Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PREGABALINE
Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)
N03AX16
PREGABALIN
Capsule, hard
AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Pregabalin
Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAÏSZETMEEL; PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;
2015-07-21
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PREGABALINE AET 25 MG HARDE CAPSULES PREGABALINE AET 50 MG HARDE CAPSULES PREGABALINE AET 75 MG HARDE CAPSULES PREGABALINE AET 100 MG HARDE CAPSULES PREGABALINE AET 150 MG HARDE CAPSULES PREGABALINE AET 200 MG HARDE CAPSULES PREGABALINE AET 225 MG HARDE CAPSULES PREGABALINE AET 300 MG HARDE 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 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 Pregabaline AET is and what it is used for 2. What you need to know before you take Pregabaline AET 3. How to take Pregabaline AET 4. Possible side effects 5. How to store Pregabaline AET 6. Contents of the pack and other information 1. WHAT PREGABALINE AET IS AND WHAT IT IS USED FOR Pregabaline AET belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults. PERIPHERAL AND CENTRAL NEUROPATHIC PAIN: Pregabaline AET 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: Pregabaline AET is used to treat a certain form of epilepsy (partial seizures with or without secondary gener Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pregabaline AET 25 mg harde capsules Pregabaline AET 50 mg harde capsules Pregabaline AET 75 mg harde capsules Pregabaline AET 100 mg harde capsules Pregabaline AET 150 mg harde capsules Pregabaline AET 200 mg harde capsules Pregabaline AET 225 mg harde capsules Pregabaline AET 300 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _[For 25 mg:]_ Each hard capsule contains 25 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 35 mg lactose monohydrate. _[For 50 mg:] _ Each hard capsule contains 50 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 70 mg lactose monohydrate. _[For 75 mg:] _ Each hard capsule contains 75 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 8.25 mg lactose monohydrate. _[For 100 mg:] _ Each hard capsule contains 100 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 11 mg lactose monohydrate. _[For 150 mg:] _ Each hard capsule contains 150 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 16.50 mg lactose monohydrate. _[For 200 mg:] _ Each hard capsule contains 200 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 22.00 mg lactose monohydrate. _[For 225 mg:] _ Each hard capsule contains 225 mg of pregabalin. _Excipients with known effect: _ 2 Each hard capsule also contains 24.75 mg lactose monohydrate. _[For 300 mg:]_ Each hard capsule contains 300 mg of pregabalin. _Excipients with known effect: _ Each hard capsule also contains 33.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. _ _ _[For 25 mg:]_ Hard capsules, size 4, with a white cap and a white body, with “25” printed in black ink on the body. The capsules contain a white to off-white powder. _[For 50 mg:]_ Hard capsules, size 3, with a white cap and a pinkish-orange body, with “50” pr Прочетете целия документ