Sencresus Film-Coated Tablets

SENCRESUS belongs to a group of medicines called Anticonvulsants including “anti-epileptic medicines”. SENCRESUS is used with or without other medicines to treat epilepsy (seizures) in adults and children over 12 years of age.

Do NOT take SENCRESUS:

• If you are allergic to the active ingredient topiramate or any of the other ingredients (listed in section 6).
• If you are pregnant or planning to become pregnant unless the conditions of the Pregnancy Prevention Programme are fulfilled.
• If you are breast-feeding
• Parents must not give SENCRESUS tablets to children of younger than 12 years old
• If you are not sure if the above applies to you, talk to your doctor or pharmacist before using SENCRESUS.

Warnings and precautions

Take special care with SENCRESUS: Discuss with your doctor or pharmacist before taking SENCRESUS if you:

• Have eye problems as your vision could be affected and you could experience pain in your eyes.
• Have breakthrough bleeding when you are using oral contraceptives and start taking SENCRESUS because the efficacy of the contraception can be decreased.
• Have liver disease as the clearance of SENCRESUS from the body may be decreased
• Have kidney disease or if you are on dialysis
• Have a history of body fluid disorders such as decreased serum bicarbonate because of kidney disease. It is important that you drink plenty of fluid while you are using SENCRESUS and your doctor should monitor your serum bicarbonate levels
• Are a woman who is at child-bearing age (able to become pregnant). SENCRESUS can cause harm to an unborn child if taken during pregnancy. Highly effective contraception (birth control) should be used during your treatment and for at least 4 weeks after the last SENCRESUS dose. Consult your doctor or healthcare professional for information regarding the Pregnancy Prevention Programme.
• Are pregnant, as SENCRESUS can cause major congenital malformations and fetal growth restriction
• Experience a rise in body temperature and decreased sweating.
• Experience behavioural changes and depression
• Develop unexplained lethargy or changes in mental status, your doctor may need to monitor your ammonia levels.

Do not share medicines prescribed for you with any other person. Always take SENCRESUS exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Your doctor will usually start you on a low dose of SENCRESUS and slowly increase your dose until the best dose is found for you. SENCRESUS tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

SENCRESUS can be taken before, during or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking SENCRESUS. Your doctor will tell you how long your treatment with SENCRESUS will last. If you have the impression that the effect of SENCRESUS is too strong or too weak, tell your doctor or pharmacist.

If you take more SENCRESUS than you should: If you take more SENCRESUS than you should, you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heartbeats or fits. In the event of an overdosage consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Take the medicine pack with you.

If you forget to take SENCRESUS: If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking SENCRESUS: Do not stop taking SENCRESUS unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop SENCRESUS, your dose may be decreased gradually over a few days.

SENCRESUS can cause side - effects. Not all side-effects reported for SENCRESUS are included in this leaflet. Should your general health worsen while taking SENCRESUS, please consult your doctor, pharmacist or other health care professional for advice.

Get emergency medical help if you have any of these signs of an allergic reaction:

• tightness in the chest
• shortness of breath; difficulty in breathing; wheezing
• convulsions (seizures)
• fast or irregular heartbeats
• loss of consciousness; fainting

Call your doctor at once if you have any of these side-effects:

• thoughts of committing suicide or attempts to commit suicide
• severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, and erythema multiforme, a condition of raised red spots that can blister
• changes in mood or behaviour, including anger, nervousness, sadness
• dizziness

These are all very serious side effects. If you have them, you may have had a serious reaction to SENCRESUS. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• viral infections (flu-like illness)
• reduced number of red blood cells
• purple patches like bruising
• allergic reactions
• decrease or loss of appetite
• weight loss
• changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking
• disturbances with sexual function (loss of libido or erectile dysfunction)
• slurred speech
• involuntary shaking in the arms, hands or legs
• sensations like numbness, tingling, pins and needles
• difficulty with memory
• tiredness, drowsiness
• loss of strength
• disturbed or poor quality sleep
• visual disturbance, blurred vision, double vision
• involuntary eye movements
• Ear pain
• A spinning sensation and ringing in the ears
• stuffy, runny nose and sore throat
• Nosebleeds
• constipation; nausea; vomiting
• Increase saliva
• stomach pain; gastritis; drooling; distorted sense of taste
• hair loss
• skin rash and/or itchy skin
• Muscle pains, twitching and weakness
• Blood in the urine and painful urination
• Frequent urination
• Menstrual disturbances
• Thirst
• Increase in body temperature

Less frequent side effects:

• abnormal blood counts, including reduced white blood cell count or platelet count
• Increased appetite
• Decreased blood potassium levels
• Decreased blood chloride levels
• Increased blood ammonia levels
• hallucinations
• restlessness or increased mental and physical activity
• panic disorders
• suicidal attempts and pyschosis
• eye problems including dry eyes, light sensitivity
• high pressure in the eye
• blindness, blind spots and blurred vision
• eye pain
• sharpness of vision and loss of focusing ability
• Unusual dilation of pupil
• decrease of loss of hearing
• diarrhoea; dry mouth
• inflammation of the pancreas
• skin discolouration
• decrease or loss of sweating
• slow heartbeat
• palpitations
• low blood pressure
• severe narrowing of blood vessels in the cold
• difficulty breathing
• changes in the sound or tone of the voice
• hot flushing
• heartburn
• flatulence
• breath odor
• Burning and tingling of the mouth
• swelling of the joints
• musculoskeletal stiffness
• co-ordination issues
• deviation in walking pattern
• liver failure
• swelling of the face
• inflamed hair follicles
• itching
• numbness
• muscle fatigue and stiffness

Unknown side effects:

• cough

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 or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SENCRESUS.

Store all medicines out of reach of children. Store at or below 25 ºC. Keep tablets in original blister pack until ready for use. Protect from moisture.

Do not store in bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated or medicines no longer needed. Be sure that any discarded medicine is out of reach of children.