Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Temazepam
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
N05CD; N05CD07
Temazepam
20 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; temazepam
Marketed
1993-12-13
NORTEM 10 MG TABLETS NORTEM 20 MG TABLETS Temazepam PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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. IN THIS LEAFLET: 1. WHAT NORTEM TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE NORTEM TABLETS 3. HOW TO TAKE NORTEM TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NORTEM TABLETS 6. FURTHER INFORMATION 1. WHAT NORTEM TABLETS ARE AND WHAT THEY ARE USED FOR Nortem Tablets contain temazepam as the active ingredient. Temazepam is an anti-anxiety drug which is used in the short-term to help people sleep. It belongs to a group of drugs called benzodiazepines. Nortem Tablets are used for: short-term treatment of insomnia (difficulty in sleeping) which is severe, disabling or causing extreme distress pre-medication before minor surgery or other procedures. 2. BEFORE YOU TAKE NORTEM TABLETS DO NOT TAKE NORTEM TABLETS IF YOU: are allergic (hypersensitive) to temazepam or other benzodiazepines (e.g. diazepam) or any of the other ingredients of this medicine have difficulty in breathing or lung problems have a condition called sleep apnoea syndrome (where breathing stops during sleep) have myasthenia gravis (a condition where the muscles become weak and tire easily) have severe liver problems TAKE SPECIAL CARE WITH NORTEM TABLETS TALK TO YOUR DOCTOR BEFORE YOU START TO TAKE THIS MEDICINE IF YOU: have long-term lung problems (taking Nortem Tablets may cause fatal breathing problems) have kidney problems have liver problems (taking Nortem Tablets may cause a disease of the brain) have a history of pro Izlasiet visu dokumentu
Health Products Regulatory Authority 07 December 2018 CRN008JZ3 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortem 20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg of temazepam. Excipients: Each tablet contains 280.0mg lactose, anhydrous. For a full a list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to pale yellow, flat bevel-edged tablets with a breakline on one side, 5K2 on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a hypnotic for the short-term management of insomnia only when it is severe, disabling or subjecting the individual to extreme distress. For pre-medication prior to minor surgery or other related procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral The treatment period should be of the shortest duration possible. This may vary from a few days to two weeks with a maximum (including tapering off) of four weeks. The dose reduction process should be tailored to the individual. In certain cases extension beyond the maximum treatment period may be necessary; if this is the case it should not take place without re-evaluation of the patient's status. The product should be taken on retiring or up to 30 minutes before going to bed. Health Products Regulatory Authority 07 December 2018 CRN008JZ3 Page 2 of 10 DOSAGE Insomnia Adults: 10 ‑ 20 mg. In exceptional circumstances, the dose may be increased to 30 ‑ 40 mg. Elderly: 10 mg. In exceptional circumstances, the dose may be increased to 20 mg. Pre-medication: The usual dose is 20 ‑ 40 mg 30 to 60 minutes before the procedure. Children: Not recommended for use in children. Treatment should be started with the lowest, recommended dose. The maximum dose should not be exceeded. Patients suffering from renal or hepatic impairment should receive a reduced dose. 4.3 CONTRAINDICATIONS Myasthenia Gravis. Hypersensitivity to temazepam, benzodiazepines or to any of the excipients. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepat Izlasiet visu dokumentu