Страна: Нидерланды
Язык: голландский
Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GABAPENTINE 300 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N03AX12
GABAPENTINE 300 mg/stuk
Capsule, hard
GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Gabapentin
Hulpstoffen: GELATINE (E 441); IJZEROXIDE GEEL (E 172); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Sandoz B.V. Page 1 / 11 Gabapentine Sandoz 100/300/400 mg, capsules hard RVG 33683-84-85 V19A 1.3.1.3 Bijsluiter april 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GABAPENTINE SANDOZ ® 100 MG, CAPSULES, HARD GABAPENTINE SANDOZ ® 300 MG, CAPSULES, HARD GABAPENTINE SANDOZ ® 400 MG, CAPSULES, HARD gabapentin 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Content of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] 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 [Nationally completed name] is gabapentin. [Nationally completed name] is 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 [Nationally completed name] 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 [Nationally completed name] in addition to the current treatment unless told otherwise. [Nationally completed name] can als Прочитать полный документ
Sandoz B.V. Pagina 1 van 19 Gabapentine Sandoz 100/300/400 mg, capsules, hard RVG 33683-84-85 V17A 1.3.1.1 SmPC April 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Gabapentine Sandoz 100 mg, capsules, hard Gabapentine Sandoz 300 mg, capsules, hard Gabapentine Sandoz 400 mg, capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 100 mg of gabapentin. Each capsule, hard contains 300 mg of gabapentin. Each capsule, hard contains 400 mg of gabapentin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard _100mg capsule, hard: _ hard gelatin capsule (size 3), with white opaque body and cap. _300mg capsule, hard: _ hard gelatin capsule (size 1), with yellow opaque body and cap. _400mg capsule, hard: _ hard gelatin capsule (size 0), with brown opaque body and cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy [Nationally completed name] 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). [Nationally completed name] 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 [Nationally completed name] is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults. Sandoz B.V. Pagina 2 van 19 Gabapentine Sandoz 100/300/400 mg, capsules, hard RVG 33683-84-85 V17A 1.3.1.1 SmPC April 2023 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section. Table 1 DOSING CHART – INITIAL TITRATION Day 1 Day 2 Day 3 300 Прочитать полный документ