Država: Malta
Jezik: angleščina
Source: Medicines Authority
Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta
N02BF02
PREGABALIN 165 mg
PROLONGED-RELEASE TABLET
PREGABALIN 165 mg
POM
ANALGESICS
Authorised
2024-03-04
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN ADALVO 82.5 MG PROLONGED-RELEASE TABLETS PREGABALIN ADALVO 165 MG PROLONGED-RELEASE TABLETS PREGABALIN ADALVO 330 MG PROLONGED-RELEASE TABLETS pregabalin 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 Pregabalin Adalvo is and what it is used for 2. What you need to know before you take Pregabalin Adalvo 3. How to take Pregabalin Adalvo 4. Possible side effects 5. How to store Pregabalin Adalvo 6. Contents of the pack and other information 1. WHAT PREGABALIN ADALVO IS AND WHAT IT IS USED FOR Pregabalin Adalvo belongs to a group of medicines used to treat neuropathic pain in adults. Pregabalin Adalvo is used to treat long lasting pain caused by damage to the nerves. A variety of diseases can cause peripheral neuropathic pain, such as diabetes or shingles. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREGABALIN ADALVO DO NOT TAKE PREGABALIN ADALVO If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Pregabalin Adalvo. - Some patients taking Pregabalin Adalvo have Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Adalvo 82.5 mg prolonged-release tablets Pregabalin Adalvo 165 mg prolonged-release tablets Pregabalin Adalvo 330 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Pregabalin Adalvo 82.5 mg prolonged-release tablets _ Each prolonged-release tablet contains 82.5 mg of pregabalin. _Pregabalin Adalvo 165 mg prolonged-release tablets _ Each prolonged-release tablet contains 165 mg of pregabalin. _Pregabalin Adalvo 330 mg prolonged-release tablets _ Each prolonged-release tablet contains 330 mg of pregabalin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet _Pregabalin Adalvo 82.5 mg prolonged-release tablet _ White, oval, unscored tablet, blank on one side and imprinted “ALV 379” in black ink on the other side with a length of 19 mm, a width of 12 mm and thickness of approximately 7 mm. _Pregabalin Adalvo 165 mg prolonged-release tablet _ Yellow, oval, unscored tablet, blank on one side and imprinted “ALV 380” in black ink on the other side with a length of 19 mm, a width of 12 mm and thickness of approximately 7 mm. _ _ _Pregabalin Adalvo 330 mg prolonged-release tablet _ Pink, oval, unscored tablet, blank on one side and imprinted “ALV 381” in black ink on the other side with a length of 19 mm, a width of 12 mm and thickness of approximately 8 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pregabalin Adalvo is indicated for the treatment of peripheral and central neuropathic pain in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose range is 165 to 660 mg per day given once daily directly after an evening meal. Treatment with pregabalin prolonged release for neuropathic pain can be started at a dose of 165 mg per day given once daily directly after an evening meal and can be increased to 330 mg given once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of pregabalin prolong Preberite celoten dokument