TOPAMAX DISPERSABLE 15 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

TOPAMAX DISPERSABLE 15 mg hard capsules

topiramate

This medicinal product 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 this leaflet includes information on 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 Topamax dispersable is and what it is used for
2. What you need to know before you take Topamax dispersable
3. How to take Topamax dispersable
4. Possible side effects
5. Storing Topamax dispersable

1. Contents of the pack and other information

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

Topamax dispersable 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 over 2 years of age, given together with other medicines

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

Do not take Topamax dispersable

• 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 dispersable if you are pregnant.
• If you are a woman of childbearing potential, do not take Topamax dispersable 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

• Do not take Topamax dispersable if you are pregnant, unless no other treatment provides adequate control of your seizures.
• If you are a woman of childbearing potential, do not take Topamax dispersable unless you are using a highly effective method of contraception during treatment. The only exception is if Topamax dispersable is the only treatment that provides adequate control of your seizures and if you plan to become pregnant. You should consult your doctor to make sure you have received information about the risks of taking Topamax dispersable during pregnancy and about the risks of seizures during pregnancy, which may put you or your 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 dispersable 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 taking Topamax dispersable.

Warnings and precautions

Consult your doctor before taking Topamax dispersable if you:

• have kidney problems, especially kidney stones, or are on 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 may become pregnant. Topamax dispersable may harm a baby during pregnancy 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 dispersable. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topamax dispersable may harm a baby during pregnancy when taken during pregnancy.

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

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 dispersable.

You may lose weight if you take Topamax dispersable, 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 dispersable have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

Topamax dispersable 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 dispersable 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 disease, 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 these symptoms may increase at higher doses of Topamax dispersable.

Other medicines and Topamax dispersable

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topamax dispersable and certain medicines can affect each other. Sometimes the dose of one of the other medicines or Topamax dispersable 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 depressant medicines such as muscle relaxants and sedatives).
• hormonal contraceptives. Topamax dispersable may make hormonal contraceptives less effective. You should use a barrier contraceptive such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topamax dispersable.

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

Using Topamax dispersable with food and drinks

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

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topamax dispersable may harm 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

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

Epilepsy treatment

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

• If you take Topamax dispersable during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares to 1-3 out of 100 babies 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 may also have a problem with their penis (hypospadias). These defects can develop in the first few months of pregnancy, even before you know you are pregnant.
• If you take Topamax dispersable 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 dispersable during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of children whose mothers took 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 dispersable. If the decision is made to use Topamax dispersable, highly effective contraceptive methods should be used during treatment and for at least 4 weeks after the last dose of Topamax dispersable.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a hormonal contraceptive with a barrier 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 (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 dispersable, you should consult your doctor as soon as 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 during pregnancy and about the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topamax dispersable:

• 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 dispersable for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of Topamax dispersable during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking Topamax dispersable to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking Topamax dispersable 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 baby at risk.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of Topamax dispersable during pregnancy. The doctor may also refer you to another specialist.
• If Topamax dispersable 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 dispersable to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Topamax dispersable (topiramate) passes into human milk. Effects in breastfed babies of mothers treated with Topamax dispersable have been seen, 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 dispersable. Your doctor will take into account the benefits of breastfeeding for the baby and the risk of treatment for the baby.

Mothers who are breastfeeding while taking Topamax dispersable 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 dispersable. Do not drive or operate tools or machines without talking to your doctor first.

Topamax dispersable contains sucrose

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

3. How to Take Topamax Dispersable

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will usually start with a low dose of Topamax dispersable and slowly increase your dose until they find the best one for you.
• The hard capsules of Topamax dispersable can be swallowed whole or can be opened and their contents sprinkled over a spoonful of any soft food. Some examples are apple sauce, custard, ice cream, oatmeal, cake, or yogurt. Drink liquids right after to make sure you swallow all the food and medicine mixture.
• Hold the hard capsule straight up so you can read the word “TOP”.
• Gently turn the transparent part of the capsule. You may find it easier to do this over a small portion of food where you will pour the spheres.
• Sprinkle all the contents of the capsule into a spoonful of soft food, taking care to see that all the prescribed dose is sprinkled onto the food.
• Make sure to swallow all the food/sphere mixture from the spoon immediately. Avoid chewing. Take liquids immediately to ensure you swallow all the mixture.
• Never store any food and medicine mixture for later use.
• You can take Topamax dispersable before, during, or after a meal. Drink plenty of liquids during the day to avoid kidney stone formation while taking Topamax dispersable.

Girls and women of childbearing age:

Treatment with Topamax dispersable should begin and continue 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 dispersable than you should

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy, tired, or less attentive; lack of coordination; have difficulty speaking or concentrating; have 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 medication along with Topamax dispersable.

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

If you forget to take Topamax dispersable

• 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 interrupt treatment with Topamax dispersable

Do not interrupt treatment without your doctor telling you to do so. Your disease symptoms may reappear. If your doctor decides that you should stop taking this medication, they will gradually decrease your dose 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 medications, this medication 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, slowness of thought, 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 blood acid levels (which can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or lost sweating (especially in small children who are 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 cause 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 (desquamation 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

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)

• 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, poor 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, uncontrollable eye movements
• Visual disturbance, 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
• Pain or inflammation of the joints, 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, 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 disorder, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or vigilance
• 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, watery eyes
• 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 acidity, feeling of fullness or bloating
• Gum bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, pain in the side or kidney
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers and toes
• 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 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 blood acid levels
• 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
• Watery eyes
• 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 of 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 Medicines Monitoring System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Topamax Dispersable

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle/carton after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Topamax Dispersable

• The active ingredient is topiramate.
• Each hard capsule of Topamax dispersable contains 15 mg of topiramate.
• The other components of Topamax dispersable are:
• sugar spheres (cornstarch, sucrose), povidone, cellulose acetate.
• capsule: gelatin, titanium dioxide (E171)
• printing ink: black ink (iron oxide black (E172), lacquer, and propylene glycol).

Appearance of the Product and Package Contents

15 mg capsules: Small white or off-white spheres in a hard gelatin capsule with the body white opaque with the legend “15 mg” engraved and the transparent cap with the legend “TOP” engraved.

Opaque HDPE plastic bottle with a guarantee closure containing 20, 28, 60, or 100 capsules with granules.

Only some 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-Cilag S.p.a

04100 Borgo S. Michele

Latina

Italy

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