TOPIRAMATE PHARMA COMBIX 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Pharma Combix 100 mg film-coated tablets EFG

Topiramate

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Topiramate Pharma Combix and what is it used for
2. Before you take Topiramate Pharma Combix
3. How to take Topiramate Pharma Combix
4. Possible side effects
5. Storing Topiramate Pharma Combix
6. Further information

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

Topiramate Pharma Combix belongs to a group of medicines called antiepileptic medicines. It is used to:

• treat seizures in adults and children over 6 years of age, given alone.
• treat seizures in adults and children over 2 years of age, given together with other medicines.
• prevent migraine headaches in adults.

2. Before you take Topiramate Pharma Combix

Do not take Topiramate Pharma Combix

• 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 Pharma Combix if you are pregnant.
• If you are a woman of childbearing potential, do not take Topiramate Pharma Combix 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 your 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 your seizures and if you plan to become pregnant. You should consult your doctor to make sure 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 guide that you will receive from your doctor.

A patient card is provided with the packaging of Topiramate Pharma Combix to remind you of the risks during pregnancy.

Warnings and precautions

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

• you have kidney problems, especially kidney stones, or are on dialysis
• you have a history of blood or body fluid disorders (metabolic acidosis)
• you have liver problems
• you have eye problems, especially glaucoma
• you have growth problems
• you follow a high-fat diet (ketogenic diet)
• you are a woman who may become pregnant. Topiramate may harm an unborn baby during pregnancy 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.
• you are pregnant. Topiramate may harm an unborn baby during pregnancy when taken 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.

It is important that you do not 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 Pharma Combix.

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

A small number of people being treated with antiepileptic drugs such as Topiramate Pharma Combix have had thoughts of harming themselves or taking their own lives. If at any time you have these thoughts, contact your doctor immediately.

Other medicines and Topiramate Pharma Combix

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

Especially tell your doctor or pharmacist if you are taking:

• other medicines that impair or reduce your thoughts, concentration, or muscular 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 contraceptive such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topiramate Pharma Combix.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topiramate Pharma Combix. You may experience irregular bleeding. In this case, continue taking your 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 discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.

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

Taking Topiramate Pharma Combix with food and drink

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

Pregnancy, breastfeeding, and fertility

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.

Migraine prevention

• In the case of migraine, do not take topiramate if you are pregnant.
• In the case of migraine, do 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 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 your seizures.
• In the case of epilepsy, do 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 control of your seizures and if you plan to become pregnant. You should consult your doctor to make sure 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 unborn 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 condition for which topiramate is used) are as follows:

There is a risk of harm to the unborn 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 without epilepsy and 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 born 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 having autism 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 hormonal contraceptive together 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, a barrier contraceptive method (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of topiramate 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 an unborn baby during pregnancy due to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking topiramate:

• 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:

• 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 unborn baby at risk.
• 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 you read the patient guide that you will receive from your doctor. A patient card is provided with the packaging of Topiramate Pharma Combix to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Topiramate Pharma Combix (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 stop treatment with Topiramate Pharma Combix. Your doctor will consider the benefits for the mother and the risk for the baby.

Breastfeeding mothers taking Topiramate 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 using machines

Topiramate may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction time. These effects, as well as your condition itself, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

Important information about some of the ingredients of Topiramate Pharma Combix

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

3. How to take Topiramate Pharma Combix

Follow the instructions for taking topiramate exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

Girls and women of childbearing potential:

Treatment with topiramate should start and continue under the supervision of a doctor experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

• Take Topiramate Pharma Combix exactly as prescribed. Your doctor will usually start with a low dose of topiramate and gradually increase your dose until the best dose for you is found.
• Topiramate Pharma Combix tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take Topiramate Pharma Combix before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking this medicine.

If you take more Topiramate Pharma Combix than you should

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

You may experience an overdose if you are taking another medicine together with Topiramate Pharma Combix.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Topiramate 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 stop taking Topiramate Pharma Combix

Do not stop treatment without your doctor telling you to. Your symptoms may come back. If your doctor decides you need to stop taking this medicine, your dose will be gradually reduced over several days.

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

4. Possible Adverse Effects

Like all medicines, Topiramato Pharma Combix can have adverse effects, although not all people suffer from them.

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

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

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

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

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

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

Frequency not known (cannot be estimated from the available data)

Very common adverse effects that include:

• Weight loss
• Tingling in arms and legs
• Somnolence or drowsiness
• Dizziness
• Diarrhea
• Nausea
• Congestion, runny nose, and sore throat
• Fatigue
• Depression

Common adverse effects that include:

• Changes in mood or behavior, including anger, nervousness, sadness
• Weight gain
• Decreased or lost appetite
• Decrease in the number of red blood cells
• Changes in thinking or alertness, including confusion, concentration problems, memory, or slowness of thought
• Difficulty speaking
• Clumsiness or walking problems
• Involuntary shaking of the arms, hands, or legs
• Decreased sense of touch or sensation
• Involuntary eye movement
• Taste alteration
• Visual disturbance, blurred vision, double vision
• Ringing in the ears
• Ear pain
• Shortness of breath
• Nosebleed
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Numbness or tingling of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Redness and/or itching of the skin
• Joint pain
• Muscle spasms, muscle twitching, or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of discomfort
• Allergic reaction

Uncommon adverse effects that include:

• Presence of crystals in the urine
• Abnormal blood count, including reduced number of white blood cells or platelets, or increased eosinophils
• Irregular or slowed heartbeat
• Swelling of the neck, armpit, or groin lymph nodes
• Increased seizures
• Verbal communication problems
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or decreased movement
• Altered or poor-quality sleep
• Alteration or distortion of smell
• Handwriting problems
• Sensation of movement under the skin
• Eyelid problems, including dry eye, sensitivity to light, eyelid twitching, and decreased vision
• Hearing loss
• Hoarseness
• Pancreatitis
• Gas
• Stomach acidity
• Loss of sensation in the mouth
• Gum bleeding
• Feeling of fullness or bloating
• Painful or burning sensation in the mouth
• Bad breath
• Loss of urine and/or feces
• Urgent need to urinate
• Pain in the kidney and/or bladder area caused by kidney stones
• Decreased or absent sweating
• Discoloration of the skin
• Localized skin swelling
• Facial swelling
• Joint swelling
• Musculoskeletal stiffness
• Increased acid levels in the blood
• Decreased potassium levels in the blood
• Increased appetite
• Increased thirst and ingestion of large amounts of liquid
• Decreased blood pressure or decreased blood pressure when standing up
• Flushing
• Flu-like syndrome
• Cold extremities (e.g., hands and face)
• Learning problems
• Alteration of sexual function (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication

Rare adverse effects that include:

• Excessive skin sensitivity
• Inability to smell
• Glaucoma, which is a blockage of fluid in the eye that causes increased pressure in the eye, pain, and decreased vision
• Renal tubular acidosis
• Severe skin reaction, including Stevens-Johnson syndrome, a serious skin disease in which the top layers of the skin separate from the bottom layers; and erythema multiforme, a disease with red raised patches that can form blisters
• Odor
• Swelling of the tissues around the eyes
• Raynaud's syndrome, a disorder that affects blood vessels, in the fingers of the hand and feet, ears, and causes pain and sensitivity to cold
• Tissue calcification (calcinosis)

Adverse effects of unknown frequency:

• Maculopathy; it is a disease of the macula, a small area in the retina where vision is most acute. Consult your doctor if you notice a change or decrease in your vision
• Conjunctival swelling of the eye
• Toxic epidermal necrolysis, which is a more severe form of Stevens-Johnson syndrome (see uncommon adverse effects)
• Eye inflammation (uveitis) with symptoms such as redness and eye pain, sensitivity to light, tearing, vision of small dots, or blurred vision

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topiramato Pharma Combix

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Topiramato Pharma Combix 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Topiramato Pharma Combix 100 mg

The active ingredient is topiramate.

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

The other components of Topiramato Pharma Combix are listed below:

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

Appearance of Topiramato Pharma Combix 100 mg and packaging content

Topiramato Pharma Combix 100 mg is presented in packages containing 60 film-coated tablets, dark yellow in color, round, biconvex, with beveled edges and smooth on both sides.

Topiramato Pharma Combix is also available in 50 mg and 200 mg film-coated tablets, in packages of 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid), Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers,

92000 Nanterre

France

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

This leaflet was approved inJanuary 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/