TOPAMAX 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

TOPAMAX 200 mg film-coated tablets

topiramate

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Topamax and what is it used for
2. What you need to know before you take Topamax
3. How to take Topamax
4. Possible side effects
5. Storing Topamax

1. Contents of the pack and other information

1. What is Topamax and what is it used for

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

• treat seizures in adults and children over 6 years of age, given alone
• treat seizures in adults and children aged 2 or more years, given together with other medicines
• to prevent migraine in adults

2. What you need to know before you take Topamax

Do not take Topamax

• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6).

Migraine prevention

• Do not take Topamax if you are pregnant.
• If you are a woman of childbearing potential, do not take Topamax unless you are using a highly effective contraceptive method during treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Epilepsy treatment

• Do not use Topamax if you are pregnant, unless no other treatment provides sufficient control of seizures.

• If you are a woman of childbearing potential, do not take Topamax unless you are using a highly effective contraceptive method during treatment. The only exception is if Topamax is the only treatment that provides sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking Topamax during pregnancy and the risks of seizures during pregnancy, which may put you or your unborn baby at risk.

Make sure to read the patient guide that you will receive from your doctor or scan the QR code to get it (see section 6 “Other sources of information”).

A patient card is provided with the pack of Topamax to remind you of the risks during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using Topamax.

Warnings and precautions

Consult your doctor before starting to take Topamax if you:

• have kidney problems, especially kidney stones, or are receiving dialysis
• have a history of blood or body fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• follow a high-fat diet (ketogenic diet)
• are a woman who may become pregnant. Topamax may harm an unborn baby during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topamax. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topamax may harm an unborn baby during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor before using Topamax.

If you have epilepsy, it is important not to stop taking your medication without consulting your doctor first.

You should consult your doctor before taking any other medicine containing topiramate that is given to you as an alternative to Topamax.

You may lose weight if you take Topamax, so your weight should be checked regularly while you are taking this medicine. If you lose too much weight or if a child taking this medicine does not gain enough weight, you should consult your doctor.

A small number of people being treated with antiepileptic drugs such as Topamax have had thoughts of harming themselves or taking their own lives. If at any time you have these thoughts, contact your doctor immediately.

Topamax may cause serious skin reactions, contact your doctor immediately if you develop a skin rash and/or blisters (see also section 4 “Possible side effects”).

Topamax may rarely cause high levels of ammonia in the blood (seen in blood tests) which can cause a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this can be a serious illness, talk to your doctor immediately if you experience any of the following symptoms (see also section 4 “Possible side effects”):

• difficulty thinking, remembering information, or solving problems
• decreased alertness or consciousness
• feeling of numbness with low energy

The risk of developing these symptoms may increase at higher doses of Topamax.

Other medicines and Topamax

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Topamax and certain medicines can affect each other. Sometimes the dose of one of the other medicines or Topamax may need to be adjusted.

In particular, tell your doctor or pharmacist if you are taking:

• other medicines that impair or decrease your thoughts, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topamax may make hormonal contraceptives less effective. You should use an additional barrier contraceptive such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topamax.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topamax. You may experience irregular bleeding. In this case, keep taking your hormonal contraceptives and tell your doctor.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start taking a new medicine.

Other medicines that you should tell your doctor or pharmacist about 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 prevent blood clotting.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Topamax.

Using Topamax with food and drink

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

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topamax may harm an unborn baby during pregnancy. If you are a woman of childbearing potential, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Migraine prevention

• In the case of migraine, do not take Topamax if you are pregnant.
• In the case of migraine, do not use Topamax if you are a woman of childbearing potential, unless you are using a highly effective contraceptive method.
• Before starting treatment with Topamax, a pregnancy test should be performed in a woman of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, do not take Topamax if you are pregnant, unless no other treatment provides sufficient control of seizures.
• In the case of epilepsy, do not use Topamax if you are a woman of childbearing potential, unless you are using a highly effective contraceptive method. The only exception is if Topamax is the only treatment that provides sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking Topamax during pregnancy and the risks of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before starting treatment with Topamax, a pregnancy test should be performed in a woman of childbearing potential.

Risks of topiramate when taken during pregnancy (regardless of the condition for which topiramate is used) are as follows:

There is a risk of harm to the unborn baby during pregnancy if Topamax is used during pregnancy.

• If you take Topamax during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 children out of 100 will have birth defects. This compares to 1-3 children out of 100 born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been seen. Boys born may also have a malformation of the penis (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take Topamax during pregnancy, your child may have a 2 to 3 times higher risk of having autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medication.
• If you take Topamax during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy and not taking antiepileptic medication were smaller and weighed less than expected at birth.
• Consult your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition with a lower risk of birth defects.

Need for contraceptive methods for women of childbearing potential:

• If you are a woman of childbearing potential, consult your doctor about other possible treatments instead of taking Topamax. If the decision is made to use Topamax, highly effective contraceptive methods should be used during treatment and for at least 4 weeks after the last dose of Topamax.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill together with a barrier contraceptive method (such as a condom or diaphragm) should be used. Consult your doctor about the most suitable contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, a barrier contraceptive method (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topamax in girls:

If you are the parent or caregiver of a girl treated with Topamax, you should consult your doctor immediately once your daughter experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby during pregnancy due to exposure to topiramate during pregnancy and the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topamax:

• Schedule an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you are taking Topamax for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may worsen.
• Your doctor will re-evaluate your treatment and assess alternative treatment options. The doctor will advise you on the risks of Topamax during pregnancy. The doctor may also refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Topamax:

• Schedule an urgent appointment with your doctor.
• If you are taking Topamax to prevent migraines, stop taking the medicine immediately and consult your doctor to assess whether you need alternative treatment.
• If you are taking Topamax for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. Worsening of your epilepsy may put you or your unborn baby at risk.
• Your doctor will re-evaluate your treatment and assess alternative treatment options. The doctor will advise you on the risks of Topamax during pregnancy. The doctor may also refer you to another specialist.
• If Topamax is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

Make sure to read the patient guide that you will receive from your doctor. The patient guide is also available by scanning a QR code; see section 6 “Other sources of information”. A patient card is provided with the pack of Topamax to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Topamax (topiramate) passes into human milk. Effects have been seen in breastfed babies of mothers treated with Topamax, including diarrhea, drowsiness, irritability, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or to stop treatment with Topamax. Your doctor will consider the importance of the benefits for the mother and the risk for the baby. Breastfeeding mothers taking Topamax should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness, and vision disturbances may occur during treatment with Topamax. Do not drive or use tools or machines without talking to your doctor first.

Topamax contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Other excipients

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Topamax

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

• Your doctor will usually start with a low dose of Topamax and gradually increase your dose until the best dose for you is found.
• Topamax tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take Topamax before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking Topamax.

Girls and women of childbearing potential:

Treatment with Topamax should be started and continued under the supervision of a doctor experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

If you take more Topamax than you should:

• Consult your doctor immediately. Take the medicine with you.
• You may feel drowsy, tired, or less alert; lack of coordination; have difficulty speaking or concentrating; have double vision or blurred vision; feel dizzy due to low blood pressure; feel depressed or agitated; or have abdominal pain or seizures (fits).

You may experience an overdose if you are taking another medicine together with Topamax.

In case of overdose or accidental ingestion, you can also contact the Toxicological Information Service, Telephone 91 5620420.

If you forget to take Topamax

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

If you stop taking Topamax

Do not stop treatment without your doctor telling you to. Your symptoms may come back. If your doctor decides that you should stop taking this medicine, your dose will be gradually decreased over several days.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Consult your doctor or seek medical attention immediately if you have the following adverse effects:

Very Common (may affect more than 1 in 10 people)

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration problems, slow thinking, memory loss, memory problems (initial, sudden change, or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased acid levels in the blood (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• Decreased or lost sweating (especially in small children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious harm
• Loss of part of the visual field

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

• Glaucoma - blockage of fluid in the eye that causes increased pressure in the eye, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy - these symptoms can be a sign of high ammonia levels in the blood (hyperammonemia), which can produce a change in brain function (hyperammonemic encephalopathy)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, can appear as skin rashes with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become widespread skin damage (shedding of the epidermis and superficial mucous membranes) with life-threatening consequences.

Not Known (cannot be estimated from available data):

• Eye inflammation (uveitis) with symptoms such as eye redness and pain, sensitivity to light, tearing, blurred vision, or seeing small dots

Other Adverse Effects Include the Following, If Severe, Please Consult Your Doctor or Pharmacist:

Very Common (may affect more than 1 in 10 people)

• Congestion, runny nose, or sore throat
• Numbness, pain, and/or tingling of various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty staying or falling asleep
• Speech problems or speech disorders, problems with pronunciation when speaking
• Clumsiness or lack of coordination, feeling of instability when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent sense of taste
• Tremors or involuntary movements; rapid, uncontrolled eye movements
• Visual disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing
• Feeling of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, general malaise, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or inflammation, muscle spasms or twitches, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count that helps protect against infections, decreased potassium levels in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood
• Swelling of the neck, armpit, or groin lymph nodes
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotion, unusual distrust, panic attack
• Reading problems, speech disorders, writing problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or awareness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch
• Altered, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eyes, eye sensitivity to light, eyelid twitching, tearing
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing up (consequently, some people taking Topamax may faint, feel dizzy, or lose consciousness when standing up or sitting down suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or bloating, stomach acid, feeling full or bloated
• Nosebleeds, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (lack of control) when urinating, urgency to urinate, side or kidney pain
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Feeling of intoxication
• Learning difficulties

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 of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue, then red) of the fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Abnormal skin odor
• Discomfort in the arms and legs
• Kidney disorder

Not Known (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is sharpest. Consult your doctor if you notice a change or decrease in your vision.

Other Adverse Effects in Children

Generally, the adverse effects observed in children are similar to those observed in adults, but the following adverse effects may be more frequent in children than in adults:

• Concentration problems
• Increased acid levels in the blood
• Having thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling of instability when walking
• General malaise
• Decreased potassium levels in the blood
• Lack of emotion
• Tearing
• Slow or irregular heartbeat

Other adverse effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Feeling of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling hot
• Learning difficulties

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topamax

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister/pack/box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Blister packs: Store in the original packaging to protect the tablets from moisture.

Bottles: Store in the original packaging and keep the bottle tightly closed to protect the tablets from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Topamax

• The active ingredient is topiramate.
• Each film-coated Topamax tablet contains 200 mg of topiramate.
• The other ingredients of Topamax are:

• tablet core: lactose monohydrate 44 mg, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate
• film coating: OPADRY® Pink, carnauba wax

1 OPADRY® contains: hypromellose, macrogol, polysorbate 80, and as a colorant, titanium dioxide E171 and iron oxide red E172.

Appearance of the Product and Package Contents

200 mg: pink, round tablets, 10 mm in diameter, with the inscription "TOP" on one side and "200" on the other side.

Opaque plastic bottle with a safety cap containing 20, 28, 30, 50, 56, 60, 100, or 200 (2x100) tablets. Each bottle includes a desiccant that should not be swallowed.

Aluminum/aluminum blister pack in strips. Package sizes of 10, 20, 28, 30, 50, 56, 60, 100, or 200 (2x100) tablets. Each blister strip (alu/alu) is contained within a protective bag.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Janssen-Pharma, S.L.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30,

Beerse, 2340

Belgium

or

Janssen-Cilag SpA

Via C. Janssen,

Borgo San Michele

04100

Latina

Italy

or

Lusomedicamenta – Sociedade Técnica Farmacêutica S.A.

Estrada Consiglieri Pedroso nº 69 B

Queluz de Baixo

2730-055 Barcarena

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:March 2024.

Other Sources of Information

The most recently approved patient guide information for this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL):

https://cima.aemps.es/cima/DocsPub/16/3252

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).