Država: Malta
Jezik: engleski
Izvor: Medicines Authority
LORAZEPAM
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N05BA06
LORAZEPAM 0.5 mg
TABLET
LORAZEPAM 0.5 mg
POM
PSYCHOLEPTICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-02-03
- 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LORANS 0.5 MG TABLETS LORANS 1 MG TABLETS LORANS 2.5 MG TABLETS lorazepam 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Lorans is and what it is used for 2. What you need to know before you take Lorans 3. How to take Lorans 4. Possible side effects 5. How to store Lorans 6. Contents of the pack and other information 1. WHAT LORANS IS AND WHAT IT IS USED FOR The name of your medicine is Lorans, called lorazepam or lorazepam tablets in the rest of the leaflet. The tablets contain lorazepam. The active ingredient is lorazepam, which is a type of medicine called a benzodiazepine. It relieves anxiety and it is used for short periods to relieve anxiety that is severe, disabling, or causing you extreme distress, and to treat difficulties sleeping that are caused by anxiety. It may also be used as a sedative shortly before a dental or surgical operation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORANS DO NOT TAKE LORANS - if you are allergic to lorazepam, or to any other benzodiazepine, or any of the other ingredients of this medicine (listed in section 6). - you have severe breathing or chest problems - you have very tired or very weak muscles, a condition called myasthenia gravis - you have serious liver problems - you suffer from breathing problems when you are asleep, a condition called sleep apnoea - you have a history of persistently abusing alcohol and / or drugs - 2 - you are breast feeding, as lorazepam may pass into breast milk (see P Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lorans 0.5 mg tablets Lorans 1 mg tablets Lorans 2.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lorazepam 0.5 mg. Each tablet contains lorazepam 1 mg. Each tablet contains lorazepam 2.5 mg. Excipient with known effect: lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Lorans 0.5 mg: White, round with rounded edge tablets, diameter about 4.7 mm. Lorans 1 mg: white, round, flat, bevelled, scored tablets, with “1.0” inscription, diameter about 6.4 mm. The tablet can be divided into equal doses. Lorans 2.5 mg: white, round, flat, bevelled, scored, tablets, diameter about 9.1 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorans is indicated for: Short-term symptomatic treatment of anxiety and insomnia caused by anxiety, where the anxiety is severe, disabling or subjecting the individual to extreme distress. Premedication before general anaesthesia or before minor surgical procedures, investigations or operative dentistry. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 2 Posology _General: _ The dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. Since the risk of withdrawal and rebound phenomena is greater after abrupt withdrawal, the drug should be discontinued gradually for all patients (see section 4.4). The maximum daily dose of 4mg should not be exceeded. In general the duration of treatment varies from a few days to 4 weeks, including the tapering off process. Extension of the treatment period should not take place without re-evaluation of the need for continued therapy. If the daily dose is taken as single dose in the evening it should not be taken on a full stomach. Due to a delayed onset of effect and depending on the length of the sleeping period a hang-over effect might be possible during the following day (see Sect Pročitajte cijeli dokument