TOPIRAMATE TECNIGEN 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Tecnigen 200 mg film-coated tablets EFG

Topiramate

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

Contents of the pack and other information

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

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

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

• treat seizures in adults and children over 6 years of age, when taken alone
• treat seizures in adults and children over 2 years of age, when taken with other medicines
• prevent migraines in adults

2. Before you take Topiramate Tecnigen

Do not take Topiramate Tecnigen

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate Tecnigen (listed in section 6).

Migraine prevention

• Do not take Topiramate Tecnigen if you are pregnant.
• If you are a woman of childbearing potential, do not take Topiramate Tecnigen 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 Tecnigen 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 Tecnigen unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramate Tecnigen is the only treatment that provides sufficient control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking Topiramate Tecnigen 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 that you will receive from your doctor.

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

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

Warnings and precautions

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

• you have kidney problems, especially kidney stones, or are receiving 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 Tecnigen 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 Tecnigen. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant. Topiramate Tecnigen may harm an unborn baby during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor before using Topiramate Tecnigen.

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 Tecnigen.

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

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

Use of other medicines

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 Tecnigen and certain medicines may affect each other. Sometimes it may be necessary to adjust the dose of one of the other medicines or Topiramate Tecnigen.

Especially tell 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 Tecnigen may make hormonal contraceptives less effective. You should use an additional barrier contraceptive method such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topiramate Tecnigen.

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

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

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 Topiramate Tecnigen.

Taking Topiramate Tecnigen with food and drink

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

Pregnancy and breastfeeding

Pregnancy

Important advice for women of childbearing potential:

Topiramate Tecnigen 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 migraines, do not take Topiramate Tecnigen if you are pregnant.
• In the case of migraines, do not use Topiramate Tecnigen if you are a woman of childbearing potential, unless you are using a highly effective method of contraception.
• Before starting treatment with Topiramate Tecnigen, a pregnancy test should be performed in a woman of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, do not take Topiramate Tecnigen if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• In the case of epilepsy, do not use Topiramate Tecnigen if you are a woman of childbearing potential, unless you are using a highly effective method of contraception. The only exception is if Topiramate Tecnigen is the only treatment that provides sufficient control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure you have received information about the risks of taking Topiramate Tecnigen 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 Tecnigen, a pregnancy test should be performed in a woman of childbearing potential.

Risks of topiramate when taken during pregnancy (regardless of the disease for which topiramate is used) are as follows:

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

• If you take Topiramate Tecnigen during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares to 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Male newborns 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 Tecnigen 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 Tecnigen 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 Tecnigen. If the decision is made to use Topiramate Tecnigen, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramate Tecnigen.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill along 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 Tecnigen in girls:

If you are the parent or caregiver of a girl treated with Topiramate Tecnigen, 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 Tecnigen:

• 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 Tecnigen for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may worsen.

Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramate Tecnigen during pregnancy. The doctor may also refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Topiramate Tecnigen:

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramate Tecnigen to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking Topiramate Tecnigen 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 re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramate Tecnigen during pregnancy. The doctor may also refer you to another specialist.

• If Topiramate Tecnigen is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

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

Breastfeeding

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

Breastfeeding mothers taking Topiramate Tecnigen should inform their doctor as soon as possible if the baby experiences anything unusual.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Topiramate Tecnigen

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 Tecnigen

Follow the instructions for taking Topiramate Tecnigen exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist.

Girls and women of childbearing potential:

Treatment with Topiramate Tecnigen should be started and continued under the supervision of a doctor experienced in the treatment of epilepsy or migraines. Visit your doctor to review your treatment at least once a year.

Take Topiramate Tecnigen exactly as prescribed by your doctor. Your doctor will usually start with a low dose of Topiramate Tecnigen and gradually increase your dose until the best dose for you is found.

The tablets of Topiramate Tecnigen should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

You can take Topiramate Tecnigen before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking Topiramate Tecnigen.

If you take more Topiramate Tecnigen 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 with Topiramate Tecnigen.

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

If you forget to take Topiramate Tecnigen

• 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 Tecnigen

Do not stop treatment without your doctor telling you to do so. Your symptoms may return. If your doctor decides that you should stop taking this medicine, your dose will be gradually decreased 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 Tecnigen 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 frequent (affecting more than 1 in 10)
• frequent: (affecting between 1 and 10 in 100)
• infrequent: (affecting between 1 and 10 in 1,000)
• rare: (affecting between 1 and 10 in 10,000)
• very rare: (affecting less than 1 in 10,000)
• unknown: (frequency cannot be estimated from available data)

Very frequent adverse effects that include:

• Weight loss
• Tingling in arms and legs, drowsiness or numbness, dizziness
• Diarrhea, nausea
• Congestion, runny nose, and sore throat
• Fatigue
• Depression

Frequent 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
• Poor pronunciation when speaking
• Clumsiness or walking problems
• Involuntary agitation of the arms, hands, or legs
• Decreased touch or sensation
• Involuntary eye movement
• Taste alteration
• Visual alteration, blurred vision, double vision
• Ringing in the ears
• Ear pain
• Shortness of breath
• Nosebleed
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tingling or numbness of the mouth
• Kidney stones
• Frequent urination
• Painful urination
• Hair loss
• Redness and/or itching of the skin
• Joint pain
• Muscle spasms, muscle twitches, or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of discomfort
• Allergic reaction

Infrequent 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 movements
• 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, involuntary blinking, and decreased vision
• Hearing loss or decrease
• Hoarseness
• Pancreatitis
• Gas
• Stomach acidity
• Loss of sensation in the mouth
• Gingival 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 blood acid levels
• Decreased potassium 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 severe skin disease in which the upper layers of the skin separate from the lower layers; and erythema multiforme, a disease with raised red spots 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, 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 edema of the eye.
• Toxic epidermal necrolysis, a more severe variety of Stevens-Johnson syndrome (see infrequent adverse effects).
• Eye inflammation (uveitis) with symptoms such as redness and eye pain, sensitivity to light, tearing, vision of small dots, or blurred vision.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Conservation of Topiramato Tecnigen

Keep out of the reach and sight of children.

No special storage conditions are required.

Store in the original packaging to protect it from moisture.

Do not use Topiramato Tecnigen 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of 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 Tecnigen

The active ingredient is topiramate.

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

The other components of Topiramato Tecnigen are listed below: Core: Lactose monohydrate, pregelatinized corn starch, sodium starch glycolate, microcrystalline cellulose, magnesium stearate. Coating: Eudragit EPO, sodium lauryl sulfate, stearic acid, magnesium stearate, talc, titanium dioxide (E 171), and yellow iron oxide (E 172).

Appearance of Topiramato Tecnigen and package contents

Topiramato Tecnigen 200 mg is presented in packages containing 60 film-coated tablets. The film-coated tablets are round, convex, and yellow in color.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, España

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra. Portugal

This prospectus was revised in January 2024

Other sources of information: The most recent approved information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es