Patient Information Leaflet

Topiramato Viatris 100 mg Film-Coated Tablets

This medicine is subject to additional monitoring. This will help speed up the detection of any new safety information. You can contribute by reporting any side effects you get. The final part of section 4 includes information on how to report these side effects.

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 further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Topiramato Viatrisbelongs to a group of medicines called “antiepileptic medicines”. It is used for:

• Treating seizures in adults and children over 6 years old when used alone.
• Treating seizures in adults and children aged 2 years when used in combination with other medicines.
• To prevent migraine in adults.

Do not take Topiramato Viatris

If you are allergic to topiramate or any of the other ingredients in this medication (listed in section 6).

Prevention of migraines

•Do not take topiramate if you are pregnant.

•If you are a fertile woman, do not take topiramate 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

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

•If you are a fertile woman, do not take topiramate unless you are using a highly effective contraceptive method during your treatment. The only exception is if topiramate is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking topiramate 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 leaflet that your doctor will give you.

A patient leaflet is provided with the packaging of Topiramato Viatris to remind you of the risks during pregnancy.

If you are unsure if any of the above applies to your case, consult your doctor or pharmacist before using topiramate.

Warnings and precautions

Before starting treatment with this medication, consult your doctor or pharmacist if:

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

If you are unsure if any of the above applies to your case, consult your doctor or pharmacist before using topiramate.

It is essential not to stop taking your medication without consulting your doctor first.

You must consult your doctor before taking any other medication containing topiramate that is given as an alternative to topiramate.

You may lose weight if you take this medication, 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 must consult your doctor.

A small number of people being treated with antiepileptic medications such as topiramate have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately. If you have epilepsy, it is essential not to stop taking your medication without consulting your doctor first.

This medication 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”). This medication 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.
• Sensation of drowsiness with low energy.

You may be at increased risk of developing these symptoms at higher doses of this medication.

Other medications and Topiramato Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.Topiramateand 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 reduce your thoughts, concentration, or muscle coordination (for example, central nervous system depressants such as muscle relaxants and sedatives).
• Birth control pills. Topiramate may make birth control pills less effective. You should use an additional barrier method such as a condom or diaphragm. You should consult your doctor about the best birth control method to use while taking topiramate.

Inform your doctor if you change your menstrual bleeding while taking birth control pills and topiramate. You may experience irregular bleeding. In this case, continue taking the birth control pills and inform your doctor.

Keep a list of all the medications you take. Show this list to your doctor and pharmacist beforestarting 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), warfarin (used to prevent blood clotting).

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking this medication.

Topiramato Viatris with food and drinks

You can takethis medicationwith or without food. Drink plenty of water during the day to prevent kidney stone formation while taking topiramate. You should avoid drinking alcohol while takingthis medication.

Pregnancy and breastfeeding

Important advice for fertile women:

Topiramate may cause harm to a babyduring pregnancy. 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

• If you have a migraine, do not take topiramate if you are pregnant.
• If you have a migraine, do not use topiramate if you are a fertile woman, unless you are using a highly effective contraceptive method.
• Before starting treatment with topiramate, a pregnancy test should be performed in a fertile woman.

Treatment of epilepsy

• If you have epilepsy, do not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you have epilepsy, do not use topiramate if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if topiramate is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking topiramate during pregnancy and about the risks of seizures during pregnancy, which may put you or your babyduring pregnancyat risk.
• Before starting treatment with topiramate, a pregnancy test should be performed 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 a babyduring pregnancy if topiramate is used during pregnancy.

• If you take topiramate during pregnancy, your child may have a higher probability of having congenital defects. In women taking topiramate, around 4 to 9children out of 100 may have congenital defects. This compares to 1‑3children out of 100 born to women with epilepsy who are not taking an antiepileptic medication. In particular, there have been observations of cleft lip (a division in the upper lip) and cleft palate (a division in the palate). Newborn males may also have a genital malformation (hypospadias). These defects may develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take topiramate during pregnancy, your child may be at a 2 to 3times 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 topiramate 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 and 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.

Necessity of contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods should be used during treatment and for at least 4weeks after the last dose of topiramate.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods such as a birth control pill together 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 birth control pills, there may be a reduced effectiveness of the birth control pill due to topiramate. Therefore, an additional barrier method (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are thefather/motheror caregiver of a girl treated with topiramate, 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 babyduring pregnancydue to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.

If you want to become pregnant while taking topiramate:

• 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 topiramate 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 topiramate during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate for migraines, stop taking the medication immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medication until you have consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your babyduring pregnancyat risk.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate is used during pregnancy, you will be closely monitored to check how your babyduring pregnancyis developing.

Make sure to read the patient leaflet that your doctor will give you. A patient leaflet is provided with the packaging of Topiramato Viatris to remind you of the risks of topiramate during pregnancy.

Driving and operating machinery

You may experience dizziness, fatigue, and vision disturbances during treatment with this medication. Do not drive or operate tools or machinerywithout speaking to your doctor first.

Excipient with known effect

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• Take this medication exactly as prescribed. Your doctor will usually start with a low dose of topiramate and gradually increase your dose to find the best one for you.

• Topiramate tablets are swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

• You can take this medication before, during, or after a meal. Drink plenty of liquids throughout the day to prevent kidney stone formation while taking this medication.

Girls and fertile women:

Topiramate treatment should begin 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 Topiramato Viatris than you should

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy, tired, or less attentive; lack of coordination; difficulty speaking or concentrating; double or blurry vision; feel dizzy due to low blood pressure; feel depressed or restless; have abdominal pain, or seizures.

• You may experience an overdose if you are taking another medication with topiramate.
• In case of overdose or accidental ingestion, you can also contact the Toxicological Information Service, Phone 91 5620420.

If you forgot to takeTopiramato Viatris

• If you forgot 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 withTopiramato Viatris

Do not stop treatment without your doctor's instructions. Your symptoms may return. If your doctor decides that you should stop taking this medication, they will gradually reduce your dose over several days.

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

Like all medications, this medication can cause side effects, although not everyone will experience them.

Consult your doctor or seek immediate medical attention if you experience the following side effects:

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

• Depression (new or worsening).

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 acidity (which may cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat).
• Decreased or loss of sweating (especially in young 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, causing 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, can 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.

Frequency not known (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, vision of small dots or blurry vision.

Other side 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 movements; rapid, uncontrollable eye movements.
• Alteration of vision, such as double vision, blurry vision, decreased vision, difficulty focusing.
• Sensation of spinning (dizziness), ringing in the ears, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, general feeling of illness, 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.
• Anomalous or altered sense of touch; alteration of touch.
• Alteration, distortion, or absence of smell.
• Unusual feeling or sensation that may precede a migraine or 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.
• Feeling drunk.
• 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 skin odor.
• Discomfort in the arms and legs.
• Renal alteration.

Frequency not known (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 side effects in children

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

-Difficulty concentrating.

-Increased blood acidity.

-Having thoughts of self-harm.

-Fatigue.

-Decreased or increased appetite.

-Aggression, abnormal behavior.

-Difficulty staying or falling asleep.

-Feeling of instability when walking.

-General feeling of illness.

-Decreased potassium levels in the blood.

-Not showing or feeling emotions.

-Watery eyes.

-Slow or irregular heartbeat.

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (dizziness).
• 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.esBy reporting side 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.

Store in the original packaging.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Topiramato Viatris

The active ingredient is topiramate.

Each film-coated tablet of Topiramato Viatris contains 100 mg of topiramate.

The other components are:

Tablet core: microcrystalline cellulose (E-460), sodium carboxymethyl starch (type A), povidone (E-1201), magnesium stearate (E-572), anhydrous colloidal silica.

Tablet coating: Opadry Yellow 03B92164 [contains: titanium dioxide (E-171), hypromellose 6cP, polyethylene glycol 400, and yellow iron oxide (E-172)].

Appearance of the product and content of the container

Topiramato Viatris 100 mg is presented in containers containing 60 film-coated, round, yellow, biconvex tablets with the inscription “G” on one face and “TO” / “100” on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Prasfarma, S.L.

C/ Sant Joan, 11-15

08560 - Manlleu (Barcelona)

Spain

Or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

Date of the last review of this leaflet:January 2024

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es

Other sources of information

The most recent approved information about this medicine is available at the following webpage (URL):https://www.aemps.gob.es/informa/topiramato-nuevas-medidas-para-evitar-la-exposicion-en-mujeres-embarazadas/