Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Pregabalin
Pinewood Laboratories Ltd
N03AX16
Pregabalin
Capsule, hard
pregabalin
Marketed
2022-10-21
PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN PINEWOOD 25 MG HARD CAPSULES, PREGABALIN PINEWOOD 50 MG HARD CAPSULES, PREGABALIN PINEWOOD 75 MG HARD CAPSULES, PREGABALIN PINEWOOD 100 MG HARD CAPSULES, PREGABALIN PINEWOOD 150 MG HARD CAPSULES, PREGABALIN PINEWOOD 200 MG HARD CAPSULES, PREGABALIN PINEWOOD 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 further questions, ask your doctor or your 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 Pinewood is and what it is used for 2. What you need to know before you take Pregabalin Pinewood 3. How to take Pregabalin Pinewood 4. Possible side effects 5. How to store Pregabalin Pinewood 6. Contents of the pack and other information 1. WHAT PREGABALIN PINEWOOD IS AND WHAT IT IS USED FOR Pregabalin Pinewood 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 Pinewood 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 Pinewood is used to treat a certain form of epilepsy (partial seizures with or withou Belgenin tamamını okuyun
Health Products Regulatory Authority 30 March 2023 CRN00DDLF Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pregabalin Pinewood 100 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pregabalin Pinewood 100 mg hard capsules: Each capsule contains 100 mg of pregabalin. Excipient(s) with known effect Each capsule contains 11 mg of lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pregabalin Pinewood 100 mg hard capsules: Size no. 3 hard capsules with maroon cap and maroon body, with approximate length of 16 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Neuropathic pain_ Pregabalin Pinewood is indicated for the treatment of peripheral and central neuropathic pain in adults. _Epilepsy_ Pregabalin Pinewood is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. _Generalised Anxiety Disorder_ Pregabalin Pinewood 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 Belgenin tamamını okuyun