Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PREGABALINE
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
N03AX16
PREGABALIN
Capsule, hard
AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; 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 ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 1-WATER; MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;
2017-05-22
PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE CAPSULES – RVG 120020-4-6-5 MODULE 1.3 Product Information Version: 2020-01 MODULE 1.3.1 Package Leaflet Replaces: 2019-08 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PREGABALINE APOTEX 25 MG, HARDE CAPSULES PREGABALINE APOTEX 75 MG, HARDE CAPSULES PREGABALINE APOTEX 150 MG, HARDE CAPSULES PREGABALINE APOTEX 300 MG, HARDE CAPSULES PREGABALINE 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 Apotex is and what it is used for 2. What you need to know before you take Pregabaline Apotex 3. How to take Pregabaline Apotex 4. Possible side effects 5. How to store Pregabaline Apotex 6. Contents of the pack and other information 1. WHAT PREGABALINE APOTEX 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 (par Baca dokumen lengkapnya
PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE CAPSULES – RVG 120020-4-6-5 MODULE 1.3 Product Information Version: 2020-01 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2019-08 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pregabaline Apotex 25 mg, harde capsules Pregabaline Apotex 75 mg, harde capsules Pregabaline Apotex 150 mg, harde capsules Pregabaline Apotex 300 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25mg, 75 mg,150 mg or 300 mg of Pregabalin Excipients with known effect _: _ 25 mg: Each hard capsule also contains 9 mg lactose monohydrate. 75 mg: Each hard capsule also contains 27 mg lactose monohydrate. 150 mg: Each hard capsule also contains 54 mg lactose monohydrate. 300 mg: Each hard capsule also contains 108 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard 25mg: Hard gelatin capsules, size no. 4, cap: opaque white colour, body: opaque white colour, Content of capsules: White powder. Imprinted APO P25 in black ink. 75mg: Hard gelatin capsules, size no. 4, cap: opaque orange colour, body: opaque white colour, Content of capsules: White powder. Imprinted APO P75 in black ink. 150 mg: Hard gelatin capsules, size no. 2, cap: opaque white colour, body: opaque white colour, Content of capsules: White powder. Imprinted APO P150 in black ink. 300mg: Hard gelatin capsules, size no. 0, cap: opaque orange colour, body: opaque white colour, Content of capsules: White powder. Imprinted APO P300 in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Neuropathic pain Pregabalin is indicated for the treatment of peripheral and central neuropathic pain in adults. PREGABALINE APOTEX 25 MG, 75 MG, 150 MG AND 300 MG, HARDE CAPSULES – RVG 120020-4-6-5 MODULE 1.3 Product Information Version: 2020-01 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2019-08 _ _ Epilepsy Pregabalin is indicated as adjunctive therapy in adults with partial seizure Baca dokumen lengkapnya