Summary of Product Characteristics: Information for the Patient

Topiramato Qualigen 100 mg Film-Coated Tablets

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these side effects..

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• 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.

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

2. What you need to know before you start taking Topiramato Qualigen

3. How to take Topiramato Qualigen

4. Possible side effects

5. Storage of Topiramato Qualigen

6. Contents of the pack and additional information

Topiramato Qualigen belongs to a group of medications called «antiepileptics». It is used:

• alone, to treat epileptic seizures in adults and children over 6 years old.
• combined with other medications, to treat epileptic seizures in adults and children over 2 years old.
• as a preventive treatment for migraines in adults.

Do not take Topiramato Qualigen

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

Prevention of migraines

• You must not take Topiramato Qualigen if you are pregnant.
• If you are a fertile woman, you must not take Topiramato Qualigen, 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 must not use Topiramato Qualigen if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, you must not take Topiramato Qualigen, unless you are using a highly effective contraceptive method during your treatment. The only exception is if Topiramato Qualigen 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 Qualigen 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 leaflet that you will receive from your doctor or scan the QR code to obtain it (see section 6 “Other sources of information”)

A patient information card is provided with the packaging of Topiramato Qualigen to remind you of the risks during pregnancy.

If you are unsure whether the above applies to your case, consult your doctor or pharmacist before taking Topiramato Qualigen.

Warnings and precautions

Consult your doctor before starting to take Topiramato Qualigen if you:

• have kidney disease, especially kidney stones or are undergoing dialysis.
• have previously had abnormal results in your blood and urine tests (metabolic acidosis).
• have liver problems.
• have eye problems, especially glaucoma.
• have a growth problem.
• are following a high-fat diet (ketogenic diet).are a woman who may become pregnant.Topiramato Qualigenmay 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 ofTopiramato Qualigen. See section “Pregnancy and breastfeeding” for more information.
• are pregnant.Topiramato Qualigenmay cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure whether the above applies to your case, consult your doctor before usingTopiramato Qualigen.

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

You should also consult your doctor before taking any medication that contains topiramate that may be provided as an alternative to Topiramato Qualigen.

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

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

If you are taking Topiramato Qualigen, you may lose weight, so you should weigh yourself regularly while taking this medicine. If you are losing too much weight, consult your doctor.

In rare cases, Topiramato Qualigen may cause high levels of ammonia in the blood (observed in blood tests), which can cause a change in brain function, especially if you are also taking a medicine called valproic acid or valproate sodium. Since this may be a serious condition, inform your doctor immediately if you experience the following symptoms (see also section 4 "Possible side effects"):

• difficulty thinking, remembering information, or solving problems

• being less alert or conscious

• feeling very sleepy and having little energy

With higher doses of Topiramato Qualigen, the risk of developing these symptoms may increase.

Children and adolescents

If a child taking this medicine is not at a healthy weight, they should be consulted with a doctor.

Other medicines and Topiramato Qualigen

Inform your doctor or pharmacist if you are using, have used recently, or should use other medicines. The effect of Topiramato Qualigen and other medicines may be altered if taken together. In some cases, the dose of the other medicines or Topiramato Qualigen may need to be adjusted.

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

• other medicines that alter or reduce your ability to think or concentrate or muscle coordination (e.g., central nervous system depressants, such as muscle relaxants and sedatives).birth control pills. Topiramato Qualigen 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 Qualigen.

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

Make a list of all the medicines you take. Show the list to your doctor or pharmacist before starting to take this medicine.

Among the medicines you need to inform your doctor or pharmacist about are 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 unsure whether the above applies to your case, consult your doctor or pharmacist before taking Topiramato Qualigen.

Topiramato Qualigen with food, drinks, and alcohol

You can take Topiramato Qualigen with or without food. While taking Topiramato Qualigen, it is recommended to drink plenty of fluids during the day to prevent kidney stones. While taking Topiramato Qualigen, you should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for fertile women:

Topiramato Qualigen 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

• You must not use Topiramato Qualigen if you are pregnant.
• You must not use Topiramato Qualigen if you are a fertile woman, unless you are using a highly effective contraceptive method.
• Before starting treatment with Topiramato Qualigen, a pregnancy test should be performed in a fertile woman.

Treatment of epilepsy:

• You must not take Topiramato Qualigen if you are pregnant, unless no other treatment offers sufficient control of seizures.
• You must not take Topiramato Qualigenif you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topiramato Qualigen 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 Qualigen during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• A pregnancy test should be performed before starting treatment with Topiramato Qualigen in a fertile woman.

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 baby during pregnancy if Topiramato Qualigen is used during pregnancy.

• If you take Topiramato Qualigen during pregnancy, your child may have a higher risk of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares with 1 to 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 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 Qualigen during pregnancy, your child may have a higher risk of 2 to 3 times 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 an antiepileptic medication.
• If you take Topiramato Qualigen during pregnancy, your child may be smaller and weigh less than expected at birth. In a study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy 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 medicines to treat your condition with a lower risk of birth defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, discuss other possible treatments with your doctor instead of Topiramato Qualigen. If you decide to use Topiramato Qualigen, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topiramato Qualigen.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together with a barrier method such as a condom or 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 contraceptive pill due to topiramate. 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 Qualigen in girls:

If you are the parent/caregiver of a girl treated with Topiramato Qualigen, you should consult your doctor immediately when 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 Qualigen:

• Make 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 Qualigen 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 Qualigen 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 Qualigen:

• Make an urgent appointment with your doctor.
• If you are taking Topiramato Qualigen for migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking Topiramato Qualigen for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your baby during pregnancy at risk.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramato Qualigen during pregnancy. The doctor may also refer you to another specialist.
• If Topiramato Qualigen 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. The patient leaflet is also available by scanning a QR code; see section 6 “Other sources of information”.

A patient information card is provided with the packaging of Topiramato Qualigen to remind you of the risks during pregnancy.

Breastfeeding

The active ingredient of Topiramato Qualigen (topiramate) passes into breast milk. Adverse effects have been observed in breastfed babies of mothers treated with topiramate, including diarrhea, feeling sleepy, feeling irritable, and low weight gain. Therefore, your doctor will discuss with you whether to interrupt breastfeeding or whether to interrupt the treatment with Topiramato Qualigen. Your doctor will take into account the importance of the benefits for the mother and the risk to the baby.

Mothers in the breastfeeding period who are taking Topiramato Qualigen should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machines

During treatment with Topiramato Qualigen, you may experience dizziness, fatigue, and visual problems. Do not drive a vehicle or operate tools or machines without consulting your doctor first.

Topiramato Qualigen 100 mg contains yellow-orange S (E 110)

This medicine may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Girls and fertile women:

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

• Normally, your doctor will first prescribe a low dose of Topiramato Qualigen, which will be gradually increased until the most suitable dose for you is found.
• Topiramato Qualigen tablets should be swallowed whole. Do not chew them as they may leave a bitter taste.
• Topiramato Qualigen can be taken before, during, or after meals. While taking Topiramato Qualigen, it is recommended to drink plenty of liquid throughout the day to prevent kidney stones.

If you take more Topiramato Qualigen than you should

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 taken.

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

Taking other medications with Topiramato Qualigen may cause an overdose.

If you forget to take Topiramato Qualigen

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

If you interrupt treatment with Topiramato Qualigen

Do not stop taking this medication unless your doctor tells you to. Symptoms may return. If your doctor decides to stop treatment, they may gradually reduce the dose over several days.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• Depression (new or worsening)

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

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

• Glaucoma – blockage of fluid in the eye that causes increased eye pressure, pain, or vision loss
• 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 (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 can turn into widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Frequency not known (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, and throat pain
• 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
• Difficulty staying or falling asleep
• Speech or language disorders, poor pronunciation when speaking
• Clumsiness or lack of coordination, feeling unstable when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary movements; rapid, uncontrollable eye movements
• Visual disturbances, such as double vision, blurry vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Nasal bleeding
• Fever, general feeling of illness, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or inflammation, 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 (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
• Swollen 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, speech, or writing difficulties
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or consciousness
• Slow or reduced body movements, abnormal or repetitive involuntary movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent sense of smell
• Unusual sensation that may precede a migraine or certain type of seizure
• Dry eyes, sensitivity 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
• 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 achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Feeling drunk
• 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
• Numbness, tingling, and color change (white, blue, then red) of the fingers and toes when exposed to cold
• Inflammation of the liver, liver insufficiency
• Stevens-Johnson syndrome, a life-threatening disease that may appear with ulcers in various mucous membrane areas (such as mouth, nose, and eyes), skin eruption, and blisters
• Unusual skin odor
• Discomfort in the arms and legs
• Renal alteration
• Increased blood acidity

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
• Conjunctivitis (inflammation of the eye)
• Toxic epidermal necrolysis, a life-threatening disease, even more severe than Stevens-Johnson syndrome, characterized by widespread blister formation and peeling of the outer skin layers (see rare side effects).

Children and adolescents

Generally, side effects observed in children are similar to those observed in adults. However, some side effects appear more frequently in children and/or may be more severe in children than in adults. More severe side effects include decreased or absent sweating and increased blood acidity. Side effects that may appear more frequently in children include upper respiratory tract diseases.

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report side effects through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at temperatures above 30°C.

Do not use this medication after the expiration date that appears on the packaging. 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 unused medicines at the pharmacy's Take-Back Point. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Topiramato Qualigen 100 mg

- The active ingredient is topiramate.

- Each film-coated tablet of Topiramato Qualigen 100 mg contains 100 mg of topiramate.

-The other components are:

Core:Microcrystalline cellulose, mannitol, sodium starch glycolate, pregelatinized maize starch L.M, crospovidone, povidone, magnesium stearate, carnauba wax.

Coating:Hydroxypropyl methylcellulose, propylene glycol, titanium dioxide (E 171), yellow-orange (E 110).

Appearance of Topiramato Qualigen 100 mg and packaging contents

Topiramato Qualigen 100 mg film-coated tablets are elongated and orange in color.

Packaging size: 60 tablets in HDPE containers containing a desiccant bag or in blisters.

Other sources of information

The most recent approved information, patient guide, on this medication 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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Responsible manufacturer

Pharmathen, S.A.

6, Dervenakion str.

153 51 Pallini, Attiki

Greece

Ó

G.L. PHARMA GMBH

Schlossplatz 1

Lannach

Austria

This medication is authorized in the EEA member states with the following names:

DK/H/1354/001-004/MR

Denmark:Maritop

Austria:Topiramat Gerot 25 mg/50 mg/100 mg/200 mg Filmtabletten

Bulgaria:Topilex 25 mg/50 mg/100 mg

Czech Republic:Topilex 25 mg/50 mg/100 mg potahované tablety

Romania:Topilex 25 mg/50 mg/100 mg/200 mg

Slovakia:Topilex 25 mg/50 mg/100 mg/200 mg

Spain:Topiramato Qualigen 100 mg/50 mg/100 mg/200 mg

This leaflet was revised in May 2024