Država: Malta
Jezik: engleski
Izvor: Medicines Authority
LORAZEPAM
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
N05BA06
LORAZEPAM 2 mg
TABLET
LORAZEPAM 2 mg
POM
PSYCHOLEPTICS
Authorised
2007-02-28
mt-pl-lorivan-2mg-tabs-a3 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LORIVAN 2 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lorivan is and what it is used for 2. What you need to know before you take Lorivan 3. How to take Lorivan 4. Possible side effects 5. How to store Lorivan 6. Contents of the pack and other information 1. WHAT LORIVAN IS AND WHAT IT IS USED FOR Lorivan contains the active substance lorazepam. Lorivan is a member of a group of medicines called benzodiazepines. It can help to relieve anxiety. Lorivan may be prescribed as short-term therapy for anxiety or sleeping difficulties due to anxiety which is significantly affecting normal daily life. It may also be used as a sedative before surgery or operative dental treatment. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORIVAN DO NOT TAKE LORIVAN • if you are allergic to lorazepam or any of the other ingredients of this medicine (listed in section 6). • if you have severe breathing or chest problems. • 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). mt-pl-lorivan-2mg-tabs-a3 2 If any of the above apply to you, do not take Lorivan. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lorivan. • if you are pregnant or trying to become pregnant. • if you abuse or have Pročitajte cijeli dokument
mt-spc-lorivan-2mg-tabs-v04-r00-a2 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT Lorivan 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lorazepam 2 mg. Excipient(s) with known effect This product contains 60.1 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Yellow, flat, scored tablets. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorivan is indicated for the short-term treatment of unacceptable disabling or distressful anxiety states including anxiety associated with psychosomatic, organic and psychotic illness and the short-term treatment of insomnia associated with anxiety. Lorivan is also used as premedication before operative dentistry and general surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually for all patients (see section 4.4). Generally, 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. Increases in the dosage of lorazepam should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses. mt-spc-lorivan-2mg-tabs-v04-r00-a2 Page 2 of 12 _Adults _ Moderate and severe anxiety: 1-4mg daily in divided doses Insomnia: 1-2mg before retiring Premedication before operative dentistry or general surgery: 2-3mg the night before operation 2-4mg one to two hours before operation _Elderly and debilitated patients _ _ _ For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated (see section 4.4 Special warni Pročitajte cijeli dokument