LOGEM 50 lamotrigine 50mg chewable/dispersible tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamotrigine, Quantity: 50 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, dispersible

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; silicon dioxide; saccharin sodium; mannitol; magnesium stearate; Flavour

Administration route:

Oral

Units in package:

28 Tablets, 100 Tablets, 56 Tablets, 14 Tablets, 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lamotrigine is an anti-epileptic drug used for the treatment of partial and generalised seizures in adults and children. There is extensive experience with lamotrigine used initially as add-on therapy. Lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 Clinical Trials).

Product summary:

Visual Identification: White to off-white, round, flat faced, bevelled edge tablets with 'LY' over '50' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-03-17

Patient Information leaflet

LOGEM
®
_lamotrigine_
CONSUMER MEDICINE INFORMATION
THERE ARE REPORTS OF SEVERE, POTENTIALLY LIFE THREATENING RASHES
ASSOCIATED WITH
LOGEM TREATMENT, PARTICULARLY IN CHILDREN. LOGEM SHOULD BE
DISCONTINUED AT THE
FIRST SIGN OF RASH UNLESS THE RASH IS CLEARLY NOT DRUG RELATED.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LOGEM. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking LOGEM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LOGEM IS USED
FOR
LOGEM contains lamotrigine as the
active ingredient and belongs to a
group of medicines called "anti-
epileptic drugs".
Anti-epileptic drugs, such as
LOGEM, are used to treat epilepsy in
adults and children aged 2 years and
older. Epilepsy is a condition where
you have repeated seizures (fits).
Initially, LOGEM is usually used in
addition to other medicines for the
treatment of epilepsy including
partial or generalised seizures and
Lennox-Gastaut Syndrome.
It is thought that this medicine works
by changing the levels of some
chemicals associated with seizures.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
LOGEM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LOGEM IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
lamotrigine
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face, lips, tongue
or any other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS ME

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LOGEM
®
_lamotrigine chewable/dispersible tablet _
1
NAME OF THE MEDICINE
Lamotrigine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
chewable/dispersible
tablet
contains
lamotrigine
as
the
active
ingredient.
Each
LOGEM
chewable/dispersible tablet contains either 25 mg, 50 mg, 100 mg or
200 mg of the active ingredient.
Excipients of known effect: saccharin and sulfites
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
LOGEM chewable/dispersible tablets have a blackcurrant odour.
LOGEM 25 mg tablets are white to off-white, round, flat faced,
bevelled edge tablets with “LY” over “25” on
one side and plain on the other side.
LOGEM 50 mg tablets are white to off-white, round, flat faced,
bevelled edge tablets with “LY” over “50” on
one side and plain on the other side.
LOGEM 100 mg tablets are white to off-white, round, flat faced,
bevelled edge tablets with “LY” over “100” on
one side and plain on the other side.
LOGEM 200 mg tablets are white to off-white, round, flat faced,
bevelled edge tablets with “LY” over “200” on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamotrigine is an anti-epileptic drug used for the treatment of
partial and generalised seizures in adults and
children.
There is extensive experience with lamotrigine used initially as
add-on therapy. Lamotrigine has also been found
to be effective as monotherapy following withdrawal of concomitant
anti-epileptic drugs.
Initial monotherapy treatment in newly diagnosed paediatric patients
is not recommended (see section 5.1 Clinical
Trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
RESTARTING THERAPY
Prescribers should assess the need for escalation to maintenance dose
when restarting lamotrigine in patients who
have discontinued lamotrigine 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 4.4 Special W