Topamax 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TOPAMAX 50 mg film-coated tablets

topiramate

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Topamax is and what it is used for

2. What you need to know before taking Topamax

3. How to take Topamax

4. Possible adverse effects

5. How to store Topamax

6. Contents of the pack and other information

1. What Topamax is and what it is used for

Topamax belongs to a group of medicines called "antiepileptic drugs". It is used for:

• treating seizures in adults and children over 6 years of age when given alone
• treating seizures in adults and children aged 2 years and older when given together with other medicines
• preventing migraine in adults

2. What you need to know before starting to take Topamax

Do not take Topamax

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

Migraine prevention

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

Epilepsy treatment

• You must not use Topamax if you are pregnant unless no other treatment provides adequate seizure control.
• If you are a woman of childbearing potential, you must not take Topamax unless you are using a highly effective method of contraception during treatment. The only exception is if Topamax is the only treatment that provides adequate seizure control and you are planning 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. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

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

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using Topamax.

Warnings and precautions

Talk to your doctor before starting to take Topamax if you:

• have kidney problems, especially kidney stones, or are undergoing dialysis
• have a history of blood or body fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are on a high-fat diet (ketogenic diet)
• are a woman who could become pregnant. Topamax may harm an unborn baby when taken 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 when taken during pregnancy.

If you are unsure whether 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 first consulting your doctor.

You should consult your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to Topamax.

You may lose weight while taking Topamax, so your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of people being treated with antiepileptic medicines such as Topamax have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

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

Topamax may rarely cause high levels of ammonia in the blood (detected in blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, speak 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 drowsy with low energy

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

Other medicines and Topamax

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. Topamax and certain medicines may interact with each other. Sometimes, the dose of either Topamax or the other medicine may need to be adjusted.

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

• other medicines that impair or reduce mental function, concentration, or coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topamax may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. Discuss with your doctor the best contraceptive method to use while taking Topamax.

Tell your doctor if your menstrual bleeding pattern changes while taking hormonal contraceptives and Topamax. Irregular bleeding may occur. In such cases, continue taking the hormonal contraceptives and inform your doctor.

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

Other medicines about which you should consult your doctor or pharmacist include other antiepileptic medicines, digoxin, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, haloperidol, propranolol, diltiazem, venlafaxine, flunarizine, St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression), and warfarin (used to prevent blood clotting).

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Topamax.

Use of Topamax with food and drinks

You may take Topamax with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topamax. You should avoid drinking alcohol when taking Top谩max.

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topamax can cause harm to a 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

• You must not take Topamax if you are pregnant and being treated for migraine.
• You must not use Topamax if you are a woman of childbearing potential and being treated for migraine, unless you are using a highly effective method of contraception.
• Before starting treatment with Topamax, a pregnancy test must be performed in women of childbearing potential.

Epilepsy treatment

• You must not take Topamax if you are pregnant and being treated for epilepsy, unless no other treatment provides sufficient seizure control.
• You must not use Topamax if you are a woman of childbearing potential and being treated for epilepsy, unless you are using a highly effective method of contraception. The only exception is if Topamax is the only treatment that provides sufficient seizure control and you are planning a pregnancy. You must 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 must be performed in women of childbearing potential.

Risks of taking topiramate during pregnancy (regardless of the condition for which topiramate is used):

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

• If you take Topamax during pregnancy, your child has an increased risk of congenital malformations. In women taking topiramate, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1–3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic medication. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Male newborns may also have a malformation of the penis (hypospadias). These defects may develop early in 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 developing 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 babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, compared with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.
• Consult your doctor if you have any questions about these risks during pregnancy.
• There may be other medications available to treat your condition with a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

• If you are a woman of childbearing potential, consult your doctor about alternative treatments instead of taking Topamax. If the decision is made to use Topamax, highly effective contraceptive methods must be used throughout 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 an oral contraceptive pill combined with a barrier method (such as a condom or diaphragm), should be used. Consult your doctor about the most appropriate 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, an additional barrier contraceptive (such as a condom or diaphragm) must be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topamax in girls:

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

If you are planning a pregnancy 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 without first consulting your doctor, as your condition could worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topamax during pregnancy. The doctor may also refer you to another specialist.

If you become pregnant or suspect 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 medication immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topamax for epilepsy, do not stop taking this medication until you have discussed it with your doctor, as your condition could worsen. Worsening of epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about 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 your baby's development.

Make sure to read the patient guide 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 Topamax packaging to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in Topamax (topiramate) passes into human milk. Effects have been observed in breastfed infants of treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should discontinue breastfeeding or discontinue treatment with Topamax. Your doctor will consider the importance of the benefits for the mother and the potential risk to the infant.

Breastfeeding mothers taking Topamax should inform their doctor as soon as possible if the infant shows any unusual symptoms.

Driving and use of machines

Dizziness, fatigue, and visual disturbances may occur during treatment with Topamax. Do not drive or operate tools or machinery without first talking to your doctor.

Topamax contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medication.

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 for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Your doctor will usually start with a low dose of Topamax and slowly 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 may take Topamax before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topamax.

Girls and women of childbearing potential:

Treatment with Topamax should be initiated and continued under the supervision of a physician 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:

• Contact your doctor immediately. Take the medicine with you.
• You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; experience double or blurred vision; feel dizzy due to a drop in blood pressure; feel depressed or restless; or have abdominal pain or seizures (attacks).

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

In case of overdose or accidental ingestion, you may also contact the Toxicology 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 a missed dose.

If you stop taking Topamax

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

If you have any further 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 everyone will experience them.

Consult your doctor or seek immediate medical attention if you experience any of 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
• Difficulty concentrating, slowed thinking, memory loss, memory problems (sudden onset or worsening)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased level of acid in the blood (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Decreased or absent sweating (especially in young children exposed to high temperatures)
• Thoughts of self-harm, attempting to cause serious injury to oneself
• Loss of part of the visual field

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

• Glaucoma – blockage of fluid in the eye causing increased eye pressure, eye pain, or vision loss
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling drowsy with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy)
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which may 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 may progress to widespread damage to the skin (detachment of the epidermis and superficial mucous membranes), which can be life-threatening.

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

• Inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred vision

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

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

• Nasal congestion, runny nose, or sore throat
• Tingling, pain, and/or numbness in various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• 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
• Speech problems or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing
• Sensation 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 swelling, muscle spasms or twitches, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (which help protect against infections), decreased blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotional expression and/or feeling, unusual distrust, panic attack
• Reading difficulties, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slowed thinking, decreased level of wakefulness or alertness
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch sensation
• Altered, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or certain types of seizures
• Dry eyes, light sensitivity, eyelid twitching, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people taking Topamax may faint, feel dizzy, or lose consciousness when standing up or sitting up suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acid, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, incontinence (lack of control when urinating), urgency to urinate, side or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Feeling drunk
• 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, then blue, followed by red) in fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Unusual skin odour
• Discomfort in arms and legs
• Kidney problems

Not known (frequency 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 any change or decrease in your vision.

Other adverse effects in children

In general, adverse effects observed in children are similar to those seen in adults, but the following adverse effects may be more common in children than in adults:

• Difficulty concentrating
• Increased level of acid in the blood
• Thoughts of self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling unsteady when walking
• General malaise
• Decreased blood potassium levels
• Lack of emotional expression and/or feeling
• Watery eyes
• Slow or irregular heartbeat

Other adverse effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topamax

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

Do not use this medicine after the expiry date stated on the blister pack/bottle/box after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topamax

• The active substance is topiramate.

• Each Topamax film-coated tablet contains 50 mg of topiramate.

• The other components of Topamax are:

• tablet core: lactose monohydrate 62 mg, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato, magnesium stearate

• film coating: OPADRY® Yellow 1, carnauba wax

1 OPADRY® contains: hypromellose, macrogol, polysorbate 80 and as colourants, titanium dioxide E171 and yellow iron oxide E172.

Nature and contents of the container

50 mg: light yellow, round tablets, 7 mm in diameter, with the imprint “TOP” on one side and “50” on the other side.

Opaque plastic bottle with a tamper-evident closure containing 20, 28, 30, 50, 56, 60, 100 or 200 (2x100) tablets. Each bottle contains a desiccant which must not be swallowed.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain:	Topamax
Denmark, Finland, Iceland, Norway, Sweden:	Topimax
France:	Epitomax
Greece:	Topamac

Date of the most recent review of this leaflet: September 2025.

Other sources of information

The most recent approved information from the patient guide for this medicinal product 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

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