Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Pregabalin
Bristol Laboratories Limited
N03AX; N03AX16
Pregabalin
225 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Other antiepileptics; pregabalin
Not marketed
2017-08-04
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PREGABALIN 25 MG CAPSULES, HARD PREGABALIN 50 MG CAPSULES, HARD PREGABALIN 75 MG CAPSULES, HARD PREGABALIN 100 MG CAPSULES, HARD PREGABALIN 150 MG CAPSULES, HARD PREGABALIN 200 MG CAPSULES, HARD PREGABALIN 225 MG CAPSULES, HARD PREGABALIN 300 MG CAPSULES, HARD 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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR Pregabalin 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 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 Page 2 of 10 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 is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will pres Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 27 August 2019 CRN008JGC Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pregabalin 225 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Light orange cap / White body size ‘1’ hard gelatin capsules imprinted with ‘144’ on cap and ‘J’ on body with black ink, filled with white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Neuropathic pain_ Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. _Epilepsy_ Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. _Generalised Anxiety Disorder_ Pregabalin 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 to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. _Epilepsy_ Pregabalin treatment can be started with 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 to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. _Generalised Anxiety Disorder_ The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per d Կարդացեք ամբողջական փաստաթուղթը