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. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Temgesic Sublingual Tablets are and what they are used for 2. Before you take Temgesic Sublingual Tablets 3. How to take Temgesic Sublingual Tablets 4. Possible side effects 5. How to store Temgesic Sublingual Tablets 6. Further information 1. WHAT TEMGESIC SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED FOR Temgesic Sublingual Tablets are strong pain killers that help lessen moderate or severe pain. 2. BEFORE YOU TAKE TEMGESIC SUBLINGUAL TABLETS DO NOT TAKE TEMGESIC If you are allergic (hypersensitive) to buprenorphine, to any of the other ingredients of Temgesic Sublingual Tablets (see section 6 ‘Further Information’) or to other opiates (drugs which are morphine – like in their action). TAKE SPECIAL CARE WITH TEMGESIC SUBLINGUAL TABLETS Before starting treatment with Temgesic, contact your doctor if you: Are or have ever been addicted to medicines or substances; Have problems with you liver; Have breathing problems or are taking medicines with may make your breathing slower or weaker. Athletes must be aware that this medicine may cause a postive reaction to ‘anti-doping’tests. TAKING OTHER MEDICINES TEMGESIC SHOULD NOT BE TAKEN WITH: Medicines containing gestodene (a hormone) ; Antibiotic medicines (troleandomycin, rifampicin); Medicines to treat fungal infections (ketoconazole); Medicines for depression (norfluoxetine); Medicines for HIV infection (protease inhibitors: Прочитайте повний документ
OBJECT 1 TEMGESIC 200 MICROGRAM SUBLINGUAL TABLETS Summary of Product Characteristics Updated 31-May-2016 | Indivior UK Limited 1. Name of the medicinal product Temgesic 200 microgram Sublingual Tablets 2. Qualitative and quantitative composition Buprenorphine hydrochloride 216 µg/tablet, equivalent to 200 µg buprenorphine base. 3. Pharmaceutical form Sublingual tablet White to creamy white, circular, biconvex tablets, embossed on one side with L. 4. Clinical particulars 4.1 Therapeutic indications As a strong analgesic for the relief of moderate to severe pain. 4.2 Posology and method of administration Administration by the sublingual route. Adults and children over 12: 1-2 tablets (200-400 micrograms) to be dissolved under the tongue every 6-8 hours or as required. The recommended starting dose for moderate to severe pain of the type typically presenting in general practice is 1 to 2 tablets, 8 hourly. Elderly: There is no evidence that dosage needs to be modified for the elderly. Children under 12 years: Temgesic Sublingual is suitable for use in children under 12 as follows: 16-25 kg (35-55 lb) ½ tablet 25-37.5 kg (55-82.5 lb) ½ - 1 tablet 37.5-50 kg (82.5-110 lb) 1-1 ½ tablets The recommended dose should be administered every 6-8 hours. Sublingual administration is not suitable for children under the age of six years. Temgesic sublingual may be used in balanced anaesthetic techniques at a dose of 400 micrograms. Special populations _Hepatic impairment_ The effects of hepatic impairment on the pharmacokinetics of buprenorphine were evaluated in a postmarketing study. Buprenorphine is extensively metabolized in the liver, and plasma levels were found to be higher for buprenorphine in patients with moderate and severe hepatic impairment compared to healthy subjects. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine. Temgesic should be used with caution in patients with moderate to severe hepatic impairment (See section 5.2). 4.3 Cont Прочитайте повний документ