“Mental health is a sickness just like diabetes and heart problems.”- Betty Jordan
Scheduling Status: Schedule 3
Proprietary name, Strength and Pharmaceutical Form
DYNA-LAMOTRIGINE 25 mg, tablets (Lamotrigine 25 mg per tablet)
DYNA-LAMOTRIGINE 50 mg, tablets (Lamotrigine 50 mg per tablet)
DYNA-LAMOTRIGINE 100 mg, tablets (Lamotrigine 100 mg per tablet)
DYNA-LAMOTRIGINE 200 mg, tablets (Lamotrigine 200 mg per tablet)
Please read this information carefully before taking DYNA-LAMOTRIGINE tablets.
- Keep this information. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT DYNA-LAMOTRIGINE CONTAINS
Active ingredient: Lamotrigine
Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, iron oxide yellow, povidone K-25, ethanol absolute, purified water and magnesium stearate.
WHAT DYNA-LAMOTRIGINE IS USED FOR
Dyna-lamotrigine tablets are used to treat various types of epilepsy, including seizures associated with Lennox-Gastaut syndrome.
BEFORE YOU TAKE DYNA-LAMOTRIGINE
Do not take DYNA-LAMOTRIGINE:
- If you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of DYNA-LAMOTRIGINE.
- If you are 65 years or older.
- If you have renal or hepatic impairment.
- If you are pregnant or breast feeding.
- If you suffer from an anaemic (blood) disease called thalassemia.
Take special care with DYNA-LAMOTRIGINE:
- Tell your doctor immediately if you develop a rash or any other signs or symptoms of hypersensitivity (e.g. fever, swollen face).
- Do not stop taking your tablets abruptly.
Taking DYNA-LAMOTRIGINE with food or drink:
Avoid the use of alcohol. Food does not affect the tablet’s function.
Pregnancy and breast-feeding:
If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. Safety in pregnancy and breast-feeding has not been established.
Driving and using machinery:
Caution is advised when operating machinery and driving since DYNA-LAMOTRIGINE can cause blurred or double vision, dizziness, drowsiness and impairment of motor skills.
Using other medicines with DYNA-LAMOTRIGINE:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of DYNA-LAMOTRIGINE with these medicines may cause undesirable interactions. Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Please consult your doctor, pharmacist or other healthcare professional for advice.
DYNA-LAMOTRIGINE interact with the following medication:
- other anti-epileptic medication (phenytoin, carbamazepine, phenobarbitone and primidone)
- pain killers (paracetamol)
- oral contraceptive tablets
HOW TO USE DYNA-LAMOTRIGINE
Always take DYNA-LAMOTRIGINE exactly as your doctor has instructed you. You should check with your doctor if you are unsure. If you have the impression that the effect of DYNA-LAMOTRIGINE is too strong or too weak, talk to your doctor or pharmacist.
The usual dose is one to two tablets once or twice a day, but you may be told to take a lower dose for the first 2 – 4 weeks.
Swallow the tablets with a little water.
Do not stop taking your tablets suddenly. Your doctor will tell you how to stop the therapy.
If you take more DYNA-LAMOTRIGINE than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.
If you forget to take DYNA-LAMOTRIGINE:
Do not take a double dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.
POSSIBLE SIDE EFFECTS
DYNA-LAMOTRIGINE can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
You may experience skin reaction such as skin rash, blistering, peeling and loosening of the skin
Muscle cramps, pain, weakness, red or irritated eyes, headache, dizziness, drowsiness and coordination abnormalities, vision abnormalities, including blurred vision and diplopia have also been reported.
Side effects of the stomach include constipation, diarrhoea, and indigestion.
STORING AND DISPOSING OF DYNA-LAMOTRIGINE
Store below 25ºC in original pack. Protect against moisture and light. Do not remove the blister from the outer carton until required for use.
- KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
- Do not use the tablets after the expiry date printed on the bottle.
- Return all unused medicine to your pharmacist
- Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)
PRESENTATION OF DYNA-LAMOTRIGINE
DYNA-LAMOTRIGINE is available in PVC/ Aluminium blister packs of 30 tablets, 10 tablets per blister.
IDENTIFICATION OF DYNA-LAMOTRIGINE
Dyna-lamotrigine 25 mg: Beige, round, flat tablet, embossed “MC” with diameter 6,0mm
Dyna-lamotrigine 50 mg: Beige, round, flat, scored tablets with diameter 8,0 mm
Dyna-lamotrigine 100 mg: Beige, round, flat, scored tablets with diameter 9,5 mm
Dyna-lamotrigine 200 mg: Beige, round, flat, scored tablets with diameter 12,7 mm
Dyna-lamotrigine 25 mg: 40/2.5/.0173
Dyna-lamotrigine 50 mg: 40/2.5/0169
Dyna-lamotrigine 100 mg: 40/2.5/0166
Dyna-lamotrigine 200 mg: 40/2.5/0167
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd.
F02 Grapevine House
Steenberg Office Park
DATE OF PUBLICATION
18 April 2008