Topiramate Teva-Ratiopharm 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Topiramate Teva-ratiopharm 50 mg film-coated tablets EFG

topiramate

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Topiramato Teva-ratiopharm is and what it is used for

Topiramato Teva-ratiopharm 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 given alone
• treating seizures in adults and children aged 2 years and older when given in combination with other medicines
• preventing migraine in adults

2. What you need to know before starting to take Topiramate Teva-ratiopharm

Do not take Topiramate Teva-ratiopharm

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

Prevention of migraines

• 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”.

Treatment of epilepsy

• 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 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 you will receive from your doctor or scan the QR code to access it (see section 6 “Other sources of information”).

A patient card is provided with the Topiramate Teva-ratiopharm packaging 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 Teva-ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Topiramate Teva-ratiopharm if:

• you have kidney problems, especially kidney stones, or are undergoing 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 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 more 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 before using topiramate.

If you have epilepsy, it is important not to stop taking your medication without first consulting your doctor.

It is important not to stop taking your medication 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 Topiramate Teva-ratiopharm.

You may lose weight while taking Topiramate Teva-ratiopharm, 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, you should consult your doctor.

A small number of people being treated with antiepileptic medicines such as Topiramate Teva-ratiopharm have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramate Teva-ratiopharm may cause serious skin reactions. Contact your doctor immediately if you develop a rash and/or blisters (see also section 4 “Possible side effects”).

Topiramate Teva-ratiopharm 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
• reduced level of alertness or consciousness
• feeling drowsy with low energy

The risk of developing these symptoms may increase at higher doses of Topiramate Teva-ratiopharm.

Other medicines and Topiramate Teva-ratiopharm

Consult your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Topiramate Teva-ratiopharm and certain medicines may interact with each other. Sometimes, the dose of one or more medicines may need to be adjusted.

Especially inform your doctor or pharmacist if you are taking:

• other medicines that impair or reduce your thinking, 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 you are 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 are taking. Show this list to your doctor and pharmacist before starting Topiramate Teva-ratiopharm.

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), and 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 Topiramate Teva-ratiopharm.

Taking Topiramate Teva-ratiopharm with food, drinks and alcohol

You may take Topiramate Teva-ratiopharm with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramate Teva-ratiopharm. You should avoid drinking alcohol while taking Topiramate Teva-ratiopharm.

Pregnancy and breastfeeding

Pregnancy

Important advice for women of childbearing potential:

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

Migraine prevention

• You must not take topiramate if you are pregnant and being treated for migraine.
• You must not use topiramate for migraine 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

• You must not take topiramate if you are pregnant and being treated for epilepsy, unless no other treatment provides sufficient seizure control.
• You must not use topiramate if you are a woman of childbearing potential and being treated for epilepsy, 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 endanger you or your unborn baby.
• 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 an increased risk of 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 medication. 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 malformation of the penis (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 medication.
• 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 with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.
• Consult your doctor if you have any questions about these risks during pregnancy.
• There may be other medications 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 alternative treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods must be used throughout 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 method (such as a condom or diaphragm) must be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Teva-ratiopharm in girls:

If you are the parent or caregiver of a girl being treated with topiramate, you must 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 Teva-ratiopharm:

• Schedule an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you take topiramate for epilepsy, do not stop taking it until you have discussed 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.

Your doctor may also refer you to another specialist.

If you become pregnant or suspect you may be pregnant while taking Topiramate Teva-ratiopharm:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate to prevent migraines, stop taking the medication 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 medication until you have discussed this with your doctor, as your condition could worsen. Worsening of epilepsy may endanger you or your unborn baby.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy.

Your doctor may also refer you to another specialist.

• If topiramate is used during pregnancy, you will be closely monitored to check your baby's development during pregnancy.

Make sure to read the patient guide you will receive from your doctor. The patient guide is also available by scanning a QR code; see section 6 “Other sources of information”. A patient card is provided with the Topiramate Teva-ratiopharm packaging to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active substance in Topiramate Teva-ratiopharm (topiramate) passes into human breast milk. Effects have been observed in breastfed infants of treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue treatment with Topiramate Teva-ratiopharm. Your doctor will consider the importance of the benefits for the mother and the potential risk to the infant.

Breastfeeding mothers taking Topiramate Teva-ratiopharm should inform their doctor as soon as possible if the infant experiences any unusual symptoms.

Driving and use of machines

Dizziness, fatigue, and visual disturbances may occur during treatment with Topiramate Teva-ratiopharm.

Do not drive or operate tools or machinery without first discussing this with your doctor.

Topiramate Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

Topiramate Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Topiramate Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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.

• Your doctor will usually start with a low dose of topiramate and slowly increase the dose until the optimal dose for you is reached.
• Topiramate tablets should be swallowed whole. Avoid chewing the tablets as this may leave a bitter taste.
• You may take topiramate before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking topiramate.

Symptoms of overdose with Topiramate Teva-ratiopharm

• 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 restless; or 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Topiramate Teva-ratiopharm

• 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 miss two or more doses.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Topiramate Teva-ratiopharm

Do not stop treatment without being instructed to do so by your doctor. Symptoms of your illness may return. If your doctor decides that you should stop taking this medicine, the dose will be gradually reduced 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.

Consult 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 onset or worsening)

Common (may affect up to 1 in 10 people):

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Problems with concentration, slowness of thinking, memory loss, memory problems (new onset, sudden change, or increased severity)
• Kidney stones, frequent urge to urinate, or painful urination

Uncommon (may affect up to 1 in 100 people):

• Increase in acid levels in the blood (can cause breathing problems including difficulty breathing, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Decreased or absent sweating (particularly in children exposed to high temperatures)
• Serious thoughts of self-harm, leading to severe self-injury
• 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 in the eye, eye pain or vision loss
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling very drowsy with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which can lead to a change in brain function (hyperammonemic encephalopathy)
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which 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 may progress to widespread damage to the skin (detachment of the epidermis and superficial mucous membranes), with potentially life-threatening consequences

Frequency not known (frequency 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 inform 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, decreased appetite
• Aggression, agitation, anger, abnormal behaviour
• Difficulty falling or staying asleep
• Problems with speech or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Decreased, lost or absent taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation 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
• 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 that help protect against infections, decreased 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
• Euphoric mood
• Hearing, seeing or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotional expression and/or inability to feel emotions, unusual distrust, panic attack
• Problems with reading, speech disorder, problems with handwriting
• Restlessness, hyperactivity
• Slowed thinking, decreased level of wakefulness or alertness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch sensation
• Impaired, 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
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people taking topiramate Teva-ratiopharm 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 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, incontinence (lack 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 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 change (white, blue then red) in fingers and toes when exposed to cold (Raynaud's phenomenon)
• Liver inflammation, liver failure
• Abnormal skin odor
• Discomfort in arms and legs
• Kidney impairment

Not known (frequency 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.

Children

In general, 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:

• Problems with concentration
• Increased acid levels in the blood
• Thoughts of self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling unsteady when walking
• General malaise
• Decreased blood potassium levels
• Lack of emotional expression and/or inability to feel emotions
• 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 (vertigo)
• 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the bottle and outer packaging, after EXP. The expiry date refers to the last day of the month indicated.

Bottle: Keep the container tightly closed to protect it from moisture.

Blister: Store below 30 °C. Keep in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topiramato Teva-ratiopharm

The active substance is topiramate.

One film-coated tablet of Topiramato Teva-ratiopharm contains 50 mg of topiramate.

The other components of Topiramato Teva-ratiopharm are listed below:
Tablet core: lactose monohydrate, pregelatinized corn starch, silicified microcrystalline cellulose, microcrystalline cellulose, sodium carboxymethyl potato starch, and magnesium stearate.
Coating: Opadry II light yellow, containing hypromellose, polydextrose, glyceryl triacetate, polyethylene glycol 8000, titanium dioxide (E171), and yellow iron oxide (E172).

What Topiramato Teva-ratiopharm looks like and contents of the pack

Topiramato Teva-ratiopharm is presented as light yellow, round, biconvex, film-coated tablets with bevelled edges.

Pack sizes:

Topiramato Teva-ratiopharm 50 mg film-coated tablets: 10, 20, 30, 50, 60, 100, and 200 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura 11,
Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid, Spain

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Finland: Topiramat ratiopharm 50 mg tabletti, kalvopäällysteinen
Austria: Topiramat ratiopharm 50 mg Filmtabletten
Germany: Topiramat ratiopharm 50 mg Filmtabletten
Spain: Topiramato Teva-ratiopharm 50 mg comprimidos recubiertos con película EFG
Sweden: Topiramat ratiopharm 50 mg filmdragerade tabletter

Date of the most recent review of this leaflet: April 2026

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

The most recently approved information (patient guide) for this medicinal product is available by scanning the following QR code with a smartphone. The same information is also available at the following web address (URL): https://cima.aemps.es/cima/DocsPub/16/3252

[QR Code]

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67990/P_67990.html