Country: United Kingdom
Language: English
Source: myHealthbox
Pregabalin
Milpharm Limited
N03AX16
Pregabalin
200mg
Capsule, hard
Oral use
Blister packs: 14, 21, 30, 56, 60, 84, 90, 100, 112 and 200 capsules; Bottle packs: 30, 200, 250 and 500 capsules
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
Antiepileptics, other antiepileptics
It is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation and for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Authorised
2015-07-16
PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN MILPHARM 25 MG CAPSULES, HARD PREGABALIN MILPHARM 50 MG CAPSULES, HARD PREGABALIN MILPHARM 75 MG CAPSULES, HARD PREGABALIN MILPHARM 100 MG CAPSULES, HARD PREGABALIN MILPHARM 150 MG CAPSULES, HARD PREGABALIN MILPHARM 200 MG CAPSULES, HARD PREGABALIN MILPHARM 225 MG CAPSULES, HARD PREGABALIN MILPHARM 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 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 Milpharm is and what it is used for 2. What you need to know before you take Pregabalin Milpharm 3. How to take Pregabalin Milpharm 4. Possible side effects 5. How to store Pregabalin Milpharm 6. Contents of the pack and other information 1. WHAT PREGABALIN MILPHARM IS AND WHAT IT IS USED FOR Pregabalin Milpharm belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults. EPILEPSY: Pregabalin Milpharm is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults. Your doctor will prescribe Pregabalin Milpharm for you tohelp treat your epilepsy when your current treatment is not controlling your condition. You should take Pregabalin Milpharm in addition to yourcurrent treatment. Pregabalin Milpharm is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment. GENERALISED ANXIETY DISORDER: Pregabalin Milp Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pregabalin Milpharm 200 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 200 mg of pregabalin. _ _ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Light orange cap/ Light orange body, size “1” hard gelatin capsule shells, imprinted with ‘Z’ on cap and ‘15’ on body with black ink contains white to off-white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Epilepsy _ Pregabalin Milpharm is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. _ _ _Generalised Anxiety Disorder _ Pregabalin Milpharm 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. _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 day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week. _Discontinuation of pregabalin _ In accordance with current Read the complete document