TOPIRAMATO 100 mg Film‑Coated Tablet

Summary of Product Characteristics: Information for the User

Topiramato Teva 100 mg Film-Coated Tablets

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

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

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

• treating seizures in adults and children over 6 years old when taken alone
• treating seizures in adults and children 2 years old or older, when taken with other medicines
• to prevent migraine in adults

Do not take Topiramato Teva

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

Prevention of migraines

• You should not take topiramate if you are pregnant.
• If you are a fertile woman, you should 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

• You should not use topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, you should 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 should 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 you read the patient leaflet that you will receive from your doctor or scan the QR code to obtain it (see section 6 “Other sources of information”).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Topiramato Teva

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

If you are unsure whether anything above applies to you, consult your doctor before using topiramate.

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

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

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

You may lose weight if you take Topiramato Teva, so your weight should be monitored 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 Topiramato Teva have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Topiramate 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”).

Topiramate 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 medicine called valproic acid or valproate sodium. Since this can be a serious condition, 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 drowsy with low energy

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

Other medicines and Topiramato Teva

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those bought without a prescription, vitamins, or herbal remedies. Topiramato Teva and certain other medicines may affect each other. Sometimes, the dose of one or both medicines may need to be adjusted.

Especially inform your doctor or pharmacist if you are taking:

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

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and topiramate. You may experience irregular bleeding. 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 using Topiramato Teva.

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 unsure whether anything above applies to you, consult your doctor or pharmacist before taking Topiramato Teva.

Taking Topiramato Teva with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Important advice for fertile women:

Topiramate may cause harm to a baby during 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, you should not take topiramate if you are pregnant.
• If you have a migraine, you should 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, you should not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you have epilepsy, you should 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 should 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.
• Before starting treatment with topiramate, a pregnancy test should be performed in a fertile woman.

Risks of topiramate during pregnancy (regardless of the condition for which topiramate is used) are as follows:

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

• If you take topiramate during pregnancy, your child may be more likely to have birth defects. In women taking topiramate, about 4 to 9 out of every 100 children will have birth defects. This compares with 1 to 3 out of every 100 children born to women with epilepsy who are not taking an antiepileptic drug. In particular, there have been reports of cleft lip (a split in the upper lip) and cleft palate (a split in the palate). Newborn boys may also have a genital malformation (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take topiramate during pregnancy, your child may be at a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared with children born to women with epilepsy who are not taking an antiepileptic drug.
• 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 who were not taking an antiepileptic drug were smaller and weighed less than expected at birth.
• Consult your doctor if you have any 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 in fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking topiramate. If you decide to use topiramate, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of topiramate.
• Highly effective contraceptive methods (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 suitable contraceptive methods for you.
• There is a possibility of reduced effectiveness of hormonal contraceptives 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 Topiramato Teva in girls:

If you are the parent/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 baby during pregnancy due to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.

If you want to become pregnant while taking Topiramato Teva:

• Book an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you are taking topiramate for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen.
• Your doctor will review 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 have become pregnant or think you may be pregnant while taking Topiramato Teva:

• Book an urgent appointment with your doctor.
• If you are taking topiramate for migraines, 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 consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your baby during pregnancy at risk.
• Your doctor will review 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 how your baby is developing during pregnancy.

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

Breastfeeding

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

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

Driving and using machines

You may experience dizziness, fatigue, and visual disturbances during treatment with Topiramato Teva. Do not drive or operate machinery without talking to your doctor first.

Topiramato Teva contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

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

Your doctor will usually start with a low dose of topiramato and gradually increase your dose to find the best one for you.

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

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

Girls and fertile women:

Topiramato treatment should begin and continue under the supervision of a doctor experienced in treating epilepsy or migraine. Visit your doctor at least once a year to review your treatment.

If you take more Topiramato Teva than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Teléfono 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Topiramato Teva

• If you forgot 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 compensate for the missed dose.

If you interrupt treatment with Topiramato Teva

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 using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The frequency of the possible side effects listed below is defined using the following convention:

• Very common (affects more than 1 in 10 people)
• Common: (affects between 1 and 10 in 100 people)
• Uncommon: (affects between 1 and 10 in 1,000 people)
• Rare: (affects between 1 and 10 in 10,000 people)
• Very rare: (affects less than 1 in 10,000 people)
• Unknown: (the frequency cannot be estimated from the available data)

Very common side effects that include:

• Weight loss
• Itching, pain, and/or numbness in several parts of the body
• Drowsiness, fatigue
• Dizziness
• Diarrhea
• Nausea
• Congestion, runny nose, and throat pain
• Depression (new or worsened)

Common side effects that include:

• Anxiety, irritability, mood changes, confusion, disorientation
• Aggression, agitation, anger, abnormal behavior
• Crises (attacks)
• Weight gain
• Decreased or lost appetite
• Anemia (decreased red blood cell count)
• Changes in thought or alertness, including confusion, concentration problems, memory problems, or slowing of thought (initial, sudden change, or worsening)
• Difficulty staying or falling asleep
• Speech or language disorders, poor pronunciation when speaking, clumsiness or walking problems, feeling unstable when walking
• Decreased ability to complete routine tasks
• Tremors or involuntary agitation of the arms, hands, or legs
• Involuntary eye movement
• Altered taste
• Visual disturbances, blurred vision, double vision
• Tinnitus (ringing in the ears)
• Ear pain
• Dizziness (vertigo)
• Shortness of breath
• Cough
• Nasal bleeding
• Vomiting
• Constipation
• Abdominal pain or discomfort, stomach or intestinal infection
• Indigestion
• Dry mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Redness and/or itching of the skin
• Joint pain or inflammation
• Muscle spasms, muscle cramps, muscle pain, or weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of discomfort
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, hives)

Uncommon side effects that include:

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (cells that help protect against infections), decreased potassium levels in the blood.
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, flank or kidney pain
• Increased eosinophils (a type of white blood cell) in the blood
• Irregular heartbeat or slowing of the heartbeat, feeling the heartbeat in the chest
• Swelling of the lymph nodes in the neck, armpits, or groin
• Problems with reading, speech disorders, handwriting problems
• Babbling, increased saliva
• Restlessness or increased mental and physical activity, hyperactivity
• Having thoughts of self-harm, attempting to cause serious injuries
• Fainting
• Movements slowed or decreased, abnormal or repetitive involuntary muscle movements
• Muscle stiffness, side pain
• Alteration, distortion, or absence of smell
• Eye problems, including dry eyes, light sensitivity, involuntary palpitating, watery eyes, and decreased vision
• Loss of a part of the visual field
• Decreased or lost hearing
• Unusual feeling or sensation that may precede a migraine or certain type of crisis
• Pancreatitis (inflammation of the pancreas)
• Gas
• Stomach acid
• Abnormal sensation of touch; altered touch
• Gingival bleeding
• Feeling full or bloated
• Bad breath
• Decreased or absent sweating (especially in young children exposed to high temperatures)
• Decoloration of the skin
• Musculoskeletal stiffness
• Increased acid levels in the blood (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Increased appetite
• Increased thirst and ingestion of large amounts of liquid
• Decreased blood pressure or decreased blood pressure when standing (consequently, some people may faint, feel dizzy, or lose consciousness when standing or sitting suddenly)
• Flush or feeling hot
• Flush or feeling hot
• Flu-like syndrome
• Cold extremities (e.g., hands, feet, and face)
• Slow or decreased body movements, abnormal or repetitive involuntary muscle movements
• Thinking slowly, decreased alertness or consciousness
• Feeling drunk
• Learning problems
• Alteration of sexual function (erectile dysfunction, loss of libido)
• Exalted mood
• Hallucinations, severe mental disorder (psychosis)
• Not showing or feeling emotion, unusual distrust, panic attack
• Increased liver enzymes

Rare side effects that include:

• Glaucoma, which is a blockage of the fluid in the eye that causes increased eye pressure, pain, and decreased vision
• Exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Wandering eye
• Renal alteration

• Severe skin reaction, including Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin rash with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become generalized skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling numb 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)
• Unusual odor of the skin
• Swelling of the tissues around the eyes
• Raynaud's syndrome, acondition that affects blood vessels, in the fingers of the hand and feet, ears, and that causes pain and sensitivity to cold
• Discomfort in the arms and legs
• Hepatitis, liver insufficiency

Side effects of unknown frequency:

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

Children and adolescents:

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

• Concentration problems
• Increased acid levels in the blood
• Having thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling unstable when walking
• General discomfort
• Decreased potassium levels in the blood
• Not showing or feeling emotion
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may appear in children are:

Common (may affect up to 1 in 10 people)

• Dizziness (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 problems

Reporting 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.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store at a temperature below30°C.

Store in the outer packaging to protect it from humidity.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Topiramato Teva

The active ingredient is topiramate.

Topiramato Teva 100 mg: each tablet contains 100 mg of topiramate.

The other components are:

Core: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, sodium carboxymethyl starch (type A), anhydrous colloidal silica, magnesium stearate.

Coating: maltodextrin, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), and macrogol 4000.

Appearance of the product and contents of the packaging

Topiramato Teva 100 mg is presented in packaging containing 60 film-coated tablets of yellow color, in capsule form. One side is scored and engraved with “T” and “100” on both sides of the score. The other side is smooth.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid

Spain

Responsible for manufacturing

Teva Operations Poland Sp. z o.o.

80 Mogilska str.

31-546 Krakow

Poland

O

Teva Pharmaceutical Works Private Limited Company
Pallagi ut 13, Debrecen, H-4042

Hungary

Date of the last review of this leaflet:February 2024

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

The latest approved information (patient guide) on this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL):https://cima.aemps.es/cima/DocsPub/16/3252

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