Kraj: Malta
Język: angielski
Źródło: Malta Medicines Authority
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
N03AX16
PREGABALIN 25 mg
HARD CAPSULE
PREGABALIN 25 mg
POM
ANTIEPILEPTICS
Authorised
2024-02-28
mt-pl-pregabalin-remedica-caps-a0 Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PREGABALIN REMEDICA 25 MG HARD CAPSULES PREGABALIN REMEDICA 75 MG HARD CAPSULES PREGABALIN REMEDICA 150 MG HARD CAPSULES PREGABALIN REMEDICA 300 MG HARD CAPSULES 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 Remedica is and what it is used for 2. What you need to know before you take Pregabalin Remedica 3. How to take Pregabalin Remedica 4. Possible side effects 5. How to store Pregabalin Remedica 6. Contents of the pack and other information 1. WHAT PREGABALIN REMEDICA IS AND WHAT IT IS USED FOR Pregabalin Remedica contains the active substance called pregabalin. It belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: Pregabalin Remedica 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. EPILEPSY: Pregabalin Remedica is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) i Przeczytaj cały dokument
mt-spc-pregabalin-remedica-caps-v01-r00-a0 page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pregabalin Remedica 25 mg hard capsules Pregabalin Remedica 75 mg hard capsules Pregabalin Remedica 150 mg hard capsules Pregabalin Remedica 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Remedica 25 mg hard capsules: Each hard capsule contains 25 mg of pregabalin. Pregabalin Remedica 75 mg hard capsules: Each hard capsule contains 75 mg of pregabalin. Pregabalin Remedica 150 mg hard capsules: Each hard capsule contains 150 mg of pregabalin. Pregabalin Remedica 300 mg hard capsules: Each hard capsule contains 300 mg of pregabalin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. Pregabalin Remedica 25 mg hard capsules: White hard capsules printed with ‘25’ marked on the body. Pregabalin Remedica 75 mg hard capsules: White and orange hard capsules printed with ‘75’ marked on the body. Pregabalin Remedica 150 mg hard capsules: White hard capsules printed with ‘150’ marked on the body. Pregabalin Remedica 300 mg hard capsules: White and orange hard capsules printed with ‘300’ marked on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuropathic pain Pregabalin Remedica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Remedica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. mt-spc-pregabalin-remedica-caps-v01-r00-a0 page 2 of 18 Generalised anxiety disorder Pregabalin Remedica is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. _Neuropathic pain_ Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased Przeczytaj cały dokument