Topiramate Viatris 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Viatris 50 mg film-coated tablets EFG

This medicine is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4, towards the end, includes information on how to report these adverse reactions.

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these reactions are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

• Treating seizures in adults and children over 6 years of age when used alone.
• Treating seizures in adults and children aged 2 years when used together with other medicines.
• Preventing migraine in adults.

2. What you need to know before starting to 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 potential, you must not take topiramate 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

You must not use topiramate if you are pregnant, unless no other treatment provides sufficient seizure control.

• If you are a woman of childbearing potential, 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 sufficient seizure control and you are planning to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

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

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

Warnings and precautions

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

You have kidney problems, especially kidney stones, or are undergoing dialysis.

You have a history of blood or fluid imbalances in the body (metabolic acidosis).

You have liver problems.

You have eye problems, especially glaucoma.

You have growth problems.

You are on a high-fat diet (ketogenic diet).

• You are a woman who could become pregnant. Topiramate may harm an unborn baby when taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate. See section “Pregnancy and breastfeeding” for further information.
• You are pregnant. Topiramate may harm an unborn baby when taken during pregnancy.

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

It is important that you do not stop taking your medicine without first consulting your doctor.

You should consult your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to this medicine.

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

A small number of people treated with antiepileptic medicines such as topiramate have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately. If you have epilepsy, it is important not to stop taking your medication without first consulting your doctor.

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 rarely cause high levels of ammonia in the blood (detected in blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may 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 level of alertness or consciousness.
• Feeling drowsy with low energy.

The risk of developing these symptoms may increase at higher doses of this medicine.

Other medicines and Topiramate Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topiramate and certain medicines may affect each other. Sometimes, the dose of one of the other medicines or of topiramate may need to be adjusted.

Especially inform your doctor or pharmacist if you are taking:

• Other medicines that impair or reduce your mental function, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• Hormonal contraceptives. Topiramate may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. You should consult your doctor about the most appropriate contraceptive method to use while taking topiramate.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and topiramate. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

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

Other medicines about which you should consult your doctor or pharmacist 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 unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Taking Topiramate Viatris with food and drink

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

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topiramate may harm an unborn baby. If you are a woman of childbearing potential, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss risks at least once a year.

Migraine prevention

• In case of migraine, you must not take topiramate if you are pregnant.
• In case of migraine, you must not use topiramate if you are a woman of childbearing potential unless you are using a highly effective method of contraception.
• Before starting treatment with topiramate, a pregnancy test must be performed in women of childbearing potential.

Epilepsy treatment

• In case of epilepsy, you must not take topiramate if you are pregnant, unless no other treatment provides sufficient seizure control.
• In case of epilepsy, you must not use topiramate if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if topiramate is the only treatment that provides sufficient seizure control and you are planning to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and the risks of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before starting treatment with topiramate, a pregnancy test must be performed in women of childbearing potential.

Risks of taking topiramate during pregnancy (regardless of the condition for which topiramate is used):

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

• If you take topiramate during pregnancy, your child has a higher chance of being born with congenital malformations. In women taking topiramate, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1–3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic medicines. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Male newborns may also have a penile malformation (hypospadias). These defects may develop early in 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 medicines.
• If you take topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.
• Consult your doctor if you have questions about these risks during pregnancy.
• There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

• If you are a woman of childbearing potential, consult your doctor about other possible treatments instead of taking 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 contraceptive pill together with a barrier method such as a condom or diaphragm) should be used. Consult your doctor about the most appropriate contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced contraceptive effectiveness due to topiramate. Therefore, an additional barrier contraceptive (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 the parent or caregiver of a girl being treated with topiramate, consult your doctor immediately once she experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby due to exposure to topiramate during pregnancy and 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 without first discussing this with your doctor, as your condition could worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of 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 for migraine prevention, stop taking the medicine immediately and consult your doctor to evaluate whether you need an 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 could worsen. Worsening of your epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate is used during pregnancy, you will be monitored closely to check how your baby is developing.

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

Driving and using machines

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

Excipient with known effect

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

3. How to take Topiramate Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

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

• Swallow the topiramate tablets whole. Avoid chewing the tablets, as they may leave a bitter taste.

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

Girls and women of childbearing potential:

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

If you take more Topiramate Viatris than you should

• Contact your doctor immediately. Take the medicine with you.

• You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; experience double or blurred vision; feel dizzy due to a drop in blood pressure; feel depressed or agitated; have abdominal pain, or seizures (fits).

• You may experience overdose if you are taking another medicine together with topiramate.

• In case of overdose or accidental ingestion, you may 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 go on 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 a forgotten 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, they will gradually reduce your dose over several days.

If you have any further questions about 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 everyone will experience them.

Contact your doctor or seek immediate medical attention if you experience any of the following adverse effects:

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

• Depression (new or worsened).

Common (may affect up to 1 in 10 people)

• Seizures (attacks).
• Anxiety, irritability, mood changes, confusion, disorientation.
• Difficulty concentrating, slowed thinking, memory loss, memory problems (initial, sudden onset, or increased 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 tiredness, and rapid or irregular heartbeat).
• Decreased or absent sweating (especially in young children exposed to high temperatures).
• Thoughts of self-harm or attempting to cause serious injury to oneself.
• Loss of part of the visual field.

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

• Glaucoma – blockage of fluid in the eye causing increased pressure, eye pain, or reduced vision.
• Difficulty thinking, remembering information, or solving problems; decreased alertness or consciousness; feeling drowsy and low energy – these symptoms may indicate high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy).
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which may appear as rashes with or without blisters. Skin irritation, mouth, throat, nose, eye, or genital ulcers or inflammation. Skin rashes may progress to widespread skin damage (detachment of the epidermis and superficial mucous membranes), which can be life-threatening.

Frequency not known (cannot be estimated from available data)

• Inflammation of the eyes (uveitis), with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred vision.

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

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

• Nasal congestion, runny nose, or sore throat.
• Tingling, pain, and/or numbness in various parts of the body.
• Drowsiness, fatigue.
• Dizziness.
• Nausea, diarrhea.
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count).
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives).
• Loss of appetite, reduced appetite.
• Aggression, agitation, anger, abnormal behaviour.
• Difficulty falling or staying asleep.
• Speech problems or speech disorders, poor pronunciation.
• Clumsiness or lack of coordination, unsteady gait.
• Reduced ability to perform routine tasks.
• Reduced, lost, or absent sense of taste.
• Involuntary tremors or shaking; rapid, uncontrollable eye movements.
• Vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing.
• Sensation of spinning (dizziness), ringing in the ears, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, general malaise, weakness.
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection.
• Dry mouth.
• Hair loss.
• Itching.
• Joint pain or swelling, muscle spasms or twitches, muscle pain or weakness, chest pain.
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (which help protect against infections), low blood potassium levels.
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood.
• Swelling of lymph nodes in the neck, armpit, or groin.
• Increased appetite.
• Elevated mood.
• Hallucinations (hearing, seeing, or feeling things that are not there), severe mental disorder (psychosis).
• Lack of emotional expression and/or feeling, unusual distrust, panic attack.
• Reading difficulties, speech disorder, handwriting problems.
• Restlessness, hyperactivity.
• Slowed thinking, reduced level of alertness or consciousness.
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements.
• Fainting.
• Abnormal sense of touch; altered touch sensation.
• Altered, distorted, or absent sense of smell.
• Unusual feeling or sensation that may precede a migraine or certain types of seizures.
• Dry eyes, light sensitivity, eyelid twitching, watery eyes.
• Hearing loss, decreased hearing, hearing loss in one ear.
• Slow or irregular heartbeat, awareness of heartbeat in the chest.
• Low blood pressure, drop in blood pressure upon standing (as a result, some people taking topiramate may faint, feel dizzy, or lose consciousness when standing up or sitting up suddenly).
• Flushing or feeling hot.
• Pancreatitis (inflammation of the pancreas).
• Excess gas or flatulence, stomach acid, feeling full or bloated.
• Bleeding gums, increased saliva, drooling, bad breath.
• Excessive fluid intake, thirst.
• Skin discoloration.
• Muscle stiffness, side pain.
• Blood in urine, urinary incontinence (lack of bladder control), urgency to urinate, side or kidney pain.
• Difficulty achieving or maintaining an erection, sexual dysfunction.
• Flu-like symptoms.
• Cold hands and feet.
• Feeling of drunkenness.
• Difficulty learning.

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 (amblyopia).
• Swelling of the eyes and around the eyes.
• Numbness, tingling, and color changes (white, then blue, then red) in fingers and toes when exposed to cold (Raynaud's phenomenon).
• Liver inflammation, liver failure.
• Abnormal body odour.
• Discomfort in arms and legs.
• Kidney impairment.

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 any change or decrease in your vision.

Other adverse effects in children

In general, adverse effects observed in children are similar to those seen in adults, but the following adverse effects may be more common in children than in adults:

• Difficulty concentrating.
• Increased blood acid levels.
• Thoughts of self-harm.
• Tiredness.
• Decreased or increased appetite.
• Aggression, abnormal behaviour.
• Difficulty falling or staying asleep.
• Feeling unsteady when walking.
• General malaise.
• Low blood potassium levels.
• Lack of emotional expression and/or feeling.
• Watery eyes.
• Slow or irregular heartbeat.

Other adverse effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (dizziness).
• Vomiting.
• Fever.

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Viatris

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

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topiramate Viatris

The active substance is topiramate.

Each Topiramate Viatris film-coated tablet contains 50 mg of topiramate.

The other components are:

Tablet core: microcrystalline cellulose (E-460), sodium carboxymethyl starch from potato (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 contents of the pack

Topiramate Viatris 50 mg is presented in packs containing 60 film-coated tablets, round, yellow, biconvex, with the imprint “G” on one side and “TO” / “50” on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

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 most recent revision of this leaflet: January 2024

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

Other sources of information

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