GABAPENTIN TEVA 800 Milligram Film Coated Tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

GABAPENTIN

Disponibil de la:

Teva Pharma B.V.

INN (nume internaţional):

GABAPENTIN

Dozare:

800 Milligram

Forma farmaceutică:

Film Coated Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Statutul autorizaţiei:

Authorised

Data de autorizare:

0000-00-00

Prospect

PRODUCT:
AMENDS:
APPROVAL:
SENIOR ARTWORK CO-ORDINATOR
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
GABAPENTIN TEVA 600 & 800 MG FC 
TABS ALL TUK V2
16843
14-5-10
GC
3
15/2/12
GP
280X190 MM
ILLUSTRATOR CS3
LEAFLET
Univers ALL 8pts body
Header: 12pts
Subhead: 10pts
SUPPLIER INSTRUCTIONS 
Artwork, text and content must NOT be altered. The only exceptions to
this are: bleeds, chokes, spreads or other adjustments required for
print reproduction purposes 
only. If you have any difficulties please contact the Teva Artwork
Team. We must receive a copy of the 3rd Party Vendors Proof before
final approval can be made.  
DESIGN DEPARTMENT 
Harlow
Date        
Signed
Date          
Signed
CUTTERGUIDE 
(not for Print) 
BLACK

PMS GREEN

GABAPENTIN TEVA 600 MG 
FILM-COATED TABLETS
GABAPENTIN TEVA 800 MG  
FILM-COATED TABLETS
GABAPENTIN
PACKAGE LEAFLET: INFORMATION FOR THE USER

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS 
MEDICINE.
•  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. Do not pass it 
on to others. It may harm them, even if their symptoms 
are the same as yours.
•  If any of the side effects gets serious, or if you notice any 
side effects not listed in this leaflet, please tell your doctor 
or pharmacist. 
IN THIS LEAFLET:
1. WHAT GABAPENTIN TEVA IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE GABAPENTIN TEVA
3. HOW TO TAKE GABAPENTIN TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE GABAPENTIN TEVA
6. FURTHER  INFORMATION

WHAT GABAPENTIN TEVA IS AND WHAT  

IT IS USED FOR
Gabapentin Teva 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 ingredient in Gabapentin Teva is gabapentin.
Gabapentin Teva is used to treat:
•  various forms of epilepsy (seizures that are initially
limited 
to

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin Teva 800 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 800 mg film-coated tablet contains 800 mg of gabapentin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval shaped, bevelled edged, film-coated tablet.
On one side engraved “7174”, and on the other side engraved “93”. 
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 adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass
of water).
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
_Discontinuation of gabapentin_
In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done
gradually over a minimum of 1 week independent of the indication.
Table 1
DOSING CHART - INITIAL TITRATION
Day l
Day 2
Day