TOPIRAMATE VIATRIS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Viatris 25 mg film-coated tablets EFG

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. See the end of section 4 for 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, 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. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Topiramate Viatris and what is it used for
2. What you need to know before you take Topiramate Viatris
3. How to take Topiramate Viatris
4. Possible side effects
5. Storage of Topiramate Viatris
6. Contents of the pack and other information

1. What is Topiramate Viatris and what is it used for

Topiramate Viatris belongs to a group of medicines called “antiepileptic medicines”. It is used for:

• Treating seizures in adults and children over 6 years of age, given alone.
• Treating seizures in adults and children over 2 years of age, given together with other medicines.
• Preventing migraines in adults.

2. What you need to know before you take Topiramate Viatris

Do not take Topiramate Viatris

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

• Migraine prevention

• You must not take topiramate if you are pregnant.
• If you are a woman of childbearing age, you must not take topiramate unless you are using a highly effective method of contraception during treatment and for at least 4 weeks after the last dose of topiramate. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

• Epilepsy treatment

• You must not take topiramate if you are pregnant unless no other treatment provides adequate control of your seizures.
• If you are a woman of childbearing age, you must not take topiramate unless you are using a highly effective method of contraception during treatment. The only exception is if topiramate is the only treatment that provides adequate control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 baby at risk.

Make sure to read the patient guide that you will receive from your doctor.

A patient card is provided with the pack of Topiramate Viatris to remind you of the risks during pregnancy.

If you are not sure if any of the above applies to your situation, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• You have kidney problems, especially kidney stones, or are on dialysis.
• You have a history of blood or body fluid disorders (metabolic acidosis).
• You have liver problems.
• You have eye problems, especially glaucoma.
• You have growth problems.

• You follow a high-fat diet (ketogenic diet).
• You are a woman who can become pregnant. Topiramate may harm an unborn baby during pregnancy. Highly effective contraceptive methods must 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 harm an unborn baby during pregnancy.

If you are not sure if any of the above applies to your situation, consult your doctor or pharmacist before taking topiramate

It is important that you do not stop taking your medicine 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 this medicine.

You may lose weight if you take this medicine, 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 topiramate have had thoughts of harming themselves or taking their own lives. If at any time you have these thoughts, contact your doctor immediately. If you have epilepsy, it is important not to stop taking your medication without consulting your doctor first.

This medicine may cause serious skin reactions, contact your doctor immediately if you develop a rash and/or blisters (see also section 4 “Possible side effects”). This medicine may, in rare cases, 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 developing these symptoms may increase with higher doses of this medicine.

Other medicines and Topiramate Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate and certain other medicines can affect each other. Sometimes the dose of one of the other medicines or of this medicine needs to be adjusted.

Especially tell your doctor or pharmacist if you are taking:

• Other medicines that impair or decrease your thoughts, concentration, or muscle coordination (such as central nervous system depressants, such as muscle relaxants and sedatives).
• Hormonal contraceptives. Topiramate may make hormonal contraceptives less effective. You should use a barrier contraceptive method such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking topiramate.

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

Taking Topiramate Viatris with food and drink

You can take this medicine with or without food. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking topiramate. You should avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding

Important advice for women of childbearing age:

Topiramate may harm an unborn baby during pregnancy. If you are a woman of childbearing age, 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 migraines, you must not take topiramate if you are pregnant.
• In the case of migraines, you must not take topiramate if you are a woman of childbearing age, unless you are using a highly effective method of contraception.
• Before starting treatment with topiramate, a pregnancy test must be performed in a woman of childbearing age.

Epilepsy treatment

• In the case of epilepsy, you must not take topiramate if you are pregnant unless no other treatment provides adequate control of your seizures.
• In the case of epilepsy, you must not take topiramate if you are a woman of childbearing age, unless you are using a highly effective method of contraception. The only exception is if topiramate is the only treatment that provides adequate control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 baby at risk.
• Before starting treatment with topiramate, a pregnancy test must be performed in a woman of childbearing age.

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 unborn baby during pregnancy if topiramate is used during pregnancy.

• If you take topiramate during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 babies out of 100 will have birth defects. This compares to 1-3 babies out of 100 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 born may also have a malformation of the penis (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take topiramate 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 topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one 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 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 age:

• If you are a woman of childbearing age, consult your doctor about other possible treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a hormonal contraceptive together with a barrier contraceptive 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 method (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent/carer 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 an unborn 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 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 discussed this with your doctor, as your condition may worsen.
• Your doctor will re-evaluate your treatment and assess 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 become pregnant or think you may be pregnant while taking topiramate:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate to prevent migraines, stop taking the medicine immediately and consult your doctor to assess whether you need alternative treatment.
• If you are taking topiramate 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 re-evaluate your treatment and assess 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 baby is developing during pregnancy.

Make sure to read the patient guide that you will receive from your doctor. A patient card is provided with the pack of Topiramate Viatris to remind you of the risks during pregnancy.

Driving and using machines

Dizziness, tiredness, and vision disturbances may occur during treatment with this medicine: Do not drive or use tools or machines without talking to your doctor first.

Excipient with known effect

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

3. How to take Topiramate Viatris

Follow exactly the instructions for administration of this medicine given by your doctor. Consult your doctor or pharmacist if you are unsure.

• Take this medicine exactly as prescribed by your doctor. Your doctor will usually start with a low dose of topiramate and gradually increase your dose until the best dose for you is found.

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

• You can take this medicine before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking this medicine.

Girls and women of childbearing age:

Treatment with topiramate should be started and continued under the supervision of a doctor experienced in the treatment of epilepsy or migraines. Visit your doctor to review your treatment at least once a year.

If you take more Topiramate Viatris than you should

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

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

If you forget to take Topiramate Viatris

• 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 stop taking Topiramate Viatris

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor or seek medical attention immediately if you have the following adverse effects:

Verycommon(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, slow thinking, 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 heartbeats).
• Decreased or lost sweating (especially in small children 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 - fluid blockage in the eye, which 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 may 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, 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 can become widespread skin damage (shedding of the epidermis and superficial mucous membranes) with life-threatening consequences.

Frequency not known (cannot be estimated from available data)

• Eye inflammation (uveitis) with symptoms such as redness and eye pain, sensitivity to light, tearing, blurred vision, or seeing small dots.

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 taste.
• Tremors or involuntary twitches; 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 platelet count (blood cells that help prevent bleeding), decreased white blood cell count that helps 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.
• Exalted mood.
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis).
• Not showing and/or feeling 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 topiramate 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.
• Nosebleeds, increased saliva, drooling, bad breath.
• Excessive fluid intake, thirst.
• Discoloration of the skin.
• Muscle stiffness, side pain.
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, side or kidney pain.
• Difficulty getting or maintaining an erection, sexual dysfunction.
• Flu-like symptoms.
• Cold fingers or toes.
• Feeling of intoxication.
• Learning difficulties.

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 and toes when exposed to cold.
• Liver inflammation, liver failure.
• Abnormal skin odor.
• Discomfort in the arms and legs.
• Kidney disorder.

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 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.
• Not showing and/or feeling 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topiramate Viatris

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Topiramate Viatris

The active ingredient is topiramate.

Each film-coated tablet of Topiramate Mylan contains 25 mg of topiramate.

The other ingredients are:

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

Tablet coating: Opadry White YS-1-7003 [contains: Titanium dioxide (E-171), hypromellose 3cP, hypromellose 6cP, polyethylene glycol 400, and polysorbate 80 (E433)].

Appearance of the product and package contents

Topiramate Viatris 25 mg is presented in packages containing 60 film-coated tablets, round, white, biconvex, and with the inscription “G” on one side and “TO” / “25” on the other.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

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 revision of this prospectus:January 2024

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

Other sources of information

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