TOPIRAMATE QUALIGEN 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Topiramate Qualigen belongs to a group of medicines called antiepileptics. It is used:

• alone to treat epileptic seizures in adults and children over 6 years of age.
• in combination with other medicines to treat epileptic seizures in adults and children over 2 years of age.
• to prevent migraine headaches in adults.

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

Do not take Topiramate Qualigen

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

Epilepsy treatment

• Do not take Topiramate Qualigen if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• If you are a woman of childbearing potential, do not take Topiramate Qualigen unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramate Qualigen 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 Qualigen 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 or scan the QR code to obtain it (see section 6 “Other sources of information”)

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

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

Warnings and precautions

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

• have kidney disease, especially kidney stones or are undergoing dialysis.
• have previously had abnormal blood test results (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. Topiramate Qualigen may harm an unborn baby during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramate Qualigen. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramate Qualigen may harm an unborn baby during pregnancy.

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

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

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

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

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

If you use Topiramate 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, Topiramate 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 sodium valproate. Since this can 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 aware
• feeling very sleepy and having little energy

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

Children and adolescents

If a child taking this medicine does not have a suitable weight, a doctor should be consulted.

Other medicines and Topiramate Qualigen

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines. The effect of Topiramate Qualigen and other medicines may be altered if taken together. It may be necessary to adjust the dose of the other medicines or of Topiramate Qualigen.

In particular, tell your doctor or pharmacist if you are taking:

• other medicines that affect or decrease your ability to think or concentrate or muscle coordination (e.g. central nervous system depressants, such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate Qualigen 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 Qualigen.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topiramate Qualigen. You may experience irregular bleeding. In this case, continue taking your hormonal contraceptives and inform your doctor.

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

Among the medicines that you must tell 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 not sure if the above applies to you, consult your doctor or pharmacist before taking Topiramate Qualigen.

Taking Topiramate Qualigen with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for women of childbearing potential:

Topiramate Qualigen may harm an unborn baby during pregnancy. If you are a woman of childbearing potential, 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 migraines, do not use Topiramate Qualigen if you are pregnant.
• In the case of migraines, do not use Topiramate Qualigen if you are a woman of childbearing potential, unless you are using a highly effective method of contraception.
• Before starting treatment with Topiramate Qualigen, a pregnancy test should be performed in a woman of childbearing potential.

Epilepsy treatment:

• In the case of epilepsy, do not take Topiramate Qualigen if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• In the case of epilepsy, do not take Topiramate Qualigen if you are a woman of childbearing potential, unless you are using a highly effective method of contraception. The only exception is if Topiramate Qualigen 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 Qualigen 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 Qualigen, a pregnancy test should be performed in a woman of childbearing potential.

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 unborn baby during pregnancy if Topiramate Qualigen is used during pregnancy.

• If you take Topiramate Qualigen during pregnancy, your child has 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 to 1-3 out of 100 children 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. Newborn boys 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 Qualigen during pregnancy, your child may have a 2 to 3 times higher risk of suffering from 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 Qualigen 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 potential:

• If you are a woman of childbearing potential, discuss with your doctor other possible treatments instead of Topiramate Qualigen. If the decision is made to use Topiramate Qualigen, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramate Qualigen.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill along 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.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Qualigen in girls:

If you are the parent or caregiver of a girl treated with Topiramate Qualigen, 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 during pregnancy 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 Qualigen:

• 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 Qualigen 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 assess alternative treatment options. The doctor will advise you on the risks of Topiramate Qualigen during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramate Qualigen to prevent migraines, stop taking the medicine immediately and consult your doctor to assess if you need an alternative treatment.
• If you are taking Topiramate Qualigen for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your unborn baby at risk.
• Your doctor will re-evaluate your treatment and assess alternative treatment options. The doctor will advise you on the risks of Topiramate Qualigen during pregnancy. The doctor may also refer you to another specialist.
• If Topiramate 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 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 Qualigen to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Topiramate Qualigen (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 interrupt breastfeeding or whether to interrupt treatment with Topiramate Qualigen. Your doctor will take into account the importance of the benefits for the mother and the risk for the baby.

Breastfeeding mothers taking Topiramate Qualigen should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

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

Topiramate Qualigen 100 mg contains orange yellow S (E 110)

This medicine may cause allergic reactions.

3. How to take Topiramato Qualigen

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

Girls and women of childbearing age:

Treatment with Topiramato Qualigen should begin and continue 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.

• Normally, your doctor will first indicate a low dose of Topiramato Qualigen, which will be slowly increased until the most suitable one for you is found.
• The tablets of Topiramato Qualigen 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 during 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you are taking other medications along with Topiramato Qualigen, an overdose may occur.

If you forget to take Topiramato Qualigen

• If you forgot a dose, take it as soon as you remember. However, if it is close to the time of 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 make up for the missed doses.

If you interrupt treatment with Topiramato Qualigen

Do not stop taking this medication unless your doctor indicates it. The symptoms may return. If the doctor decides to interrupt the treatment, they may gradually reduce the dose over several days.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people suffer from them.

Consult your doctor or seek medical attention immediately if you have 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
• Concentration problems, slowness of thought, memory loss, memory problems (initial, sudden change, or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased acid level in the blood (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or lost sweating
• Having thoughts of self-harm, attempting to cause serious harm

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

• Glaucoma - blockage of fluid 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 levels of ammonia 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 (desquamation and superficial mucous membrane detachment) with life-threatening consequences.

Frequency not known (cannot be estimated from available data):

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

Other side effects include the following; if they are severe, please consult your doctor or pharmacist:

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

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

Common (may affect up to 1 in 10 people)

• Anemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger
• Difficulty staying or falling asleep
• Speech problems or speech disorders, problems with handwriting
• 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 movements; 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
• 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 twitches, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells that help protect against infections, decreased potassium level 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 vigilance
• 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 Topiramato Qualigen 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 acid, feeling of being full or bloated
• Nosebleeds, 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 getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers and toes
• Feeling of drunkenness
• 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 surrounding area
• 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
• Increased acid level in the blood

Not known (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
• Inflammation of the conjunctiva (of the eye)
• Toxic epidermal necrolysis, a life-threatening disease, even more severe than Stevens-Johnson syndrome, characterized by widespread blistering and detachment of the outer layers of the skin (see rare side effects).

Children and adolescents

Generally, the side effects observed in children are similar to those observed in adults. However, some side effects occur more frequently in children and/or may be more severe in children than in adults. Side effects that may be more severe include decreased or lost sweating and increased acid level in the blood. Side effects that may occur more frequently in children include upper respiratory tract diseases.

If you experience side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report side effects through the Spanish Medicines for Human Use Pharmacovigilance System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Topiramato Qualigen

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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 ingredients are:

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

Coating:Hypromellose, propylene glycol, titanium dioxide (E 171), orange yellow (E 110).

Appearance of Topiramato Qualigen 100 mg and package contents

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

Package size: 60 tablets in HDPE containers with a desiccant bag or in blisters.

Other sources of information

The most recently 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 manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Pharmathen, S.A.

6, Dervenakion str.

153 51 Pallini, Attiki

Greece

Or

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 film-coated tablets

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 prospectus was revised in May 2024