Topiramate Qualigen 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Topiramate Qualigen 50 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Topiramato 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.
• as a preventive treatment for migraines in adults.

2. What you need to know before taking Topiramato Qualigen

Do not take Topiramato Qualigen

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

Prevention of migraines

• You must not take Topiramato Qualigen if you are pregnant.
• If you are a woman of childbearing potential, you must not take Topiramato Qualigen unless you are using a highly effective method of contraception during 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 seizure control.
• If you are a woman of childbearing potential, you must not take Topiramato Qualigen unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramato Qualigen is the only treatment that provides sufficient seizure control and you plan to become pregnant. You should consult your doctor to ensure 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 guide you will receive from your doctor or scan the QR code to access it (see section 6 “Other sources of information”).

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

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

Warnings and precautions

Talk to your doctor before starting Topiramato Qualigen if you:

• have kidney disease, especially kidney stones or are undergoing dialysis.
• have previously had abnormal blood or body fluid test results (metabolic acidosis).
• have liver problems.
• have eye problems, especially glaucoma.
• have a growth disorder.
• are on a high-fat diet (ketogenic diet).
• are a woman who could become pregnant. Topiramato Qualigen may harm an unborn baby if taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Qualigen. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramato Qualigen may harm an unborn baby if taken during pregnancy.

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

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

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

A small number of people treated with antiepileptic medicines such as Topiramato Qualigen have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramato 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 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 elevated levels of ammonia in the blood (detected in blood tests), which may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. 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
• reduced alertness or awareness
• feeling very drowsy and lacking energy

The risk of developing these symptoms may increase with higher doses of Topiramato Qualigen.

Children and adolescents

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

Other medicines and Topiramato Qualigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. The effect of Topiramato Qualigen and other medicines may be altered if taken together.

Sometimes it may be necessary to adjust the dose of other medicines or of Topiramato Qualigen.

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

• other medicines that affect or reduce your ability to think, concentrate, or coordinate movements (e.g., central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramato Qualigen may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. You should consult your doctor about the most appropriate contraceptive method to use while taking Topiramato Qualigen.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Topiramato Qualigen. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

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

Medicines you should inform your doctor or pharmacist about include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John’s wort (Hypericum perforatum) (a herbal preparation used to treat depression), and warfarin used to prevent blood clotting.

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

Taking Topiramato Qualigen with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

Pregnancy

Important advice for women of childbearing potential:

Topiramato 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 risks at least once a year.

Prevention of migraines

• In case of migraine, you must not use Topiramato Qualigen if you are pregnant.
• In case of migraine, you must not use Topiramato Qualigen if you are a woman of childbearing potential unless you are using a highly effective method of contraception.
• Before starting treatment with Topiramato Qualigen, a pregnancy test must be performed in women of childbearing potential.

Treatment of epilepsy:

• In case of epilepsy, you must not take Topiramato Qualigen if you are pregnant, unless no other treatment offers sufficient seizure control.
• In case of epilepsy, you must not take Topiramato Qualigen if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Topiramato Qualigen is the only treatment that provides sufficient seizure control and you plan to become pregnant. You must consult your doctor to ensure 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 unborn baby at risk.
• Before starting treatment with Topiramato Qualigen, a pregnancy test must be performed in women of childbearing potential.

Risks of topiramate when taken during pregnancy (regardless of the condition for which topiramate is used):

There is a risk of harm to the unborn baby if Topiramato Qualigen is used during pregnancy.

• If you take Topiramato Qualigen during pregnancy, your child has a higher risk of having congenital malformations. In women taking topiramate, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1 to 3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic medication. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Newborn boys may also have a malformation of the penis (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramato Qualigen during pregnancy, your child may have a 2 to 3 times higher risk of developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medication.
• If you take Topiramato Qualigen during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, compared to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.
• Consult your doctor if you have questions about these risks during pregnancy.
• There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in women of childbearing potential:

• If you are a woman of childbearing age, talk to your doctor about other possible treatments instead of Topiramato Qualigen. If the decision is made to use Topiramato Qualigen, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Qualigen.
• 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 diaphragm) should be used. Consult your doctor about the most appropriate 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 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 or caregiver of a girl being treated with Topiramato 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 due to exposure to topiramate during pregnancy and the need to use highly effective contraceptive methods.

If you plan to become pregnant while taking Topiramato 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 Topiramato Qualigen for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition could worsen.
• Your doctor will reassess 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 become pregnant or think you might be pregnant while taking Topiramato Qualigen:

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramato Qualigen to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topiramato Qualigen for epilepsy, do not stop taking this medicine until you have discussed it with your doctor, as your condition could worsen. Worsening epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess 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 monitored closely to check your baby’s development during pregnancy.

Make sure to read the patient guide 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 Topiramato Qualigen package to remind you of the risks during pregnancy.

Breastfeeding

The active ingredient in Topiramato Qualigen (topiramate) passes into breast milk. Effects have been observed in infants breastfed by treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue treatment with Topiramato Qualigen. Your doctor will consider the importance of the benefits for the mother and the risk for the infant.

Breastfeeding mothers taking Topiramato Qualigen should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

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

Topiramato Qualigen 50 mg contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Topiramato Qualigen

Follow exactly the dosing instructions for this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Girls and fertile women:

Treatment with Topiramato Qualigen should be initiated and continued under the supervision of a physician experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

• Your doctor will usually start you on a low dose of Topiramato Qualigen, gradually increasing it until the most appropriate dose for you is reached.
• Topiramato Qualigen tablets should be swallowed whole. Do not chew them, as they may leave a bitter taste.
• Topiramato Qualigen may be taken before, during, or after meals. While taking Topiramato Qualigen, it is recommended to drink plenty of fluids throughout the day to help prevent kidney stones.

If you take more Topiramato Qualigen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

• Seek medical advice immediately. Bring the medicine packaging with you.
• You may experience drowsiness, fatigue, or reduced alertness; lack of coordination; difficulty speaking or concentrating; double or blurred vision; dizziness due to low blood pressure; feelings of depression or restlessness; abdominal pain; or seizures (fits).

Overdose may be more likely if you are taking other medicines together with Topiramato Qualigen.

If you forget to take Topiramato Qualigen

• If you miss 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 with your regular schedule. If you miss two or more doses, consult your doctor.
• Do not take a double dose to make up for a missed dose.

If you stop taking Topiramato Qualigen

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

If you have any further 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 everyone will experience them.

Consult your doctor or seek immediate medical attention if you experience any of 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
• Difficulty concentrating, slowed thinking, memory loss, memory problems (initial, sudden onset, or worsening severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased level of acid in the blood (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Decreased or absent sweating
• Thoughts of self-harm, attempting to cause serious harm to oneself

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

• Glaucoma – blockage of fluid in the eye causing increased pressure in the eye, eye pain, or vision loss.
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of lethargy with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which may lead to changes in brain function (hyperammonemic encephalopathy).
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which 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 may progress to widespread damage to the skin (detachment of the epidermis and superficial mucous membranes), with potentially life-threatening consequences.

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

• Inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred vision

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

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

• Nasal congestion, runny nose, sore throat
• Tingling, pain, and/or numbness in various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger
• Difficulty falling or staying asleep
• Speech problems or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing
• Sensation of spinning (dizziness), 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
• Joint pain or swelling, 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 blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotional expression, unusual distrust, panic attack
• Reading difficulties, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slowed thinking, decreased level of wakefulness or alertness
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch sensation
• Disturbance, distortion, or absence of smell
• Unusual feeling or sensation that may precede a migraine or certain types of seizures
• Dry eyes, sensitivity of eyes to light, eyelid twitching, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling heartbeat in the chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people taking Topiramato Qualigen may faint, feel dizzy, or lose consciousness when standing up or sitting up suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acidity, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, incontinence (lack of control) when urinating, urgency to urinate, pain in the side or kidney
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• 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) in fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Stevens-Johnson syndrome, a potentially life-threatening condition that may present with ulcers in various mucosal areas (such as mouth, nose, and eyes), skin rash, and blisters
• Abnormal skin odor
• Discomfort in arms and legs
• Kidney impairment
• Increased level of acid in the blood

Frequency not known (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is sharpest. 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 condition even more severe than Stevens-Johnson syndrome, characterized by widespread blistering and detachment of the outer layers of the skin (see rare adverse effects).

Children and adolescents

In general, 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 absent sweating and increased levels of acid in the blood. Adverse effects that may occur more frequently in children include upper respiratory tract illnesses.

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

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report adverse effects via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Qualigen

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the Sigre Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topiramato Qualigen 50 mg

• The active substance is topiramate.
• Each Topiramato Qualigen 50 mg film-coated tablet contains 50 mg of topiramate.
• The other components are:

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

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

Appearance of Topiramato Qualigen 50 mg and contents of the pack

Topiramato Qualigen 50 mg film-coated tablets are round and yellow in colour.

Pack size: 60 tablets in HDPE containers containing a desiccant pouch or in blisters.

Other sources of information

The most recent approved information, patient guide, about this medicine is available by scanning the following QR code with a smartphone. The same information is also available at the following website (URL):

https://cima.aemps.es/cima/DocsPub/16/3252

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the EEA under 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 50 mg/50 mg/100 mg/200 mg

This leaflet has been reviewed in May 2024