Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lormetazepam
Waymade Healthcare Plc
N05CD06
Lormetazepam
1mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010100
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER LORMETAZEPAM 1MG TABLETS Your medicine is called Lormetazepam 1mg Tablets but throughout this leaflet they will be referred to as Lormetazepam Tablets. Lormetazepam Tablets are available in strengths of 0.5mg & 1mg. 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 get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Lormetazepam Tablets are and what they are used for 2. Before you take Lormetazepam Tablets 3. How to take Lormetazepam Tablets 4. Possible side-effects 5. How to store Lormetazepam Tablets 6. Further information 1. WHAT LORMETAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Lormetazepam Tablets. Lormetazepam is a member of a group of medicines called benzodiazepines. Lormetazepam is used for short-term therapy to help with sleeping difficulties which are significantly affecting your normal daily life. 2. BEFORE YOU TAKE LORMETAZEPAM TABLETS WARNINGS AND PRECAUTIONS: Talk to your doctor before using Lormetazepam Tablets: if you have severe breathing or chest problems if you are allergic to benzodiazepines or any of the other ingredients in Lormetazepam Tablets (see list under ‘What Lormetazepam Tablets contain’) if you have myasthenia gravis (very weak or tired muscles) if you have serious liver problems if you suffer from sleep apnoea (breathing problems when you are asleep) if you are breastfeeding, since the drug may pass into breast milk. TAKE SPECIAL CARE WITH LORMETAZEPAM TABLETS: if you are pregnant, or trying to become pregnant (see below) if you abuse or have in the past a Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lormetazepam 1 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.00 mg of lormetazepam _Excipients with known effect:_ Each tablet contains 86.40 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Round white tablets, scored on one side. The tablet can be divided into equal doses. Round white tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. Generally, it varies from a few days to two weeks with a maximum period, including gradual reduction, of four weeks. Adults: 0.5mg to 1.5mg before retiring. Subsequently the initial dosage may be increased to 2 mg in individual cases if this proves necessary. Elderly: The lower adult dose is preferable for elderly patients. _Paediatric population _ Lormetazepam must not be used in children and adolescents under 18 years of age without a careful assessment of the need for the treatment. For patients with mild to moderate chronic respiratory insufficiency or hepatic insufficiency a dose reduction should be considered. The tablets should be taken with a small amount of liquid before going to bed. 4.3 CONTRAINDICATIONS Lormetazepam is contraindicated in patients with: • Hypersensitivity to benzodiazepines or to any of the excipients of Lormetazepam tablets • Myasthenia gravis • Severe respiratory insufficiency (for example, severe chronic obstructive pulmonary disease), sleep apnoea syndrome. • Acute intoxication with alcohol, hypnotics, analgesics or psychotropic drugs (neuroleptics, antidepressants, lithium). • Severe liver insufficiency. Pregnancy and lactation (see also 4.6 “Fertility, Lesen Sie das vollständige Dokument