Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GABAPENTINE 400 mg/stuk
Glenmark Arzneimittel GmbH Industriestrasse 31 82194 GROBENZELL (DUITSLAND)
N03AX12
GABAPENTINE 400 mg/stuk
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 ; NATRIUMLAURILSULFAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, 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 ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Gabapentin
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; NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;
2018-04-25
NL/H/3976/001-003/IAin/016 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Gabapentine Glenmark 100 mg harde capsules Gabapentine Glenmark 300 mg harde capsules Gabapentine Glenmark 400 mg harde capsules G abapentin 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 [Name to be completed nationally] are and what they are used for 2. What you need to know before you take [Name to be completed nationally] 3. How to take [Name to be completed nationally] 4. Possible side effects 5. How to store [Name to be completed nationally] 6. Contents of the pack and other information 1. WHAT X ARE AND WHAT THEY ARE USED FOR [Name to be completed nationally] belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain ( LONG LASTING PAIN CAUSED BY DAMAGE TO THE NERVES ). The active substance in [Name to be completed nationally] is gabapentin. [NAME TO BE COMPLETED NATIONALLY] ARE USED TO TREAT: • Various forms of EPILEPSY (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child 6 years of age and older will prescribe [Name to be completed nationally] to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take [Name to be completed nationally] in addition to the current treatment unless told otherwise. [Name to be completed nationally] can also be used on its own to treat adults and children over Lue koko asiakirja
NL/H/3976/001-003/IA/019 1 SUMMARY OF PRODUCT CHARACTERISTICS NL/H/3976/001-003/IA/019 2 1. NAME OF THE MEDICINAL PRODUCT Gabapentine Glenmark 100 mg harde capsules Gabapentine Glenmark 300 mg harde capsules Gabapentine Glenmark 400 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg of gabapentin. Each 300 mg hard capsule contains 300 mg of gabapentin. Each 400 mg hard capsule contains 400 mg of gabapentin. Excipients with known effect Each 100 mg hard capsule contains 6.5 mg lactose (as monohydrate). Each 300 mg hard capsule contains 19.50 mg lactose (as monohydrate). Each 400 mg hard capsule contains 26.00 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard 100 mg: Size ‘3’ Hard Gelatin Capsule with white opaque cap and white opaque Body, imprinted with Glenmark logo “G” on Cap and ‘456’ on body with black ink, filled with white to off-white powder. 300 mg: Size ‘1’ Hard Gelatin Capsule with Light Yellow to Yellow cap and Light Yellow to Yellow Body, imprinted with Glenmark logo “G” on Cap and ‘457’ on body with black ink, filled with white to off-white powder. 400 mg: Size ‘0’ Hard Gelatin Capsule with Light Orange to Orange cap and Light Orange to Orange body, imprinted with Glenmark logo “G” on Cap and ‘458’ on body with black ink, filled with white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1). Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above. Treatment of peripheral neuropathic pain Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in Lue koko asiakirja