Topiramate Torrent 100 mg film-coated tablets – patient leaflet, side effects, dosage

1. WHAT TOPIRAMATE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Topiramate belongs to a group of medicines called “antiepileptic medicines.” It is used:

• alone to treat seizures in adults and children over age 6
• with other medicines to treat seizures in adults and children over age 2
• to prevent migraine headaches in adults

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE FILM-COATED TABLETS

Do not take Topiramate film-coated tablets

if you are allergic to topiramate or any of the other ingredients of Topiramate film-coated tablets (listed in section 6). Migraine prevention

• You must not use Topiramate film-coated tablets if you are pregnant.

• If you are a woman who is able to become pregnant, you must not take Topiramate film-coated tablets unless you use highly

  effective contraception (birth control) during your treatment. See below under “Pregnancy, breast-feeding and fertility – Important advice for women”.

Treatment of epilepsy

• You must not use Topiramate film-coated tablets if you are pregnant, unless no other treatment gives sufficient seizure control for

  you.

• If you are a woman who is able to become pregnant, you must not take Topiramate film-coated tablets unless you use highly

  effective contraception (birth control) during your treatment. Do not stop taking Topiramate film-coated tablets or your contraception until you have discussed this with your doctor. Your doctor will advise you further and make sure you are aware of and understand all of the risks of taking Topiramate film-coated tablets during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy, breast-feeding and fertility – Important advice for women”. Make sure you read the patient guide that you will receive from your doctor.

A patient card is provided with the Topiramate film-coated tablets package to remind you of the risks in pregnancy. If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate film-coated tablets. Warnings and precautions

Check with your doctor or pharmacist before taking Topiramate film-coated tablets if you:

• have kidney problems, especially kidney stones, or are getting kidney dialysis
• have a history of blood and body fluid abnormality (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have a growth problem
• are on a high fat diet (ketogenic diet)

• are a woman who is able to become pregnant. Topiramate film-coated tablets can harm an unborn child when taken during

  pregnancy. Highly effective contraception (birth control) must be used during your treatment and for at least 4 weeks after the last Topiramate film-coated tablets dose. See section ‘pregnancy and breastfeeding’ for further information.

• are pregnant. Topiramate film-coated tablets can harm an unborn child when taken during pregnancy. If you are not sure if any of the above apply to you, talk to your doctor before using Topiramate film-coated tablets. If you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor. You should also to talk to your doctor before taking any medicine containing topiramate that is

given to you as an alternative to Topiramate film-coated tablets.

You may lose weight if you use Topiramate film-coated tablets so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor. A small number of people being treated with anti-epileptic medicines such as Topiramate film-coated tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Topiramate 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 (see also section 4 ‘Possible side effects’):

• difficulty thinking, remembering information, or solving problems
• being less alert or aware
• feeling very sleepy with low energy

At higher doses of Topiramate Torrent film-coated tablets, the risk of developing these symptoms may increase. Other medicines and Topiramate film coated tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Topiramate film-coated tablets and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate film-coated tablets will have to be adjusted.

Especially, tell your doctor or pharmacist if you are taking:

• other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g. central nervous system

  depressant medicines such as muscle relaxants and sedatives).

• hormonal contraceptives. Topiramate film-coated tablets can affect how well some hormonal contraceptive (birth control) methods.

  An additional barrier method of contraception such as a condom or pessary/diaphragm should be used. You should talk to your doctor about the best kind of contraception to use while you are taking Topiramate film-coated tablets. Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topiramate film-coated tablets. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine. Other medicines you should discuss with your doctor or pharmacist include other anti-epileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine, St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression), warfarin used to thin the blood. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate film-coated tablets. Taking Topiramate film-coated tablets with food and drink

You can take Topiramate film-coated tablets with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate film-coated tablets. You should avoid drinking alcohol when taking Topiramate film-coated tablets. Pregnancy and breast-feeding

Important advice for women who are able to become pregnant

Topiramate film-coated tablets can harm an unborn child. If you are a woman who is able to become pregnant, talk to your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year. Migraine prevention:

• For migraine, you must not use Topiramate film-coated tablets if you are pregnant.

• For migraine, you must not use Topiramate film-coated tablets if you are a woman who is able to become pregnant unless you are

  using highly effective contraception (birth control).

• Before the start of treatment with Topiramate film-coated tablets a pregnancy test should be performed in a woman who is able to

  become pregnant.

Treatment of epilepsy:

• For epilepsy, you must not use Topiramate film-coated tablets if you are pregnant, unless you and your doctor have agreed that no

  other treatment gives sufficient seizure control for you.

• For epilepsy, you must not use Topiramate film-coated tablets if you are a woman who is able to become pregnant unless you are

  using highly effective contraception. Do not stop taking Topiramate film-coated tablets or your contraception (birth control) until you have discussed this with your doctor. Your doctor will make sure you have received information about the risks of taking Topiramate film-coated tablets during pregnancy and about the risks of seizures during pregnancy, which may put you or your unborn child at risk.

• Before the start of treatment with Topiramate film-coated tablets a pregnancy test should be performed in a woman who is able to

  become pregnant.

The risks of topiramate when taken during pregnancy. The risks apply whether topiramate is taken for migraine prevention or treatment of epilepsy.

There is a risk of harm to the unborn child if Topiramate film-coated tablets is used during pregnancy.

• If you take Topiramate film-coated tablets during pregnancy, your child has a higher risk for birth defects. In women who take

  topiramate, around 4 - 9 children in every 100 will have birth defects. This compares to 1-3 children in every 100 born to women who do not have epilepsy and do not take an antiepileptic treatment. Particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth) have been observed. Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant.

• If you take Topiramate film-coated tablets during pregnancy, your child may have a 2- to 3-fold higher risk for autism spectrum

  disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared with children born to women with epilepsy not taking antiepileptic medication.

• If you take Topiramate film-coated tablets during pregnancy, your child may be smaller and weigh less than expected at birth. In one

  study, around 18 in every 100 children of mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while around 5 in every 100 children born to women without epilepsy and not taking antiepileptic medication were smaller and weighed less than expected at birth.

• Talk to your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition that have a lower risk of birth defects.

Need for contraception (birth control) in women who are able to become pregnant:

• If you are a woman who is able to become pregnant, talk to your doctor about other possible treatments instead of Topiramate

  film-coated tablets If the decision is made to use Topiramate film-coated tablets, you must use highly effective contraception during your treatment and for at least 4 weeks after the last Topiramate film-coated tablets dose.

• One highly effective contraception (such as an intrauterine device) or two complementary contraceptives such as birth control pill

  together with a barrier method of birth control (such as a condom or pessary/diaphragm) must be used. Talk to your doctor about what contraception is most appropriate for you.

• Topiramate film-coated tablets can affect how well some hormonal contraceptive (birth control) methods work. If you are taking

  hormonal contraceptives, an additional barrier contraceptive method (such as a condom or pessary/diaphragm) should be used.

• Tell your doctor if you experience irregular menstrual bleeding.

If you wish to become pregnant while taking Topiramate film-coated tablets:

• Do not stop using your contraception until you have discussed this with your doctor.

• If you take Topiramate film-coated tablets for epilepsy, do not stop taking it until you have discussed this with your doctor.

  Suddenly stopping Topiramate film-coated tablets can cause seizures to start again or happen more often or last longer than before. This may put you or your unborn child at risk.

• Your doctor will reassess your treatment as they may need to change or stop your medicine. The doctor will counsel you about

  the risks of Topiramate film-coated tablets during pregnancy. He/she may also refer you to another specialist. If you have become pregnant or think you may be pregnant while taking Topiramate film-coated tablets:

• Schedule an urgent appointment with your doctor.

• If you are taking Topiramate film-coated tablets to prevent migraine, stop taking the medicine straight away, and contact your

  doctor. Your doctor will assess your condition and discuss your options with you.

• If you are taking Topiramate film-coated tablets for epilepsy, do not stop taking this medicine unless your doctor tells you to.

  Suddenly stopping Topiramate film-coated tablets can cause seizures to start again or happen more often or last longer than before. This may put you or your unborn child at risk.

• If you are taking Topiramate film-coated tablets for epilepsy, your doctor will assess your condition and discuss options with you.

  Your doctor will make sure you are aware of and understand all the risks of Topiramate film-coated tablets during pregnancy. They may advise that you need to switch to another medicine to treat your epilepsy. If so, they will explain how to make the change to this new medicine. He/she may also refer you to another specialist.

• If Topiramate film-coated tablets is used during pregnancy for epilepsy, you will be monitored closely to check how your unborn

  child is developing.

Make sure you read the patient guide that you will receive from your doctor.

A patient card is provided with the Topiramate film-coated tablets package to remind you of topiramate risks in pregnancy. Breast-feeding

The active substance in Topiramate film-coated tablets (topiramate) passes into human milk. Effects have been seen in breastfed babies of treated mothers, including diarrhea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breast-feeding or whether to abstain from treatment with Topiramate film-coated tablets. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby.

Mothers who breast-feed while taking Topiramate film-coated tablets must tell the doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Topiramate film-coated tablets. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate 50mg, 100mg and 200mg film-coated tablets contain lecithin (soya oil)

If you are allergic to peanuts or soya, do not use this medicinal product.

Other ingredients

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. This medicine contains mannitol and may have a mild laxative effect.

3. HOW TO TAKE TOPIRAMATE FILM-COATED TABLETS

Always take Topiramate film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Take Topiramate film-coated tablets exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate film-coated tablets and slowly increase your dose until the best dose is found for you.
• Topiramate film-coated tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

• Topiramate film-coated tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate film-coated tablets.

If you take more Topiramate film-coated tablets than you should

• See a doctor right away. Take the medicine pack with you.

• You may feel sleepy, tired, or less alert; lack coordination; have difficulty speaking or concentrating, have double or blurred vision;

  feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain, or seizures (fits) Overdose can happen if you are taking other medicines together with Topiramate film- coated tablets. If you forget to take Topiramate film-coated tablets

  • 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 Topiramate film-coated tablets

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Topiramate film-coated tablets can cause side effects, although not everybody gets them. Tell your doctor, or seek medical attention immediately if you have the following side effects:

Very common (may affect more than 1 in 10 people):

• Depression (new or worse)

Common (may affect up to 1 in 10 people):

• Seizures (fits)
• Anxiety, irritability, changes in mood, confusion, disorientation
• Problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden change or increased severity)
• Kidney stone, frequent or painful urination

Uncommon (may affect up to 1 in 100 people):

• Increased acid level in the blood (may cause troubled breathing including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and fast or uneven heart beats)
• Decreased or loss of sweating (particularly in young children who are exposed to high temperatures)
• Having thoughts of serious self-harm, trying to cause serious self-harm
• Loss of part of the field of vision

Rare (may affect up to 1 in 1000 people)

• Glaucoma - blockage of fluid in the eye causing increased pressure in the eye, pain and decreased vision
• Difficulty thinking, remembering information, or solving problems, being less alert or aware, feeling very sleepy with low energy – these symptoms may be a sign of a high level of ammonia in the blood (hyperammonaemia), which can lead to a change in brain function (hyperammonaemic encephalopathy).
• Serious skin reactions, such as Stevens-Johnson syndrome - these may appear as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, nose, eyes and around the genitals.

Not known (frequency cannot be estimated from the available data)

• Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision
• Toxic epidermal necrolysis is a life-threatening condition , characterized by widespread blistering and sloughing of the outer layers of the skin

Other side effects include the following, if they get serious, please tell your doctor or pharmacist: Very common (may affect more than 1 in 10 people)

• Stuffy, runny nose or sore throat
• Tingling, pain and/or numbness of various body parts
• Sleepiness, tiredness
• Dizziness
• Nausea, diarrhoea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Problems with speech or speech disorder, slurred speech
• Clumsiness or lack of concentration, feeling of unsteadiness when walking
• Decreased ability to complete routine tasks
• Decreased, loss of, or no sense of taste
• Involuntary trembling or shaking; rapid, uncontrollable movements of the eyes
• Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nose bleeds
• Fever, not feeling well, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle spasms or twitching, muscle aches or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decrease in platelets (blood cells that help stop bleeding), decrease in white blood cells that help to protect you against infection, decrease in potassium, level in the blood
• Increase in liver enzymes, increase in eosinophils (a type of white blood cell) in the blood
• Swollen glands in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Showing and/or feeling no emotion, unusual suspiciousness, panic attack
• Problems with reading, speech disorder, problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased wakefulness or alertness
• Reduced or slow body movements, involuntary abnormal or repetitive muscle movements
• Fainting
• Abnormal sense of touch; impaired sense of touch
• Impaired, distorted, or no sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eye, sensitivity of the eyes to light, eyelid twitching, watery eyes
• Decreased or loss of hearing, loss of hearing in one ear
• Slow or irregular heartbeat, feeling your heart beating in your chest
• Low blood pressure, low blood pressure upon standing (consequently, some people taking topiramate may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• Flushing or feeling warm
• Pancreatitis (inflammation of the pancreas)
• Excessive passing of gas or wind, heartburn, abdominal fullness or bloating
• Bleeding gums, increased saliva, drooling, breath odour
• Excessive intake of fluids, thirst
• Skin discolouration
• Muscle stiffness, pain in the side
• Blood in urine, incontinence (lack of control) of urine, urgent desire to urinate, flank or kidney pain
• Difficulty getting or keeping an excretion, sexual dysfunction
• Flu-like symptoms
• Cold fingers and toes
• Feeling drunk
• Learning disability

Rare (may affect up to 1 in 1000 people)

• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Swelling in and around the eyes
• Numbness, tingling and colour change (white, blue then red) in fingers and toes when exposed to the cold
• Inflammation of the liver, liver failure
• Stevens Johnson syndrome, a potentially life-threatening condition that may be present with sores in multiple mucosal sites (such as the mouth, nose, and eyes), a skin rash, and blistering
• Abnormal skin odour
• Discomfort in your arms or legs
• Kidney disorder

Not known (frequency cannot be estimated from the available data)

• 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.
• Toxic epidermal necrosis, a life-threatening condition related to, yet more severe than, Stevens-Johnson syndrome, characterized by widespread blistering and sloughing of the outer layers of the skin (see rare side effects)

Children

The side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than adults:

• Problems with concentration
• Increased acid level in the blood
• Having thoughts of serious self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• Not feeling well
• Decrease in potassium level in the blood
• Showing and/or feeling no emotion
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increase in eosionphils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling warm
• Learning disability

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Topiramate film-coated tablets

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging (blisters, bottles) in order to protect from moisture. Keep the bottle tightly closed in order to protect from moisture.

Do not use Topiramate film-coated tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Topiramate film-coated Tablets supplied in bottles must be used within 60 days of opening. There is a space provided on the bottle for you to write the date that you opened them.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Topiramate film-coated tablets contain

The active substance is topiramate.

Each tablet contains either 25mg, 50mg, 100mg or 200mg of the active substance. The other ingredients are mannitol, starch (pregelatinised), cellulose (microcrystalline), croscarmellose sodium, silica (colloidal anhydrous), magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogols (macrogol 3350), talc.

The following ingredients are also in the

• 50mg and 100mg tablets - lecithin (Soya) (E322) and iron oxide yellow (E172).
• 200mg tablets - lecithin (Soya) (E322) and iron oxide red (E172).

What Topiramate tablets looks like and contents of the pack

Topiramate Torrent 25mg Film-coated Tablets are round, biconvex, white tablets

Topiramate Torrent 50mg Film-coated Tablets are round, biconvex, light yellow tablets

Topiramate Torrent 100mg Film-coated Tablets are round, biconvex, yellow tablets

Topiramate Torrent 200mg Film-coated Tablets are oval, biconvex, salmon-coloured tablets

Topiramate Torrent Film-coated Tablets are available in packs of 60 tablets.

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd., 3rd Floor, Nexus Building,4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom Manufacturer

Coripharma ehf., Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland

Other sources of information:

The same information is also available on the following website: https://torrentpharmauk.healthcare/topiramate This leaflet was last updated in 05/2024

Topiramate Pregnancy Prevention Programme Patient Card

Important information for all female patients who could become pregnant

PRESCRIBING DOCTOR’S NAME:

PRESCRIBING DOCTOR’S PHONE NUMBER: Contraception and Pregnancy Prevention

Important information to know

What you must do

• Topiramate is an effective medicine for epilepsy and prevention of migraine.
• Topiramate can seriously harm a baby when taken during pregnancy.
• Use effective birth control (contraception) at all times during your treatment with topiramate and for at least 4 weeks after the last dose.
• Discuss with your doctor about which method of birth control is most suitable for you.

• It is important to visit your doctor to review your treatment at least once each year.

  • Read the package leaflet carefully before use.
  • Read the Patient Guide for the topiramate pregnancy prevention programme. You should have received a copy from your doctor or it can be found online at www.medicines.org.uk by entering “topiramate” in the search box and then clicking on “Risk Materials”.
  • If you are thinking about having a baby, make an appointment with your GP. Do not stop using topiramate and contraception before you have talked to your doctor.
  • If you think you are pregnant and are taking topiramate for epilepsy, do not stop using topiramate. This may cause your seizures to start again or happen more often and last longer. Make an urgent appointment with your GP or epilepsy team (within a few days).
  • If you think you are pregnant and are taking topiramate for migraine prevention, stop taking topiramate straight away and contact your GP. 1

4

2 3