Consumer medicine information

Lamotrigine GH 25 mg Tablets

Lamotrigine

BRAND INFORMATION

Brand name

Lamotrigine GH

Active ingredient

Lamotrigine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Lamotrigine GH 25 mg Tablets.

1. Why am I using Lamotrigine GH?


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

2. What should I know before I use Lamotrigine GH?


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 Lamotrigine GH? 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 Lamotrigine GH?

  • Lamotrigine GH tablets may be swallowed whole or dispersed in a small volume of water (at least enough to cover the whole tablet).
  • Lamotrigine GH tablets are not chewable tablets.

More instructions can be found in Section 4. How do I use Lamotrigine GH? in the full CMI.

5. What should I know while using Lamotrigine GH?

Things you should do
  • Remind any doctor, dentist or pharmacist when you visit that you are using Lamotrigine GH.
  • Contact your doctor immediately if you develop any skin rash such as spots or ‘hives’ during Lamotrigine GH treatment.
Things you should not do
  • For epilepsy patients, do not stop taking Lamotrigine GH or change the dose without first checking with your doctor.
  • Do not take a double dose to make up for any that you may have missed.
Driving or using machines
  • Make sure you know how you react to Lamotrigine GH before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.
Looking after your medicine
  • Store Lamotrigine GH tablets in a cool dry place where the temperature stays below 25°C.
  • Keep your tablets in the bottle until it is time to take them. If you take the capsules out of the bottle they may not keep as well.

For more information, see Section 5. What should I know while using Lamotrigine GH? in the full CMI.

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

BRAND INFORMATION

Brand name

Lamotrigine GH

Active ingredient

Lamotrigine

Schedule

S4

 

Notes

Distributed by Generic Health 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

Lamotrigine GH tablets containing 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
List of excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lamotrigine GH 25 mg tablets are uncoated white, circular, flat bevelled tablets, with '25' debossed on one side and a central breakline on the other side.
Lamotrigine GH 50 mg tablets are uncoated white, circular, flat bevelled tablets, with '50' debossed on one side and a central breakline on the other side.
Lamotrigine GH 100 mg tablets are uncoated white, circular, flat bevelled tablets, with '100' debossed on one side and a central breakline on the other side.
Lamotrigine GH 200 mg tablets are uncoated white, capsule-shaped, biconvex tablets with '200' debossed on one side and plain on the other side.

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 13 11 26 (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

Lamotrigine is a substituted asymmetric triazine. It is a white to pale cream-coloured powder. It is slightly soluble in ethanol and chloroform, 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)

(S4) Prescription Only Medicine.

Summary Table of Changes

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