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 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 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 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. 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 point 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 breast-feeding - important advice for women”.
• Before starting treatment with Topamax, women of childbearing potential should have a pregnancy test.

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 been informed about the risks 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 the unborn baby if Topamax is taken during pregnancy.

• Taking Topamax 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 newborn boys, a developmental defect of the penis (hypospadias) may also occur. These defects can develop early in pregnancy, even before the patient knows she is pregnant.
• Taking Topamax during pregnancy may increase the risk of autism spectrum disorder, 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 than expected birth weight. In one study, 18% of children whose mothers took topiramate during pregnancy were smaller and weighed less at birth than expected, while in women without epilepsy who did not take antiepileptic medicines, this applied to 5% of newborns.
• If you have any doubts, 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 using contraception in women of childbearing potential:

• Women of childbearing potential should discuss with their doctor the possibility of using other treatment options instead of Topamax. If the decision is made to start treatment with Topamax, highly effective contraception should be used during treatment and for at least 4 weeks after the last dose of Topamax.
• 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) 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 reduce their effectiveness. Therefore, you should use an additional barrier method of contraception (such as a condom or diaphragm).
• 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 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 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 point 6. “Pack contents and other information”. A patient card is included with the packaging of Topamax, which reminds you of the risk associated with taking topiramate during pregnancy.

Breast-feeding

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 the mother and the risk to the baby.

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. Do not drive or operate any tools or machines 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, contact your doctor before taking this medicine.

3. How to take Topamax

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, 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. Alternatively, you can carefully open the capsule and sprinkle the contents onto a small amount of soft food (e.g., apple sauce, custard, yogurt),
• hold the capsule upright to read “TOP” on it,
• then twist off the empty part of the capsule,
• a better way to administer the medicine may be to mix it with small amounts of food, onto which the capsule contents are sprinkled,
• pour the contents of the capsule onto a spoonful of soft food, making sure the entire dose is used,
• make sure you swallow the entire contents of the spoonful of the medicine/food mixture. Do not chew. After taking the medicine, drink some liquid right away to make sure you swallow the entire dose,
• never store the medicine/food mixture for later use,
• Topamax can be taken before, during, or after meals. While taking Topamax, drink plenty of fluids during the day to prevent kidney stones from forming.

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.

What to do if you take more Topamax than you should

• contact your doctor immediately. Also, take the packaging of your 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.

What to do if you forget to take Topamax

• 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, contact your doctor,
• do not take a double dose (two doses at the same time) to make up for a missed dose.

What to do if you stop taking Topamax

Do not stop treatment unless your doctor tells you to. If you stop taking Topamax, 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor or pharmacist if you get 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 disturbances, slowed thinking, 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 difficulties, 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,
• difficulties with thinking, remembering, or solving problems, decreased alertness or consciousness, feeling of strong drowsiness with lack of energy - may be symptoms of high blood ammonia levels (hyperammonemia), which can lead to brain function changes (hyperammonemic encephalopathy),
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis - may occur as a rash with blisters or without. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes can 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 symptoms such as eye redness, pain, sensitivity to light, tearing, blurred vision, or floaters.

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

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

• nasal congestion,
• 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 (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, difficulty falling asleep or waking up,
• speech or language disturbances, slurred speech,
• ataxia or lack of coordination, feeling of imbalance while walking,
• reduced ability to perform routine tasks,
• taste disturbances, loss of taste,
• involuntary trembling or seizures, rapid uncontrolled eye movements,
• vision disturbances, such as double vision, blurred vision, reduced visual field, focusing difficulties,
• vertigo, ringing in the ears, ear pain,
• shortness of breath,
• cough,
• nosebleeds,
• fever, malaise, loss of strength,
• vomiting, constipation, abdominal pain or discomfort, indigestion, gastrointestinal infection,
• dry mouth,
• hair loss,
• itching,
• joint or muscle pain, swelling, muscle spasms or twitching, muscle weakness or pain, 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),
• lymph node swelling 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,
• reading difficulties, speech or language 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 touch sensation,
• abnormal sense of smell or its absence,
• unusual sensation or feeling 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,
• low blood pressure, low blood pressure when standing up (which may cause dizziness, lightheadedness, or loss of consciousness in some people taking Topamax),
• hot flashes, feeling of heat,
• pancreatitis,
• excessive gas, heartburn, feeling of fullness in the stomach or bloating, indigestion, gastrointestinal infection,
• gum bleeding, excessive saliva production, 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,
• 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)

• 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,
• hepatitis, liver failure,
• unpleasant body odor,
• upper and lower limb discomfort,
• 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 observed 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, difficulty falling asleep or waking up,
• feeling of imbalance while walking,
• malaise,
• low 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)

• 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 of heat,
• 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 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:
• sucrose 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 gelatin 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 gelatin 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 hard 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, contact your local representative of the marketing authorization holder:

Janssen-Cilag Polska sp. z o.o.

ul. Iłżecka 24

02-135 Warsaw

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 moving to the website, enter the name of the medicine and then open “Materiały do pobrania” (Downloadable materials).