Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Pregabalin
Wockhardt UK Limited
N03A
Pregabalin
225 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
ANTIEPILEPTICS
Not marketed
2015-10-02
PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN WOCKHARDT 25 MG HARD CAPSULES PREGABALIN WOCKHARDT 50 MG HARD CAPSULES PREGABALIN WOCKHARDT 75 MG HARD CAPSULES PREGABALIN WOCKHARDT 100 MG HARD CAPSULES PREGABALIN WOCKHARDT 150 MG HARD CAPSULES PREGABALIN WOCKHARDT 200 MG HARD CAPSULES PREGABALIN WOCKHARDT 225 MG HARD CAPSULES PREGABALIN WOCKHARDT 300 MG HARD CAPSULES Pregabalin READ ALL 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 is and what it is used for 2. What you need to know before you take pregabalin 3. How to take pregabalin 4. Possible side effects 5. How to store Pregabalin Wockhardt Hard Capsules 6. Contents of the pack and other information 1. WHAT PREGABALIN 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 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 Read the complete document
Health Products Regulatory Authority 14 May 2020 CRN009PZJ Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pregabalin Wockhardt 225 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin. _Excipients with known effect:_ Each hard capsule also contains 24.75 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. Hard capsules, size 1, with a pinkish-orange cap and a white body, with “225” printed in black ink on the body. The capsules contain a 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. Ba Read the complete document