Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Pregabalin
Basics GmbH
N03AX16
Pregabalin
Oral solution
pregabalin
Not marketed
2022-01-28
PACKAGE LEAFLET: INFORMATION FOR THE USER PREGABALIN BASICS 20 MG/ML ORAL SOLUTION 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, pharmacist or nurse - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What PREGABALIN BASICS is and what it is used for 2. What you need to know before you take PREGABALIN BASICS? 3. How to take PREGABALIN BASICS? 4. Possible side effects 5. How to store PREGABALIN BASICS? 6. Contents of the pack and other information 1. WHAT PREGABALIN BASICS IS AND WHAT IT IS USED FOR PREGABALIN BASICS 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 BASICS 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 BASICS is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation-epileptic fits starting on one specific part of the brain) in adults. Your doctor will prescribe PREGABALIN BASICS for you to help treat your epilepsy when your current treatment is not controlling your condition. You should Lestu allt skjalið
Health Products Regulatory Authority 15 March 2024 CRN00F28H Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PREGABALIN BASICS 20 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 20 mg of pregabalin. Excipients with known effect: Each ml contains 2.0 mg of methyl parahydroxybenzoate (E218). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuropathic pain PREGABALIN BASICS is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy PREGABALIN BASICS is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder PREGABALIN BASICS 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 (7.5 to 30 ml) per day given in either two or three divided doses. _ _ _Neuropathic pain_ Pregabalin treatment can be started at a dose of 150 mg (7.5 ml) per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg (30 ml) per day after an additional 7-day interval. _Epilepsy_ Pregabalin treatment can be started with a dose of 150 mg (7.5 ml) per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after 1 week. The maximum dose of 600 mg (30 ml) per day may be achieved after an additional week. _ _ _Generalised Anxiety Disorder_ The dose range is 150 to 600 mg (7.5 to 30 ml) 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 (7.5 ml) per day. Based on individual patient response an Lestu allt skjalið