Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gabapentin
Accord-UK Ltd
N02BF01
Gabapentin
300mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04080100; GTIN: 5055565732670
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Gabapentin, Capsules, 100, 300, 400mg, 100 pack, UK 296x210 (Reel Fed) 51012651 Leaflet for Blisters 1249 R.Paul 21/04/2022 page 4 page 1 approved for print/date PROOF ROUND Technical Approval DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: NON PRINTING COLOURS COLOURS 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com T. Hull 03.05.2022 05.05.2022 T. Hull 296x210 9pt Accord Barnstaple n/a GABAPENTIN ALL STRENGTHS 100 CAPSULES PIL - UK Black Profile BBBB4524 2 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. Version 7 12.02.2020 Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): 51012651 BBBB4524 GABAPENTIN ACCORD-UK 100MG, 300MG AND 400MG CAPSULES PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN CAPSULES 3 HOW TO TAKE GABAPENTIN CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE GABAPENTIN CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY ARE USED FOR Gabapentin capsules Read the complete document
OBJECT 1 GABAPENTIN 300MG CAPSULES Summary of Product Characteristics Updated 19-Jul-2022 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Gabapentin Accord-UK 300mg capsules 2. Qualitative and quantitative composition Each capsule contains 300mg of gabapentin Excipients with known effect: Each 300 mg hard capsule contains 50.5mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsules,hard Size 1, yellow-yellow, hard gelatin capsules printed with C and GK. 4. Clinical particulars 4.1 Therapeutic indications Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation 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 generalisation in adults and adolescents aged 12 years and above. Treatment of peripheral neuropathic p Read the complete document