Leaflet: information for the user

topiramato cinfa 50 mg film-coated tabletsEFG

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 starting to take this medicine, as it contains important information for you

• 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 only for you, and you must 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. Contents of the pack and additional information

Topiramato cinfa belongs to a group of medicines called “anti-epileptic medicines”. It is used for:

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

Do not take topiramato cinfa

• If you are allergic to topiramato, soybean oil, or any of the other components of this medication (listed in section 6). This medication contains soybean oil. Do not use in case of peanut or soy allergy.

• Prevention of migraines
• • Do not take topiramato cinfa if you are pregnant.
  • If you are a fertile woman, do not take topiramato cinfa, unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy and breastfeeding – Important advice for women”.

• Treatment of epilepsy
• • Do not use topiramato cinfa if you are pregnant, unless no other treatment offers sufficient control of seizures.
  • If you are a fertile woman, do not take topiramato cinfa, unless you are using a highly effective contraceptive method during your treatment. The only exception is if topiramato cinfa 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 cinfa during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy and breastfeeding – Important advice for women”.

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

A patient information leaflet is provided with the packaging of topiramato cinfa 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take topiramato cinfa 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 cinfa 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 cinfa. See section “Pregnancy and breastfeeding” for more information.
• You are pregnant. Topiramato cinfa 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 cinfa.

If you have epilepsy, 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 topiramato that is given as an alternative to topiramato cinfa.

You may lose weight if you take topiramato, 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 medications such as topiramato have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Topiramato 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 medication called valproic acid or valproate sodium. 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”):

-Difficulty thinking, remembering information, or solving problems

-Decreased state of alertness or consciousness

-Sensation of drowsiness with low energy

You may increase the risk of developing these symptoms at higher doses of topiramato.

Topiramato cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Topiramato and certain medications may affect each other. Sometimes, the dose of one or both medications may need to be adjusted.

Especially inform your doctor or pharmacist if you are taking:

• Other medications that impair or decrease your thoughts, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• Birth control pills. Topiramato cinfa may make birth control pills less effective. You should use an additional barrier method such as a condom or diaphragm. You should consult your doctor about the best birth control method to use while taking topiramato cinfa.

Tell your doctor if you change your menstrual bleeding while taking birth control pills and topiramato cinfa. You may experience irregular menstrual bleeding. In this case, continue taking the birth control pills and inform your doctor.

Keep a list of all the medications you take. Show this list to your doctor and pharmacist before starting a new medication.

Other medications that you should consult your doctor or pharmacist about include other antiepileptic medications, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's Wort (Hypericum perforatum) (a herbal preparation used to treat depression), and warfarin used to prevent blood clotting.

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before taking topiramato.

Topiramato cinfa with food and drinks

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

Pregnancy and breastfeeding

Important advice for fertile women:

Topiramato cinfa 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:

• Incase of migraines, do not take topiramato cinfa if you are pregnant.
• In case of migraines, do not use topiramato cinfa if you are a fertile woman, unless you are using a highly effective contraceptive method.
• Before starting treatment with topiramato cinfa, a pregnancy test should be performed in a fertile woman.

Treatment of epilepsy:

• In case of epilepsy, do not take topiramato cinfa if you are pregnant, unless no other treatment offers sufficient control of seizures.
• In case of epilepsy, do not use topiramato cinfa if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if topiramato cinfa 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 cinfa during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• Before starting treatment with topiramato cinfa, a pregnancy test should be performed in a fertile woman.

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

There is a risk of harm to the baby during pregnancy if topiramato cinfa is used during pregnancy.

• If you take topiramato cinfa during pregnancy, your child may have a higher chance of having birth defects. In women taking topiramato, around 4 to 9 out of 100 children will have birth defects. This compares with 1-3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medication. In particular, a cleft lip (a division in the upper lip) and a cleft palate (a division in the palate) have been observed. Newborn boys may also have a genital malformation (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take topiramato cinfa during pregnancy, your child may have a 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 medication.

• If you take topiramato cinfa during pregnancy, your child may be smaller and weigh less than expected at birth. In a study, 18% of children born to mothers taking topiramato 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 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 medications to treat your condition with a lower risk of birth 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 cinfa. If the decision is made to use topiramato cinfa, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of topiramato cinfa.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a birth control 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.
• If you are taking birth control pills, there may be a reduced effectiveness of the birth control pill due to topiramato. 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 cinfa in girls:

If you are the parent/caregiver of a girl treated with topiramato cinfa, 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 topiramato during pregnancy and about the need to use highly effective contraceptive methods.

If you want to become pregnant while taking topiramato cinfa:

• 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 cinfa 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 cinfa 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 cinfa:

• Book an urgent appointment with your doctor.
• If you are taking topiramato cinfa for migraines, stop taking the medication immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking topiramato cinfa for epilepsy, do not stop taking this medication 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 cinfa during pregnancy. The doctor may also refer you to another specialist.
• If topiramato cinfa 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 information leaflet is provided with the packaging of topiramato cinfa to remind you of the risks of topiramato during pregnancy.

Breastfeeding

The active ingredient of topiramato cinfa (topiramato) passes into breast milk. Adverse effects have been observed in breastfed infants of mothers treated with topiramato, including diarrhea, drowsiness, irritability, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or whether to stop taking topiramato. 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 should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machines

Topiramato may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

topiramato cinfa contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

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

• Your doctor will usually start with a low dose of topiramato and gradually increase your dose to find the best one for you.
• Topiramato tablets are swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take topiramato before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking topiramato.

Girls and fertile women:

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

If you take more topiramato cinfa than you should

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy, tired, or less attentive; lack of coordination; difficulty speaking or concentrating; double or blurred vision, feeling dizzy due to low blood pressure, feeling depressed or restless; or abdominal pain or seizures.

You may experience an overdose if you are taking another medication with topiramato.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take topiramato cinfa

• If you forgot 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 to compensate for the missed doses.

If you interrupt the treatment with topiramato cinfa

Do not stop treatment without your doctor's instructions. Your symptoms may reappear. 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 medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Consult your doctor or seek immediate medical attention 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, problems with memory (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 irregular or arrhythmic heartbeat)
• Decreased or loss of sweating (especially in small 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)

Frequency not known (cannot be estimated from available data)

• Uveitis – inflammation of the eyes with symptoms such as redness and pain, sensitivity to light, tearing, vision of small dots or blurry vision

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, runny nose, 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 falling or staying asleep
• Speech or language disorders, poor pronunciation when speaking
• Clumsiness or lack of coordination, feeling of instability 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, blurry vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, general malaise, weakness
• Vomiting, constipation, abdominal pain or discomfort, 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 disorders, difficulty writing by hand
• Restlessness, hyperactivity
• Slow thinking, decreased state of vigilance or alertness
• Abnormal, involuntary, or repetitive movements of the body
• 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 down suddenly)
• Flush, feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excessive gas or flatulence, stomach acid, feeling full or bloated
• Nosebleeds, 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
• Inflammation of the liver, 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 skin odor
• Discomfort in the arms and legs
• Renal alteration

Frequency not known (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
• Toxic epidermal necrolysis, a life-threatening disease, even more severe than Stevens-Johnson syndrome, characterized by widespread blistering and skin shedding (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 falling or staying asleep
• Feeling of instability 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 occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in blood
• Hyperactivity
• Feeling hot
• Difficulty learning

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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.

Do not store at a temperature above 25°C.

Do not use this medication 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Topiramato Cinfa Composition

• The active ingredient is topiramate.

Each film-coated topiramato cinfa tablet contains 50 mg of topiramate.

• The other components are:

Tablet core: mannitol, pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate.Covering layer:opadry II yellow 85G32312 (polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol, soy lecithin (E-322), and yellow iron oxide (E-172)).

Product appearance and packaging contents

Yellowish clear, cylindrical, film-coated, biconvex tablets with the code “V3” on one side.

Presented in aluminum/aluminum blisters or HDPE bottles with LDPE caps.

Each package contains 60 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

BALKANPHARMA DUPNITSA AD

3 Samokovsko Shosse Str., Dupnitsa 2600 – Bulgaria

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:January 2024

Other sources of information

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69136/P_69136.html

QR code to:https://cima.aemps.es/cima/dochtml/p/69136/P_69136.html

The most recent approved information on the patient guide for this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following webpage:(3252 (aemps.es)):

QR code to:3252 (aemps.es)