Topamax

Leaflet accompanying the packaging: patient information

Topamax, 25 mg, coated tablets

Topamax, 50 mg, coated tablets

Topamax, 100 mg, coated tablets

Topamax, 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 section 4.

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

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Topamax and what is it used for

Topamax 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 Topamax

When not to take Topamax

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

Migraine prevention

• Topamax must not be taken during pregnancy.
• If you are of childbearing potential, you should not take Topamax without using highly effective contraception during treatment. See below under "Pregnancy and breastfeeding - important advice for women".

Epilepsy treatment

• Topamax 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 Topamax without using highly effective contraception during treatment. The only exception is when Topamax is the only medicine that controls your seizures and you plan to become pregnant. You should discuss this with your doctor to ensure you have received information about the risk of taking Topamax during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn baby 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 attached to the Topamax packaging, reminding you of the risk associated with pregnancy. If you are unsure whether any of the above applies to you, you should consult your doctor or pharmacist before taking Topamax.

Warnings and precautions

Before starting treatment with Topamax, you should discuss with your doctor if you have:

• kidney problems, especially kidney stones or dialysis,
• blood and body fluid disorders (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. Topamax taken during pregnancy may harm your unborn baby. During treatment and for at least 4 weeks after the last dose of Topamax, you should use highly effective contraception. More information can be found in the "Pregnancy and breastfeeding" section.
• if you are pregnant. Topamax taken during pregnancy may harm your unborn baby.

If you are unsure whether any of the above warnings apply to you, you should consult your doctor before taking Topamax. If you have epilepsy, it is important not to stop taking your medicine without consulting your doctor. You should consult your doctor before taking any medicine containing topiramate that has been prescribed for you as a substitute for Topamax. During treatment with Topamax, 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 your child taking this medicine does not gain enough weight, you should consult your doctor. A small number of people taking antiepileptic medicines, such as Topamax, have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, you should contact your doctor immediately. Topamax may cause severe skin reactions; if you experience a rash and/or blisters on your skin, you should immediately inform your doctor (see also section 4 "Possible side effects"). Topamax 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. As 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"): difficulties with thinking, remembering, or solving problems, decreased alertness or awareness, feeling very drowsy with a lack of energy.

The risk of these symptoms may increase with high doses of Topamax.

Topamax and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Topamax may interact with other medicines. As a result, your doctor may need to adjust the dose of your other medicines or adjust the dose of Topamax. 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 (such as central nervous system depressants, such as muscle relaxants and sedatives), hormonal contraceptives. Topamax 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 most suitable method of contraception to use while taking Topamax.

You should tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Topamax. Irregular menstrual bleeding may occur. In this case, you should continue taking 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) (used to treat depression), warfarin (an anticoagulant), should be discussed with your doctor or pharmacist. If you are unsure whether the above text applies to you, you should consult your doctor or pharmacist before taking Topamax.

Topamax with food, drink, and alcohol

You can take Topamax with or without food. You should drink plenty of fluids during the day to prevent kidney stones while taking Topamax. You should avoid drinking alcohol while taking Topamax.

Pregnancy and breastfeeding

Important advice for women of childbearing potential Topamax may harm your unborn baby. Women of childbearing potential should discuss other possible treatments with their doctor. At least once a year, you should visit your doctor to review your treatment and discuss the risks.

• In the case of migraine, Topamax must not be taken during pregnancy.
• In the case of migraine, Topamax must not be taken if you are of childbearing potential, unless you are using highly effective contraception.
• Before starting treatment with Topamax, women of childbearing potential should have a pregnancy test.

Epilepsy treatment

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

Risk of taking topiramate during pregnancy (regardless of the disease being treated):
There is a risk of harm to your unborn baby if you take Topamax during pregnancy.

• Taking Topamax during pregnancy increases the risk of birth defects in your 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 newborn boys, a developmental defect of the penis (hypospadias) may also occur. These defects can develop early in pregnancy, even before you know you are pregnant.
• Taking Topamax during pregnancy may increase the risk of your child developing autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) by 2 to 3 times compared to children born to women with epilepsy who are not taking antiepileptic medicines.
• Taking Topamax during pregnancy may result in your baby being smaller and having a lower birth weight than expected. 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 figure was 5% of newborns.
• If you have any doubts, 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 other possible treatments with their doctor. If Topamax is chosen, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Topamax.
• 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 is 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 Topamax in girls:
Parents or guardians of girls taking Topamax should immediately contact their doctor when their daughter 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 highly effective contraception.
If you want to become pregnant while taking Topamax:

• 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 Topamax 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 Topamax during pregnancy and may refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Topamax:

• You should make an urgent appointment with your doctor.
• If you are taking Topamax to prevent migraines, you should stop taking it immediately and contact your doctor, who will assess whether alternative treatment is necessary.
• If you are taking Topamax 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 baby at risk.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risks of taking Topamax during pregnancy and may refer you to another specialist.
• If Topamax is taken during pregnancy, you will be closely monitored to check the development of your 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 attached to the Topamax packaging, reminding you of the risk associated with pregnancy. Breastfeeding The active substance of Topamax, 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 Topamax. Your doctor will consider the importance of the medicine for you and the risk for your baby. Mothers taking Topamax during breastfeeding should immediately inform their doctor if they notice any change in their child's behavior.

Driving and using machines

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

Topamax contains lactose

Topamax coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Other ingredients

This medicine contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially "sodium-free".

3. How to take Topamax

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

Girls and women of childbearing potential: Treatment with Topamax should be started and supervised by a doctor experienced in the treatment of epilepsy or migraines. You should visit your doctor at least once a year to review your treatment.

Taking a higher dose of Topamax 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 disturbances, 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 Topamax.

Missing a dose of Topamax

• 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 regular dosing schedule. 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 Topamax

You should not stop treatment unless your doctor tells you to. After stopping treatment, your symptoms may return. If your doctor decides to stop treatment, the dose of Topamax 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, slowed 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 difficulties, 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,
• difficulties with thinking, remembering, or solving problems, decreased alertness or awareness, feeling very drowsy 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 may develop into severe, widespread 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 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 seen in adults, but the following side effects may occur more frequently in children than in adults:

• concentration problems,
• metabolic acidosis,
• thoughts of severe self-harm,
• fatigue,
• decreased or increased appetite,
• aggression, abnormal behavior,
• sleep disturbances,
• feeling unbalanced while walking,
• feeling unwell,
• low blood potassium levels,
• 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)

• feeling dizzy (vertigo),
• 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 hot,
• learning difficulties.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Topamax

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister/bottle and carton. The expiry date (EXP) refers to the last day of the month stated. Do not store above 25°C. Blisters: store in the original package to protect the tablets from moisture. Bottles: store in the original package and keep the bottle tightly closed to protect the tablets from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Topamax contains

• The active substance is topiramate.
• Each Topamax tablet contains 25 mg, 50 mg, 100 mg, or 200 mg of topiramate.
• The other ingredients are:
• tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate
• coating: OPADRY white, yellow, pink, Carnauba wax

OPADRY contains: hypromellose, macrogol, polysorbate 80, and as colorants: titanium dioxide E 171 (in all strengths), yellow iron oxide E 172 (50 and 100 mg), red iron oxide E 172 (200 mg).

What Topamax looks like and contents of the pack

25 mg: white, round tablets, 6 mm in diameter, with "TOP" engraved on one side and "25" on the other; 50 mg: light yellow, round tablets, 7 mm in diameter, with "TOP" engraved on one side and "50" on the other; 100 mg: yellow, round tablets, 9 mm in diameter, with "TOP" engraved on one side and "100" on the other; 200 mg: salmon, round tablets, 10 mm in diameter, with "TOP" engraved on one side and "200" on the other. Non-transparent plastic (HDPE) bottle with a child-resistant closure, containing 28 tablets (coated tablets 25 mg, 50 mg, 100 mg, 200 mg), 100 tablets (coated tablets 100 mg and 200 mg), or a package containing 200 tablets (2 x 100 tablets - coated tablets 100 mg and 200 mg). Each package contains a desiccant, which should not be swallowed. Blisters of aluminum/aluminum foil containing 28 or 56 tablets (coated tablets 25 mg, 50 mg, 100 mg, 200 mg) packaged in a carton. Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Manufacturer

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium, Janssen-Cilag S.p.A., Via C. Janssen, Borgo S. Michele, 04100 Latina, Italy, Lusomedicamenta - Sociedade Técnica Farmacêutica S.A., Estrada Consiglieri Pedroso nº 69 B, Queluz de Baixo, 2730-055 Barcarena, Portugal

To obtain more detailed information, you should contact your local representative of the marketing authorization holder: Janssen-Cilag Polska sp. z o.o., tel. +48 22 237 60 00

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

Date of last revision of the leaflet 03/2024
The same information is also available on the following website (URL): https://rejestry.ezdrowie.gov.pl/rpl/search/public
After transferring to the website, you should enter the name of the medicine and then open "Materials to download".