Leaflet: information for the user

Topiramato Tecnigen 50 mg film-coated tablets

Topiramato

This medicine is subject to additional monitoring, which will speed up the detection of any 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 leaflet carefully before starting to take the medicine.

• Keep this leaflet 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 are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Topiramato Tecnigen belongs to a group of medicines called “antiepileptic medicines”. It is used for:

• treating seizures in adults and children over 6 years old when taken alone
• treating seizures in adults and children over 2 years old when taken with other medicines
• preventing migraine in adults

Do not take Topiramato Tecnigen

Prevention of migraines

Treatment of epilepsy

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

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

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using Topiramato Tecnigen.

Warnings and precautions

Before starting treatment with Topiramato 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 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. Topiramato Tecnigen may cause harm to a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topiramato Tecnigen. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant. Topiramato Tecnigen may cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure whether anything above applies to you, consult your doctor before using Topiramato Tecnigen.

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 Tecnigen.

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

A small number of people being treated with antiepileptic drugs such as Topiramato Tecnigen have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those bought without a prescription, vitamins or herbal remedies. Topiramato Tecnigen and certain medicines may affect each other. Sometimes, the dose of one of the other medicines or Topiramato Tecnigen 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. Topiramato Tecnigen may make hormonal contraceptives less effective. You should use an additional barrier method such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topiramato Tecnigen.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topiramato Tecnigen.You may experience irregular bleeding. 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 Topiramato Tecnigen.

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 whether anything above applies to you, consult your doctor or pharmacist before taking Topiramato Tecnigen.

Taking Topiramato Tecnigen with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

Important advice for fertile women:

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

Treatment of epilepsy

• Do not take Topiramato Tecnigen if you are pregnant, unless no other treatment offers sufficient control of seizures.
• Do not use Topiramato Tecnigen if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topiramato Tecnigen 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 Topiramato Tecnigen during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• A pregnancy test should be performed before starting treatment with Topiramato Tecnigen 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 Topiramato Tecnigen is used during pregnancy.

• If you take Topiramato Tecnigen during pregnancy, your child will have a higher probability of having congenital defects. In women taking topiramate, around 4 to 9 children out of 100 will have congenital defects. This compares with 1-3 children out of 100 born to women without epilepsy and not taking an antiepileptic drug. In particular, there have been observations of cleft lip (a division in the upper lip) and cleft palate (a division in the palate). Newborn males may also have a genital malformation (hypospadias). These defects may develop in the early stages of pregnancy, even before you know you are pregnant.

If you take Topiramato Tecnigen 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 an antiepileptic drug.

If you take Topiramato Tecnigen 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 drug 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 congenital defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Topiramato Tecnigen. If the decision is made to use Topiramato Tecnigen, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topiramato Tecnigen.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a hormonal contraceptive pill together with a barrier method (such as a condom or diaphragm)) should 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 diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Tecnigen in girls:

If you are the parent/caregiver of a girl being treated with Topiramato 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 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 Topiramato Tecnigen:

• 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 Topiramato 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 Topiramato Tecnigen during pregnancy. The doctor may also refer you to another specialist.

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

• Book an urgent appointment with your doctor.
• If you are taking Topiramato Tecnigen for migraines, stop taking the medication immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking Topiramato Tecnigen for epilepsy, do not stop taking this medication until you have discussed this 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 re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramato Tecnigen during pregnancy. The doctor may also refer you to another specialist.

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

Breastfeeding

The active ingredient of Topiramato Tecnigen (topiramate) passes into breast milk. There have been observations of effects in breastfed babies of mothers treated with Topiramato Tecnigen, 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 taking Topiramato Tecnigen. 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 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 operating machinery

You may experience dizziness, fatigue, and visual disturbances during treatment with Topiramato Tecnigen. Do not drive or operate tools or machines without speaking to your doctor first.

Important information about some of the components of Topiramato Tecnigen

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 Tecnigen as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Girls and fertile women:

Treatment with Topiramato Tecnigen should begin 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 Topiramato Tecnigen exactly as prescribed. Your doctor will generally start with a low dose of Topiramato Tecnigen and gradually increase your dose to find the best one for you.

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

You can take Topiramato Tecnigen before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking Topiramato Tecnigen.

If you take more Topiramato Tecnigen 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 are taking another medication with Topiramato Tecnigen.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Phone 91 5620420.

If you forget to take Topiramato Tecnigen

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take 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 compensate for the missed dose.

If you interrupt treatment with Topiramato Tecnigen

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 decrease your dose over several days.

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

Like all medications, Topiramato Tecnigen may have adverse effects, although not everyone will experience them.

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

• Very frequent (affects more than 1 in 10)
• Frequent: (affects between 1 and 10 in 100)
• Rare: (affects between 1 and 10 in 1,000)
• Rare: (affects between 1 and 10 in 10,000)
• Very rare: (affects less than 1 in 10,000)
• Unknown: (the frequency cannot be estimated from the available data)

Very frequent adverse effects that include:

• Weight loss
• Tickling 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 loss of appetite
• Decreased number of red blood cells
• Changes in thought or alertness, including confusion, concentration problems, memory problems, or slowness of thought
• Speech difficulties
• Clumsiness or walking problems
• Involuntary agitation of arms, hands, or legs
• Decreased touch or sensation
• Involuntary eye movement
• Alteration of taste
• Visual alteration, blurred vision, double vision
• Tinnitus in the ears
• Ears pain
• Lack of air
• Nasal bleeding
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Dry mouth
• Tickling 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 cramps, or muscle weakness
• Chest pain
• Fever
• Loss of strength
• General feeling of discomfort
• Allergic reaction

Rare adverse effects that include:

• Presence of crystals in the urine
• Abnormal blood count, including reduction of white blood cells or platelets, or increase of eosinophils
• Irregular heartbeat or slowing of the heartbeat
• Swelling of the lymph nodes in the neck, armpits, or groin
• Increased seizures
• Verbal communication problems
• Babbling
• Increased restlessness or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slow or decreased movements
• Altered or poor sleep
• Alteration or distortion of the sense of smell
• Writing difficulties
• Sensation of movement under the skin
• Eye problems, including dry eyes, light sensitivity, involuntary blinking, and decreased vision
• Decreased or loss of hearing
• Snoring
• Pancreatitis
• Gas
• Stomach acid
• Loss of sensitivity to touch in the mouth
• Gingival bleeding
• Sensation of being full or swelling
• 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 absence of sweating
• Decoloration of the skin
• Localized skin swelling
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increased levels of acid in the blood
• 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
• Shortness of breath
• Sinusitis
• 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 the fluid in the eye that causes an increase in eye pressure, pain, and decreased vision
• Tubular renal 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 patches that can form blisters
• Bad smell
• Swelling of the tissues around the eyes
• Raynaud's syndrome. A disorder that affects the blood vessels, in the fingers of the hand and feet, ears, and that causes pain and sensitivity to cold
• Tissue calcification (calcinoses)

Adverse effects of unknown frequency:

• Maculopathy 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, which is a more severe form of Stevens-Johnson syndrome (see rare adverse effects).
• Uveitis, an inflammation of the eyes with symptoms such as redness and pain in the eyes, light sensitivity, tearing, seeing small dots or blurred vision

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of 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 disposed of through drains or trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Topiramato Tecnigen

The active ingredient is topiramate.

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

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

Appearance of Topiramato Tecnigen and contents of the package

Topiramato Tecnigen 50 mg is presented in packages containing 60 film-coated tablets. The film-coated tablets are round, convex, and yellow in color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Responsible for manufacturing:

Atlantic Pharma - Produções Farmacêuticas, S.A.

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

This leaflet has been revised in January 2024

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