Consumer medicine information

1. Why am I using SANDOZ LAMOTRIGINE?

SANDOZ LAMOTRIGINE contains the active ingredient lamotrigine. SANDOZ LAMOTRIGINE is used to treat epilepsy.
For more information, see Section 1. Why am I using SANDOZ LAMOTRIGINE? in the full CMI.

2. What should I know before I use SANDOZ LAMOTRIGINE?

Do not use if you have ever had an allergic reaction to lamotrigine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions take any other medicine, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use SANDOZ LAMOTRIGINE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with lamotrigine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SANDOZ LAMOTRIGINE?

• SANDOZ LAMOTRIGINE tablets may be swallowed whole or dispersed in a small volume of water (at least enough to cover the whole tablet).

• SANDOZ LAMOTRIGINE tablets are not chewable tablets.

5. What should I know while using SANDOZ LAMOTRIGINE?

6. Are there any side effects?

Common side effects include dizziness, movement problems, tremors, skin rash, headache, nausea, vomiting, feeling drowsy or tired, blurred or double vision, rapid, uncontrollable eye movements, trouble sleeping, feeling sleepy, irritability, aggression or agitation, hallucinations, confusion, increased activity in children, joint, back or stomach pain, respiratory or lung problems, depression, loss of memory, liver problems, diarrhoea, dry mouth.
Serious side effects include serious allergic reactions, liver and blood problems
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI

Notes

Distributed by Sandoz Pty Ltd

Boxed Warnings

Severe, potentially life-threatening rashes have been reported in association with the use of lamotrigine, particularly in children. Accordingly, lamotrigine should be discontinued at the first sign of rash unless the rash is clearly not drug related (see Section 4.2 Dose and Method of Administration).

1 Name of Medicine

Lamotrigine.

2 Qualitative and Quantitative Composition

Each Sandoz Lamotrigine 25 tablet contain 25 mg lamotrigine.
Each Sandoz Lamotrigine 50 tablet contain 50 mg lamotrigine.
Each Sandoz Lamotrigine 100 tablet contain 100 mg lamotrigine.
Each Sandoz Lamotrigine 200 tablet contain 200 mg lamotrigine.
Excipient with known effects. Contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White round flat tablets, with a breakline on one side and 25, 50 or 100 debossed on the other, containing 25, 50 or 100 mg lamotrigine respectively; or capsule-shaped biconvex tablets with 200 debossed on one side and plain on the other containing 200 mg lamotrigine.

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. Overdose has resulted in the following clinical features: nystagmus, ataxia, dizziness, somnolence, blurred vision, headache, vomiting, impaired consciousness, grand mal convulsion and coma. QRS broadening (intraventricular conduction delay) has also been observed in overdose patients. Acute ingestion of doses in excess of 10 to 30 times the maximum therapeutic dose of lamotrigine, have been reported. Overdoses involving quantities up to 15 g have been reported for lamotrigine, some of which have been fatal.
A patient who ingested a dose calculated to be between 4 and 5 g lamotrigine was admitted to hospital with coma lasting 8 - 12 hours, followed by recovery over the next 2 - 3 days. A further patient who ingested 5.6 g lamotrigine was found unconscious. Following treatment with activated charcoal for suspected intoxication the patient recovered after sleeping for 16 hours.
Treatment. No specific antidotes are available to treat overdosage. In the event of overdosage, the patient should be admitted to hospital and given appropriate supportive therapy as clinically indicated. Measures should be taken to protect the airway as consciousness may be impaired.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Lamotrigine was not genotoxic in assays for gene mutation or chromosomal damage.
Carcinogenicity. There was no evidence of carcinogenicity following daily oral administration of lamotrigine to mice and rats for up to two years at doses of up to 30 and 10 mg/kg respectively.
Effect of lamotrigine on cardiac rhythm and conduction. In vitro studies show that lamotrigine exhibits Class IB antiarrhythmic activity at therapeutically relevant concentrations (see Section 4.4 Special Warnings and Precautions for Use). It inhibits human cardiac sodium channels with rapid onset and offset kinetics and strong voltage dependence, consistent with other Class IB antiarrhythmic agents. Lamotrigine did not slow ventricular conduction (widen QRS) in healthy individuals in a thorough QT study; however, it could slow ventricular conduction and increase the risk of arrhythmia in people with structural heart disease or myocardial ischemia. Elevated heart rates could also increase the risk of ventricular conduction slowing with lamotrigine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Description. Lamotrigine is a substituted asymmetric triazine. It is a white to pale cream-coloured powder. It is slightly soluble in methanol, and very slightly soluble in water. The pKa of lamotrigine at 25°C is 5.7.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLAMOTR.gif Chemical name: 3,5-diamino-6-(2,3 - dichlorophenyl)-1,2,4 - triazine).
Molecular formula: C₉H₇Cl₂N₅.
Molecular weight: 256.1.
CAS number. 84057-84-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SLAMOTST.gif