TOPIRAMATE STADA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate STADA 25 mg film-coated tablets EFG

Topiramate STADA 50 mg film-coated tablets EFG

Topiramate STADA 100 mg film-coated tablets EFG

Topiramate STADA 200 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

Topiramate Stada belongs to a group of medicines called “antiepileptic medicines”.

It is used for:

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

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

Do not take Topiramate Stada

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

Migraine prevention

• Do not take Topiramate Stada if you are pregnant.
• If you are a woman of childbearing potential, do 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

• Do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of seizures.
• If you are a woman of childbearing potential, do 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 control of seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and the risks of seizures during pregnancy, which may put you or your baby at risk.

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

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

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

Warnings and precautions

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

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

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

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

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

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

A small number of people being treated with antiepileptic drugs such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

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

Topiramate may rarely cause high levels of ammonia in the blood (seen in blood tests) which can cause a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this can be a serious disease, talk to your doctor immediately if you experience any of the following symptoms (see also section 4 “Possible side effects”):

• difficulty thinking, remembering information or solving problems
• decreased alertness or consciousness
• feeling of numbness with low energy

The risk of developing these symptoms may increase with higher doses of topiramate.

Other medicines and Topiramate Stada

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, vitamins or herbal medicines. Topiramate and certain medicines may affect each other. Sometimes it may be necessary to adjust the dose of one of the other medicines or of topiramate.

In particular, tell 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 depressant medicines such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate may make hormonal contraceptives less effective. You should use an additional barrier contraceptive such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking topiramate.

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

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before taking topiramate.

Other medicines that you should consult your doctor or pharmacist about include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's Wort (Hypericum perforatum) (a herbal preparation used to treat depression), warfarin used to prevent blood clotting.

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

Taking Topiramate Stada with food and drinks

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

Pregnancy, breastfeeding and fertility

Pregnancy

Important advice for women of childbearing potential:

Topiramate may harm 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

• In the case of migraine, do not take topiramate if you are pregnant.
• In the case of migraine, do not take 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 should be performed in a woman of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of seizures.
• In the case of epilepsy, do not take 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 control of seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and the risks of seizures during pregnancy, which may put you or your baby at risk.
• Before starting treatment with topiramate, a pregnancy test should be performed in a woman of childbearing potential.

Risks of topiramate when taken during pregnancy (regardless of the disease 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 will have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 out of 100 children will have birth defects. This compares to 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been seen. Boys may also have a malformation of the penis (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take topiramate during pregnancy, your child may have a 2 to 3 times higher risk of developing autistic spectrum disorders, intellectual disabilities or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medication.
• If you take topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy and not taking antiepileptic medication were smaller and weighed less than expected at birth.
• Consult your doctor if you have questions about this risk during pregnancy.
• There may be other medicines to treat your condition with a lower risk of birth defects.

Need for contraceptive methods for women of childbearing 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 should 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 with a barrier contraceptive method (such as a condom or diaphragm) should be used. Consult your doctor about the most suitable contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Stada in girls:

If you are the parent or 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 the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate Stada:

• Schedule an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you are taking topiramate for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on 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 Stada:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. Worsening of your epilepsy may put you or your baby at risk during pregnancy.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

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

Breastfeeding

Topiramate passes into breast milk. Effects in breastfed babies of mothers treated with topiramate have been seen, including diarrhea, drowsiness, irritability, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or to stop treatment with topiramate. Your doctor will take into account the benefits for the mother and the risk for the baby.

Breastfeeding mothers 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 using machines

Dizziness, fatigue, and vision disturbances may occur during treatment with topiramate. Do not drive or operate tools or machines without talking to your doctor first.

Topiramate Stada 25 mg contains sodium

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

Topiramate Stada 50 mg, 100 mg, and 200 mg contain sodium and soy lecithin

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

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

3. How to take Topiramato STADA

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

Girls and women of childbearing age:

Treatment with topiramate should begin and continue under the supervision of a doctor with experience in the treatment of 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 slowly increase your dose until they find the best one for you.

Topiramate tablets should be 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 fluids during the day to avoid the formation of kidney stones while taking topiramate.

If you take moreTopiramatoStadathan 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 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 medication with topiramate.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, Telephone 91 5620420.

If you forget to takeTopiramatoStada

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

If you stop treatment withTopiramatoStada

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 medication, they will gradually decrease your dose over several days.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

Consult your doctor or seek medical attention immediately 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 (attacks).
• Anxiety, irritability, mood changes, confusion, disorientation.
• Concentration problems, slow thinking, memory loss, memory problems (initial, sudden change, or increased severity).
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Increased blood acid levels (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat).
• Decreased or lost sweating (especially in small children exposed to high temperatures).
• Having thoughts of self-harm, attempting to cause serious harm 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 that causes increased pressure in the eye, pain, or decreased vision.
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy - these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (hyperammonemic encephalopathy).
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin rashes with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become widespread skin damage (shedding of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data)

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

Other side effects include the following, if they are severe, please consult your doctor or

pharmacist:

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

• Congestion, runny nose, or sore throat.
• Numbness, pain, and/or tingling of 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, hives).
• Loss of appetite, decreased appetite.
• Aggression, agitation, anger, abnormal behavior.
• Difficulty staying or falling asleep.
• Speech problems or speech disorders, poor pronunciation when speaking.
• Clumsiness or lack of coordination, feeling of instability when walking.
• Decreased ability to complete routine tasks.
• Decreased, lost, or absent sense of taste.
• Tremors or involuntary twitches; rapid, uncontrollable eye movements.
• Visual disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing.
• Feeling of spinning (vertigo), ringing in the ears, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, general malaise, weakness.
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection.
• Dry mouth.
• Hair loss.
• Itching.
• Joint pain or inflammation, muscle spasms or twitches, muscle pain or weakness, chest pain.
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count that helps protect against infections, decreased potassium levels in the blood.
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood.
• Swelling of the neck, armpit, or groin lymph nodes.
• Increased appetite.
• Exalted mood.
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis).
• Lack of emotion, unusual distrust, panic attack.
• Reading problems, speech disorders, handwriting problems.
• Restlessness, hyperactivity.
• Slow thinking, decreased alertness or awareness.
• 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.
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure.
• Dry eyes, eye sensitivity to light, eyelid twitching, watery eyes.
• Decreased or lost hearing, hearing loss in one ear.
• Slow or irregular heartbeat, feeling the heart beating in the chest.

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

• Flushing or feeling hot.
• Pancreatitis (inflammation of the pancreas).
• Excess gas or bloating, stomach acid, feeling full or bloated.
• Gum bleeding, increased saliva, drooling, bad breath.
• Excessive fluid intake, thirst.
• Skin discoloration.
• Muscle stiffness, side pain.

? Blood in the urine, incontinence (loss of bladder control), urgent need to urinate, pain in the side or kidney.

• Difficulty getting or maintaining an erection, sexual dysfunction.
• Flu-like symptoms.
• Cold hands and feet.
• Feeling of drunkenness.
• Learning difficulties.

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

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

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

• Liver inflammation, liver failure.
• Abnormal skin odor.
• Discomfort in the arms and legs.
• Kidney damage.

Unknown (cannot be estimated from available data)

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

Other side effects in children

Generally, the 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 blood acid levels.
• Having thoughts of self-harm.
• Fatigue.
• Decreased or increased appetite.
• Aggression, abnormal behavior.
• Difficulty staying or falling asleep.
• Feeling of instability when walking.
• General malaise.
• Decreased potassium levels in the blood.
• Lack of emotion.
• Watery eyes.
• Slow or irregular heartbeat.

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Feeling of spinning (vertigo).
• Vomiting.
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in the blood.
• Hyperactivity.
• Feeling hot.
• Learning difficulties.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Topiramato STADA

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofTopiramato Stada

The active ingredient is topiramate.

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

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

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

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

The other ingredients are:

Tablet core: mannitol (E421), pregelatinized starch (from corn), microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Coating:

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 package contents

The 25 mg tablets are round, white, biconvex, and have a engraved legend: "V1" on one side.

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

The 100 mg tablets are round, yellow, biconvex, and have a engraved legend: "V4" on one side.

The 200 mg tablets are oval, salmon, biconvex, and have a engraved legend: "V5" on one side.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

BALKANPHARMA DUPNITSA AD

3, Samokovsko Shosse Str.

2600 Dupnitsa,

Bulgaria

or

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

Date of last revision of this leaflet:January 2024.

Other sources of information

The most recently approved information is the product information and patient information leaflet. Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es