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

1. What topiramate 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 aged 2 years and above

• to prevent migraine headaches in adults.

2. What you need to know before you take topiramate tablets

Do not take topiramate tablets:

• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). Migraine prevention:
• You must not use topiramate tablets if you are pregnant.
• If you are a woman who is able to become pregnant, you must not take topiramate tablets, unless you use highly effective contraception (birth control) during your treatment. See below under “Pregnancy and breast-feeding – Important advice for women”.

Treatment of epilepsy:

• You must not use topiramate 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 tablets unless you use highly effective contraception (birth control) during your treatment. Do not stop taking topiramate 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 tablets during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy and breast-feeding – 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 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 tablets.

Warnings and precautions

Talk to your doctor before taking topiramate 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 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 tablets dose. See section ‘Pregnancy and breast-feeding’ for further information.

  • are pregnant. Topiramate 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 tablets.

If you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor.

You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to this medicine.

You may lose weight if you use topiramate 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 antiepileptic medicines such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Topiramate tablets can cause serious skin reactions, tell your doctor immediately if you develop a skin rash and/or blisters (see also section 4 ‘Possible side effects’).

Topiramate tablets 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 tablets, the risk of developing these symptoms may increase.

Other medicines and topiramate tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate tablets and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or this medicine 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 tablets can affect how well some hormonal contraceptive (birth control) methods work. 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 tablets.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and topiramate 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 antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, 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.

Topiramate tablets with food and drink

You can take topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate tablets. You should avoid drinking alcohol when taking Topiramate tablets.

Pregnancy and breast-feeding

Important advice for women who are able to become pregnant

Topiramate 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 tablets if you are pregnant.
• For migraine, you must not use topiramate 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 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 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 tablets if you are a woman who is able to become pregnant unless you are using highly effective contraception. Do not stop taking topiramate 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 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 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 tablets are used during pregnancy.

• If you take topiramate 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 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 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 tablets. If the decision is made to use topiramate tablets, you must use highly effective contraception during your treatment and for at least 4 weeks after the last topiramate tablet 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 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.

Use of topiramate tablets in girls:

If you are a parent or a caregiver of a girl treated with topiramate tablets, you must contact her doctor immediately once your child experiences her first period (menarche). The doctor will inform you about the risks to an unborn child due to topiramate exposure during pregnancy, and the need for using highly effective contraception.

If you wish to become pregnant while taking topiramate tablets:

• Schedule an appointment with your doctor.
• Do not stop using your contraception until you have discussed this with your doctor.
• If you take topiramate tablets for epilepsy, do not stop taking it until you have discussed this with your doctor. Suddenly stopping topiramate 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 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 tablets:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate 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 tablets for epilepsy, do not stop taking this medicine unless your doctor tells you to. Suddenly stopping topiramate 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 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 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 tablets are 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 tablets package to remind you of topiramate risks in pregnancy.

Breast-feeding

The active substance in topiramate tablets (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers, including diarrhoea, 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 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 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. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Warning! Each bottle contains a desiccant capsule. This is a small canister on which “Do not eat” is written. Do not eat this.

Topiramate tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take topiramate tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose is found for you.
• Topiramate tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramate can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.

If you take more topiramate 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.

If you forget to take topiramate 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 to make up for a forgotten dose.

If you stop taking topiramate 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, this medicine 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.

Open & folding size: 320 x 670 mm (OUT) + 260 x 69 mm (PAC) (FF size-33 x 69 mm)

(6029722) Date : 18/03/2024, 29/03/2024, 03/04/2024, (R) 03_08_2024, 04_09_2024, 09_09_2024, 13_09_2024, 17_09_2024

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Rare (may affect up to 1 in 1,000 people):

• Glaucoma – blockage of fluid in the eye causing increased pressure in the eye, pain, or 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 (hyperammonemia), which can lead to a change in brain function (hyperammonemic encephalopathy)
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - these may appear as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, nose, eyes and around the genitals. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

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.

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 coordination, 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 blurred vision, double 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 tablets may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
• Flushing, 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 side
• Blood in urine, incontinence (lack of control) of urine, urgent desire to urinate, flank or kidney pain

• Difficulty getting or keeping an erection, sexual dysfunction

  • Flu-like symptoms
  • Cold fingers and toes
  • Feeling drunk
  • Learning disability.

Rare (may affect up to 1 in 1,000 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
• 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.

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 eosinophils (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 tablets

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

Do not use this medicine after the expiry date, which is stated on the carton and bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25ºC. Keep the container tightly closed in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What topiramate tablets contain

The active substance is topiramate.

Each Topiramate Accord 25 mg film-coated tablet contains 25 mg topiramate. Each Topiramate Accord 50 mg film-coated tablet contains 50 mg topiramate. Each Topiramate Accord 100 mg film-coated tablet contains 100 mg topiramate. Each Topiramate Accord 200 mg film-coated tablet contains 200 mg topiramate.

The other ingredients are lactose monohydrate (see section 2: topiramate tablets contain lactose), cellulose microcrystalline, starch, pregelatinised (i.e. potato starch), croscarmellose sodium and magnesium stearate.

• The 25 mg tablets are coated with hypromellose, titanium dioxide (E171) and macrogol.
• The 50 mg and 100 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol and iron oxide yellow (E172)
• The 200 mg tablets are coated with hypromellose, titanium dioxide (E171), macrogol and iron oxide red (E172).

What topiramate tablets look like and contents of the pack

Film-coated tablet.

Topiramate Accord is available in four strengths containing either 25 mg, 50 mg, 100 mg and 200 mg topiramate.

The 25 mg film-coated tablets are round, biconvex film-coated tablets, approximately 6 mm in diameter, with bevelled edges. The white tablets are debossed TP on one side and 25 on the other side.

The 50 mg film-coated tablets are round, biconvex film-coated tablets, approximately 7 mm in diameter, with bevelled edges. The light yellow tablets are debossed TP on one side and 50 on the other side.

The 100 mg film-coated tablets are round, biconvex film-coated tablets, approximately 9 mm in diameter, with bevelled edges. The dark yellow tablets are debossed TP on one side and 100 on the other side.

The 200 mg film-coated tablets are round, biconvex film-coated tablets, approximately 12.7 mm in diameter, with bevelled edges. The red tablets are debossed TP on one side and 200 on the other side.

Topiramate film-coated tablets are available in aluminium/aluminium blisters in packs sizes of 10, 14, 20, 28, 30, 50, 56, 60, 100, 120 and 200 film-coated tablets or in high density polyethylene (HDPE) bottles fitted with a white opaque polypropylene child resistant closure with wad having induction sealing liner supplied in cardboard cartons in pack sizes of 14, 30, 60, 100 and 200 film-coated tablets. In each container there is a desiccant canister, which should not be swallowed. Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

This leaflet was last revised in 09/2024.

Other sources of information

The same information is also available on the following website:

www.accord-healthcare-products.co.uk

Open & folding size: 320 x 670 mm (OUT) + 260 x 69 mm (PAC) (FF size-33 x 69 mm)

(6029722) Date : 18/03/2024, 29/03/2024, 03/04/2024, (R) 03_08_2024, 04_09_2024, 09_09_2024, 13_09_2024, 17_09_2024