Topiramate Side Effects

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Answer the side-effect intent for topiramate without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is topiramate?

Topiramate contains the active ingredient Topiramate.

• Active ingredient — Topiramate
• Registration number — 42/2.5/0277; 42/2.5/0278; 42/2.5/0279
• Registration holder — Zydus Healthcare SA (Pty) Ltd

It is approved for:

• Topiramate the active ingredient of TOPIRAMATE UNICORN falls in the category of anticonvulsants
• TOPIRAMATE UNICORN is used to help control some types of seizures in the treatment of epilepsy
• In adults TOPIRAMATE UNICORN can be used on its own or in combination with other medicine to treat your epilepsy
• In children aged 4 years and over TOPIRAMATE UNICORN can be used in combination with other medicine to treat epilepsy

Common side effects of topiramate

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Reduced number of red blood cells
• Weight loss, decrease in appetite
• Weight increase
• Depression, anxiety, changes in mood or behaviour (including aggression, nervousness, sadness, anger)
• Dizziness, sleepiness, feeling tired, tingling or pins and needles sensation
• Changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking
• Ringing sound in the ears, ear pain
• Nausea, diarrhoea, vomiting, constipation, abdominal pain, indigestion, dry mouth
• Tingling or numbness of the mouth
• Runny nose, nose bleeds, shortness of breath
• Cough
• Hair loss (temporary)
• Joint pain, muscle spasms, muscle twitching or muscle weakness
• Chest pain
• Fever, loss of strength, general feeling of feeling unwell

Less frequent side effects

• Abnormal blood counts, including reduced white blood cell count or platelet count or increased eosinophils
• Swollen glands in the neck, armpit or groin
• Problems with verbal communication
• Problems with coordination
• Drooling, increased saliva flow
• Restlessness or increased mental and physical activity
• Impaired sense of smell, or loss of smell
• Problems with handwriting
• Hoarseness of the voice
• Bleeding gums
• Fullness or bloating of the stomach, breath odour
• Decrease or loss of sweating
• Swelling
• Muscle stiffness
• Increased acid levels in the blood
• Problems with learning

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic (hypersensitive) to topiramate or any of the other ingredients of TOPIRAMATE UNICORN (listed in section 6)
• If you are pregnant or breastfeeding your baby
• TOPIRAMATE UNICORN should not be given to children under 2 years of age

Use with care, and tell your doctor, if

• If you have glaucoma (increased pressure in the eye). If you experience sudden blurring of vision, pain and redness of the eyes, typically during the first month of starting TOPIRAMATE UNICORN, you should tell your doctor immediately, as this can indicate glaucoma
• If your kidney or liver function is impaired
• If you have a history of kidney stones. Take special care with TOPIRAMATE UNICORN and inform your doctor:
• If you have thoughts of inflicting harm to or killing yourself after starting your treatment with TOPIRAMATE UNICORN. If you have any thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately
• If you start feeling depressed or if your mood changes while taking TOPIRAMATE UNICORN
• If you experience visual field defect (a loss of part of your usual vision field) in either one of, or both your eyes
• If you experience metabolic acidosis (a condition that occurs when your body produces excessive quantities of acid). Symptoms may include nausea, vomiting, fast breathing and lack of energy
• If you or your child experience a decrease in sweating and increased body temperature (fever) while taking TOPIRAMATE UNICORN. 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 doctor right away if you have a high fever, a fever that does not go away, or decreased sweating. It is important to drink enough fluids while taking TOPIRAMATE UNICORN. Drinking enough fluids while exercising or exposed to warm temperatures may reduce the risk of heat-related side effects
• TOPIRAMATE UNICORN may cause high levels of ammonia in your blood (seen in blood tests) which can lead to a change in your brain function, especially if you are also taking a medicine called valproic acid. If you develop symptoms such as difficulty thinking, difficulty remembering information or solving problems, feeling very sleepy with low energy, contact your doctor immediately. You may lose weight while taking TOPIRAMATE UNICORN. Your weight should be checked regularly while taking TOPIRAMATE UNICORN. If you lose weight, you should consider a dietary supplement or increase your food intake. Children and adolescents: TOPIRAMATE UNICORN is indicated to treat epilepsy in children aged 4 years and over when used in combination with other anti-epileptic medicine. You should not give TOPIRAMATE UNICORN to your child if he is younger than 2 years of age

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking TOPIRAMATE UNICORN
• Do not take TOPIRAMATE UNICORN if you are pregnant or breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Oral birth control pills (topiramate may cause for this birth control method to be ineffective)
• Phenytoin, carbamazepine, valproic acid, phenobarbital, primidone (used to treat epilepsy)
• Digoxin (used to treat heart failure and a fast heartbeat)
• Alcohol and medicine that suppress the central nervous system like sleeping tablets or medicine for anxiety
• Amitriptyline, imipramine, moclobemide, St John’s wort, (used to treat depression)
• Lithium (used to treat mania)
• Risperidone (used to treat psychosis, a severe mental disorder)
• Hydrochlorothiazide (used to remove excess water from your body)
• Metformin, pioglitazone, glyburide (used to treat high blood sugar levels)
• Warfarin (used to thin your blood)
• Propranolol and diltiazem (used to treat certain heart conditions). TOPIRAMATE UNICORN with food, drink and alcohol: You can take TOPIRAMATE UNICORN with or without food. Drink plenty of fluids during the day to avoid dehydration and prevent kidney stones while taking TOPIRAMATE UNICORN. You should avoid drinking alcohol when taking TOPIRAMATE UNICORN

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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