Lamotrigine Accord 200mg Tablets tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lamotrigine

Available from:

Accord Healthcare Limited

ATC code:

N03AX09

INN (International Name):

lamotrigine

Dosage:

200mg

Pharmaceutical form:

tablets

Units in package:

(56/4x14/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-17

Patient Information leaflet

PACKAGE LEAFLET – INFORMATION FOR
THE USER
LAMOTRIGINE ACCORD
25MG TABLETS
LAMOTRIGINE ACCORD
50MG TABLETS
LAMOTRIGINE ACCORD
100MG TABLETS
LAMOTRIGINE ACCORD
200MG TABLETS
(LAMOTRIGINE)
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 you doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Lamotrigine Tablets are and what they
are used for
2. What you need to know before you take
Lamotrigine Tablets
3. How to take Lamotrigine Tablets
4. Possible side effects
5. How to store Lamotrigine Tablets
6. Contents of the pack and other information 1. WHAT LAMOTRIGINE TABLETS ARE
AND WHAT THEY ARE USED FOR
Lamotrigine belongs to a group of medicines
called anti-epileptics. It is used to treat two
conditions-EPILEPSY and BIPOLAR DISORDER.
Lamotrigine works by blocking the signals in the
brain that trigger epileptic seizures (fits).
LAMOTRIGINE USED TO TREAT EPILEPSY.
•
For adults and children aged 13 years and over,
Lamotrigine can be used alone or in
combination with other anti-epileptic medicines.
Lamotrigine can also be used with other
medicines to treat the seizures that occur with a
condition called Lennox-Gastaut Syndrome.
•
For children aged 2 to 12 years, Lamotrigine
can be used with other medicines, to treat those
conditions. Lamotrigine can be used alone to
treat a type of epilepsy called typical absence
seizures.
LAMOTRIGINE IS ALSO USED TO TREAT BIPOLAR
DISORDER.
People with bipolar disorder (sometimes called
_manic depression_) have extreme mood swings,
with periods of mania (excitement or euphoria)
alternating with peri

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Lamotrigine Accord 200 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lamotrigine 200 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Light yellow to yellow coloured, capsule shaped, biconvex, uncoated
tablets
debossed with ‘E’ and ‘D’ on either side of the scoreline on
one side and
breakline on the other side.
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 tablet
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 tablet is not indicated for the acute treatment of manic
or depressive
episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lamotrigine tablets should be swallowed whole, and should not be
chewed or
crushed.
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 tablet in patients who have discontinued
Lamotrigine
tablet for any reason, since the risk of serious rash is associated
with high
initial doses and exceeding the recommended dose escalation for
lamotrigine
(see section