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 treating seizures in adults and children over 6 years of age.
• with other medicines for treating 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 you are allergic to topiramate or any of the other ingredients of this medicine (listed in Section 6). Migraine prevention
• Topiramate Aurovitas must not be taken during pregnancy.
• If you are of childbearing potential, you should not take Topiramate Aurovitas without using a highly effective contraceptive method during treatment. See also the section below entitled “Pregnancy, breastfeeding and fertility – important advice for women”.

storing the medicine, and what the package contains, see Section 6.

• Topiramate Aurovitas must not be taken if you are pregnant, unless no other treatment is effective to control your seizures.
• If you are of childbearing potential, you must not take Topiramate Aurovitas without using a highly effective contraceptive method during treatment. The only exception is when Topiramate Aurovitas is the only medicine that controls your seizures and you plan to become pregnant. You must discuss this with your doctor to ensure you are fully aware of the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may harm you or your unborn baby.

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 in 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 abnormalities (metabolic acidosis)
• liver problems
• eye 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 baby. During treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas, you must use a highly effective method of 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 baby.

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

Topiramate Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take. Topiramate Aurovitas may interact with other medicines. Sometimes, your doctor may need to adjust the dose of the medicines you are taking or change the dose of Topiramate Aurovitas.

• other medicines that have a negative effect 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.

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

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 while taking Topiramate Aurovitas.

Pregnancy, breastfeeding, and fertility

Important advice for women of childbearing potential

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

Migraine prevention:

• Topiramate Aurovitas must not be taken during pregnancy.
• Topiramate Aurovitas must not be taken if you are of childbearing potential unless you use a highly effective method of contraception.
• Before starting Topiramate Aurovitas, women of childbearing potential should have a pregnancy test.

Epilepsy treatment:

• Topiramate Aurovitas must not be taken if you are pregnant unless no other treatment is effective to control your seizures.
• Topiramate Aurovitas must not be taken if you are of childbearing potential unless you use a highly effective method of contraception. The only exception is when Topiramate Aurovitas is the only medicine that controls your seizures and you plan to become pregnant. You must discuss this with your doctor to ensure you are fully aware of the risks of taking Topiramate Aurovitas during pregnancy and the risk of seizures during pregnancy, which may harm you or your unborn baby.
• Before starting Topiramate Aurovitas, women of childbearing potential should have a pregnancy test.

The 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 baby. In women taking topiramate, birth defects occur in about 4-9 out of 100 babies. For comparison, this figure is 1-3 out of 100 babies 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 male newborns, a developmental defect of the penis (hypospadias) may also occur. These defects can develop early in pregnancy, even before the patient knows they are pregnant.
• The risk of autism spectrum disorder, intellectual disability, or attention deficit hyperactivity disorder (ADHD) in the child may be 2 to 3 times higher than in children born to women with epilepsy who are not taking antiepileptic medicines.

If you have any doubts, you should ask your 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 potential:

• Women of childbearing potential should discuss the possibility of using other treatment options instead of Topiramate Aurovitas with their doctor. If the decision is made to start treatment with Topiramate Aurovitas, a highly effective contraceptive method should be used during treatment and for at least 4 weeks after the last dose of Topiramate Aurovitas.
• A single highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill in combination with a mechanical contraceptive method, such as a condom or diaphragm/cervical cap) should be used. 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.

Use of Topiramate Aurovitas in girls:

• Parents or guardians of girls treated with Topiramate Aurovitas should immediately contact the doctor when the girl has her first menstrual period. The doctor will inform them about the risk to the unborn baby resulting from exposure to topiramate during pregnancy and the need to use a highly effective method of contraception.
• If you want to become pregnant while taking Topiramate Aurovitas:

You should make an appointment with your doctor.

• Do not stop using contraception until you have discussed this with your doctor.
• If you are taking Topiramate Aurovitas for epilepsy, do 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 and may 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.
• If you are taking Topiramate Aurovitas for migraine prevention, you should stop taking it immediately and contact your doctor, who will assess whether alternative treatment is needed.
• If you are taking Topiramate Aurovitas for epilepsy, do not stop taking it without consulting your doctor, as this may worsen your condition. Worsening of epilepsy may put you or your unborn baby 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 and may refer you to another specialist.
• If Topiramate Aurovitas is taken during pregnancy, you will be closely monitored to check the development of the unborn baby.

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 in 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 been reported. 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 baby.

Mothers taking Topiramate Aurovitas during breastfeeding 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. Do not drive or operate any tools or machines without medical advice.

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

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. You should visit your doctor at least once a year 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 have a bitter taste.
• Topiramate Aurovitas can be taken before, during, or after meals. While taking Topiramate Aurovitas, you should drink plenty of fluids to prevent 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 disturbances or concentration problems, double or blurred vision, dizziness due to low blood pressure, feeling depressed or agitated, abdominal pain, or seizures.

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

Missing a dose of Topiramate Aurovitas

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

Stopping treatment with Topiramate Aurovitas

Do 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, ask your doctor or pharmacist.

4. Possible side effects

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

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 (new or worsening).

Common (may affect up to 1 in 10 people)

• Seizures
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration problems, slow thinking, memory loss, memory problems (new, sudden change, or increased severity)
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Metabolic acidosis (may 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 consciousness, feeling extremely drowsy with a lack of energy - may be symptoms of high ammonia levels in the blood (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)

• Eye inflammation (uveitis) with the following symptoms: eye redness, pain, sensitivity to light, tearing, blurred vision, or floaters.

Other side effects that you should report to your doctor or pharmacist:

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

• Inflammation of the nasal passages and throat
• Numbness, pain, and/or tingling of different parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anemia (decreased red blood cell count)
• Allergic reactions (such as skin rash, redness, itching, swelling of the face, hives)
• Lack of appetite, decreased appetite
• Aggression, agitation, anger, unusual behavior
• Sleep disturbances and waking up
• Speech difficulties or speech disturbances, slurred speech
• Difficulty walking or lack of coordination, feeling unbalanced while walking
• Decreased ability to perform routine tasks
• Taste disturbances, loss of taste
• Involuntary trembling or twitching; rapid, uncontrolled eye movements
• Vision disturbances, such as double vision, blurred vision, decreased visual field, vision problems
• Feeling of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, malaise, loss of strength
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or swelling, muscle cramps or twitching, muscle pain or weakness, chest pain
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells responsible for blood clotting), decreased white blood cell count (fighting infections), decreased potassium levels in the blood
• Increased liver enzyme activity, increased eosinophil count in the blood (a type of white blood cell)
• Swollen lymph nodes in the neck, armpits, and groin
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disturbances (psychosis)
• Lack of emotions and emotional expression, unusual suspiciousness, panic attacks
• Reading difficulties, speech disturbances, difficulties with handwriting
• Restlessness, increased mental and physical activity
• Slow thinking, decreased alertness
• Weakened or slow body movements, involuntary, abnormal, or repetitive muscle contractions
• Fainting
• Abnormal sensation of touch; disturbed sense of touch
• Abnormal sense of smell or loss of smell
• Unusual feeling or sensation preceding the onset of migraine or a certain type of seizure
• Dry eyes, sensitivity to light, involuntary eye movements, tearing
• Hearing loss, hearing loss in one ear
• Slow or irregular heartbeat, feeling of heartbeat in the chest
• Decreased blood pressure, decreased blood pressure when standing up (which may cause a feeling of fainting, dizziness, or loss of consciousness in some people taking Topiramate Aurovitas when they stand up or sit down suddenly)
• Hot flashes, feeling of heat
• Pancreatitis
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating
• Gum bleeding, excessive salivation, drooling, bad breath
• Excessive fluid intake and increased thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, urinary incontinence, sudden urge to urinate, pain in the side or kidney pain
• Difficulty getting or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold sensation in fingers and toes
• Feeling of intoxication
• Difficulty learning.

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

• Elevated mood
• Loss of consciousness
• Loss of vision in one eye, transient blindness, night blindness
• Lazy eye
• Eye and surrounding tissue swelling
• Numbness, tingling, and color change (white, blue, and then red) of the fingers and toes after exposure to cold
• Hepatitis, liver failure
• Unpleasant body odor
• Discomfort in the arms and legs
• Kidney problems.

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 acidity (metabolic acidosis)
• Thoughts of severe self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, unusual behavior
• Sleep disturbances and waking up
• Feeling unbalanced while walking
• Malaise
• Decreased potassium levels in the blood
• Lack of emotions and 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)

• Vertigo (dizziness of inner ear origin)
• Vomiting
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophil count in the blood (a type of white blood cell)
• Hyperactivity
• Feeling of heat
• Difficulty learning.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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

Side effects can also be reported to the marketing authorization holder.

5. How to store Topiramate Aurovitas

Keep this medicine out of the sight and reach of children.

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

Store in a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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: 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” embossed on one side and “22” on the other side.

Topiramate Aurovitas, 50 mg, coated tablets:

Light yellow, round, biconvex coated tablets with “E” embossed 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” embossed 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” embossed 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

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 your smartphone. The same information is also available on the following website (URL):