Leaflet: information for the user

TOPAMAX DISPERSABLE 50 mg hard capsules

topiramate

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Topamax dispersable belongs to a group of medicines called “anti-epileptic medicines”. It is used for:

• treating seizures in adults and children over 6 years old when taken alone
• treating seizures in adults and children 2 or more years old when taken with other medicines
• preventing migraine in adults

Do not take Topamax dispersable

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

Prevention of migraines

• You should not take Topamax dispersable if you are pregnant.
• If you are a fertile woman, you should not take Topamax dispersable unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Treatment of epilepsy

• You should not use Topamax dispersable if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, you should not take Topamax dispersable unless you are using a highly effective contraceptive method during your treatment. The only exception is if Topamax dispersable is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure that you have received information about the risks of taking Topamax dispersable during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Make sure to read the patient guide that you will receive from your doctoror scan the QR code to obtain it (see section6 “Other sources of information”).

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

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using Topamax dispersable.

Warnings and precautions

Consult your doctor before starting to take Topamax dispersable if you:

• have kidney problems, especially kidney stones, or are receiving dialysis
• have a history of blood or fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are following a high-fat diet (ketogenic diet)
• are a woman who may become pregnant. Topamax dispersable may cause harm to a baby during gestation when taken during pregnancy. You should use highly effective contraceptive methods during your 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 cause harm to a baby during gestation when taken during pregnancy.

If you are unsure whether anything above applies to your case, consult your doctor before using 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 medication containing topiramate that is given as an alternative to Topamax dispersable.

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

A small number of people being treated with antiepileptic medications such as Topamax dispersable have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Topamax dispersable may cause severe 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 cause high levels of ammonia in the blood (seen in blood tests) which may cause a change in brain function, especially if you are also taking a medication called valproic acid or valproate sodium. Since this can 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

You may increase the risk of developing these symptoms at higher doses of Topamax dispersable.

Other medications and Topamax dispersable

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Topamax dispersable and certain medications may affect each other. Sometimes, the dose of one or both medications may need to be adjusted.

Especially, inform your doctor or pharmacist if you are taking:

• other medications 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 dispersable may make hormonal contraceptives less effective. You should use an additional barrier method 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 you change your menstrual bleeding while taking hormonal contraceptives and Topamax dispersable. You may experience irregular bleeding. In this case, continue taking the hormonal contraceptives and inform your doctor.

Keep a list of all the medications you take. Show this list to your doctor and pharmacist before starting a new medication..

Other medications that you should consult your doctor or pharmacist about include other antiepileptic medications, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, 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 anything above applies to you, consult your doctor or pharmacist before taking Topamax dispersable..

Use of Topamax dispersable with food and drinks

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

Pregnancy and breastfeeding

Important advice for fertile women:

Topamax dispersable may cause harm to a baby during gestation. If you are a fertile woman, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Prevention of migraines

• You should not take Topamax dispersable if you are pregnant.
• You should not use Topamax dispersable if you are a fertile woman, unless you are using a highly effective contraceptive method.
• A pregnancy test should be performed before starting treatment with Topamax dispersable in a fertile woman.

Treatment of epilepsy

• You should not take Topamax dispersable if you are pregnant, unless no other treatment offers sufficient control of seizures.
• You should not use Topamax dispersable if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topamax dispersable is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure that you have received information about the risks of taking Topamax dispersable during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.
• A pregnancy test should be performed before starting treatment with Topamax dispersable in a fertile woman.

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 gestation if Topamax dispersable is used during pregnancy.

• If you take Topamax dispersable during pregnancy, your child will have a higher probability of having congenital defects. In women taking topiramate, around 4 to 9 out of 100 children will have congenital defects. This compares with 1-3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medication. In particular, labial leporine (a cleft lip) and palatal cleft (a cleft palate) have been observed. Male newborns may also have a genital malformation (hypospadias). These defects can develop in the early stages 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 developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking an antiepileptic medication.
• If you take Topamax dispersable during pregnancy, your child may be smaller and weigh less than expected at birth.In a 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 who were not taking an 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 medications to treat your condition with a lower risk of congenital defects.

defects.

Necessity of contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Topamax dispersable. If you decide to use Topamax dispersable, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topamax dispersable.
• You should use 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). Consult your doctor about the most suitable contraceptive methods for you.
• If you are taking hormonal contraceptives, there may be a reduced effectiveness of the contraceptive due to topiramate. Therefore, you should use an additional barrier method (such as a condom or diaphragm).
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topamax in girls:

If you are the parent/caregiver of a girl being treated with Topamax dispersable, you should 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 gestation due to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.

If you want to become pregnant while taking Topamax dispersable:

• Book 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 consulted with your doctor, as your condition may worsen.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topamax dispersable during pregnancy. The doctor may also refer you to another specialist.

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

• Book an urgent appointment with your doctor.
• If you are taking Topamax dispersable for migraines, stop taking the medication immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topamax dispersable for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your baby during gestation at risk.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about 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 gestation.

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 section6 “Other sources of information”. A patient card is provided with the packaging of Topamax dispersable to remind you of the risks of topiramate during pregnancy.

Lactation

The active ingredient of Topamax dispersable (topiramate) passes into breast milk. Adverse effects have been observed in breastfed infants of mothers treated with Topamax dispersable, including diarrhea, feeling sleepy, feeling irritable, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or whether to stop taking Topamax dispersable. Your doctor will take into account the importance of the benefits for the mother and the risk to the baby.

Mothers who are breastfeeding and taking Topamax dispersable should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machines

You may experience dizziness, fatigue, and visual disturbances during treatment with Topamax dispersable. Do not drive or operate tools or machines without speaking to your doctor first.

Topamax dispersable contains saccharose

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

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

• Your doctor will usually start with a low dose ofTopamax dispersableand gradually increase your dose to find the best one for you.
• The hard capsules ofTopamax dispersablecan be swallowed whole or opened and sprinkled with the contents onto a spoon with any type of soft food. Some examples are apple sauce, custard, ice cream, oatmeal, biscuits, or yogurt. Drink liquids immediately afterwards to ensure you swallow all the food and medicine mixture.
• Hold the hard capsule straight 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 beads.
• Sprinkle all the contents of the capsule onto a spoonful of soft food, making sure all the prescribed dose is sprinkled onto the food.
• Make sure to swallow all the food/bead mixture 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 takeTopamax dispersablebefore, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while takingTopamax dispersable.

Girls and fertile women:

Topamax dispersable treatment should start and continue under the supervision of a doctor experienced in treating 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 blurry vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain, or seizures.

You may experience an overdose if you are taking another medication with Topamax dispersable.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Phone 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 to take your next dose, skip the missed dose and continue as usual. Consult your doctor if you miss two or more doses.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt the treatment with Topamax dispersable

Do not stop treatment without your doctor telling you to do so. Your symptoms may reappear. If your doctor decides 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.

Like all medications, this medication may have adverse effects, although not all people may experience them.

Consult your doctor or seek immediate medical attention if you experience 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, slowness of thought, memory loss, problems with memory (initial, sudden change or increase in severity)
• Kidney stones, frequent or painful urination

Uncommon(may affect up to 1 in 100 people)

• Increased blood acid levels (which may 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 exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious injuries
• 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 eye pressure, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (encephalopathy)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin eruptions with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin eruptions can become generalized skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

• Uveitis (inflammation of the eyes) with symptoms such as redness and pain in the eyes, sensitivity to light, tearing, seeing small dots or blurry vision

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

• Tickling, pain, and/or numbness in several 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, urticaria)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty staying or falling asleep
• Speech or language 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 taste
• Tremors or involuntary, uncontrolled movements of the eyes
• Alteration of vision, such as double vision, blurry vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nasal bleeding
• 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 cramps, 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 lymph nodes in the neck, armpits, or groin
• Increased appetite
• Exalted mood
• Heard, seen, or felt things that are not there, severe mental disorder (psychosis)
• Not showing or feeling emotions, unusual distrust, panic attack
• Difficulty reading, speech disorder, difficulty writing by hand
• Restlessness, hyperactivity
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; alteration of touch
• Alteration, distortion, or absence of smell
• Sensation or feeling that may precede a migraine or a certain type of seizure
• Dry eyes, sensitivity of the eyes to light, eyelid tremor, 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 (consequently, some people may faint, feel dizzy, or lose consciousness when standing or sitting suddenly)
• Flush or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excessive gas or flatulence, stomach acid, feeling full or bloated
• Gingival bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Decoloration of the skin
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss 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
• Sensation of intoxication
• Difficulty learning

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

• Abnormally exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Wandering eye
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue, then red) of the fingers of the hands and feet when exposed to cold
• Inflammation of the liver, liver insufficiency
• Unusual odor of the skin
• Discomfort in the arms and legs
• Renal alteration

Unknown (cannot be estimated from available data)

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

Other adverse effects in children

Generally, 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 blood acid levels
• Having thoughts of self-harm
• Fatigue
• Increased or decreased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling of instability when walking
• General malaise
• Decreased potassium levels in the blood
• Not showing or feeling emotions
• Watery eyes
• Slow or irregular heartbeat

Other adverse effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

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

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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 at a temperature above 25 °C. Keep the bottle perfectly closed to protect the capsules from moisture.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines that you no longer need at theSIGREpharmacy drop-off point. If in doubtask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Topamax Dispersable

• The active ingredient is topiramate.

• Each hard capsule of Topamax Dispersable contains 50 mg of topiramate.

• The other components of Topamax Dispersable are:

• sugar spheres (cornstarch, sucrose), povidone, cellulose acetate.
• capsule:gelatin, titanium dioxide (E171)
• ink:black ink (iron oxide black (E172), shellac, and propylene glycol).

Appearance of the product and contents of the package

50 mg capsules: Small white to off-white spheres in a hard gelatin capsule with a white opaque body with a debossed legend “50” and a transparent cap with a debossed legend “TOP”.

HDPE opaque plastic bottle with a child-resistant closure containing 20, 28, 60, or 100 capsules with granules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

JANSSEN-PHARMA, S.L.

Pº de las Doce Estrellas, 5-7

28042 Madrid

Spain

Responsible manufacturer

Janssen-Cilag S.p.a

04100 Borgo S. Michele

Latina

Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2024.

Other sources of information

The most recent 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

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