Gabapentin 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gabapentin

Available from:

Accord-UK Ltd

ATC code:

N02BF01

INN (International Name):

Gabapentin

Dosage:

400mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5055565732687

Patient Information leaflet

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
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2.
3.
4.
5.
6.
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2.
3.
[e-mail]
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

Summary of Product characteristics

OBJECT 1
GABAPENTIN 400MG 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 400mg capsules
2. Qualitative and quantitative composition
Each capsule contains 400mg of gabapentin
Excipients with known effect:
Each 400 mg hard capsule contains 67.33mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules,hard
Size 0, orange-orange hard gelatin capsules printed with C and GL.
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