Prospect: information for the user

Topiramato Pharma Combix 50 mg film-coated tablets EFG

Topiramato

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 the entire prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• 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 prospect, inform your doctor or pharmacist. See section 4.

1. What is Topiramato Pharma Combix and for what it is used

2. Before taking Topiramato Pharma Combix

3. How to take Topiramato Pharma Combix

4. Possible adverse effects

5. Storage of Topiramato Pharma Combix

6. Additional information

Topiramato Pharma Combix belongs 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 Pharma Combix

• 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 topiramate 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 to read the patient leaflet that you will receive from your doctor.

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

Warnings and precautions

Before starting treatment with Topiramato Pharma Combix, consult your doctor or pharmacist if:

• you have kidney problems, especially kidney stones, or are receiving dialysis
• you have a history of blood or fluid disorders (metabolic acidosis)
• you have liver problems
• you have eye problems, especially glaucoma
• you have growth problems
• you are following a high-fat diet (ketogenic diet)
• you are a woman who may become pregnant. Topiramate may cause harm to a baby during pregnancy when taken during pregnancy. You must 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.
• you are pregnant. Topiramate may cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure if any of the 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 must consult your doctor before taking any other medication containing topiramate that is given as an alternative to Topiramato Pharma Combix.

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 drugs like Topiramato Pharma Combix have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Other medicines and Topiramato Pharma Combix

Inform your doctor or pharmacist if you are using or have recently used other medicines, even those bought without a prescription, vitamins or herbal remedies. Topiramato Pharma Combix and certain other medicines may affect each other. Sometimes the dose of one or other of the medicines 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 must use an additional barrier method such as a condom or a diaphragm. You must 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 this medicine.

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.

If you are unsure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Taking Topiramato Pharma Combix with food and drink

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

Pregnancy, breastfeeding and fertility

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

• Do not take topiramate if you are pregnant.
• Do not use topiramate if you are a fertile woman, unless you are using a highly effective contraceptive method.
• A pregnancy test must be performed before starting treatment with topiramate in a fertile woman.

Treatment of epilepsy

• Do not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• 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, which may put you or your baby during pregnancy at risk.
• A pregnancy test must be performed before starting treatment with topiramate in a fertile woman.

Risks of topiramate when taken 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 will have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 out of every 100 children will have birth defects. This compares with 1-3 children out of every 100 born to women who do not have epilepsy and are not taking an antiepileptic treatment. In particular, there have been observations of cleft lip (a division in the upper lip) and cleft palate (a division 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 have 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 medicine.
• 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 and not taking an antiepileptic medicine 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 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 must 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) must 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 a diaphragm) must be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent/caregiver of a girl being treated with topiramate, you must 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 topiramate:

• 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. The doctor may also refer you to another specialist.

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

• 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 it 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. 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 leaflet that you will receive from your doctor. A patient information leaflet is provided with the packaging of Topiramato Pharma Combix to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient ofTopiramato Pharma Combix(topiramate) passes into breast milk. There have been observations of effects in breastfed babies of mothers treated with, 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 takingTopiramato Pharma Combix. 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 Pharma Combix 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 machines

Topiramate may cause symptoms such as drowsiness, dizziness or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Important information about some of the components of Topiramato Pharma Combix

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

Follow exactly the administration instructions for topiramato as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 to review your treatment at least once a year..

• Take Topiramato Pharma Combix exactly as prescribed. Your doctor will usually start with a low dose of topiramato and gradually increase your dose to find the best one for you.
• Swallow Topiramato Pharma Combix tablets whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take Topiramato Pharma Combix before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking this medication.

If you take more Topiramato Pharma Combix than you should

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy or tired, or have abnormal body movements, difficulty standing and walking, feel dizzy due to low blood pressure, or have irregular heartbeats or seizures.

You may experience an overdose if you take another medication with Topiramato Pharma Combix.

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

If you forget to take Topiramato Pharma Combix

• 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 interrupt treatment with Topiramato Pharma Combix

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 product, ask your doctor or pharmacist.

Like all medications, Topiramato Pharma Combix may have 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 (may affect more than 1 in 10 people)

Common (may affect between 1 in 100 and 1 in 10 people)

Uncommon (may affect between 1 in 1,000 and 1 in 100 people)

Rare (may affect between 1 in 10,000 and 1 in 1,000 people)

Very rare (may affect fewer than 1 in 10,000 people)

Frequency not known (cannot be estimated from available data)

Very common side effects that include:

- Weight loss

- Tingling in arms and legs

- Drowsiness or drowsiness

- Dizziness

- Diarrhea

- Nausea

- Congestion, runny nose, and sore throat

- Fatigue

- Depression

Common side effects that include:

- Changes in mood or behavior, including anger, nervousness, sadness

- Weight gain

- Decreased or lost appetite

- Decreased number of red blood cells

- Changes in thought or alertness, including confusion, concentration, memory, or slowness of thought

- Poor pronunciation when speaking

- Clumsiness or difficulty walking

- Involuntary agitation of arms, hands, or legs

- Decreased touch or sensation

- Involuntary eye movement

- Alteration of taste

- Visual alteration, blurred vision, double vision

- Buzzing in the ears

- Ear pain

- Shortness of breath

- Nasal bleeding

- Vomiting

- Constipation

- Stomach pain

- Indigestion

- Dry mouth

- Tingling or drowsiness of the mouth

- Kidney stones

- Frequent urination

- Painful urination

- Hair loss

- Redness and/or itching of the skin

- Joint pain

- Muscle spasms, muscle cramps, or muscle weakness

- Chest pain

- Fever

- Loss of strength

- General feeling of discomfort

- Allergic reaction

Uncommon side effects that include:

- Presence of crystals in the urine

- Abnormal blood count, including reduction in white blood cells or platelets, or increase in eosinophils

- Irregular heartbeat or slowing of the heartbeat

- Swelling of the lymph nodes in the neck, armpits, or groin

- Increase in seizures

- Verbal communication problems

- Babbling

- Restlessness or increase in mental and physical activity

- Loss of consciousness

- Fainting

- Slow or decreased movements

- Altered or poor sleep quality

- Alteration or distortion of the sense of smell

- Handwriting difficulties

- Sensation of movement under the skin

- Eye problems, including dry eyes, light sensitivity, involuntary blinking, and decreased vision

- Decreased or lost hearing

- Hoarseness

- Pancreatitis

- Gas

- Stomach acid

- Loss of sensitivity to touch in the mouth

- Bleeding gums

- Feeling of being full or bloated

- Painful or burning sensation in the mouth

- Bad breath

- Loss of urine and/or stool

- Urgent need to urinate

- Pain in the kidney and/or bladder area caused by kidney stones

- Decreased or absent sweating

- Skin discoloration

- Localized skin swelling

- Facial swelling

- Joint swelling

- Muscle stiffness

- Increased acid levels in the blood

- Decreased potassium levels in the blood

- Increased appetite

- Increased thirst and consumption of large amounts of liquid

- Decreased blood pressure or decreased blood pressure when standing up

- Shortness of breath

- Nosebleed

- Vomiting

- Constipation

- Stomach pain

- Indigestion

- Dry mouth

- Tingling or drowsiness of the mouth

Rare side effects that include:

- Excessive skin sensitivity

- Inability to smell

- Glaucoma, which is a blockage of the fluid in the eye that causes increased eye pressure, pain, and decreased vision

- Renal tubular acidosis

- Severe skin reaction, including Stevens-Johnson syndrome, a serious skin disease in which the upper layers of the skin separate from the lower layers; and erythema multiforme, a disease with raised red patches that may form blisters

- Odor

- Swelling of the tissues around the eyes

- Raynaud's syndrome. A disorder that affects blood vessels, in the fingers and toes, ears, and that causes pain and sensitivity to cold

- Calcification of tissues (calcinoses)

Side effects of unknown frequency:

- Maculopathy; it 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

- Conjunctival swelling of the eye

- Toxic epidermal necrolysis, a more severe form of Stevens-Johnson syndrome (see uncommon side effects)

- Uveitis, an eye inflammation with symptoms such as redness and pain in the eyes, light sensitivity, tearing, seeing small dots or blurred vision

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 of 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 medication.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Topiramato Pharma Combix after the expiration date that appears 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 the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Topiramato Pharma Combix 50 mg

The active ingredient is topiramate.

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

The other components of Topiramato Pharma Combix are listed below:

Microcrystalline cellulose, anhydrous lactose, sodium starch glycolate (potato), magnesium stearate, anhydrous colloidal silica, coating agent (hypromellose –E464-, titanium dioxide-E171-, macrogol, yellow iron oxide –E172-, polysorbate)

Appearance of Topiramato Pharma Combix 50 mg and contents of the package

Topiramato Pharma Combix 50 mg is presented in packages containing 60 film-coated tablets, yellowish clear, round, biconvex, bisected and smooth on both sides.

Topiramato Pharma Combix is also available in film-coated tablets of 100 mg and 200 mg, in packages of 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid), Spain

Responsible for manufacturing

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

This leaflet has been approved inJanuary 2024

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