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 learn how to report side effects, see point 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See point 4.

Table of 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 packaging 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 epileptic seizures in adults and children over 6 years of age.
• in combination with other medicines for the treatment of epileptic 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

• if the patient is allergic to topiramate or any of the other ingredients of this medicine (listed in point 6). Migraine prevention
• Topiramate Aurovitas should not be taken during pregnancy.
• If the patient is of childbearing age, she should not take Topiramate Aurovitas without using highly effective contraception during treatment. See below in the section "Pregnancy, breastfeeding, and fertility - important advice for women".
  Epilepsy treatment

Topiramate Aurovitas should not be taken if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures.

• If the patient is of childbearing age, she should not take Topiramate Aurovitas without using highly effective contraception during treatment. The only exception is when Topiramate Aurovitas is the only medicine that provides sufficient control of seizures, and the patient plans to become pregnant. The patient should discuss this with her doctor to ensure she has received information about the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may put the patient or the unborn child at risk.

It is essential to read the patient guide provided by the doctor or scan the QR code (see point 6 "Contents of the packaging and other information"). A patient card is attached to the packaging of Topiramate Aurovitas, which reminds about the risk associated with pregnancy.
If the patient is unsure whether any of the above applies to them, they should consult their doctor or pharmacist before taking Topiramate Aurovitas.

Warnings and precautions

Before starting treatment with Topiramate Aurovitas, the patient should discuss the following with their doctor or pharmacist:

• kidney problems, especially kidney stones or dialysis
• blood and body fluid disorders (metabolic acidosis)
• liver problems
• vision problems, especially glaucoma
• growth problems
• if the patient is on a high-fat diet (ketogenic diet)
• if the patient is a woman of childbearing age. 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, a highly effective method of contraception should be used. Further information can be found in the section "Pregnancy, breastfeeding, and fertility".
• if the patient is pregnant. Topiramate Aurovitas taken during pregnancy may harm the unborn child.

If the patient is unsure whether any of the above applies to them, they should consult their doctor before starting treatment with Topiramate Aurovitas.
If the patient has epilepsy, it is essential not to stop taking the medicine without consulting a doctor.
It is crucial not to stop taking the medicine without consulting a doctor first.
The patient should consult their doctor before taking any medicine containing topiramate that has been prescribed as a substitute for Topiramate Aurovitas.
During treatment with Topiramate Aurovitas, the patient may lose weight, so it is essential to regularly monitor their body weight during treatment with this medicine. If the patient loses too much weight or if a child taking this medicine does not gain enough weight, they should consult their doctor.
In a small number of people taking antiepileptic medicines, such as Topiramate Aurovitas, thoughts of self-harm or suicide have occurred.
If such thoughts occur, the patient should contact their doctor immediately.
Topiramate Aurovitas may cause severe skin reactions; if a rash and/or blisters appear on the skin, the patient should immediately inform their doctor (see also point 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 the patient is also taking a medicine containing valproic acid or sodium valproate.
As this can be a life-threatening condition, the patient should immediately tell their doctor if they experience any of the following side effects (see also point 4 "Possible side effects"):

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

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

Topiramate Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Topiramate Aurovitas may interact with other medicines. In some cases, the dose of the medicines taken by the patient may need to be adjusted or the dose of Topiramate Aurovitas may need to be changed.
In particular, the patient should inform their doctor or pharmacist if they are taking:

• other medicines that have a negative effect on 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. The patient should use an additional barrier method of contraception, such as a condom or diaphragm/cervical cap. The patient should discuss with their doctor the best method of contraception to use while taking Topiramate Aurovitas.

The patient should tell their doctor if their menstrual bleeding changes while taking hormonal contraceptives and Topiramate Aurovitas. Irregular menstrual bleeding may occur. In such cases, the patient should continue taking hormonal contraceptives and inform their doctor.
The patient should keep a list of all medicines they are taking. When starting a new medicine, the patient should show this list to their 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), the patient should consult their doctor or pharmacist.

Topiramate Aurovitas with food, drink, and alcohol

Topiramate Aurovitas can be taken with or without food.
The patient should drink plenty of fluids during the day to prevent the formation of kidney stones while taking Topiramate Aurovitas.
The patient should avoid consuming alcohol while taking Topiramate Aurovitas.

Pregnancy, breastfeeding, and fertility

Important advice for women of childbearing age
Topiramate Aurovitas may harm the unborn child. Women of childbearing age should discuss other possible treatment options with their doctor. At least once a year, the patient should visit their doctor to review their treatment and discuss the risks.

Migraine prevention:

• In the case of migraine, Topiramate Aurovitas should not be taken during pregnancy.
• In the case of migraine, Topiramate Aurovitas should not be taken if the patient is of childbearing age unless she is using a highly effective method of contraception.
• Before starting treatment with Topiramate Aurovitas, a pregnancy test should be performed in women of childbearing age.

Epilepsy treatment:

• In the case of epilepsy, Topiramate Aurovitas should not be taken if the patient is pregnant unless no other treatment method provides sufficient control of epileptic seizures.
• In the case of epilepsy, Topiramate Aurovitas should not be taken if the patient is of childbearing age unless she is using a highly effective method of contraception. The only exception is when Topiramate Aurovitas is the only medicine that provides sufficient control of seizures, and the patient plans to become pregnant. The patient should discuss this with her doctor to ensure she has received information about the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may put the patient or the unborn child at risk.
• Before starting treatment with Topiramate Aurovitas, a pregnancy test should be performed in women of childbearing age.

The risk of taking topiramate during pregnancy (regardless of the disease being treated):
There is a risk of harm to the unborn child if Topiramate Aurovitas is taken during pregnancy.

• 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 rate is 1-3 out of 100 children born to women who do not have epilepsy and do not take 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.
• The risk of the child developing autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) may be 2 to 3 times higher than in children born to women with epilepsy who do not take 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.

• In case of doubts, the patient should ask their doctor about the risks during pregnancy.
• Other medicines used to treat this disease may be available, which are associated with a lower risk of birth defects.

Necessity of contraception in women of childbearing age:

• Women of childbearing age should discuss other possible treatment options with their doctor. If they decide to start treatment with Topiramate Aurovitas, they should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas.
• The patient should use one highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as a contraceptive pill, in combination with a mechanical method of contraception (such as a condom or diaphragm/cervical cap). The patient should discuss with their doctor which method of contraception is most suitable for them.
• If the patient is taking hormonal contraceptives, topiramate may decrease their effectiveness. Therefore, the patient should use an additional barrier method of contraception (such as a condom or diaphragm/cervical cap).
• If irregular menstrual bleeding occurs, the patient should inform their doctor.

Taking Topiramate Aurovitas in girls:
Parents or guardians of girls treated with Topiramate Aurovitas should immediately contact their doctor when the girl experiences 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 the patient wants to become pregnant while taking Topiramate Aurovitas:

• The patient should make an appointment with their doctor.
• The patient should not stop using contraception until they have discussed this with their doctor.
• If the patient is taking Topiramate Aurovitas for epilepsy, they should not stop taking it without consulting their doctor, as their condition may worsen.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of taking Topiramate Aurovitas during pregnancy and may refer them to another specialist.

If the patient becomes pregnant or suspects they may be pregnant while taking Topiramate Aurovitas:

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

It is essential to read the patient guide provided by the doctor. The patient guide can also be obtained by scanning the QR code, see point 6 "Contents of the packaging and other information". A patient card is attached to the packaging of Topiramate Aurovitas, which reminds about 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, the doctor will discuss with the patient whether to stop breastfeeding or stop taking Topiramate Aurovitas. The doctor will consider the importance of the medicine for the mother and the risk to the child.
Mothers taking Topiramate Aurovitas during lactation should immediately inform their doctor if they notice any changes in their child's behavior.

Driving and using machines

While taking Topiramate Aurovitas, dizziness, fatigue, and vision disturbances may occur. The patient should not drive, operate any machinery, or use tools without consulting their doctor.

Topiramate Aurovitas contains lactose

If the doctor has informed the patient that they have an intolerance to some sugars, they should contact their 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 considered "sodium-free".

3. How to take Topiramate Aurovitas

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Girls and women of childbearing age
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, the patient should visit their doctor to review their treatment.

• The doctor will usually start treatment with a low dose of Topiramate Aurovitas and gradually increase it until the optimal dose for the patient is determined.
• 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, the patient should drink plenty of fluids to prevent the formation of kidney stones.

Taking a higher dose of Topiramate Aurovitas than recommended

• The patient should immediately contact their doctor. They should also take the packaging of the medicine with them.
• The patient may experience the following symptoms: drowsiness, fatigue, or decreased alertness, lack of coordination, speech or concentration disorders, double or blurred vision, dizziness due to low blood pressure, feeling of depression or excitement, abdominal pain, or seizures.

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

Missing a dose of Topiramate Aurovitas

• If a dose is missed, the patient should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose and continue treatment as usual. If the patient misses two or more doses, they should contact their doctor.
• The patient should not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping treatment with Topiramate Aurovitas

The patient should not stop treatment unless their doctor advises them to do so. After stopping treatment, the symptoms of the underlying disease may return. If the doctor decides to stop treatment, the dose of the medicine may be gradually decreased over a few days.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Topiramate Aurovitas can cause side effects, although not everybody gets them.

The patient should tell their doctor or pharmacist if they 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, leading to increased pressure in the eye, pain, and impaired vision
• Difficulty thinking, remembering, or solving problems, decreased alertness or awareness, feeling extremely sleepy with a lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy)
• 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 (exfoliation and erosion of the skin and mucous membranes), which can be life-threatening.

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 the patient notices any changes in their vision or impaired vision, they should contact their 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 acidity (metabolic acidosis)
• Thoughts of severe self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty falling asleep and waking up
• Feeling unbalanced while walking
• Malaise
• Decreased potassium levels in the blood
• Lack of emotional expression
• Tearfulness
• Slow or irregular heartbeat.

Other side effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• Vertigo (dizziness 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Topiramate Aurovitas

The medicine should be stored out of sight and reach of children.
The patient should not take 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.
The medicine should be stored at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Topiramate Aurovitas contains

• The active substance of Topiramate Aurovitas 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.

• Other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, cornstarch, sodium carboxymethylcellulose (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) for this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the website (URL):