Topamax Dispersable 50 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

TOPAMAX DISPERSIBLE 50 mg hard capsules

topiramate

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

Read all of this leaflet carefully before you start taking this medicine, because 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Topamax dispersible is and what it is used for

2. What you need to know before taking Topamax dispersible

3. How to take Topamax dispersible

4. Possible side effects

5. How to store Topamax dispersible

6. Contents of the pack and other information

1. What Topamax dispersible is and what it is used for

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

• treat seizures in adults and children over 6 years of age when used alone
• treat seizures in adults and children aged 2 years and older when used in combination with other medicines
• prevent migraine in adults

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

Do not take Topamax dispersible

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

Prevention of migraine

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

Treatment of epilepsy

• You must not use Topamax dispersible if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you are a woman of childbearing potential, you must not take Topamax dispersible unless you are using a highly effective method of contraception during treatment. The only exception is if Topamax dispersible is the only treatment that provides sufficient 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 dispersible 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 guide 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 dispersible pack 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 dispersible.

Warnings and precautions

Talk to your doctor before starting to take Topamax dispersible 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 dispersible 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 dispersible. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topamax dispersible may harm an unborn baby when taken during pregnancy.

If you are unsure whether the above applies to your case, consult your doctor before using Topamax dispersible.

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 dispersible.

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

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

Topamax dispersible 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 dispersible may rarely cause elevated 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 condition may be serious, 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 level of alertness or consciousness
• feeling drowsy with low energy

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

Other medicines and Topamax dispersible

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topamax dispersible and certain medicines may interact with each other. Sometimes, the dose of either Topamax dispersible 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 your thinking, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topamax dispersible may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. Consult your doctor about the most appropriate contraceptive method to use while taking Topamax dispersible.

Tell your doctor if your menstrual bleeding pattern changes while you are taking hormonal contraceptives and Topamax dispersible. Irregular bleeding may occur. In this case, 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 dispersible.

Use of Topamax dispersible with food and drinks

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

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topamax dispersible may 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 dispersible if you are pregnant and being treated for migraine.
• You must not use Topamax dispersible 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 dispersible, a pregnancy test must be performed in women of childbearing potential.

Epilepsy treatment

• You must not take Topamax dispersible if you are pregnant and being treated for epilepsy, unless no other treatment provides adequate seizure control.
• You must not use Topamax dispersible 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 dispersible is the only treatment providing adequate seizure control and you are planning to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking Topamax dispersible during pregnancy and about the risks of seizures during pregnancy, which may place you or your unborn baby at risk.
• Before starting treatment with Topamax dispersible, a pregnancy test must be performed in women of childbearing potential.

Risks of topiramate when taken during pregnancy (regardless of the condition being treated with topiramate):

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

• If you take Topamax dispersible 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 to 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 palate) 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 dispersible 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 dispersible during pregnancy, your child may be smaller than expected and have lower birth weight. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.
• Consult your doctor if you have 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 other possible treatments instead of taking Topamax dispersible. If the decision is made to use Topamax dispersible, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topamax dispersible.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together 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 dispersible, 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 about the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topamax dispersible:

• 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 dispersible for epilepsy, do not stop taking it without first discussing this with 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 dispersible during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking Topamax dispersible 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 dispersible for epilepsy, do not stop taking this medication until you have discussed it with your doctor, as your condition could worsen. Worsening of your epilepsy may place 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 dispersible during pregnancy. The doctor may also refer you to another specialist.
• If Topamax dispersible is used during pregnancy, you will be monitored closely to check your baby's development.

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

Breastfeeding

The active ingredient in Topamax dispersible (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 to discontinue breastfeeding or to discontinue treatment with Topamax dispersible. Your doctor will consider the importance of the benefits for the mother and the potential risk for the infant.

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

Driving and use of machines

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

Topamax dispersible contains sucrose

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

3. How to take Topamax dispersible

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Your doctor will usually start you on a low dose of Topamax dispersible and slowly increase your dose until the best dose for you is found.
• Topamax dispersible hard capsules may be swallowed whole or may be opened and the contents sprinkled onto a spoonful of soft food. Examples include apple sauce, custard, ice cream, porridge, pudding, or yogurt. Drink fluids immediately afterwards to ensure you swallow all of the mixture of food and medicine.
• Hold the hard capsule upright so that you can read the word “TOP”.
• Gently twist the transparent part of the capsule. You may find it easier to do this over a small amount of food onto which you will pour the spheres.
• Sprinkle the entire contents of the capsule onto a spoonful of soft food, taking care to ensure that the full prescribed dose is sprinkled onto the food.
• Be sure to swallow the entire mixture of food/spheres from the spoon immediately. Avoid chewing. Immediately drink fluids to ensure you swallow all of the mixture.
• Never store any mixture of food and medicine for later use.
• You may take Topamax dispersible before, during, or after meals. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topamax dispersible.

Girls and women of childbearing potential:

Treatment with Topamax dispersible 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 dispersible 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 (fits).

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

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

If you forget to take Topamax dispersible

• 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 with your regular schedule. 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 dispersible

Do not stop treatment unless your doctor tells you to. 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 cause adverse effects, although not everyone experiences 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, sudden change, or increased severity)
• 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 pressure in the eye, eye pain, or reduced vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which may 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 of the skin (detachment of the epidermis and superficial mucous membranes), with potentially life-threatening consequences.

Not known (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, swelling of the face, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling or staying asleep
• Problems with speech or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to perform 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 that help protect against infections, low 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
• Problems with reading, speech disorder, difficulty writing by hand
• 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 of warmth
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acid, feeling of fullness or bloating
• 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 of drunkenness
• 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 changes (white, blue then red) in fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Unusual body odor
• Discomfort in arms and legs
• Kidney problems

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 any change or decrease in your vision.

Other adverse effects in children

In general, adverse effects observed in children are similar to those observed 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 behavior
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• General malaise
• Low 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 of warmth
• 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 dispersible

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

Do not use this medicine after the expiry date stated on the bottle/carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25 °C. Keep the bottle tightly closed to protect the capsules from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Topamax dispersible

• The active substance is topiramate.

• Each Topamax dispersible capsule contains 50 mg of topiramate.

• The other components of Topamax dispersible are:

• sugar spheres (corn starch, sucrose), povidone, cellulose acetate.

• capsule: gelatin, titanium dioxide (E171)

• printing ink: black ink (black iron oxide (E172), shellac, and propylene glycol).

Appearance of the product and contents of the pack

50 mg capsules: Small white to off-white beads in a hard gelatin capsule with an opaque white body printed with "50 mg" and a transparent cap printed with "TOP".

Opaque high-density polyethylene (HDPE) plastic bottle with tamper-evident closure containing 20, 28, 60, or 100 capsules with granules.

Only certain pack 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-Cilag S.p.a
04100 Borgo S. Michele
Latina
Italy

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

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

Other sources of information

The most recently approved information for the patient guide about 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/16/32522

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