Lamotrigine 200 mg Tablets

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat two conditions - epilepsy and bipolar disorder. LAMOTRIGINE MSQ is used to treat epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits)

• For adults and children over 12 years of age, LAMOTRIGINE MSQ can be used on its own or with other medicines, to treat epilepsy. LAMOTRIGINE MSQ can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome.
• For children aged between 2 and 12 years, LAMOTRIGINE MSQ can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

LAMOTRIGINE MSQ is also used to treat bipolar disorder. People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair). For adults aged 18 years and over, LAMOTRIGINE MSQ can be used on its own or with other medicines, to prevent the periods of depression that occur in bipolar disorder. It is not yet known how LAMOTRIGINE MSQ works in the brain to have this effect.

Do not take LAMOTRIGINE MSQ

• If you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of LAMOTRIGINE MSQ (listed in section 6). An allergic reaction may include rash, itching, swelling of the face, lips, or hands/feet or breathing difficulties.

Warnings and precautions

Special care should be taken with LAMOTRIGINE MSQ:

• if you have any kidney problems.
• if you have ever developed a rash after taking lamotrigine or other medicines for bipolar disorder or epilepsy.
• if you experience a rash or sunburn after taking LAMOTRIGINE MSQ and having been exposed to sun or artificial light (e.g. solarium). Your doctor will check your treatment and may advise you to avoid sunlight or protect yourself against the sun (e.g. use of a sunscreen and/or to wear protective clothing).
• if you have ever developed meningitis after taking LAMOTRIGINE MSQ.
• if you are already taking medicine that contains lamotrigine.
• if you have a condition called Brugada syndrome. Brugada syndrome is a genetic disease that results in abnormal electrical activity within the heart. ECG abnormalities which may lead to arrhythmias (abnormal heart rhythm) can be triggered by lamotrigine.

If any of these applies to you tell your doctor, who may decide to lower the dose or that LAMOTRIGINE MSQ is not suitable for you.

Important information about potentially life-threatening reactions

A small number of people taking LAMOTRIGINE MSQ get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These can include Stevens – Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking LAMOTRIGINE MSQ. Read the description of these symptoms in Section 4 of this leaflet under ‘Potentially life-threatening reactions’.

Do not share medicines prescribed for you with any other person. Always take LAMOTRIGINE MSQ exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It may take a while to find the best dose of LAMOTRIGINE MSQ for you. The dose you take will depend on:

• your age
• whether you are taking LAMOTRIGINE MSQ with other medicines
• whether you have any kidney or liver problems

Your doctor will prescribe a low dose to start, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose). Never take more LAMOTRIGINE MSQ tablets than your doctor tells you to.

For Epilepsy and seizures associated with Lennox-Gastaut Syndrome:

The usual effective dose for adults and children aged 12 years or over is between 100 mg and 200 mg each day. For children aged 2 to 12 years, the effective dose depends on their body weight - usually, it is between 1 mg and 15 mg for each kilogram of the child’s weight, up to a maximum of 200 mg daily. LAMOTRIGINE MSQ tablets are not recommended for children aged under 2 years.

For Bipolar disorder:

The usual effective dose for adults (over 18 years) is between 100 mg and 200 mg each day. This dosage may be higher if you are also taking other medicines with LAMOTRIGINE MSQ. LAMOTRIGINE MSQ is not recommended for bipolar disorder in children younger than 18 years of age.

Take your LAMOTRIGINE MSQ tablets as directed and for as long as directed; do not stop them, even if you feel better. Your doctor will tell you how long your treatment with LAMOTRIGINE MSQ will last.

If you have the impression that the effect of LAMOTRIGINE MSQ is too strong or too weak, tell your doctor or pharmacist.

Take your dose of LAMOTRIGINE MSQ once or twice a day, as your doctor advises. It can be taken with or without food. Your doctor may also advise you to start or stop taking other medicines, depending on what condition you are being treated for and the way you respond to treatment.

• Swallow your tablets whole. Do not break, chew, or crush them.
• Always take the full dose that your doctor has prescribed. Never take only part of a tablet.

If you take more LAMOTRIGINE MSQ than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet or some tablets with you so your doctor will know what you have taken. If you take too much LAMOTRIGINE MSQ tablets you may be more likely to have serious side effects which may be fatal. Someone who has taken too much LAMOTRIGINE MSQ tablets may have any of these symptoms.

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of coordination, affecting their balance (ataxia)
• heart rhythm changes (detected usually on ECG)
• loss of consciousness, fits (convulsions) or coma.

If you forget to take LAMOTRIGINE MSQ If you forget to take LAMOTRIGINE MSQ at the right time, take one a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LAMOTRIGINE MSQ LAMOTRIGINE MSQ tablets must be taken for as long as your doctor recommends. Do not stop unless your doctor advises you to. To stop taking LAMOTRIGINE MSQ, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking LAMOTRIGINE MSQ, your epilepsy may come back or get worse.

LAMOTRIGINE MSQ can have side effects. Not all side effects reported for LAMOTRIGINE MSQ are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LAMOTRIGINE MSQ, please consult your health care provider for advice.

Potentially life-threatening reactions:

A small number of people taking LAMOTRIGINE MSQ get an allergic reaction or potentially life-threatening skin reaction, which may develop into more serious problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with LAMOTRIGINE MSQ, especially if the starting dose is too high or if the dose is increased too quickly or if LAMOTRIGINE MSQ is taken with another medicine called valproate. Some of the symptoms are more common in children, so parents should be especially careful to watch out for them. Symptoms of these reactions include:

• skin rashes or redness, which may develop into life-threatening skin reactions including widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS hypersensitivity syndrome)
• ulcers in the mouth, throat, nose or genitals
• a sore mouth or red or swollen eyes (conjunctivitis)
• a high temperature (fever), flu-like symptoms or drowsiness
• swelling around your face or swollen glands in your neck, armpit or groin
• unexpected bleeding or bruising, or the fingers turning blue
• a sore throat or more infections (such as colds) than usual
• increased levels of liver enzymes seen in blood tests
• an increase in a type of white blood cell (eosinophils)
• enlarged lymph nodes
• involvement of the organs of the body including liver and kidneys.

In many cases, these symptoms will be signs of less serious side effects but you must be aware that they are potentially life-threatening and can develop into more serious problems, such as organ failure, if they are not treated. If you notice any of these symptoms, contact a doctor immediately. Your doctor may decide to carry out tests on your liver, kidneys or blood and may tell you to stop taking LAMOTRIGINE MSQ. In case you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis your doctor will tell you that you must never use lamotrigine, as in LAMOTRIGINE MSQ, again.

If any of the following happens, stop taking LAMOTRIGINE MSQ and tell your doctor immediately or go to the casualty department at your nearest hospital:

• rashes, hives, itching, chest constriction, shortness of breath or swelling of the face, lips, tongue, hands/feet, fainting, high temperature
• severe skin reactions with blisters, sores or ulceration
• high temperature, enlarged lymph glands in neck/armpits/groin.

These are all very serious side effects. If you have them, you may have had a serious reaction to LAMOTRIGINE MSQ. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections, and/or anaemia
• double vision, blurred vision
• jerky movements of eyeballs
• an increase in the frequency of seizures.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent headache
• skin rash
• aggression or irritability
• feeling sleepy or drowsy
• feeling dizzy
• shaking or tremors
• difficulty in sleeping (insomnia)
• feeling agitated
• diarrhoea
• dry mouth
• feeling sick (nausea) or being sick (vomiting)
• feeling tired
• pain in your back or joints, or elsewhere.

Less frequent

• clumsiness and lack of coordination (ataxia)
• double vision or blurred vision
• unusual hair loss or thinning (alopecia)
• skin rash or sunburn after exposure to sun or artificial light (photosensitivity)
• a life-threatening skin reaction (Stevens-Johnson syndrome): (see also the information at the beginning of Section 4)
• a group of symptoms together including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis). These symptoms usually disappear once treatment is stopped however if the symptoms continue or get worse contact your doctor
• rapid, uncontrollable eye movements (nystagmus)
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• a life-threatening skin reaction (toxic epidermal necrolysis): see also the information at the beginning of Section 4
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): see also the information at the beginning of Section 4
• a high temperature (fever): see also the information at the beginning of Section 4
• swelling around the face (oedema) or swollen glands in the neck, armpit or groin (lymphadenopathy): see also the information at the beginning of Section 4
• changes in liver function, which will show up in blood tests, or liver failure: see also the information at the beginning of Section 4
• a serious disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation): see also the information at the beginning of Section 4

Frequency unknown

• bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis or take steroids
• inflammation of the kidney (tubulointerstitial nephritis), or inflammation of both the kidney and the eye (tubulointerstitial nephritis and uveitis syndrome)
• nightmares
• lower immunity because of lower levels of antibodies called immunoglobulins in the blood which help protect against infection.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LAMOTRIGINE MSQ.

Store all medicines out of reach and sight of children.

• Store at or below 25 °C.
• Protect from moisture.
• Keep the blisters in the carton until required for use.
• Do not use after the expiry date stated on the label / carton. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).