Gabapentin 400mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Gabapentin

Beschikbaar vanaf:

DE Pharmaceuticals

ATC-code:

N02BF01

INN (Algemene Internationale Benaming):

Gabapentin

Dosering:

400mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04080100

Bijsluiter

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Gabapentin Capsules
100/300/400mg x 100’s (UK)
296x210 (Reel Fed)
50970769
Leaflet for Blisters
6991
T. Hull
17/06/19
* 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.
approved for print/date
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Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
FMD info
NA (not a carton)

No

Yes
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Details
GABAPENTIN ALL STRENGTHS 100 CAPSULES UK
Black
Profile
BBBA5277
RH
18-06-19
296x210
8pt
Accord Barnstaple
n/a
n/a
01
Version 2
01.11.2017
page 4
page 1
50970769 BBBA5277
_Continued over page_
_Continued top of next column_
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 belong to a group of
medicines used to treat:
•
VARIOUS FORMS OF EPILEPSY – Gabapentin
capsules can be used o

Productkenmerken

OBJECT 1
GABAPENTIN 400MG CAPSULES
Summary of Product Characteristics Updated 29-Jul-2019 | 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
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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
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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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)
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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