Leaflet: information for the user

Topiramato pensa pharma 25 mg film-coated tablets

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 this leaflet carefully before you start taking this medicine, because it contains important information for you.

-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 only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Topiramato Pensa Pharma

3. How to take Topiramato Pensa Pharma

4. Possible adverse effects

5. Storage of Topiramato Pensa Pharma

6. Contents of the pack and additional information

Topiramato Pensa Pharma belongs to a group of medications called “antiepileptic medications”. It is used for:

•trating seizures in adults and children over 6 years old when administered alone

•trating seizures in adults and children 2 or more years old when administered with other medications

•to prevent migraine in adults.

Do not take Topiramato Pensa Pharma

- If you are allergic (hypersensitive) to topiramate or to any of the other components of this medicine (including those listed in section 6).

- In the prevention of migraines:

- Epilepsy treatment:

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

A patient leaflet is provided with the packaging of Topiramato Pensa Pharma 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 Pensa Pharma.

Warnings and precautions

Consult your doctor before starting to take Topiramato Pensa Pharma if you:

- have kidney problems, especially kidney stones, or are receiving dialysis

- have a history of blood or fluid disorders (metabolic acidosis)

- have liver problems

- have eye problems, especially glaucoma

- have growth problems

- are following a high-fat diet (ketogenic diet)

- are taking Topiramato Pensa Pharma for epilepsy and are pregnant or a fertile woman (for more information, see section “Pregnancy and breastfeeding”).

- are a woman who may become pregnant. Topiramato Pensa Pharma 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 Topiramato Pensa Pharma. See section “Pregnancy and breastfeeding” for more information

- are pregnant. Topiramato Pensa Pharma may cause harm to a baby during pregnancy when taken during pregnancy.

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

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 Pensa Pharma.

You may lose weight if you take Topiramato Pensa Pharma, so your weight must be monitored 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 must consult your doctor.

A small number of people being treated with antiepileptic drugs such as Topiramato Pensa Pharma have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Topiramato Pensa Pharma may cause high levels of ammonia in the blood (seen in blood tests) which may cause a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this can be a serious condition, talk to your doctor immediately if you experience any of the following symptoms (see also section 4 “Possible side effects”):

You may increase the risk of developing these symptoms at higher doses of Topiramato Pensa Pharma.

Other medicines and Topiramato Pensa Pharma

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. Topiramato Pensa Pharma and certain medicines may affect each other. Sometimes, the dose of one of the other medicines or of Topiramato Pensa Pharma may need to be adjusted.

Especially, inform your doctor or pharmacist if you are taking:

- other medicines that incapacitate or decrease your thoughts, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).

- hormonal contraceptives. Topiramato Pensa Pharma 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 Topiramato Pensa Pharma.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topiramato Pensa Pharma. 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 starting a new 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, St. John's Wort (Hypericum perforatum) (a herbal preparation used to treat depression).

If you are unsure whether anything above applies, consult your doctor or pharmacist before taking Topiramato Pensa Pharma.

Topiramato Pensa Pharma with food and drinks:

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

Pregnancy and breastfeeding

Important advice for fertile women:

Topiramato Pensa Pharma 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.

Migraine prevention:

• Do not take Topiramato Pensa Pharma if you are pregnant.
• Do not use Topiramato Pensa Pharma 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 Topiramato Pensa Pharma in a fertile woman.

Epilepsy treatment::

• Do not take Topiramato Pensa Pharma if you are pregnant, unless no other treatment offers sufficient control of seizures.
• Do not use Topiramato Pensa Pharma if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topiramato Pensa Pharma 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 Pensa Pharma 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 Topiramato Pensa Pharma in a fertile woman.

The 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 Pensa Pharma is used during pregnancy.

• If you take Topiramato Pensa Pharma during pregnancy, your child may have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of every 100 children will have birth defects. This compares with 1 to 3 out of every 100 children born to women with epilepsy who are 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 boys 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 Topiramato Pensa Pharma during pregnancy, your child may have a higher risk of 2 to 3 times 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 Pensa Pharma 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 who were 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 birth defects.

Necessity of contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Topiramato Pensa Pharma. If the decision is made to use Topiramato Pensa Pharma, highly effective contraceptive methods must be used during your treatment and for at least 4 weeks after the last dose of Topiramato Pensa Pharma.
• 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.
• If you are taking hormonal contraceptives, there may be a reduced effectiveness of the hormonal contraceptive 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 Topiramato Pensa Pharma in girls:

If you are the parent/caregiver of a girl treated with Topiramato Pensa Pharma, 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 Topiramato Pensa Pharma:

• 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 Pensa Pharma for epilepsy, do not stop taking it until you have consulted 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 Pensa Pharma 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 Pensa Pharma:

• Book an urgent appointment with your doctor.
• If you are taking Topiramato Pensa Pharma for migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking Topiramato Pensa Pharma 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 re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramato Pensa Pharma during pregnancy. The doctor may also refer you to another specialist.
• If Topiramato Pensa Pharma 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 Pensa Pharma to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient of Topiramato Pensa Pharma (topiramate) passes into breast milk. There have been observations of effects in breastfed babies of mothers treated with Topiramato Pensa Pharma, 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 Pensa Pharma. 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 Pensa Pharma must inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will usually start with a low dose of Topiramato Pensa Pharma and gradually increase your dose to find the best one for you.

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

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

Girls and fertile women:

Treatment with Topiramato Pensa Pharma should begin and continue under the supervision of a doctor experienced in treating epilepsy or migraine. Visit your doctor at least once a year to review your treatment.

If you take more Topiramato Pensa Pharma than you should:

Consult your doctor immediately. Bring the medication with you.

You may feel drowsy, tired, or less attentive, lack of coordination, have difficulty speaking or concentrating; have double or blurred vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain, or seizures.

You may experience an overdose if you are taking another medication with Topiramato Pensa Pharma.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Phone: 91 562 04 20.

If you forget to take Topiramato Pensa Pharma:

- 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 compensate for the missed dose.

If you interrupt treatment with Topiramato Pensa Pharma:

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 the use of this product, ask your doctor or pharmacist.

Like all medicines, Topiramato Pensa Pharma may cause side effects, although not everyone will experience them.

Consult your doctor or seek medical attention immediately if you experience the following side effects:

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

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Difficulty concentrating, slowness of thought, memory loss, memory problems (initial, sudden change or worsening)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased blood acidity (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or loss of sweating (especially in young children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious injuries
• Loss of a part of the visual field

Rare (may affect up to 1 in 1,000 people)

• Glaucoma: blockage of fluid in the eye that causes increased eye pressure, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (encephalopathy)

Other side effects include the following, if severe, please consult your doctor or pharmacist:

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

• Congestion, coughing, or sore throat
• Tickling, pain, and/or numbness in several parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty staying or falling asleep
• Speech problems or speech disorders, poor pronunciation when speaking
• Clumsiness or lack of coordination, feeling unstable when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary, uncontrolled movements of the eyes
• Alteration of vision, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nasal bleeding
• Fever, general malaise, weakness
• Vomiting, constipation, abdominal pain, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain, muscle spasms, muscle weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells that help protect against infections, decreased potassium levels in blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpits, or groin
• Increased appetite
• Exalted mood
• Heard, seen, or felt things that are not there, severe mental disorder (psychosis)
• Not showing or feeling emotions, unusual distrust, panic attack
• Difficulty reading, speech disorder, difficulty writing by hand
• Restlessness, hyperactivity
• Slow thinking, decreased state of vigilance or alertness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; alteration of touch
• Alteration, distortion, or absence of smell
• Unusual feeling that may precede a migraine or a certain type of seizure
• Dry eyes, sensitivity of the eyes to light, eyelid tremor, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing up (consequently, some people may faint, feel dizzy, or lose consciousness when standing up or sitting suddenly)
• Flush, feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excessive gas or flatulence, stomach acid, feeling full or bloated
• Nasal bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Decoloration of the skin
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, side or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Sensation of intoxication
• Difficulty learning

Rare (may affect up to 1 in 1,000 people)

• Abnormally exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Wandering eye
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue then red) of the fingers of the hands and feet when exposed to cold
• Liver inflammation, liver insufficiency
• Stevens-Johnson syndrome, a life-threatening disease that may present with ulcers in various mucous membrane areas (such as mouth, nose, and eyes), skin rash, and blisters
• Unusual body odor
• Discomfort in the arms and legs
• Alteration of the kidney

Unknown (cannot be estimated from available data)

• 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.
• Uveitis: inflammation of the eyes with symptoms such as redness and eye pain, sensitivity to light, tearing, blurred vision, or seeing small dots or blurred vision.
• Toxic epidermal necrolysis, a life-threatening disease, even more severe than Stevens-Johnson syndrome, characterized by widespread blistering and shedding of the outer layers of the skin (see rare side effects).

Other side effects in children

Generally, side effects observed in children are similar to those observed in adults, but the following side effects may be more common in children than in adults:

• Difficulty concentrating
• Increased blood acidity
• Having thoughts of self-harm
• Fatigue
• Increased or decreased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling unstable when walking
• General malaise
• Decreased potassium levels in blood
• Not showing or feeling emotions
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may appear in children are:

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for 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 this medication out of the sight and reach of children.

No special storage conditions are required.

Store in the outer packaging to protect it from moisture.

Do not use Topiramato Pensa Pharma 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. Deposit the packaging and unused medicines at the SIGRE collection point of 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 Pensa Pharma

The active ingredient is topiramate. Each film-coated tablet of Topiramato Pensa Pharma contains 25 mg of topiramate.

The other components of Topiramato Pensa Pharma are listed below: mannitol, pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, purified water. Coating layer: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, and talc.

Appearance of Topiramato Pensa Pharma and contents of the packaging

Topiramato Pensa Pharma 25 mg is presented in film-coated, rounded, and white tablets.

It is presented in bottles containing 60 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es

Other sources of information

The most recent approved information (leaflet) is available on the following website (URL): https://cima.aemps.es/cima/dochtml/p/69423/P_69423.html