Leaflet: information for the user

Topiramato Normon 25 mg film-coated tablets EFG

This medicine is subject to additional monitoring, which will facilitate 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 refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms of disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What is Topiramato Normon and for what it is used

2. What you need to know before starting to take Topiramato Normon

3. How to take Topiramato Normon

4. Possible adverse effects

5. Storage of Topiramato Normon

6. Contents of the pack and additional information

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

• treating seizures in adults and children over 6 years old, administered alone
• treating seizures in adults and children over 2 years old, administered in combination with other medicines
• to prevent migraine in adults

Do not take Topiramato Normon

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

Prevention of migraines

• You should not take Topiramato Normon if you are pregnant.
• If you are a fertile woman, you should not take Topiramato Normon, unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Treatment of epilepsy

• You should not use Topiramato Normon if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, you should not take Topiramato Normon, unless you are using a highly effective contraceptive method during your treatment. The only exception is if Topiramato Normon is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure that you have received information about the risks of taking Topiramato Normon during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Make sure to read the patient guide that your doctor will provide you with.

A patient card is provided with the packaging of Topiramato Normon 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 Normon.

Warnings and precautions

Consult your doctor before starting to take Topiramato Normon 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 a woman who may become pregnant. Topiramato Normon may cause harm to a baby during pregnancy when taken during pregnancy. You should use highly effective contraceptive methods during your treatment and for at least 4 weeks after the last dose of Topiramato Normon. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramato Normon 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 Normon.

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 should consult your doctor before taking any other medication containing topiramate that is given as an alternative to Topiramato Normon.

You may lose weight if you take Topiramato Normon, 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 should consult your doctor.

A small number of people being treated with antiepileptic medications like Topiramato Normon have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Topiramato Normon may cause severe skin reactions, contact your doctor immediately if you develop a skin rash and/or blisters (see also section 4 “Possible side effects”).

Topiramato Normon may 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 medication called valproic acid or valproate sodium. Since this can be a serious disease, speak 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

-feeling drowsy with low energy

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

Other medications and Topiramato Normon

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication. Topiramato Normon and certain medications may affect each other. Sometimes, the dose of one of the other medications or Topiramato Normon 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).
• hormonal contraceptives. Topiramato Normon may make hormonal contraceptives less effective. You should use an additional barrier method such as a condom or a diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topiramato Normon.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topiramato Normon. You may experience irregular bleeding. In this case, continue taking the hormonal contraceptives 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), warfarin used to prevent blood clotting.

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

Use of Topiramato Normon with food and drinks

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

Pregnancy and breastfeeding

Important advice for fertile women

Topiramato Normonmay 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

• You should not takeTopiramato Normonif you are pregnant.
• You should not useTopiramato Normonif you are a fertile woman, unless you are using a highly effective contraceptive method.
• Before starting treatment withTopiramato Normon,a pregnancy test should be performed in a fertile woman.

Treatment of epilepsy

• You should not takeTopiramato Normonif you are pregnant, unless no other treatment offers sufficient control of seizures.
• You should not useTopiramato Normonif you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is ifTopiramato Normonis the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You should consult your doctor to ensure that you have received information about the risks of takingTopiramato Normonduring pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• Before starting treatment withTopiramato Normon,a pregnancy test should be performed in a fertile woman.

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 a baby during pregnancy if Topiramato Normon is used during pregnancy.

• If you takeTopiramato Normonduring pregnancy, your child will have a higher probability of having congenital defects. In women taking topiramate, around 4 to 9 children out of 100 will have congenital defects. This compares with 1-3 children out of 100 born to women without epilepsy and not taking an antiepileptic 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 takeTopiramato Normonduring pregnancy, your child may have a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking an antiepileptic medication.
• If you takeTopiramato Normonduring pregnancy, your child may be smaller and weigh less than expected at birth. In a study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy and not taking an antiepileptic 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 congenital defects.

Need for contraceptive methods for fertile women

• If you are a fertile woman, consult your doctor about other possible treatments instead of takingTopiramato Normon.If you decide to useTopiramato Normon,highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose ofTopiramato Normon.
• You should use a highly effective contraceptive method (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). 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, you should use an additional barrier method (such as a condom or a diaphragm).
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Normon in girls:

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

If you want to become pregnant while taking Topiramato Normon:

• Schedule an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you are takingTopiramato Normonfor 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 ofTopiramato Normonduring pregnancy. The doctor may also refer you to another specialist.

If you have become pregnant or think you may be pregnant while takingTopiramato Normon:

• Schedule an urgent appointment with your doctor.
• If you are takingTopiramato Normonto prevent migraines, stop taking the medication immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are takingTopiramato Normonfor 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 ofTopiramato Normonduring pregnancy. The doctor may also refer you to another specialist.
• IfTopiramato Normonis 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 your doctor will provide you with. A patient card is provided with the packaging of Topiramato Normon to remind you of the risks of topiramate during pregnancy.

Driving and operating machines

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

Topiramato Normon contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as 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 should be 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 throughout the day to prevent kidney stone formation while taking topiramato.

Girls and fertile women:

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

If you take more Topiramato Normon 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 blurry 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.

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 Normon:

• If you forgot 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 miss 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 Normon:

Do not stop treatment without your doctor's permission. 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 medication, ask your doctor or pharmacist.

Like all medications, Topiramato Normon may have 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, slow thinking, memory loss, problems with memory (initial, sudden change or worsening)

-Kidney stones, frequent or painful urination

Rare (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 lost sweating (especially in small children exposed to high temperatures)

-Having thoughts of self-harm, attempting to cause serious injuries

-Loss of part of the visual field

Very 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)

-Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin eruptions with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin eruptions may become generalized skin damage (peeling of the skin and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

-Uveitis (inflammation of the eyes) with symptoms such as redness and pain in the eyes, sensitivity to light, tearing, seeing 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, urticaria)

-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 movements; rapid, uncontrollable eye movements

-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 feeling of illness, 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

Rare (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 the blood

-Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood

-Swelling of the lymph nodes in the neck, armpits, or groin

-Increased appetite

-Exalted mood

-Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)

-Not showing or feeling emotions, unusual distrust, panic attack

-Reading problems, speech disorders, writing difficulties

-Restlessness, hyperactivity

-Slow thinking, decreased state of vigilance or alertness

-Abnormal or repetitive involuntary muscle movements

-Fainting

-Abnormal sensation of touch; alteration of touch

-Alteration, distortion, or absence of smell

-Sensation or feeling that may precede a migraine or 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 (consequently, some people may faint, feel dizzy, or lose consciousness when standing or sitting suddenly)

-Flush or feeling hot

-Pancreatitis (inflammation of the pancreas)

-Excessive gas or flatulence, stomach acid, feeling full or bloated

-Gingival 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

-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

-Wandering 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

-Inflammation of the liver, liver insufficiency

-Unusual skin odor

-Discomfort in the arms and legs

-Renal alteration

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.

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 frequent 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 of instability when walking

-General feeling of illness

-Decreased potassium levels in the 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)

-Sensation of spinning (vertigo)

-Vomiting

-Fever

Rare (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 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 86°F (30°C).

Store in the original packaging to protect it from humidity.

Do not use Topiramato Normon 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 the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Topiramato Normon

- The active ingredient is topiramate.

- Topiramato Normon 25 mg: each tablet contains 25 mg of topiramate.

- The other components (excipients) are:

• Core: lactose, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and colloidal silica.
• Coating: hypromellose, titanium dioxide (E-171), and macrogol 6000.

Appearance of Topiramato Normon and contents of the packaging

Topiramato Normon 25 mg is presented in packaging containing 28 and 60 film-coated tablets, white or almost white, round, biconvex, and printed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 – Tres Cantos – Madrid, Spain

Last review of this leaflet:June 2024

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

The most recent approved information; educational material (patient guide) about this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL):https://cima.aemps.es/cima/DocsPub/16/3252.