Lamictal 25mg dispersible tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Lamotrigine

Fáanlegur frá:

Lexon (UK) Ltd

ATC númer:

N03AX09

INN (Alþjóðlegt nafn):

Lamotrigine

Skammtar:

25mg

Lyfjaform:

Dispersible tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04080100

Upplýsingar fylgiseðill

REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store. By reporting side effects, you can help
provide more information on the safety of this
medicine
5. HOW TO STORE LAMICTAL
•
KEEP OUT OF THE SIGHT AND REACH AND
CHILDREN.
•
Lamictal does not require any special storage
conditions.
•
Do not take Lamictal after the expiry date which
is stated on the blister and carton.
•
If your doctor tells you to stop taking this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
•
If your medicine becomes discoloured or show
any other signs of deterioration, ask your
pharmacist who will advise you what to do.
•
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT LAMICTAL CONTAINS
•
The active substance is lamotrigine.
Each dispersible/chewable tablet contains
25mg lamotrigine.
•
The other ingredients are: calcium carbonate,
hyprolose, aluminium magnesium silicate,
poly (O-carboxymethyl) starch, sodium salt,
povidone K30, saccharin sodium,
magnesium stearate and blackcurrant flavour.
WHAT LAMICTAL LOOKS LIKE AND CONTENTS OF THE
PACK
•
Lamictal dispersible/chewable tablets are white
to off-white with a blackcurrant odour, square
with rounded corners. They are marked
‘GSCL5’ on one side and ‘25’ on the other.
•
Each pack contains blisters of 56 tablets.
MANUFACTURER AND LICENCE HOLDER
This medicine is manufactured by
GlaxoSmithKline
Pharmaceuticals S.A., UI. Grunwaldzka 189, 60-322
Poland
and is procured from within the EU and
repackaged by the Product Licence Holde

Vara einkenni

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Not applicable
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
3.
PHARMACEUTICAL FORM
Not applicable
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Not applicable
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not applicable
4.3.
CONTRAINDICATIONS
Not applicable
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable
4.6.
PREGNANCY AND LACTATION
Not applicable
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable
4.8.
UNDESIRABLE EFFECTS
Not applicable
4.9.
OVERDOSE
Not applicable
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Not applicable
5.2.
PHARMACOKINETIC PROPERTIES
Not applicable
5.3.
PRECLINICAL SAFETY DATA
Not applicable
6.
PHARMACEUTICAL PARTICULARS
6.1.
LIST OF EXCIPIENTS
Not applicable
6.2.
INCOMPATIBILITIES
Not applicable
6.3.
SHELF LIFE
Not applicable
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Not applicable
6.5.
NATURE AND CONTENTS OF CONTAINER
Not applicable
6.6.
INSTRUCTION FOR USE AND HANDLING (, AND DISPOSAL)
Not applicable
No Data Held
ADMINISTRATIVE DATA
7.
MARKETING AUTHORISATION HOLDER
Not applicable
8.
MARKETING AUTHORISATION NUMBER
Not applicable
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Not applicable
10.
DATE OF REVISION OF THE TEXT
Not applicable