Label: Information for the User

Topiramato STADA 25 mg Film-Coated Tablets

Topiramato STADA 50 mg Film-Coated Tablets

Topiramato STADA 100 mg Film-Coated Tablets

Topiramato STADA 200 mg Film-Coated Tablets

This medicine is subject to additional monitoring, which will facilitate 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 label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you experience is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Topiramato Stadabelongs to a group of medicines called “antiepileptic medicines”.

It is used for:

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

Do not take Topiramato Stada

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

Prevention of migraines

• Do not take Topiramato Stada if you are pregnant.
• If you are a fertile woman, do not take topiramate unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Treatment of epilepsy

• Do not use topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, do not take topiramate unless you are using a highly effective contraceptive method during your treatment. The only exception is if topiramate is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking topiramate during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

A patient leaflet is provided with the packaging of Topiramato Stada 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 topiramate.

Warnings and precautions

Consult your doctor before starting to take Topiramato Stada if you:

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

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

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

A small number of people being treated with antiepileptic medicines such as topiramate have had thoughts of self-harm or suicide. 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 sodium valproate. 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 increase the risk of developing these symptoms at higher doses of topiramate.

Other medicines and Topiramato Stada

Inform your doctor or pharmacist if you are using, have used recently or may have to use other medicines, even those bought without a prescription, vitamins or herbal remedies. Topiramate and certain medicines may affect each other. Sometimes the dose of one or other 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 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 a 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 menstrual 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 topiramate.

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 topiramate.

Topiramato Stada with food and drinks

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

Pregnancy, breastfeeding and fertility

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

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

Treatment of epilepsy

• During epilepsy, do not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• During epilepsy, do not use topiramate if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if topiramate is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking topiramate during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.
• 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 the baby during pregnancy if topiramate is used during pregnancy.

• If you take topiramate during pregnancy, your child may have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares with 1 to 3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medicine. In particular, a cleft lip (a split in the upper lip) and a cleft palate (a split in the palate) have been observed. 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 have a 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 medicine. In a study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy and not taking an antiepileptic medicine 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 fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods should be used during 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 a diaphragm) should be used. Consult your doctor about the most suitable contraceptive methods for you.
• If you are taking hormonal contraceptives, there may be a reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier method (such as a condom or a diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Stada 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 Stada:

• 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 re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.

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

• 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 if 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 at risk during pregnancy.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

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

Breastfeeding

The active ingredient of topiramate passes into breast milk. Effects have been observed 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 interrupt breastfeeding or whether to interrupt the treatment with topiramate. 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 topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

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

Topiramato Stada 25 mg contains sodium

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

Topiramato Stada 50 mg, 100 mg and 200 mg contains sodium and soy lecithin

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

This medicine contains soy oil. It should not be used in case of allergy to peanuts or soy.

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

Girls and fertile women:

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

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

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

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

If you take more Topiramato Stada than you should

Consult your doctor immediately. Bring the medication with you.

You may feel drowsy, tired, or less attentive; lack of coordination; have difficulty speaking or concentrating; have double or blurry vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain, or seizures.

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

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Phone 91 5620420.

If you forgot to take Topiramato Stada

• If you forgot to take a dose, take it as soon as you remember. However, if it is almost time to take your next dose, skip the missed dose and continue as usual. Consult your doctor if you miss two or more doses.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt the treatment with Topiramato Stada

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

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

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

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

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

• Depression (new or worsened).

Common (may affect up to 1 in 10 people)

• Seizures.
• Anxiety, irritability, mood changes, confusion, disorientation.
• Problems with concentration, slowness of thought, memory loss, problems with memory (initial, sudden change or increase in severity).
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Increased blood acidity (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat).
• Decreased or loss of sweating (especially in small children exposed to high temperatures).
• Having thoughts of self-harm, attempting to cause serious injuries.
• Loss of part of the visual field.

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

• Glaucoma – blockage of fluid in the eye that causes increased eye pressure, pain, or decreased vision.
• Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high levels of ammonia in the blood (hyperammonemia), which can cause a change in brain function (encephalopathy).
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin eruptions with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin eruptions can become generalized skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

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

Other side effects include the following, if severe, please consult your doctor or pharmacist:

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

• Congestion, runny nose, or sore throat.
• Tickling, pain, and/or numbness in several parts of the body.
• Drowsiness, fatigue.
• Dizziness.
• Nausea, diarrhea.
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anemia (low blood count).
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, urticaria).
• Loss of appetite, decreased appetite.
• Aggression, agitation, anger, abnormal behavior.
• Difficulty falling or staying asleep.
• Speech or language disorders, poor pronunciation when speaking.
• Clumsiness or lack of coordination, feeling unstable when walking.
• Decreased ability to complete routine tasks.
• Decreased, lost, or absent taste.
• Tremors or involuntary movements; rapid, uncontrollable eye movements.
• Visual 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 feeling of illness, 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 cramps, muscle pain or weakness, chest pain.
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells that help protect against infections, decreased potassium levels in the blood.
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood.
• Swelling of the lymph nodes in the neck, armpits, or groin.
• Increased appetite.
• Exalted mood.
• Heard, seen, or felt things that are not there, severe mental disorder (psychosis).
• Not showing or feeling emotions, unusual distrust, panic attack.
• Difficulty reading, speech disorders, difficulty writing by hand.
• Restlessness, hyperactivity.
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements.
• Fainting.
• Abnormal sensation of touch; altered touch.
• Altered, distorted, or absent sense of smell.
• Sensation or feeling that may precede a migraine or certain type of seizure.
• Dry eyes, sensitivity to light, eyelid tremor, watery eyes.
• Decreased or lost hearing, hearing loss in one ear.
• Slow or irregular heartbeat, feeling the heart beating in the chest.

? Decreased blood pressure, decreased blood pressure when standing (consequently, some people may faint, feel dizzy, or lose consciousness when standing up or sitting suddenly).

• Rubor or feeling hot.
• Pancreatitis (inflammation of the pancreas).
• Excessive gas or flatulence, stomach acid, feeling full or bloated.
• Nosebleeds, increased saliva, drooling, bad breath.
• Excessive intake of liquids, thirst.
• Decoloration of the skin.
• Muscle rigidity, side pain.

? Blood in the urine, incontinence (loss of control) when urinating, urgency to urinate, side or kidney pain.

• Difficulty achieving or maintaining an erection, sexual dysfunction.
• Symptoms of a cold.
• Cold hands and feet.
• Sensation of intoxication.
• Difficulty learning.

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

• Abnormally exalted mood.
• Loss of consciousness.
• Blindness in one eye, temporary blindness, night blindness.
• Wandering eye.
• Swelling of the eyes and around the eyes.

? Numbness, tingling, and color change (white, blue then red) of the fingers of the hands and feet when exposed to cold.

• Inflammation of the liver, liver insufficiency.
• Unusual odor of the skin.
• Discomfort in the arms and legs.
• Alteration of the kidney.

Unknown (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is more acute. Consult your doctor if you notice a change or decrease in your vision.

Other side effects in children

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

• Difficulty concentrating.
• Increased blood acidity.
• Having thoughts of self-harm.
• Fatigue.
• Increased or decreased appetite.
• Aggression, abnormal behavior.
• Difficulty falling or staying asleep.
• Feeling unstable when walking.
• General feeling of illness.
• Decreased potassium levels in the blood.
• Not showing or feeling emotions.
• Watery eyes.
• Slow or irregular heartbeat.

Other side effects that may appear in children are:

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 the blood.
• Hyperactivity.
• Feeling hot.
• Difficulty learning.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 out of reach and sight of children.

No special storage conditions are required.

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

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

Composition ofTopiramato Stada

The active ingredient is topiramate.

Each film-coated tablet of Topiramato Stada 25 mg contains 25 mg of topiramate.

Each film-coated tablet of Topiramato Stada 50 mg contains 50 mg of topiramate.

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

Each film-coated tablet of Topiramato Stada 200 mg contains 200 mg of topiramate.

The other components are:

Core of the tablet:mannitol (E421), pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Covering layer:

Topiramato Stada 25 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc.

Topiramato Stada 50 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soy lecithin (E322), and yellow iron oxide (E172).

Topiramato Stada 100 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soy lecithin (E322), and yellow iron oxide (E172).

Topiramato Stada 200 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soy lecithin (E322), and red iron oxide (E172).

Appearance of Topiramato Stada and contents of the package

The 25 mg tablets are round, white, biconvex, and have a legend engraved: “V1” on one face.

The 50 mg tablets are round, light yellow, biconvex, and have a legend engraved: “V3” on one face.

The 100 mg tablets are round, yellow, biconvex, and have a legend engraved: “V4” on one face.

The 200 mg tablets are oval, salmon-colored, biconvex, and have a legend engraved: “V5” on one face.

Topiramato Stada is presented in packages containing 60 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

BALKANPHARMA DUPNITSA AD

3, Samokovsko Shosse Str.

2600 Dupnitsa,

Bulgaria

Last review date of this prospectus:January 2024.

Other sources of information

The most recent approved information is the product information and patient information leaflet.The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es