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 this 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 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 package leaflet

• 1. What is Topamax and what is it used for
• 2. Before you take 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 to treat seizures in adults and children over 6 years of age,
• in combination with other medicines to treat seizures in adults and children over 2 years of age,
• to prevent migraine headaches in adults.

2. Before you take 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 used during pregnancy.
• If you are of childbearing potential, you should not take Topamax without using a highly effective contraceptive method during treatment. See below under “Pregnancy and breast-feeding - important advice for women”.

Epilepsy treatment

• Topamax must not be used 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 a highly effective contraceptive method during treatment. The only exception is when Topamax 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 Topamax 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 attached to the packaging of Topamax, which reminds you of the risk associated with pregnancy. If you are not sure 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 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. Topamax taken during pregnancy may harm your unborn child. During treatment and for at least 4 weeks after the last dose of Topamax, you should use highly effective contraception. Further information is provided in the section “Pregnancy and breast-feeding”.
• if you are pregnant. Topamax taken during pregnancy may harm your unborn child.

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 taking their own lives. If you ever have these thoughts, you should contact your doctor immediately. Topamax may cause severe skin reactions; if a rash or blisters appear on the 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. 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 extremely sleepy with a lack of energy.

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

Topamax with 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 have a negative effect on thinking, concentration, or muscle coordination (such as central nervous system depressants, muscle relaxants, and sedatives). 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 best method of contraception to use while taking Topamax.

If you are taking hormonal contraceptives and experience changes in menstrual bleeding, you should inform your doctor. In such cases, you should continue to use 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 the formation of kidney stones while taking Topamax. You should avoid drinking alcohol while taking Topamax.

Pregnancy and breast-feeding

Important advice for women of childbearing potential Topamax may harm your unborn child. Women of childbearing potential should discuss with their doctor the possibility of using other treatments instead of Topamax. If the decision is made to start treatment with Topamax, 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 methods of contraception, 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.

Use of Topamax in girls:
Parents or guardians of girls treated with Topamax must immediately contact the 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 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 risk 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 child at risk.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risk of taking Topamax during pregnancy and may refer you to another specialist.
• If Topamax is used during pregnancy, you will be closely monitored to check the development of your 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 attached to the packaging of Topamax, which reminds you of the risk associated with pregnancy. Breast-feeding The active substance of Topamax, topiramate, passes into breast milk. In children breast-fed 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 breast-feeding or stop taking Topamax. Your doctor will consider the importance of the medicine for you and the risk for your child. Mothers taking Topamax during breast-feeding 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, tiredness, 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 instructed you. If you are unsure, you should 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 the formation of 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 monitor your treatment.

Overdose of Topamax

• 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 vision 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 Topamax.

Missed 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, Topamax 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 (new or worsening).

Common (may affect up to 1 in 10 people)

• seizures,
• anxiety, irritability, mood changes, confusion, disorientation,
• concentration problems, slowed thinking, memory problems, or memory disturbances (new, sudden change, or increased severity),
• kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• metabolic acidosis (which may cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, 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 eyeball, 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 (encephalopathy associated with hyperammonemia),
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - may appear 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)

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

Other side effects that you should discuss with your doctor or pharmacist:

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

• inflammation of the nasal passages and throat,
• tingling, pain, and/or numbness in different parts of the body,
• drowsiness, tiredness,
• dizziness,
• nausea, diarrhea,
• weight loss.

Common (may affect up to 1 in 10 people)

• anemia (reduced red blood cell count),
• allergic reactions (such as skin rash, redness, itching, swelling of the face, hives),
• loss of appetite, decreased appetite,
• aggression, agitation, anger, abnormal behavior,
• sleep disturbances and waking up,
• speech difficulties or speech disturbances, slurred speech,
• ataxia or lack of coordination, feeling unbalanced while walking,
• reduced ability to perform routine tasks,
• reduced, lost, or absent sense of taste,
• involuntary trembling or convulsions; rapid uncontrolled eye movements,
• vision disturbances, such as double vision, blurred vision, reduced visual field, vision problems,
• feeling of spinning (dizziness), ringing in the ears, ear pain,
• shortness of breath,
• cough,
• nasal bleeding,
• 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 spasms, muscle pain or weakness, chest pain,
• weight gain.

Uncommon (may affect up to 1 in 100 people)

• reduced platelet count (blood cells responsible for blood clotting), reduced white blood cell count (fighting infections), reduced 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 disorders (psychosis),
• lack of emotional expression and emotional response, unusual suspicion, panic attacks,
• reading difficulties, speech disturbances, difficulties with handwriting,
• restlessness, increased mental and physical activity,
• slowed thinking, decreased alertness,
• weak or slow body movements, involuntary abnormal or repetitive muscle contractions,
• falls,
• abnormal sensation of touch; disturbed sense of touch,
• abnormal sense of smell or loss of smell,
• unusual feeling or sensation preceding the onset of a 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,
• low blood pressure, low blood pressure when standing up (which may cause dizziness, lightheadedness, or fainting in some people taking Topamax),
• hot flashes, feeling of heat,
• pancreatitis,
• excessive gas, heartburn, feeling of fullness in the stomach or bloating,
• gum bleeding, excessive saliva production, drooling, bad breath,
• excessive thirst and fluid intake,
• skin discoloration,
• muscle stiffness, side pain,
• blood in the urine, incontinence, sudden urge to urinate, pain in the side or kidney area,
• difficulty achieving or maintaining an erection, sexual dysfunction,
• flu-like symptoms,
• feeling of cold in the fingers and toes,
• feeling of intoxication,
• learning difficulties.

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

• abnormally 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 upon exposure to cold,
• liver inflammation, liver failure,
• unpleasant body odor,
• discomfort in the arms and legs,
• kidney problems.

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,
• tiredness,
• decreased or increased appetite,
• aggression, abnormal behavior,
• sleep disturbances and waking up,
• feeling unbalanced while walking,
• malaise,
• low potassium levels in the blood,
• lack of emotional expression and emotional response,
• tearing,
• slow or irregular heartbeat.

Other side effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• dizziness (feeling of spinning),
• 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,
• learning difficulties.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor. You can also report side effects 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. You can also report side effects 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 refers to the last day of the month. 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. You should 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 side;
50 mg: light yellow, round tablets, 7 mm in diameter, with “TOP” engraved on one side and “50” on the other side;
100 mg: yellow, round tablets, 9 mm in diameter, with “TOP” engraved on one side and “100” on the other side;
200 mg: salmon-colored, round tablets, 10 mm in diameter, with “TOP” engraved on one side and “200” on the other side.
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 pack containing 200 tablets (2 x 100 tablets - coated tablets 100 mg and 200 mg). Each pack 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 being redirected to the website, you should enter the name of the medicine and then open “Materiały do pobrania” (Materials for download).