Topiramate Aurovitas

Leaflet accompanying the packaging: information for the user

Topiramate Aurovitas, 25 mg, coated tablets

Topiramate Aurovitas, 50 mg, coated tablets

Topiramate Aurovitas, 100 mg, coated tablets

Topiramate Aurovitas, 200 mg, coated tablets

Topiramate
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 may get. To find out how to report side effects, see section 4.

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• 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 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 leaflet:

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

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

Topiramate Aurovitas belongs to a group of medicines called antiepileptic medicines. It is used:

• as a single medicine for the treatment of seizures in adults and children over 6 years of age.
• in combination with other medicines for the treatment of seizures in adults and children over 2 years of age.
• to prevent migraine headaches in adults.

2. Important information before taking Topiramate Aurovitas

When not to take Topiramate Aurovitas

• Topiramate Aurovitas must not be taken during pregnancy.
• If you are of childbearing potential, you should not take Topiramate Aurovitas without using highly effective contraception during treatment. See also the section below on “Pregnancy, breastfeeding and fertility – important advice for women”.

and epilepsy treatment

• Topiramate Aurovitas must not be taken if you are pregnant, unless no other treatment is effective in controlling your seizures.
• If you are of childbearing potential, you should not take Topiramate Aurovitas without using highly effective contraception during treatment. The only exception is when Topiramate Aurovitas is the only medicine that controls your seizures and you are planning to become pregnant. You should discuss this with your doctor to ensure you have received information about the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn child at risk.

You must read the patient guide provided by your doctor or scan the QR code (see section 6 "Package contents and other information"). A patient card is included with the packaging of Topiramate Aurovitas, which reminds you of the risk associated with pregnancy.

Warnings and precautions

Before taking Topiramate Aurovitas, you should discuss it with your doctor or pharmacist if you have:

• kidney problems, especially kidney stones or dialysis
• blood and body fluid disorders (metabolic acidosis)
• liver problems
• vision problems, especially glaucoma
• growth problems
• if you are on a high-fat diet (ketogenic diet)
• if you are a woman of childbearing potential. Topiramate Aurovitas taken during pregnancy may harm the unborn child. During treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas, you should use highly effective contraception. Further information can be found in the section "Pregnancy, breastfeeding and fertility".
• if you are pregnant. Topiramate Aurovitas taken during pregnancy may harm the unborn child.

If you are not sure if any of the above applies to you, you should consult your doctor before taking Topiramate Aurovitas.

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

It is important that you do not stop taking your medicine without consulting your doctor first.

You should consult your doctor before taking any other medicine containing topiramate that has been prescribed for you as a substitute for Topiramate Aurovitas.

During treatment with Topiramate Aurovitas, you may lose weight, so you should regularly check your body weight during treatment with this medicine. If you lose too much weight or if a child taking this medicine does not gain enough weight, you should consult your doctor.

In a small number of people taking antiepileptic medicines, such as Topiramate Aurovitas, thoughts of self-harm or suicide have occurred.

If you ever have these thoughts, you should contact your doctor immediately.

Topiramate Aurovitas may cause severe skin reactions; if a rash and/or blisters appear on the skin, you should immediately inform your doctor (see also section 4. "Possible side effects").

Topiramate Aurovitas may rarely cause an increase in blood ammonia levels (detected in blood tests), which can lead to changes in brain function, especially if you are also taking a medicine containing valproic acid or sodium valproate.

Because this can be a serious condition, you should immediately tell your doctor if you experience any of the following side effects (see also section 4 "Possible side effects"):

• difficulty thinking, remembering or solving problems
• decreased alertness or awareness
• feeling very sleepy with a lack of energy.

The risk of these symptoms may increase with high doses of Topiramate Aurovitas.

Topiramate Aurovitas and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Topiramate Aurovitas may interact with other medicines. As a result, it may sometimes be necessary to adjust the dose of the medicines you are taking or to change the dose of Topiramate Aurovitas.

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

• other medicines that can harm or decrease thinking, concentration or muscle coordination (e.g. central nervous system depressants, such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate Aurovitas may decrease the effectiveness of hormonal contraceptives. You should use an additional barrier method of contraception, such as a condom or diaphragm/cervical cap. You should discuss with your doctor the best method of contraception to use while taking Topiramate Aurovitas.

You should tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Topiramate Aurovitas. Irregular bleeding may occur. In this case, you should continue to take hormonal contraceptives and inform your doctor.

You should keep a list of all the medicines you are taking. When starting a new medicine, you should show this list to your doctor and pharmacist.

Taking other medicines, such as 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 (an anticoagulant), you should consult your doctor or pharmacist.

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

Topiramate Aurovitas with food, drink and alcohol

You can take Topiramate Aurovitas with or without food. You should drink plenty of fluids during the day to prevent kidney stones from forming while taking Topiramate Aurovitas.

You should avoid drinking alcohol while taking Topiramate Aurovitas.

Pregnancy, breastfeeding and fertility

Important advice for women of childbearing potential

Topiramate Aurovitas may harm the unborn child. Women of childbearing potential should discuss other possible treatments with their doctor. At least once a year, you should visit your doctor to check your treatment and discuss the risks.

Migraine prevention:

• In the case of migraine, Topiramate Aurovitas must not be taken during pregnancy.
• In the case of migraine, Topiramate Aurovitas must not be taken if you are of childbearing potential unless you are using highly effective contraception.
• Before starting Topiramate Aurovitas in women of childbearing potential, a pregnancy test should be performed.

Epilepsy treatment:

• In the case of epilepsy, Topiramate Aurovitas must not be taken if you are pregnant, unless no other treatment is effective in controlling your seizures.
• In the case of epilepsy, Topiramate Aurovitas must not be taken if you are of childbearing potential unless you are using highly effective contraception. The only exception is when Topiramate Aurovitas is the only medicine that controls your seizures and you are planning to become pregnant. You should discuss this with your doctor to ensure you have received information about the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn child at risk.
• Before starting Topiramate Aurovitas in women of childbearing potential, a pregnancy test should be performed.

Risk of taking topiramate during pregnancy (regardless of the disease being treated):

• Taking Topiramate Aurovitas during pregnancy increases the risk of birth defects in the child. In women taking topiramate, birth defects occur in about 4-9 out of 100 children. For comparison, this figure is 1-3 out of 100 children born to women who do not have epilepsy and are not taking antiepileptic medicines. In particular, cleft lip (cleft lip) and cleft palate (cleft palate) have been observed. In newborn boys, a developmental defect of the penis (hypospadias) may also occur. These defects can develop early in pregnancy, even before the patient knows she is pregnant.
• Taking Topiramate Aurovitas during pregnancy may increase the risk of autism spectrum disorders, intellectual disability or attention deficit hyperactivity disorder (ADHD) in the child by 2 to 3 times compared to children born to women with epilepsy who are not taking antiepileptic medicines.

In the case of taking Topiramate Aurovitas during pregnancy, the child may be smaller and have a lower than expected birth weight. In one study, 18% of children whose mothers took topiramate during pregnancy were smaller and weighed less than expected, while in women without epilepsy who did not take antiepileptic medicines, this applied to 5% of newborns.

• If in doubt, you should ask your doctor about the risks during pregnancy.
• There may be other medicines used to treat this disease that are associated with a lower risk of birth defects.

Necessity of contraception in women of childbearing potential:

• Women of childbearing potential should discuss the possibility of using other treatments instead of Topiramate Aurovitas with their doctor. If the decision is made to start treatment with Topiramate Aurovitas, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas.
• You should use one highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods, such as a contraceptive pill, in combination with a barrier method (such as a condom or diaphragm/cervical cap). You should discuss with your doctor which contraceptive method will be most suitable for you.
• If you are taking hormonal contraceptives, topiramate may decrease their effectiveness. Therefore, you should use an additional barrier method of contraception (such as a condom or diaphragm/cervical cap).
• If you experience irregular menstrual bleeding, you should inform your doctor.

Taking Topiramate Aurovitas in girls:

The parents or guardians of a girl treated with Topiramate Aurovitas must immediately contact the doctor when the girl has her first menstrual period. The doctor will inform them about the risk to the unborn child resulting from exposure to topiramate during pregnancy and the need to use highly effective contraception.

If you want to become pregnant while taking Topiramate Aurovitas:

• You should make an appointment with your doctor.
• You should not stop using contraception until you have discussed this with your doctor.
• If you are taking Topiramate Aurovitas for epilepsy, you should not stop taking it without consulting your doctor, as your condition may worsen.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risks of taking Topiramate Aurovitas during pregnancy. Your doctor may also refer you to another specialist.

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

• You should make an urgent appointment with your doctor.
• In the case of migraine prevention, you should immediately stop taking the medicine and contact your doctor, who will assess whether alternative treatment is necessary.
• If you are taking Topiramate Aurovitas for epilepsy, you should not stop taking it without consulting your doctor, as this may worsen your condition. Worsening of epilepsy may put you or your unborn child at risk.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risks of taking Topiramate Aurovitas during pregnancy. Your doctor may also refer you to another specialist.
• If Topiramate Aurovitas is taken during pregnancy, you will be closely monitored to check the development of the unborn child.

You must read the patient guide provided by your doctor. The patient guide can also be obtained by scanning the QR code, see section 6 "Package contents and other information". A patient card is included with the packaging of Topiramate Aurovitas, which reminds you of the risk associated with pregnancy.

Breastfeeding

The active substance of Topiramate Aurovitas, topiramate, passes into breast milk. In children breastfed by mothers taking this medicine, side effects such as diarrhea, drowsiness, irritability, and poor weight gain have occurred. Therefore, your doctor will discuss with you whether to stop breastfeeding or stop taking Topiramate Aurovitas. Your doctor will consider the importance of the medicine for the mother and the risk to the child.

Mothers taking Topiramate Aurovitas during lactation must immediately inform their doctor if they notice any changes in their child's behavior.

Driving and using machines

While taking Topiramate Aurovitas, you may experience dizziness, fatigue, and vision disturbances. You should not drive, operate machinery, or use tools without consulting your doctor.

Topiramate Aurovitas contains lactose

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

Topiramate Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Topiramate Aurovitas

You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Girls and women of childbearing potential

Treatment with Topiramate Aurovitas should be started and supervised by a doctor experienced in the treatment of epilepsy or migraine. At least once a year, you should visit your doctor to check your treatment.

• Your doctor will usually start treatment with a low dose of Topiramate Aurovitas and gradually increase it until the optimal dose for you is reached.
• Topiramate Aurovitas tablets should be swallowed whole. It is not recommended to chew the tablets, as they may leave a bitter taste.
• Topiramate Aurovitas can be taken before, during, or after a meal. While taking Topiramate Aurovitas, you should drink plenty of fluids to avoid kidney stones.

Taking a higher dose of Topiramate Aurovitas than recommended

• You should immediately contact your doctor. You should also take the packaging of the medicine with you.
• You may experience the following symptoms: drowsiness, feeling tired or less alert, lack of coordination, speech or concentration disorders, double or blurred vision, dizziness due to low blood pressure, feeling depressed or agitated, abdominal pain or seizures.

Overdose can also occur when taking other medicines with Topiramate Aurovitas.

Missing a dose of Topiramate Aurovitas

• If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and continue with your treatment. If you miss two or more doses, you should contact your doctor.
• You should not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping treatment with Topiramate Aurovitas

You should not stop treatment unless your doctor tells you to. After stopping treatment, the symptoms of the underlying disease may return. If your doctor decides to stop treatment, the dose of the medicine may be gradually decreased over a few days.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should tell your doctor or pharmacist if you experience any of the following side effects:

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

• Depression (for the first time or worsening of existing depression).

Common (may affect up to 1 in 10 people)

• Seizures
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration disorders, slow thinking, memory loss, memory disorders (for the first time, sudden change or increased severity)
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Metabolic acidosis (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid irregular heartbeat)
• Decreased or absent sweating (especially in young children in a hot environment)
• Thoughts of severe self-harm
• Loss of part of the visual field.

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

• Glaucoma, which is characterized by fluid accumulation in the eye chamber, causing increased pressure in the eyeball, pain, and impaired vision
• Difficulty thinking, remembering, or solving problems, decreased alertness or awareness, feeling very sleepy with a lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (encephalopathy associated with hyperammonemia)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - may occur as a rash with blisters or without. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes can transform into severe, extensive skin damage (peeling of the skin and mucous membranes), which can have life-threatening consequences.

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

• Macular degeneration - a disease of the macula, the part of the retina responsible for sharp vision. If you notice any changes in your vision or blurred vision, you should contact your doctor.

Children

Side effects in children are generally similar to those observed in adults, but the following side effects may occur more frequently in children than in adults:

• Concentration problems
• Increased blood acid levels (metabolic acidosis)
• Thoughts of severe self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, unusual behavior
• Difficulty falling asleep and waking up
• Feeling unbalanced while walking
• Feeling unwell
• Low blood potassium levels
• Lack of emotional expression
• Tearing
• Slow or irregular heartbeat.

Other side effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• Dizziness (vertigo of labyrinthine origin)
• Vomiting
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Increased number of eosinophils in the blood (a type of white blood cell)
• Hyperactivity
• Feeling hot
• Difficulty learning.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

You can also report side effects to the marketing authorization holder.

5. How to store Topiramate Aurovitas

The medicine should be stored out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister or bottle after EXP. The expiry date refers to the last day of the month stated.

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Topiramate Aurovitas contains

• The active substance is topiramate.

Each coated tablet contains 25 mg of topiramate.

Each coated tablet contains 50 mg of topiramate.

Each coated tablet contains 100 mg of topiramate.

Each coated tablet contains 200 mg of topiramate.

• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, maize starch, sodium carboxymethyl starch (type A), magnesium stearate.

Coating:hypromellose 2910 (3cp and 6cp), titanium dioxide (E 171), macrogol 400, polysorbate 80, iron oxide yellow (E 172) (for 50 mg and 100 mg), iron oxide red (E 172) (only for 200 mg).

What Topiramate Aurovitas looks like and contents of the pack

Coated tablets.

Topiramate Aurovitas, 25 mg, coated tablets:

White, round, biconvex coated tablets with "E" engraved on one side and "22" on the other side.

Topiramate Aurovitas, 50 mg, coated tablets:

Light yellow, round, biconvex coated tablets with "E" engraved on one side and "33" on the other side.

Topiramate Aurovitas, 100 mg, coated tablets:

Dark yellow, round, biconvex coated tablets with beveled edges, with "E" engraved on one side and "23" on the other side.

Topiramate Aurovitas, 200 mg, coated tablets:

Pink, round, biconvex coated tablets with beveled edges, with "E" engraved on one side and "24" on the other side.

Topiramate Aurovitas coated tablets are available in blisters and HDPE containers.

Pack sizes:

Blisters:

28 and 60 coated tablets.

HDPE containers:

28 and 60 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Topiramate Aurovitas

Portugal:

Topiramato Limeg

Date of last revision of the leaflet 02/2024

Other sources of information

The latest approved information (Patient Guide) about this medicine is available by scanning the QR code below with your smartphone. The same information is also available on the website (URL):