TOPIRAMATE CINFA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Cinfa 25 mg Film-Coated TabletsEFG

This medication is subject to additional monitoring, which will make it easier to detect new information on its safety. You can contribute by reporting any side effects you may have. The last part of section 4 includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you

• 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Topiramate Cinfa and what is it used for
2. What you need to know before you take Topiramate Cinfa
3. How to take Topiramate Cinfa
4. Possible side effects
5. Storing Topiramate Cinfa
6. Contents of the pack and other information

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

Topiramate Cinfa belongs to a group of medicines called “antiepileptic medicines”. It is used to:

• treat seizures in adults and children over 6 years old, given alone
• treat seizures in adults and children over 2 years old, given with other medicines
• prevent migraine in adults

2. What you need to know before you take Topiramate Cinfa

Do not take Topiramate Cinfa

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

• Migraine prevention

• Do not take Topiramate Cinfa if you are pregnant.
• If you are a woman of childbearing age, do not take Topiramate Cinfa unless you are using a highly effective contraceptive method during treatment. See below under “Pregnancy and breastfeeding – Important advice for women”.

• Epilepsy treatment

• Do not take Topiramate Cinfa if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• If you are a woman of childbearing age, do not take Topiramate Cinfa unless you are using a highly effective contraceptive method during treatment. The only exception is if Topiramate Cinfa 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 Cinfa during pregnancy and the risks of seizures during pregnancy.

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

A patient card is provided with the pack of Topiramate Cinfa 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 taking Topiramate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Topiramate Cinfa if:

• you have kidney problems, especially kidney stones, or are on 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 Cinfa may harm a 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 Cinfa. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant. Topiramate Cinfa may harm a baby during pregnancy when taken during pregnancy.

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

If you have epilepsy, it is important not to 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 Cinfa.

You may lose weight if you take topiramate, so your weight should be checked 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 should consult your doctor.

A small number of people being treated with antiepileptic medicines such as topiramate have had thoughts of harming themselves or taking their own lives. If at any time you have these thoughts, contact your doctor immediately.

Topiramate may rarely cause high levels of ammonia in the blood (seen in blood tests) which can 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 illness, 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 alertness or consciousness
• feeling of numbness with low energy

The risk of developing these symptoms may be increased at higher doses of topiramate.

Taking Topiramate Cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Topiramate and certain medicines can affect each other. Sometimes the dose of one of the other medicines or topiramate may need to be adjusted.

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

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topiramate Cinfa. 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 you start taking a new medicine.

Other medicines that you should tell 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), warfarin used to prevent blood clotting.

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

Taking Topiramate Cinfa with food and drink

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

Pregnancy and breastfeeding

Important advice for women of childbearing age:

Topiramate Cinfa may harm a baby during pregnancy. If you are a woman of childbearing age, 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 migraine, do not take Topiramate Cinfa if you are pregnant.
• In the case of migraine, do not take Topiramate Cinfa if you are a woman of childbearing age, unless you are using a highly effective contraceptive method.
• Before starting treatment with Topiramate Cinfa, a pregnancy test should be performed in a woman of childbearing age.

Epilepsy treatment:

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

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 baby during pregnancy if Topiramate Cinfa is used during pregnancy.

• If you take Topiramate Cinfa 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 division in the upper lip) and cleft palate (a division in the palate) 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 Cinfa 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 Cinfa 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 age:

• If you are a woman of childbearing age, consult your doctor about other possible treatments instead of taking Topiramate Cinfa. If the decision is made to use Topiramate Cinfa, highly effective contraceptive methods should be used during treatment and for at least 4 weeks after the last dose of Topiramate Cinfa.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill 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 (such as a condom or diaphragm) should be used in addition.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Cinfa in girls:

If you are the parent or caregiver of a girl treated with Topiramate 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 topiramate during pregnancy and the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate Cinfa:

• 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 Cinfa 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 on the risks of Topiramate Cinfa during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramate Cinfa to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking Topiramate Cinfa 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 baby at risk during pregnancy.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you on the risks of Topiramate Cinfa during pregnancy. The doctor may also refer you to another specialist.
• If Topiramate 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 guide that you will receive from your doctor.

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

Breastfeeding

The active ingredient of Topiramate Cinfa (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 stop treatment with topiramate. Your doctor will take into account the importance of the benefits for the mother and the risk for the baby. Breastfeeding mothers taking topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Topiramate may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction speed. These effects, as well as your own illness, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor has assessed your response to this medicine.

Topiramate Cinfa contains sodium.

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

3. How to take Topiramate Cinfa

Follow exactly the instructions of administration of this medicine given to you 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 topiramate and gradually increase your dose until the best dose for you is found.
• Topiramate tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take topiramate before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking topiramate.

Girls and women of childbearing age:

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

If you take more Topiramate Cinfa than you should

• Consult your doctor immediately. Take the medicine with you.
• You may feel drowsy, tired, or less alert; lack of coordination; have difficulty speaking or concentrating; have double vision or blurred vision, feel dizzy due to low blood pressure, feel depressed or restless; or have abdominal pain or seizures (attacks).

You may experience an overdose if you are taking another medicine with topiramate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Topiramate Cinfa

• 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 to make up for forgotten doses.

If you stop taking Topiramate Cinfa

Do not stop treatment without your doctor telling you to do so. Your symptoms may come back. 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor or seek medical attention immediately if you have the following adverse effects:

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

• Depression (new or worsened)

Frequent (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration problems, slow thinking, memory loss, memory problems (initial, sudden change, or increased severity)
• Kidney stones, frequent or painful urination

Infrequent (may affect up to 1 in 100 people)

• Increased blood acid levels (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• Decreased or lost sweating (especially in young children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious harm
• Loss of 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 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 (hyperammonemic encephalopathy)

Frequency Not Known (cannot be estimated from available data)

• Eye inflammation (uveitis) with symptoms such as eye redness and pain, sensitivity to light, tearing, blurred vision, or seeing small spots

Other Adverse Effects Include the Following; if Severe, Please Consult Your Doctor or Pharmacist:

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

• Congestion, runny nose, or sore throat
• Numbness, pain, and/or tingling of various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Frequent (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 of instability when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary twitching; rapid, uncontrollable eye movements
• Visual disturbance, such as double vision, blurred vision, decreased vision, difficulty focusing
• Feeling 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 or inflammation, muscle spasms or twitches, muscle pain or weakness, chest pain
• Weight gain

Infrequent (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count that helps protect against infections, decreased potassium levels in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood
• Swelling of the neck, armpit, or groin lymph nodes
• Increased appetite
• Exalted mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Not showing and/or feeling emotion, unusual distrust, panic attack
• Reading problems, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or vigilance
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eyes, eye sensitivity to light, eyelid twitching, 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 taking topiramate may faint, feel dizzy, or lose consciousness when standing up or sitting down suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or bloating, stomach acidity, feeling of fullness or bloating
• Gum bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, side or kidney pain
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers or toes
• Feeling of drunkenness
• Learning difficulties

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

• Abnormally exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue, then red) of the fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening disease that can present with ulcers in several areas of the mucous membranes (such as the mouth, nose, and eyes), a skin rash, and blisters
• Abnormal skin odor
• Discomfort in the arms and legs
• Kidney disorder

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 sharpest. Consult your doctor if you notice a change or decrease in your vision
• Toxic epidermal necrosis, 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 adverse effects)

Other Adverse Effects in Children

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

• Concentration problems
• Increased blood acid levels
• Having thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling of instability when walking
• General malaise
• Decreased potassium levels in the blood
• Not showing and/or feeling emotion
• Watery eyes
• Slow or irregular heartbeat

Other adverse effects that may occur in children are:

Frequent (may affect up to 1 in 10 people)

• Feeling of spinning (vertigo)
• Vomiting
• Fever

Infrequent (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in the blood
• Hyperactivity
• Feeling hot
• Learning difficulties

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topiramate Cinfa

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Topiramate Cinfa

• The active ingredient is topiramate.

Each film-coated topiramate cinfa tablet contains 25 mg of topiramate.

• The other ingredients are:

Core of the tablet:mannitol, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. Coating:Opadry II White 85F18422 (polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol).

Appearance of the Product and Package Contents

White, cylindrical, film-coated, biconvex tablets with the code "V1" on one side.

Available 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:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

BALKANPHARMA DUPNITSA AD

3 Samokovsko Shosse Str., Dupnitsa 2600 - Bulgaria

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:January 2024

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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/69135/P_69135.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69135/P_69135.html

The most recently approved information about 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 website (3252 (aemps.es)):

QR code to: 3252 (aemps.es)