Topamax

Package leaflet: Information for the patient

Topamax, 25 mg, coated tablets
Topamax, 50 mg, coated tablets
Topamax, 100 mg, coated tablets
Topamax, 200 mg, coated tablets
Topiramatum
This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. Patients can also help by reporting any adverse reactions that occur after using the medicine. To find out
how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Topamax is and what it is 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 Topamax is and what it is used for

Topamax belongs to a group of medicines called antiepileptic drugs. It is used:

• as monotherapy in the treatment of epileptic seizures in adults and children over 6 years of age,
• in combination with other medicines for the treatment of epileptic seizures in adults and children aged 2 years and older,
• for the prevention of migraine headaches in adults.

2. Important information before taking Topamax

When not to take Topamax

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

Prevention of migraine

• Topamax must not be used during pregnancy.
• If the patient is of childbearing age, Topamax must not be taken without using a highly effective method of contraception during treatment. See below in section "Pregnancy and breastfeeding – important advice for women".

Treatment of epilepsy

• Topamax must not be used if the patient is pregnant, unless no other treatment method provides adequate seizure control.
• If the patient is of childbearing age, Topamax must not be used without using a highly effective method of contraception during treatment. The only exception is when Topamax is the only medicine providing adequate seizure control and the patient is planning to become pregnant. The patient should talk to the doctor to ensure she has received information about the risks of using Topamax during pregnancy and the risks of seizures occurring during pregnancy. See below in section "Pregnancy and breastfeeding – important advice for women".

It is essential to read the Patient Guide provided by the doctor or
scan the QR code (see section 6 "Contents of the pack and other information").
A patient card is included in the Topamax packaging, reminding of the risks associated with
pregnancy.
If the patient is unsure whether any of the symptoms described above apply, he or she should
consult a doctor or pharmacist before taking Topamax.
Warnings and precautions
Before starting Topamax, discuss with the doctor if any of the following apply:

• kidney problems, especially kidney stones or dialysis,
• abnormalities in blood and body fluids (metabolic acidosis),
• liver disorders,
• vision problems, especially glaucoma,
• growth disorders,
• if a high-fat diet (ketogenic diet) is being used,
• if the patient is a woman of childbearing age. Topamax taken during pregnancy may harm the unborn child. A highly effective method of contraception must be used during treatment and for at least 4 weeks after taking the last dose of Topamax. Further information can be found in the section "Pregnancy and breastfeeding",
• if the patient is pregnant. Topamax taken during pregnancy may harm the unborn child.

If in doubt whether any of the above warnings apply, the patient should talk to the doctor before
taking Topamax.
If the patient has epilepsy, it is important not to stop taking the medicine without consulting the
doctor.
The patient should consult the treating doctor before taking any medicine containing topiramate
prescribed as a substitute for Topamax.
While taking Topamax, the patient may lose weight; therefore, body weight should be monitored
regularly during treatment. If the patient loses too much weight or if a child taking this medicine does not gain sufficient weight, the treating doctor should be consulted.
A small number of people taking antiepileptic medicines, such as Topamax, have had thoughts of
harming themselves or of suicide.
If such thoughts occur, contact the doctor immediately.
Topamax may cause severe skin reactions; if a rash and/or blisters appear on the skin, the doctor
should be informed immediately (see also section 4. "Possible side effects").
Topamax may, in rare cases, cause increased levels of ammonia in the blood (detected in blood
tests), which may lead to changes in brain function, especially if the patient is also taking a medicine containing valproic acid or sodium valproate.
As this may be an acute condition, the doctor should be informed immediately if any of the
following side effects occur (see also section 4. "Possible side effects"):

• difficulty thinking, remembering or solving problems,
• reduced alertness or consciousness,
• feeling very sleepy with lack of energy.

The risk of these symptoms may increase when high doses of Topamax are used.
Topamax and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take.
Topamax may interact with other medicines. Therefore, the dose of other medicines taken by the
patient may sometimes need to be adjusted, or the dose of Topamax may need to be changed.
In particular, inform the doctor or pharmacist if the patient is taking:

• other medicines that have harmful effects or reduce thinking, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives), or hormonal contraceptives. Topamax may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. Talk to the doctor about the best method of contraception to use during treatment with Topamax.

Tell the doctor if menstrual bleeding changes while using hormonal contraceptives and Topamax.
Irregular bleeding may occur. In such a case, continue using hormonal contraceptives and inform
the doctor.
Keep a list of all medicines being taken. Show this list to the doctor and pharmacist when starting
a new treatment.
The use of other medicines such as antiepileptic drugs, digoxin, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, haloperidol, propranolol, diltiazem, venlafaxine, flunarizine, St John's wort (Hypericum perforatum) (used to treat depression), warfarin (an anticoagulant), should be discussed with the doctor or pharmacist.
If the patient is unsure whether the above applies, he or she should consult a doctor or pharmacist before taking Topamax.
Topamax with food, drink and alcohol
Topamax may be taken with or without food. Drink plenty of fluids during the day to help prevent
the formation of kidney stones while taking Topamax. Alcohol should be avoided while taking Topamax.
Pregnancy and breastfeeding
Important advice for women of childbearing potential
Topamax may harm the unborn child. Women of childbearing age should discuss other possible
treatment options with their doctor. At least once a year, visit the doctor to review treatment and
discuss risks.
Prevention of migraine

• For migraine, Topamax must not be used during pregnancy.
• For migraine, Topamax must not be used if the patient is of childbearing age unless she is using a highly effective method of contraception.
• Before starting Topamax in a woman of childbearing age, a pregnancy test must be performed.

Treatment of epilepsy

• For epilepsy, Topamax must not be used if the patient is pregnant, unless no other treatment method provides adequate seizure control.
• For epilepsy, Topamax must not be used if the patient is of childbearing age unless she is using a highly effective method of contraception. The only exception is when Topamax is the only medicine providing adequate seizure control and the patient is planning to become pregnant. The patient should talk to the doctor to ensure she has received information about the risks of using Topamax during pregnancy and the risks of seizures occurring during pregnancy, which may place the patient or unborn child at risk.
• Before starting Topamax in a woman of childbearing age, a pregnancy test must be performed.

Risk of using topiramate during pregnancy (regardless of the disease for which topiramate is used):
There is a risk of harm to the unborn child if Topamax is used during pregnancy.

• Using Topamax during pregnancy increases the risk of congenital malformations in the child. In women taking topiramate, congenital malformations occur in approximately 4–9 out of 100 children. For comparison, this rate is 1–3 out of 100 children born to women who do not have epilepsy and do not take antiepileptic medicines. In particular, cleft lip (cleft upper lip) and cleft palate (cleft palate) have been observed. In male newborns, a developmental defect of the penis (hypospadias) may also occur. These defects may develop early in pregnancy, even before the patient knows she is pregnant.
• When Topamax is used during pregnancy, the risk of autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) in the child may be 2 to 3 times higher than in children born to women with epilepsy who do not take antiepileptic medicines.
• When Topamax is used during pregnancy, the child may be smaller and have lower than expected birth weight. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, whereas this occurred in 5% of newborns born to women without epilepsy who did not take antiepileptic medicines.
• If in doubt, ask the doctor about the risks during pregnancy.
• Other medicines used to treat this condition may be available that carry a lower risk of congenital malformations.

Necessity of using contraception in women of childbearing age:

• Women of childbearing age should discuss with their doctor the possibility of using other treatment methods instead of Topamax. If the decision is made to start treatment with Topamax, a highly effective method of contraception must be used during treatment and for at least 4 weeks after taking the last dose of Topamax.
• One highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as a contraceptive pill combined with a mechanical method (such as a condom or diaphragm/cervical cap), should be used. Talk to the doctor to find out which method of contraception is most suitable for the patient.
• If the patient uses hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, an additional barrier method of contraception (such as a condom or diaphragm/cervical cap) should be used.
• If irregular menstrual bleeding occurs, inform the doctor.

Use of Topamax in girls:
Parents or guardians of a girl being treated with Topamax must contact the doctor immediately
when the girl has her first menstrual period. The doctor will inform them about the risk to the
unborn child from exposure to topiramate during pregnancy and the need to use a highly effective
method of contraception.
If the patient wishes to become pregnant while taking Topamax:

• Make an appointment with the doctor.
• Do not stop using contraception until this issue has been discussed with the doctor.
• If the patient takes Topamax for epilepsy, do not stop taking it without consulting the doctor, as the condition may worsen.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Topamax during pregnancy. The doctor may also refer her to another specialist.

If the patient becomes pregnant or suspects she may be pregnant while taking Topamax:

• Make an urgent appointment with the doctor.
• If taking Topamax for migraine prevention, stop taking the medicine immediately and contact the doctor, who will assess whether alternative treatment is necessary.
• If the patient takes Topamax for epilepsy, do not stop taking it without consulting the doctor, as this may worsen the condition. Worsening epilepsy may place the patient or unborn child at risk.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risks of using Topamax during pregnancy. The doctor may also refer her to another specialist.
• If Topamax is used during pregnancy, the patient will remain under close monitoring to check the development of the unborn child.

It is essential to read the Patient Guide provided by the doctor. The Patient Guide can also be
obtained by scanning the QR code; see section 6. "Contents of the pack and other information".
A patient card is included in the Topamax packaging, reminding of the risks associated with using
topiramate during pregnancy.
Breastfeeding
The active substance of Topamax (topiramate) passes into human milk. Adverse effects such as
diarrhoea, drowsiness, irritability and poor weight gain have been observed in infants breastfed
by mothers taking this medicine. Therefore, the doctor will discuss with the patient whether to
stop breastfeeding or to stop using Topamax. The doctor will consider the importance of the
medicine for the mother and the risk for the child.
Mothers taking Topamax during lactation must inform the doctor immediately if they notice any
change in their child's behaviour.
Driving and using machines
Dizziness, fatigue and visual disturbances may occur while taking Topamax.
Do not drive, operate any machinery or use tools before seeking medical advice.
Topamax contains lactose
Topamax coated tablets contain lactose. If the patient has been informed by the doctor that he or
she has an intolerance to certain sugars, he or she should contact the doctor before taking this
medicine.
Other ingredients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, so the medicine is considered "sodium-free".

3. How to use Topamax

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• Your doctor usually starts treatment with a low dose of Topamax and gradually increases it until the optimal dose for the individual patient is established.
• Topamax tablets should be swallowed whole. Chewing the tablets is not recommended, as they may leave a bitter taste.
• Topamax may be taken before, during, or after a meal. While taking Topamax, you should drink plenty of fluids to help prevent kidney stone formation.

Girls and women of childbearing age:
Treatment with Topamax should be initiated and supervised by a doctor experienced in the treatment of epilepsy or migraine. You should visit your doctor at least once a year for treatment monitoring.

Taking more Topamax than prescribed

• Contact your doctor immediately. Also, bring the medicine package with you.
• You may experience the following symptoms: drowsiness, fatigue or reduced alertness, lack of coordination, speech or concentration difficulties, double or blurred vision, dizziness due to low blood pressure, feelings of depression or agitation, abdominal pain, or seizures.

Overdose may also occur when Topamax is taken together with other medicines.

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 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.

Stopping Topamax Do not stop taking this medicine unless your doctor tells you to. After stopping treatment, symptoms of the underlying disease may return. If your doctor decides to discontinue treatment, the dose of Topamax may be gradually reduced over a period of several days.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should tell your doctor or pharmacist if any of the following adverse reactions occur:

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

• Depression (new onset or worsening of existing depression)

Common (may affect up to 1 in 10 people)

• Seizures,
• Anxiety, irritability, mood changes, confusion, disorientation,
• Difficulty concentrating, slowed thinking, memory loss, memory disturbances (new onset, 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 fast or irregular heartbeat),
• Reduced or absent sweating (particularly in young children exposed to high environmental temperatures),
• Thoughts or attempts of severe self-harm,
• Loss of part of the visual field.

Rare (may affect up to 1 in 1000 people)

• Glaucoma, characterized by fluid buildup in the eye chamber, leading to increased intraocular pressure, eye pain, and blurred vision,
• Difficulty thinking, remembering, or solving problems, decreased alertness or consciousness, feeling extremely drowsy with lack of energy – these may be signs of high blood ammonia levels (hyperammonemia), which may lead to brain dysfunction (hyperammonemia-related encephalopathy),
• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis – may present as blistering rash or non-blistering rash. Skin irritation, ulcers, or swelling in the mouth, throat, nose, eyes, and genital areas. Skin rashes may progress to severe, widespread skin damage (detachment of the outer layer of skin and mucous membranes), which may be life-threatening.

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

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

Other adverse reactions that should be reported to your doctor or pharmacist:

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

• Inflammation of the mucous membranes of the nose and throat,
• Tingling, pain, and (or) numbness in various parts of the body,
• Drowsiness, fatigue,
• Dizziness,
• Nausea, diarrhoea,
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anaemia (reduced number of red blood cells),
• Allergic reactions (such as skin rash, redness, itching, facial swelling, hives),
• Loss of appetite, reduced appetite,
• Aggression, restlessness, anger, abnormal behaviour,
• Difficulty falling asleep and waking up,
• Slurred or impaired speech,
• Impaired motor coordination or lack of coordination, feeling unsteady while walking,
• Reduced ability to perform routine tasks,
• Reduced, lost, or absent sense of taste,
• Involuntary tremors or twitching; rapid, uncontrolled eye movements,
• Visual disturbances such as double vision, blurred vision, reduced field of vision, focusing problems,
• Sensation 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 twitches, muscle pain or weakness, chest pain,
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Reduced platelet count (platelets responsible for blood clotting), reduced white blood cell count (cells that fight infections), decreased blood potassium levels,
• Increased liver enzyme activity, increased blood eosinophil count (a type of white blood cell),
• Swelling of lymph nodes in the neck, armpits, and groin,
• Increased appetite,
• Elevated mood,
• Hallucinations (seeing, hearing, or feeling things that are not present), severe mental disturbances (psychosis),
• Inability to feel or express emotions, unusual suspiciousness, panic attacks,
• Reading difficulties, speech disturbances, handwriting difficulties,
• Restlessness, increased mental and physical activity,
• Slowed thinking, reduced level of alertness,
• Weak or slow body movements, involuntary abnormal or repetitive muscle contractions,
• Falls,
• Abnormal sensation or impaired perception of touch,
• Impaired, distorted, or loss of sense of smell,
• Unusual sensation or feeling that precedes migraine or certain types of seizures,
• Dry eyes, light sensitivity, involuntary eye movements, tearing,
• Hearing loss or reduced hearing, hearing loss in one ear,
• Slow or irregular heartbeat, palpitations,
• Low blood pressure, low blood pressure upon standing (which in some people taking Topamax may result in feeling faint, dizzy, or losing consciousness when standing up or sitting down suddenly),
• Hot flushes, feeling of warmth,
• Pancreatitis,
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating,
• Bleeding gums, excessive saliva production, drooling, bad breath,
• Excessive fluid intake and increased thirst,
• Skin discoloration,
• Muscle stiffness, flank pain,
• Blood in urine, urinary incontinence, sudden urge to urinate, flank or kidney pain,
• Difficulty achieving or maintaining erection, sexual dysfunction,
• Flu-like symptoms,
• Cold sensation in fingers of hands and feet,
• Feeling of alcohol intoxication,
• Learning difficulties.

Rare (may affect up to 1 in 1000 people)

• Abnormally elevated mood,
• Loss of consciousness,
• Vision loss in one eye, transient blindness, night blindness,
• Lazy eye,
• Swelling of the eye and tissues around the eye,
• Numbness, tingling, and skin color changes (white, blue, then red) in fingers of hands and feet upon cold exposure,
• Hepatitis, liver failure,
• Unpleasant body odour,
• Discomfort in upper and lower limbs,
• Kidney disorders.

Not known (frequency cannot be estimated from available data)

• Macular degeneration – a disease of the macula (the central part of the retina responsible for sharp vision). If you notice any changes in vision or blurred vision, contact your doctor.

Children

Adverse reactions in children are generally similar to those observed in adults, but the following adverse reactions 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 behaviour,
• Difficulty falling asleep and waking up,
• Feeling unsteady while walking,
• Malaise,
• Low blood potassium levels,
• Inability to feel or express emotions,
• Tearing,
• Slow or irregular heartbeat.

Other adverse reactions that may occur in children:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (dizziness),
• Vomiting,
• Fever;

Uncommon (may affect up to 1 in 100 people)

• Increased blood eosinophil count (a type of white blood cell),
• Hyperactivity,
• Feeling of warmth,
• Learning difficulties.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 pack/bottle and carton.
The expiry date (EXP) refers to the last day of the specified month.
Do not store above 25°C.
Blister packs: store in the original packaging to protect the tablets from moisture.
Bottles: store in the original packaging and keep the bottle tightly closed to protect the tablets from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Topamax contains

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

OPADRY contains: hypromellose, polyethylene glycol, polysorbate 80 and as colorants: titanium dioxide E 171 (in all strengths), yellow iron oxide E 172 (50 mg 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-coloured, round tablets, 10 mm in diameter, with "TOP" engraved on one side and "200" on the other side.

Opaque plastic (HDPE) bottle with a tamper-evident 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 container includes a desiccant which must not be swallowed.

Aluminium/Aluminium foil blisters containing 28 or 56 tablets (coated tablets 25 mg, 50 mg, 100 mg, 200 mg), packed in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, contact the local representative of the Marketing Authorisation Holder:
Janssen-Cilag Polska sp. z o.o.
tel. +48 22 237 60 00

This medicinal product is authorised in the European Economic Area member states under the following names:

The same information is also available at the following website (URL):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After navigating to the website, enter the name of the medicinal product and then open "Materials for download".