Lamotrigine 100mg dispersible tablets sugar free

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Lamotrigine

Tillgänglig från:

Actavis UK Ltd

ATC-kod:

N03AX09

INN (International namn):

Lamotrigine

Dos:

100mg

Läkemedelsform:

Dispersible tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04080100; GTIN: 5012617015600

Bipacksedel

AAAH7370
_Continued top of next column_
Lamotrigine 5mg, 25mg & 100mg tablet leaflet - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAH7370
2
05.03.15
jh
10.03.15
jh
Iceland
170 x 320
7
05.03.15
06.03.15
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 LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR
2 BEFORE YOU TAKE LAMOTRIGINE TABLETS
3 HOW TO TAKE LAMOTRIGINE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE LAMOTRIGINE TABLETS
6
FURTHER INFORMATION
1 WHAT LAMOTRIGINE TABLETS IS AND WHAT IT IS USED FOR
Lamotrigine tablets belong to a group of medicines called
anti-epileptics. It is
used to treat two conditions - EPILEPSY and BIPOLAR DISORDER.
Lamotrigine tablets TREATS EPILEPSY by blocking the signals in the
brain that
trigger epileptic seizures (fits).
• For adults and children aged 13 years and over, Lamotrigine
tablets can be
used on its own or with other medicines, to treat epilepsy.
Lamotrigine tablets
can also be used with other medicines to treat the seizures that occur
with a
condition called Lennox-Gastaut syndrome.
• For children aged between 2 and 12 years, Lamotrigine tablets can
be used
with other medicines, to treat those conditions. It can be used on its
own to
treat a type of epilepsy called typical absence seizures.
Lamotrigine tablets also TREATS BIPOLAR DISORDER.
People with bipolar disorder (sometimes called

Produktens egenskaper

OBJECT 1
LAMOTRIGINE ACTAVIS 100MG DISPERSIBLE TABLETS
Summary of Product Characteristics Updated 04-Aug-2015 | Accord-UK Ltd
1. Name of the medicinal product
Lamotrigine Actavis 100mg Dispersible Tablets
2. Qualitative and quantitative composition
Each tablet contains lamotrigine 100mg
For excipients, see 6.1.
3. Pharmaceutical form
“Dispersible Tablet“
White or almost white, round, flat-faced, uncoated tablets with
“100“ marked on one side.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy
_Adults and adolescents aged 13 years and above_
− Adjunctive or monotherapy treatment of partial seizures and
generalised seizures, including tonic-clonic
seizures.
− Seizures associated with Lennox-Gastaut syndrome. Lamotrigine
Dispersible Tablets is given as
adjunctive therapy but may be the initial antiepileptic drug (AED) to
start with in Lennox-Gastaut
syndrome.
_Children and adolescents aged 2 to 12 years_
− Adjunctive treatment of partial seizures and generalised seizures,
including tonic-clonic seizures and
the seizures associated with Lennox-Gastaut syndrome.
− Monotherapy of typical absence seizures.
Bipolar disorder
_Adults aged 18 years and above_
− Prevention of depressive episodes in patients with bipolar I
disorder who experience predominantly
depressive episodes (see section 5.1).
Lamotrigine Dispersible Tablets is not indicated for the acute
treatment of manic or depressive episodes.
4.2 Posology and method of administration
Administration
Lamotrigine Dispersible Tablets may be chewed, dispersed in a small
volume of water (at least enough to
cover the tablet) or swallowed whole with a little water.
If the calculated dose of lamotrigine (for example for treatment of
children with epilepsy or patients with
hepatic impairment) does not equate to whole tablets, the dose to be
administered is that equal to the
lower number of whole tablets.
Restarting therapy
Prescribers should assess the need for escalation to maintenance dose
when restarting Lamotrigine
Dispersible Tablets in patients w