TOPIRAMATE FARMALIDER 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Farmalider 100 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

• Treat seizures in adults and children aged 6 years and above, taken alone.
• Treat seizures in adults and children aged 2 years and above, taken together with other medicines.
• Prevent migraine headaches in adults.

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

Do not take Topiramate Farmalider

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

Epilepsy treatment

• Do not take topiramate 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 unless you are using a highly effective contraceptive method during treatment. The only exception is if topiramate 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 during pregnancy and about the risks of seizures during pregnancy, which may put you or your unborn baby at risk.

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

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take topiramate 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 are on a high-fat diet (ketogenic diet).
• you are a woman who may become pregnant. Topiramate may harm an unborn baby 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. See section “Pregnancy and breastfeeding” for more information.
• you are pregnant, as topiramate may harm an unborn baby when taken during pregnancy.

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

If you have epilepsy, it is important not to stop taking your medicine without first consulting your doctor.

You should consult your doctor before taking any other medicine containing topiramate that is given to you as an alternative to topiramate.

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 is not gaining 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, in rare cases, 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 disease, 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 increase with higher doses of topiramate.

Other medicines and Topiramate Farmalider

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 decrease your thoughts, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate 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.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and topiramate. 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 take topiramate.

Other medicines that you should discuss with your doctor or pharmacist 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 Farmalider with food and drinks

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, breastfeeding, and fertility

Important advice for women of childbearing age:

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

Epilepsy treatment:

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

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 the unborn baby if topiramate is used during pregnancy.

• If you take topiramate during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, around 4 to 9 out of 100 children will have birth defects. This compares to 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been seen. Boys born 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 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 antiepileptic medication.
• If you take topiramate 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. If the decision is made to use topiramate, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of topiramate.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill together 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, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Farmalider in girls:

If you are the parent or caregiver of a girl treated with topiramate, you should consult your doctor immediately once your daughter experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby due to exposure to topiramate during pregnancy and about the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate Farmalider:

• 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 for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition may worsen.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. Worsening of your epilepsy may put you or your unborn baby at risk.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate 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. The patient guide is also available by scanning a QR code; see section 6 “Other sources of information”. A patient card is provided with the pack of topiramate to remind you of the risks of topiramate during pregnancy.

Breastfeeding

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

Mothers who are breastfeeding and taking topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness, and vision disturbances may occur during treatment with topiramate. Do not drive or use tools or machines without talking to your doctor first.

Topiramate Farmalider contains sodium

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

3. How to take Topiramate Farmalider

Follow exactly the instructions for administration of this medicine given by your doctor. 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 should be started and continued 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.

If you take more Topiramate Farmalider than you should

• 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.
• You may feel drowsy or 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 (convulsions).

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

If you forget to take Topiramate Farmalider

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Consult your doctor if you forget two or more doses.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Topiramate Farmalider

Do not stop treatment without your doctor telling you to do so. Your symptoms may come back. If your doctor decides you need to 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 have 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 acid levels in the blood (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or arrhythmic heartbeats).
• Decreased or lost sweating (especially in small 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 - fluid blockage in the eye that causes increased pressure in the eye, 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).
  • Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin rashes with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become widespread skin damage (shedding of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

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

Other Adverse Effects Include the Following; if they are 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 sense of taste.
• Tremors or involuntary twitching; rapid, uncontrolled 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.
• Pain or inflammation of the joints, muscle spasms or cramps, 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.
• Elevated mood.
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis).
• Lack of emotion and/or feeling, unusual distrust, panic attack.
• Reading problems, speech disorders, handwriting problems.
• Restlessness, hyperactivity.
• Slow thinking, decreased alertness or wakefulness.
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements.
• Fainting.
• Abnormal sense 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.
• Discoloration of the skin.
• Muscle stiffness, side pain.
• Blood in the urine, incontinence (lack of control) when urinating, urgency to urinate, side or kidney pain.
• Difficulty achieving or maintaining an erection, sexual dysfunction.
• Flu-like symptoms.
• Cold fingers or toes.
• Feeling of intoxication.
• Learning difficulties.

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

• Abnormally elevated 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.

Unknown (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is most acute. Consult your doctor if you notice a change or decrease in your vision.

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 acid levels in the blood.
• 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.
• Lack of emotion and/or feeling.
• 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, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topiramate Farmalider

Keep this medicine out of sight and reach of children.

Store in the outer packaging to protect it from moisture.

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the 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 Farmalider

• The active ingredient is topiramate. Each film-coated tablet contains 100 mg of topiramate.
• The other ingredients are:

Core of the tablet:mannitol, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate. Coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soy lecithin (E322), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Topiramate Farmalider 100 mg is presented in packages containing 60 film-coated tablets, which are round and yellow in color.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmalider, S.A.

C/ La Granja, 1

1. Alcobendas, Madrid

Spain

Manufacturer:

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Other Sources of Information

Date of the Last Revision of this Leaflet:June 2024

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/).