Munatrep 5 mg/25 mg/50 mg/100 mg/200 mg Tablets

The active substance is lamotrigine. MUNATREP 5 mg TABLETS: Each uncoated tablet contains lamotrigine 5 mg. MUNATREP 25 mg TABLETS: Each uncoated tablet contains lamotrigine 25 mg. MUNATREP 50 mg TABLETS: Each uncoated tablet contains lamotrigine 50 mg. MUNATREP 100 mg TABLETS: Each uncoated tablet contains lamotrigine 100 mg. MUNATREP 200 mg TABLETS: Each uncoated tablet contains lamotrigine 200 mg. The other ingredients are black currant flavour; cellulose, microcrystalline; magnesium carbonate; magnesium stearate; polacrilin potassium, povidone and sucralose.

MUNATREP belong to a group of medicines called antiepileptics. They are used to treat two conditions – epilepsy and bipolar disorder.

EPILEPSY

• For adults and children aged 12 years and over MUNATREP can be used on their own or with other medicines, to treat certain types of seizures in patients with epilepsy.

• For children aged between 2 and 12 years MUNATREP can be used with other medicines, to treat certain types of seizures in patients with epilepsy. It is recommended that MUNATREP are not used on their own to treat epilepsy in children under 12 years of age.

• MUNATREP can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut Syndrome.

BIPOLAR DISORDER

• For adults 18 years of age and over MUNATREP are used to help prevent the mood episodes that occur in patients with bipolar disorder, mainly by preventing the depressive phases.

Do not take MUNATREP:

• If you are hypersensitive (allergic) to lamotrigine, or any of the other ingredients of MUNATREP.
• If you are pregnant or breast-feeding.
• If you have kidney or liver problems.
• If you are over the age of 65 years.

Take special care with MUNATREP:

• Some patients may experience severe seizures, which may lead to serious health problems, usually causing death. If you experience a severe seizure while you are taking MUNATREP, see a doctor as soon as possible. Your doctor may consider withdrawing MUNATREP therapy if worsening of seizure control occurs.
• You may develop a rash while taking MUNATREP. These skin reactions are most likely to happen within the first 8 weeks of starting treatment. Although most patients who develop a rash have mild symptoms, some individuals may develop a serious (sometimes fatal i.e. causing death) skin reaction that requires hospitalisation. Scarring and deaths have been reported. Serious skin reactions occur more often in children than in adults.
• Rashes may be more likely to occur if you:
• take MUNATREP in combination with another medicine called valproate
• start on too high a dose
• increase your dose too quickly
• It is not possible to predict whether a mild rash will develop into a more serious reaction. Therefore, if you develop any of these symptoms after you start taking MUNATREP, get a doctor’s help straight away: skin rash, a high temperature (fever), swollen lymph glands, itching, swelling around your face, blood and liver problems, unexpected bleeding or bruising, flu-like symptoms or drowsiness. A doctor should evaluate your condition and decide if you should continue taking MUNATREP.
• Patients with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide. Call your doctor at once if you have any thoughts about suicide or hurting yourself.
• While you are taking MUNATREP, your doctor may decide to carry out tests on your liver, kidneys or blood.
• Never take more MUNATREP than your doctor tells you to.
• To stop taking MUNATREP, it is important that your dose is reduced gradually, over a period of 2 weeks. If you suddenly stop taking MUNATREP your epilepsy may come back or get worse.
• Since the effective dose for children depends on their body weight, the weight of a child must be monitored and the dose reviewed as weight changes occur.
• MUNATREP should be used cautiously in patients taking folate antagonists (medicines which interfere with folic acid metabolism).

Taking MUNATREP with food and drink:

MUNATREP can be taken with or without food.

Always take MUNATREP exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

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

• Use MUNATREP as directed by your doctor.
• Do not increase your dose of MUNATREP or take more frequent doses than those indicated by your doctor.
• Your doctor will start you on a low dose, and gradually increase the dose over a few weeks until you reach a dose that works for you (called the effective dose).
• The dose you take will depend on your age and whether you are taking MUNATREP with other medicines.
• The usual effective dose of MUNATREP for adults and children aged over 12 years is between 100 mg and 400 mg each day.
• For children aged 2 to 12 years, the effective dose depends on their body weight – usually it’s between 1 mg and 15 mg for each kilogram of the child’s weight, up to a maximum of 400 mg daily.
• MUNATREP should not be given to patients aged under 18 years to treat bipolar disorder.

If you take more MUNATREP than you should:

• Symptoms of overdose may include sedation (having a soothing, calming or tranquilizing effect), clumsiness and lack of coordination, double vision, nausea and vomiting.
• If you have taken more MUNATREP than you should, you should be admitted to hospital and given appropriate treatment. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MUNATREP: Do not take a double dose to make up for forgotten individual doses.

MUNATREP can have side-effects. Allergic reaction or potentially serious skin reaction, get a doctor’s help straight away. You may experience an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening problems if not treated. Symptoms of these reactions include:

• skin rashes or redness
• angioedema (trouble in breathing, swelling of face, mouth, hands or feet)
• high temperature (fever), flu-like symptoms or drowsiness
• swelling around your face or swollen glands in your neck, armpit or groin
• unusual bleeding or bruising
• a sore throat or more infections than usual
• rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens-Johnson syndrome)
• severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis)

In many cases these symptoms will be signs of less serious side effects. However, you must be aware that they are potentially serious – so, if you notice any of these symptoms see a doctor as soon as possible. Call your doctor at once if you have any of these serious side effects:

• seizures that happen more often
• trouble in breathing, swelling of face, mouth, hands or feet
• depression
• hallucinations (“seeing” or “hearing” things that aren’t really there)

Other side effects include:

• changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced number of white blood cells, reduced numbers of platelets which can cause bleeding or bruising.
• headache
• changes in liver function
• feeling dizzy or drowsy
• clumsiness and lack of coordination
• feeling “wobbly” or unsteady when you move about
• rapid, uncontrollable eye movements
• anxiety
• confusion
• irritability
• difficulty in sleeping
• shaking or tremors
• double or blurred vision
• feeling tired
• nausea (feeling sick) or vomiting (being sick)
• sensitivity of the skin to light
• aggression
• pain in your back or joints, or elsewhere
• numbness, tingling, pins and needles
• sensation of spinning or whirling (vertigo)
• worsening of Parkinson’s disease

If any of the side effects become severe or troublesome, please tell your doctor or pharmacist. Not all side effects reported for MUNATREP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MUNATREP, please consult your doctor, pharmacist or other health care professional for advice.

Store at or below 30 °C (room temperature). Keep blisters in the original carton until required for use. Keep the containers tightly closed. Store all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).