Topiramate Pharma Combix 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Pharma Combix 50 mg film-coated tablets EFG

Topiramate

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. The end of section 4 includes information on how to report adverse reactions.

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse reactions you experience to be serious, or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Topiramato Pharma Combix 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. Before taking Topiramato Pharma Combix

Do not take Topiramato Pharma Combix

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

Migraine prevention

• You must not take topiramate 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”.

Epilepsy treatment

• 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 about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

A patient card 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 undergoing 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 are on a high-fat diet (ketogenic diet)
• you are a woman who could become pregnant. Topiramate may harm a baby during pregnancy when taken while pregnant. 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 a baby during pregnancy when taken while pregnant.

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.

It is important that you do not stop taking your medicine without first consulting your doctor.

You should consult your doctor before taking any other medicine containing topiramate that is prescribed as an alternative to Topiramato Pharma Combix.

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 enough weight, you should consult your doctor.

A small number of people treated with antiepileptic medicines such as Topiramato Pharma Combix have had thoughts of harming themselves or of suicide. If you ever have such thoughts, contact your doctor immediately.

Other medicines and Topiramato Pharma Combix

Inform 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 remedies. Topiramato Pharma Combix and certain medicines may affect each other. Sometimes the dose of one or more 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 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. You should consult your doctor about the best contraceptive method to use while taking topiramate.

Tell your doctor if you experience changes in your menstrual bleeding 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 this medicine.

Other medicines 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 unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Taking Topiramato Pharma Combix with food and drinks

You may take Topiramato Pharma Combix with or without food. Drink plenty of fluids throughout the day to help 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 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 risks at least once a year.

Migraine prevention

• In the case of migraine, you must not take topiramate if you are pregnant.
• In the 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.

Epilepsy treatment

• In the case of epilepsy, you must not take topiramate if you are pregnant, unless no other treatment provides sufficient seizure control.
• In the 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 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 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 baby will have 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 1–3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic medication. 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 baby 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 with 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 contraceptive methods 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 contraceptive effectiveness due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent or caregiver of a girl being 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 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:

• 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 re-evaluate your treatment and consider 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 become pregnant or think you might 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 assess whether you need an alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed it with your doctor, as your condition could worsen. Worsening epilepsy may put you or your unborn baby at risk.
• Your doctor will re-evaluate your treatment and consider 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 monitored closely to check your baby's development during pregnancy.

Make sure to read the patient guide you will receive from your doctor. A patient card is provided with the packaging of Topiramato Pharma Combix to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active substance of Topiramato Pharma Combix (topiramate) passes into breast milk. Effects have been observed in infants breastfed by 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 Topiramato Pharma Combix. Your doctor will consider the importance of the benefits for the mother and the risk for the infant.

Mothers who are breastfeeding and taking Topiramato Pharma Combix 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 use of machines

Topiramate may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce your reaction time. These effects, as well as your underlying condition, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special alertness, until your doctor has assessed your response to this medicine.

Important information about some of the components of Topiramato Pharma Combix

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

3. How to take Topiramate Pharma Combix

Follow exactly the dosing instructions for topiramate given by your doctor. If you have any doubts, consult your doctor or pharmacist.

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 Pharma Combix exactly as prescribed. Your doctor will usually start you on a low dose of topiramate and slowly increase the dose until the optimal dose for you is reached.
• Topiramate Pharma Combix tablets should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
• You may take Topiramate Pharma Combix before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking this medicine.

If you take more Topiramate Pharma Combix than you should

• Contact your doctor immediately. Bring the medicine with you.
• You may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have irregular 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, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 with your regular schedule. Consult your doctor if you miss 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 Pharma Combix

Do not stop treatment without first consulting your doctor. Your symptoms may return. If your doctor decides you should discontinue this medicine, they will gradually reduce your dose 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, Topiramate Pharma Combix may cause adverse effects, although not everyone experiences 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 fewer than 1 in 10,000 people)
Frequency not known (cannot be estimated from available data)

Very common adverse effects include:

• Weight loss
• Tingling sensations in arms and legs
• Drowsiness or numbness
• Dizziness
• Diarrhea
• Nausea
• Nasal congestion, runny nose, and sore throat
• Fatigue
• Depression

Common adverse effects include:

• Changes in mood or behavior, including anger, nervousness, sadness
• Weight gain
• Decreased or loss of appetite
• Decrease in red blood cell count
• Changes in thinking or alertness, including confusion, difficulty concentrating, memory problems, or slowed thinking
• Impaired speech
• Clumsiness or difficulty walking
• Involuntary tremors in arms, hands, or legs
• Reduced sense of touch or sensation
• Involuntary eye movements
• Taste disturbances
• Visual disturbances, blurred vision, double vision
• Ringing in the ears (tinnitus)
• Ear pain
• Shortness of breath
• Nosebleeds
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Skin redness and/or itching
• Joint pain
• Muscle spasms, twitches, or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of being unwell
• Allergic reaction

Uncommon adverse effects include:

• Presence of crystals in urine
• Abnormal blood count, including reduced number of white blood cells or platelets, or increased eosinophils
• Irregular heartbeat or slowed heart rate
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased seizures
• Problems with verbal communication
• Drooling
• Restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or reduced movements
• Disturbed or poor-quality sleep
• Impaired or distorted sense of smell
• Problems with handwriting
• Sensation of movement under the skin
• Eye problems including dry eye, light sensitivity, involuntary eye twitching, and decreased vision
• Decreased or loss of hearing
• Hoarseness
• Inflammation of the pancreas
• Gas (flatulence)
• Stomach acidity
• Loss of sensitivity to touch in the mouth
• Bleeding gums
• Feeling of fullness or bloating
• Painful or burning sensation in the mouth
• Bad breath
• Urinary and/or fecal incontinence
• Urgent need to urinate
• Pain in the kidney and/or bladder area due to kidney stones
• Decreased or absent sweating
• Skin discoloration
• Localized skin swelling
• Facial swelling
• Joint swelling
• Musculoskeletal stiffness
• Increased blood acidity (metabolic acidosis)
• Low potassium levels in the blood (hypokalemia)
• Increased appetite
• Increased thirst and drinking large amounts of fluid
• Low blood pressure or drop in blood pressure upon standing (orthostatic hypotension)
• Hot flushes
• Flu-like syndrome
• Cold extremities (e.g., hands and face)
• Learning difficulties
• Sexual dysfunction (erectile dysfunction, loss of libido)
• Hallucinations
• Reduced verbal communication

Rare adverse effects include:

• Excessive skin sensitivity
• Inability to smell (anosmia)
• Glaucoma, which is a blockage of fluid in the eye causing increased eye pressure, pain, and vision loss
• Renal tubular acidosis
• Serious skin reactions, including Stevens-Johnson syndrome, a severe skin disease in which the outer layers of skin separate from the lower layers; and erythema multiforme, a condition characterized by raised red spots that may blister
• Unusual body odor
• Swelling of tissues around the eyes
• Raynaud's syndrome: a disorder affecting blood vessels in fingers, toes, and ears, causing pain and sensitivity to cold
• Tissue calcification (calcinosis)

Adverse effects with frequency not known:

• Maculopathy; a disease of the macula, a small area in the retina where vision is sharpest. Consult your doctor if you notice changes or a decrease in your vision
• Swelling of the eye conjunctiva
• Toxic epidermal necrolysis, a more severe form of Stevens-Johnson syndrome (see uncommon adverse effects)
• Inflammation of the eye (uveitis), with symptoms such as eye redness and pain, light sensitivity, tearing, seeing small floating spots, or blurred vision

Reporting of adverse effects

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

5. Storage of Topiramate Pharma Combix

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Topiramate Pharma Combix after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Information for the user

Composition of Topiramate Pharma Combix 50 mg

The active substance is topiramate.

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

The other components of Topiramate Pharma Combix are listed below:

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

Appearance of Topiramate Pharma Combix 50 mg and contents of the pack

Topiramate Pharma Combix 50 mg is presented in packs containing 60 film-coated tablets. The tablets are light yellow, round, biconvex, with bevelled edges and smooth on both sides.

Topiramate Pharma Combix is also available in 100 mg and 200 mg film-coated tablets, in packs 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 in January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/