Topiramate Stada 25 mg film-coated tablets EFG

Package leaflet: Information for the user

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 quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any adverse reaction not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

1. What Topiramato Stada is and what it is used for

Topiramato Stada 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 as monotherapy.
• Treating seizures in adults and children over 2 years of age when given in combination with other medicines.
• Preventing migraine in adults.

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

Do not take Topiramate Stada

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

Prevention of migraines

• You must not take Topiramate Stada 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 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.

A patient card is provided with the Topiramate Stada 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.

Warnings and precautions

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

• have kidney problems, especially kidney stones, or are undergoing 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 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.
• are pregnant. Topiramate may harm an unborn baby when taken during pregnancy.

If you are unsure whether 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.

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

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

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

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 may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. As 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.

Other medicines and Topiramate Stada

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription, vitamins, or herbal remedies. Topiramate and certain medicines may interact with each other. Sometimes, the dose of one or more of the medicines may need to be adjusted.

In particular, 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. Consult your doctor about the most appropriate contraceptive method to use while taking topiramate.

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

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

Other medicines about which you should consult your doctor or pharmacist 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), 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.

Taking Topiramate Stada with food and drink

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

Pregnancy, breastfeeding and fertility

Pregnancy

Important advice for women of childbearing potential:

Topiramate may harm an unborn 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.

Prevention of migraines

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

Treatment of epilepsy

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

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

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

• If you take topiramate during pregnancy, your child has a higher chance of having congenital malformations. In women taking topiramate, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1 to 3 out of every 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 observed. Male newborns may also have a penile malformation (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
• If you take topiramate during pregnancy, your child may have a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medicines.
• If you take topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.
• Consult your doctor if you have questions about these risks during pregnancy.
• There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

• If you are a woman of childbearing potential, consult your doctor about other possible treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together with a barrier method such as a condom or diaphragm) should be used. Consult your doctor about the most appropriate contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness due to topiramate. Therefore, an additional barrier contraceptive method (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Stada in girls:

If you are the parent or caregiver of a girl being treated with topiramate, consult your doctor immediately once she experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby due to exposure to topiramate during pregnancy and the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate 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 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 and may refer you to another specialist.

If you become pregnant or think you might be pregnant while taking Topiramate Stada:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate for migraine prevention, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition could worsen. Worsening epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy and may refer you to another specialist.
• If topiramate is used during pregnancy, you will be monitored closely to check your baby’s development during pregnancy.

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

Breastfeeding

The active ingredient of topiramate passes into 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. Your doctor will consider 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 shows any unusual symptoms.

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 machinery without first talking to your doctor.

Topiramate Stada 25 mg contains sodium

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

Topiramate Stada 50 mg, 100 mg and 200 mg contains sodium and soya lecithin

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

This medicine contains soya oil. It must not be used if you are allergic to peanuts or soya.

3. How to take Topiramate Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, 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.

Take topiramate exactly as prescribed for you. 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 they 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.

If you take more Topiramate Stada than you should

Contact your doctor immediately. Bring the medicine with you.

You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; experience double or blurred vision; feel dizzy due to a drop in blood pressure; feel depressed or agitated; 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, you may also contact the Toxicology Information Service, Telephone 91 5620420.

If you forget to take Topiramate Stada

• 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 a missed dose.

If you stop taking Topiramate Stada

Do not stop treatment unless your doctor tells you to. Symptoms of your condition may return. If your doctor decides that you should stop taking this medicine, your dose will be gradually reduced over several days.

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

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

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

• Depression (new or worsened).

Common (may affect up to 1 in 10 people)

• Seizures (attacks).
• Anxiety, irritability, mood changes, confusion, disorientation.
• Difficulty concentrating, slowed thinking, memory loss, memory problems (sudden onset, sudden change, or increased severity).
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Increased level of acid in the blood (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat).
• Decreased or loss of sweating (especially in young children exposed to high temperatures).
• Thoughts of self-harm, attempting to cause serious injury to oneself.
• Loss of part of the visual field.

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

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

Not known (cannot be estimated from available data):

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

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

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

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

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count).
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives).
• Loss of appetite, decreased appetite.
• Aggression, agitation, anger, abnormal behaviour.
• Difficulty falling or staying asleep.
• Speech problems 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, reduced vision, difficulty focusing.
• Sensation of spinning (dizziness), ringing in the ears, ear pain.
• Shortness of breath.
• Cough.
• Nosebleeds.
• Fever, general malaise, weakness.
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection.
• Dry mouth.
• Hair loss.
• Itching.
• Joint pain or swelling, muscle spasms or twitches, muscle pain or weakness, chest pain.
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells (which help protect against infections), 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.
• Elevated mood state.
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis).
• Lack of emotional expression and/or feeling, unusual distrust, panic attack.
• Reading difficulties, speech disorder, handwriting problems.
• Restlessness, hyperactivity.
• Slowed thinking, 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 loss of hearing, hearing loss in one ear.
• Slow or irregular heartbeat, awareness of heartbeat in the chest.

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

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

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

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

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.
• Swelling of the eyes and around the eyes.

? Numbness, tingling, and color changes (white, then blue, then red) in fingers and toes when exposed to cold.

• Liver inflammation, liver failure.
• Abnormal skin odour.
• Discomfort in arms and legs.
• Kidney impairment.

Not known (cannot be estimated from available data)

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

Other adverse effects in children

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

• Difficulty concentrating.
• Increased level of acid 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 feeling.
• Watery eyes.
• Slow or irregular heartbeat.

Other adverse effects that may occur in children include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

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

5. Storage of Topiramate Stada

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Topiramate Stada

The active substance is topiramate.

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

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

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

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

The other components are:

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

Coating layer:

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

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

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

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

Appearance of Topiramate Stada and contents of the pack

The 25 mg tablets are round, white, biconvex, with an imprint: “V1” on one side.

The 50 mg tablets are round, light yellow, biconvex, with an imprint: “V3” on one side.

The 100 mg tablets are round, yellow, biconvex, with an imprint: “V4” on one side.

The 200 mg tablets are oval, salmon-coloured, biconvex, with an imprint: “V5” on one side.

Topiramate Stada is available in packs 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 the most recent review of this leaflet: January 2024.

Other sources of information

The most recently approved information is the product information and the patient information card. Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es