TOPIRAMATE QUALIGEN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Topiramate Qualigen 25 mg Film-Coated Tablets EFG

This medication is subject to additional monitoring, which will help to quickly identify new safety information. You can contribute by reporting any side effects you may have. 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Topiramate 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. Storing Topiramate Qualigen
6. Pack contents and further 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 migraines 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 contraceptive method 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 contraceptive method 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 baby at risk.

Make sure to read the patient guide that you will receive from your doctor or scan the QR code to get 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 and body fluid test results (metabolic acidosis).
• have liver problems.
• have eye problems, especially glaucoma.
• have a growth problem.
• are on a high-fat diet (ketogenic diet).
• are a woman who may become pregnant. Topiramate Qualigen may harm a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramate Qualigen. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramate Qualigen may harm a baby during pregnancy when taken during pregnancy.

If you are not sure if the above applies to your case, consult your doctor before using 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 medication that contains topiramate that may be provided as an alternative to Topiramate Qualigen.

A small number of people who were being treated with antiepileptic drugs like 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.

If you are taking 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, tell your doctor immediately if you have 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, you should consult a doctor.

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.

Sometimes 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 your 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 consult 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 you need to 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 your case, 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 a 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 contraceptive method.
• 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 contraceptive method. 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 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 condition for which topiramate is used) are as follows:

There is a risk of harm to the 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 split in the upper lip) and cleft palate (a split in the palate) have been observed. Male newborns may also have a malformation of the penis (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take Topiramate 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, talk to your doctor about 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 birth control 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.
• Tell 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 a 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 evaluate alternative treatment options. The doctor will advise you about 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 evaluate 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 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 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 discontinue breastfeeding or to discontinue 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 25 mg contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Topiramate Qualigen

Follow the instructions for taking this medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

Girls and women of childbearing potential:

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

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

If you take more Topiramate Qualigen 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.

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

If you are taking other medicines with Topiramate Qualigen, an overdose may occur.

If you forget to take Topiramate 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 make up for missed doses.

If you stop taking Topiramate Qualigen

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

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

4. Possible Adverse Effects

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

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

Very 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, slow thinking, 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 blood acid levels (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• Decreased or lost sweating
• Having thoughts of self-harm, attempting to cause serious harm

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

• Glaucoma - fluid blockage in the eye that causes increased eye pressure, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy - these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (hyperammonemic encephalopathy).
• 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.

Frequency Not Known (cannot be estimated from available data):

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

Other Adverse 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 sore throat
• Numbness, pain, and/or tingling of various 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, 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
• Visual disturbances, 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 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, unusual distrust, panic attack
• Reading problems, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or wakefulness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eyes, eye sensitivity to light, eyelid twitching, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing up (consequently, some people taking 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 acidity, feeling of fullness or bloating
• Nosebleeds, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgent need to urinate, side or kidney pain
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold fingers and 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 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 damage
• Increased blood acid levels

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

Children and Adolescents

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet.

Adverse Effect Reporting

If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report adverse effects 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 Topiramato Qualigen

Keep out of sight and reach of children.

No special storage conditions are required.

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

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

6. Package Contents and Additional Information

Composition of Topiramato Qualigen 25 mg

• The active ingredient is topiramate.
• Each film-coated tablet of Topiramato Qualigen 25 mg contains 25 mg of topiramate.
• The other ingredients are:

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

Coating:Hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E 171).

Appearance of Topiramato Qualigen 25 mg and Package Contents

Topiramato Qualigen 25 mg film-coated tablets are round and white.

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 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

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 medicine 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 25 mg/50 mg/100 mg/200 mg

This leaflet was last revised in May 2024