Topamax

Leaflet accompanying the packaging: patient information

Topamax, 15 mg, hard capsules

Topamax, 25 mg, hard capsules

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 you.

• 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See point 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,
• for the prevention of 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 a woman of childbearing age, do not take Topamax without using highly effective contraception during treatment. See also the section below on "Pregnancy and breast-feeding - important advice for women".
• Before starting treatment with Topamax, women of childbearing age must have a pregnancy test.

Epilepsy treatment

• Topamax must not be taken if you are pregnant, unless no other treatment provides adequate control of seizures.
• If you are a woman of childbearing age, do not take Topamax without using highly effective contraception during treatment. The only exception is if Topamax is the only medicine that provides adequate control of seizures and you plan to become pregnant. You should discuss this with your doctor to ensure you have been informed 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.
• Before starting treatment with Topamax, women of childbearing age must have a pregnancy test.

You must read the patient guide provided by your doctor or scan the QR code (see section 6 "Package contents and other information").
A patient card is included with the packaging of 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 age. Topamax taken during pregnancy may harm the unborn child. 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 section "Pregnancy and breast-feeding",
• if you are pregnant. Topamax taken during pregnancy may harm the 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 during treatment with this medicine, you should regularly check your body weight. If you lose too much weight or if your child taking this medicine does not gain enough weight, you should consult your doctor.
In a small number of people taking antiepileptic medicines such as Topamax, thoughts of self-harm or suicide have occurred.
If such thoughts occur, you should contact your doctor immediately.
Topamax may cause severe skin reactions; if a rash and/or blisters occur 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. Since this can be a serious condition, you should immediately tell your doctor if you experience any of the following side effects (see also section 4 "Possible side effects"):

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

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

Topamax and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Topamax may interact with other medicines. In some cases, your doctor may need to adjust the dose of your medicines or change 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 best 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 such cases, 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 breast-feeding

Important advice for women of childbearing age
Topamax may harm the unborn child. Women of childbearing age 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.
Migraine prevention

• 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 a woman of childbearing age, unless you are using highly effective contraception.
• Before starting treatment with Topamax, women of childbearing age must have a pregnancy test.

Epilepsy treatment

• In the case of epilepsy, Topamax must not be taken if you are pregnant, unless no other treatment provides adequate control of seizures.
• In the case of epilepsy, Topamax must not be taken if you are a woman of childbearing age, unless you are using highly effective contraception. The only exception is if Topamax is the only medicine that provides adequate control of seizures and you plan to become pregnant. You should discuss this with your doctor to ensure you have been informed 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.
• Before starting treatment with Topamax, women of childbearing age must have a pregnancy test.

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

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

• Women of childbearing age 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 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.

Use of Topamax in girls:
Parents or guardians of girls treated with Topamax must immediately contact the doctor when the girl has her first menstrual period. The doctor will inform them about the risk to the unborn child resulting from exposure to topiramate during pregnancy and the need to use highly effective contraception.
If you want to become pregnant while taking 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 for migraine prevention, you should stop taking the medicine 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 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 the unborn child.

You must read the patient guide provided by your doctor. The patient guide can also be obtained by scanning the QR code, see section 6 "Package contents and other information". A patient card is included with the packaging of 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 low weight gain have occurred. 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 the mother and the risk for the child.
Mothers taking Topamax during breast-feeding must immediately inform their doctor if they notice any change in their child's behavior.

Driving and using machines

While taking Topamax, dizziness, fatigue, and vision disturbances may occur.
You should not drive or operate any machinery or tools without first consulting your doctor.

Topamax contains sucrose

The hard capsules contain sucrose. 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.

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 hard capsules can be swallowed whole. You can also carefully open the capsule and sprinkle the entire contents into a small amount of soft food (such as applesauce, sweet custard, ice cream, oatmeal, pudding, or yogurt). Each time you take the medicine, you should drink a liquid to ensure that the entire medicine and food are swallowed,
• you should hold the capsule upright to read "TOP",
• then you should twist and pull the two parts of the capsule apart. A better way to give the medicine may be to mix it with small amounts of food, onto which the capsule contents are sprinkled,
• you should sprinkle the capsule contents onto a spoonful of soft food, making sure that the entire dose of medicine is used,
• you should make sure that you swallow the entire contents of the spoonful of the medicine/food mixture. Do not chew. After taking the medicine, you should drink a liquid immediately to ensure that the entire medicine and food are swallowed,
• you should never store the mixture of medicine and food for later use,
• you can take Topamax before, during, or after a meal. While taking Topamax, you should drink plenty of fluids to prevent kidney stones.

Girls and women of childbearing age:
Treatment with Topamax 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 monitor 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 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 Topamax.

Missing a dose of Topamax

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 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 (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid irregular heartbeat),
• decreased or absent sweating (especially in small children in a hot environment),
• thoughts of severe self-harm,
• loss of part of the visual field.

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

• glaucoma, which is characterized by fluid accumulation in the eye chamber, causing increased pressure in the eyeball, pain, and impaired vision,
• difficulty thinking, remembering, or solving problems, decreased alertness or awareness, feeling very sleepy with a lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (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 (peeling 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 report to 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, 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),
• loss of appetite, decreased appetite,
• aggression, agitation, anger, abnormal behavior,
• difficulty sleeping and waking up,
• speech difficulties or speech disturbances, unclear speech,
• lack of coordination or clumsiness, 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,
• 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 disorders (psychosis),
• lack of emotional expression, unusual suspiciousness, panic attacks,
• difficulty reading, speech disturbances, difficulty with handwriting,
• restlessness, increased mental and physical activity,
• slow thinking, decreased alertness,
• weak or slow body movements, involuntary, abnormal, or repetitive muscle contractions,
• falls,
• abnormal sensation of touch; disturbed sense of touch,
• abnormal, disturbed sense of smell or its absence,
• unusual feeling or sensation predicting the occurrence 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 Topamax 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 saliva production, drooling, bad breath,
• excessive fluid intake and increased thirst,
• skin discoloration,
• muscle stiffness, side pain,
• blood in the urine, incontinence, sudden urge to urinate, pain in the side or kidney,
• difficulty achieving or maintaining an erection, sexual dysfunction,
• flu-like symptoms,
• feeling of cold fingers and toes,
• feeling of intoxication,
• difficulty learning.

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

• abnormal elevated mood,
• loss of consciousness,
• loss of vision in one eye, transient blindness, night blindness,
• lazy eye,
• swelling of the eye and surrounding tissues,
• numbness, tingling, and color change of the skin (white, blue, and then red) of the fingers and toes after exposure to cold,
• liver inflammation, liver failure,
• unpleasant body odor,
• discomfort in the upper and lower limbs,
• kidney problems.

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

• macular degeneration - a disease of the macula, the yellow spot of the retina, the area of sharpest 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,
• difficulty sleeping and waking up,
• feeling unbalanced while walking,
• malaise,
• decreased potassium levels in the blood,
• lack of emotional expression,
• tearing,
• slow or irregular heartbeat.

Other side effects that may occur in children include:

Common (may affect up to 1 in 10 people)

• feeling of spinning (dizziness),
• 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 any not listed in this leaflet, you should tell your doctor. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 bottle/carton. The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store the bottle tightly closed to protect the capsules from moisture.
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 Topamax contains

• The active substance is topiramate.
• Each hard capsule of Topamax contains 15 mg or 25 mg of topiramate.
• The other ingredients are:
• sugar spheres (cornstarch, sucrose), povidone, cellulose acetate
• capsule shell: gelatin, titanium dioxide (E 171)
• ink: black ink (iron oxide black (E 172), pharmaceutical glaze, propylene glycol).

What Topamax looks like and contents of the pack

15 mg capsules: small, white or almost white pellets in hard white, opaque capsules with "15 mg" marked on the lower part and "TOP" marked on the transparent upper part
25 mg capsules: small, white or almost white pellets in hard white, opaque capsules with "25 mg" marked on the lower part and "TOP" marked on the transparent upper part
A non-transparent plastic (HDPE) bottle with a child-resistant closure containing 60 pellets in capsules.

Marketing authorization holder

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

Manufacturer

Janssen-Cilag S.p.A.
Via. C. Janssen
Borgo S. Michele
04100 Latina
Italy
To obtain more detailed information, you should contact your local representative of the marketing authorization holder:
Janssen-Cilag Polska sp. z o.o.
ul. Iłżecka 24
02-135 Warsaw
phone: +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
This information is also available on the following website (URL):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After moving to the website, you should enter the name of the medicine and then open "Materiały do pobrania" (Downloadable materials).