Topalex ® 25 mg/50 mg/100 mg Tablets

TOPALEX belongs to a group of medicines called antiepileptic medicines. TOPALEX is used to treat various types of epilepsy. TOPALEX may be used on its own to treat adults and children aged 2 years and over. It can also be used in combination with other anti-epileptic medicines in both adults and children aged 4 years and over.

Do not take TOPALEX:

• if you are hypersensitive (allergic) to topiramate or any of the ingredients of TOPALEX.
• if you are pregnant or think you may be pregnant.
• If you are breastfeeding as TOPALEX may reach your baby through your milk.
• TOPALEX should not be given to children under 2 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking TOPALEX:

• Sudden blurring of vision, pain and redness of the eyes has occurred in both adults and children, typically during the first month of starting TOPALEX. This can indicate raised pressure within the eye (glaucoma). If you develop any eye symptoms, particularly in the first few weeks of treatment, you should tell your doctor immediately. If your doctor thinks you have raised pressure within the eye, he/she will advise you on how to stop taking TOPALEX and may refer you for specific eye treatment. You may also need to revisit your doctor to ensure your epilepsy is kept under control.
• If you are taking a contraceptive pill as well as TOPALEX and your menstrual bleeding patterns change (e.g. if you experience breakthrough bleeding, spotting or if you miss a period), consult your doctor.
• Blood tests may show an increase in acidity. Your doctor will monitor this, if necessary, and may adjust the amount of TOPALEX you are taking.
• It is important to drink plenty of water when taking TOPALEX especially if you are taking exercise or the weather is hot. If you, or a close relative, have ever had kidney stones, you have a greater risk for kidney stone formation, which may cause acute pain in the flank (side of the abdomen), and TOPALEX may increase this risk.
• You may notice a change in your mood, or experience feelings of depression while taking TOPALEX. Patients taking TOPALEX can sometimes have thoughts of harming themselves or taking their own lives. If you get these thoughts at any time, contact your doctor or go to a hospital straight away.
• TOPALEX can cause serious skin reactions, tell your doctor immediately if you develop a skin rash (see also section 4 `Possible side effects').
• If you suffer from problems with your liver, please tell your doctor before taking TOPALEX. Your doctor may want to prescribe a lower dose.
• If you are losing weight or a child taking TOPALEX is not gaining enough weight, the amount of food being eaten should be increased. You may experience significant and continuing weight loss while taking TOPALEX. You should therefore be weighed and monitored regularly.
• You should be careful how much alcohol you drink while taking TOPALEX, or if you are taking any medicines that make you sleepy or less alert (these include tranquillisers, anti-depressants and sleeping pills), as the combined effect might make you feel less alert than usual.
• TOPALEX may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalised for this condition. Call your healthcare provider right away if you have a high fever, a fever that does not go away, or decreased sweating.
• TOPALEX may in rare cases cause high levels of ammonia in the blood (seen in blood tests) which can lead to a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor immediately if the following symptoms occur:
• Difficulty thinking, remembering information, or solving problems
• Being less alert or aware
• Feeling very sleepy with low energy
• At higher doses of TOPALEX, the risk of developing these symptoms may increase.

Do not share medicines prescribed for you with any other person. Always take TOPALEX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with TOPALEX will last. Do not stop treatment early because you may experience a seizure (fit). If you have the impression that the effect of TOPALEX is too strong or too weak, tell your doctor or pharmacist. Your doctor will start with a low dose and slowly increase the dose to the lowest amount needed to control your epilepsy. It is recommended that the tablets not be broken. Always swallow the tablets with plenty of water.

If you are taking only TOPALEX to treat your epilepsy: Your doctor will prescribe the correct dosage for you. TOPALEX is taken twice a day. Take half the dose in the morning and half in the evening.

If you are taking TOPALEX and other anti-epileptic medicines: Your doctor will prescribe the correct dosage for you. TOPALEX is taken twice a day. Take half the dose in the morning and half in the evening.

If you use more TOPALEX than you should: Signs and Symptoms Overdosage of topiramate have been reported. Signs and symptoms included: convulsions (fits), drowsiness (feeling sleepy), difficulty speaking, blurred vision, double vision, impaired mental state, lethargy, problems with coordination, almost unconscious, low blood pressure, stomach pain, agitation, dizziness and depression. Topiramate overdose can result in increased acid levels in the blood. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

If you forget to take TOPALEX: If you miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose and then carry on as before.

Effects when treatment with TOPALEX is stopped: Do not suddenly stop taking TOPALEX without first checking with your doctor. TOPALEX should be withdrawn gradually. Always check that you have enough tablets and do not run out.

TOPALEX can cause side-effects: Frequent side effects include:

• Weight loss
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy, runny nose and sore throat
• Tiredness
• Depression
• Changes in mood or behaviour, including anger, nervousness, sadness
• Weight gain
• Decrease or loss of appetite
• Reduced number of red blood cells
• Changes in thinking and alertness, including confusion, problems with concentration, memory or slow thinking
• Slurred speech
• Clumsiness, or problems with walking
• Involuntary shaking in the arms, hands or legs
• Reduced sense of touch or sensation
• Involuntary movement of the eyes
• Distorted sense of taste
• Visual disturbance, blurred vision, double vision
• Ringing sound in the ears
• Ear pain
• Shortness of breath
• Nose bleeds
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Skin rash and/or itchy skin
• Joint pain
• Muscle spasms, muscle twitching or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of feeling unwell

Less Frequent side-effects include:

• Crystals in the urine
• Abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils
• Irregular heartbeat or slowness of the heartbeat
• Swollen glands in the neck armpit or groin
• Increase in seizures
• Problems with verbal communication
• Drooling, increased saliva flow
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or diminished movements
• Disturbed or poor quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Feeling of movement under the skin
• Eye problems including dry eyes, light sensitivity, involuntary twitching, tearing and decreased vision
• Decreased or loss of hearing
• Hoarseness of the voice
• Inflammation of the pancreas
• Gas

Side-effects of unknown frequency:

• Maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. You should call your doctor if you notice a change or decrease in your vision
• Swelling of the conjunctiva of the eye

Not all side effects reported for TOPALEX are included in this leaflet. Should your general health worsen while taking TOPALEX, please consult your doctor, pharmacist or other health care professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction 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 TOPALEX tablets.

Store at or below 25° C. Keep container tightly closed. Store in the original package/container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Store all medicines out of reach of children. Do not use these tablets:

• after the expiry date shown on the label.
• if the tablets do not look as described below.