Lamotrigine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lamotrigine

Available from:

Actavis UK Ltd

ATC code:

N03AX09

INN (International Name):

Lamotrigine

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5012617014047

Patient Information leaflet

LAMOTRIGINE 25MG, 50MG, 100MG & 200MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lamotrigine have also had thoughts of harming or killing themselves.
If at any time you have these thoughts, immediately contact your
doctor.
IF YOU’RE TAKING LAMOTRIGINE FOR EPILEPSY
The seizures in some types of epilepsy may occasionally become
worse or happen more often while taking Lamotrigine. Some patients
may experience severe seizures, which may cause serious health
problems. If your seizures happen more often, or if you experience a
severe seizure while you’re taking Lamotrigine, SEE A DOCTOR AS SOON
AS POSSIBLE.
LAMOTRIGINE SHOULD NOT BE GIVEN TO PEOPLE AGED UNDER 18 YEARS
TO TREAT BIPOLAR DISORDER. Medicines to treat depression and other
mental health problems increase the risk of suicidal thoughts and
behaviour in children and adolescents aged under 18 years.
OTHER MEDICINES AND LAMOTRIGINE TABLETS
Tell your doctor or pharmacist if you are taking, have recently taken
or
might take any other medicines including herbal medicines or other
medicines bought without a prescription.
IF YOU ARE TAKING CERTAIN MEDICINES, YOUR DOCTOR MAY NEED TO
CHECK THE DOSE OF LAMOTRIGINE. These include:
•
oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin,
topiramate, lacosamide, perampanel or zonisamide to treat for
epilepsy
•
lithium, olanzapine or aripiprazole used to treat mental health
problems
•
bupropion used to treat mental health problems or to stop smoking.
Some medicines interact with Lamotrigine Tablets or make it more
likely that you’ll have side effects. These include:
•
valproate (for epilepsy and mental health problems)
•
carbamazepine used to treat epilepsy and mental health problems
•
phenytoin, primidone or phenobarbitone (for epilepsy)
•
risperidone, used to treat mental health problems
•
rifampicin (an antibiotic)
•
a combination of lopinavir and ritonavir or atazanavir and ritonavir
(to treat Human Immunodeficiency Virus infection)
•
hormonal contraceptives, such as the Pill (s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lamotrigine 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamotrigine 50mg per tablet
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Pale yellow, round, flat, bevel edged, uncoated tablet de-bossed with
“LMT” on
one side and 50 on the other with a straight line separating “5”
and “0”.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
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 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 is not indicated for acute treatment of manic and
depressive
episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lamotrigine tablets should be swallowed whole, and should not be
chewed or
crushed.
Lamotrigine dispersible/chewable tablets may be chewed, dispersed in a
small
volume of water (at least enough to cover the whole 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