Label: information for the user

TOPAMAX 50 mg film-coated tablets

topiramate

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

Topamax belongs to a group of medicines called “antiepileptic medicines”. It is used for:

• treating seizures in adults and children over 6 years old when taken alone
• treating seizures in adults and children 2 or more years old when taken with other medicines
• preventing migraine in adults

Do not take Topamax

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

Prevention of migraines

• Do not take Topamax if you are pregnant.
• If you are a fertile woman, do not take Topamax unless you are using a highly effective contraceptive method during your treatment. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Treatment of epilepsy

• Do not use Topamax if you are pregnant, unless no other treatment offers sufficient control of seizures.

• If you are a fertile woman, do not take Topamax unless you are using a highly effective contraceptive method during your treatment. The only exception is if Topamax is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking Topamax during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Make sure to read the patient leaflet that you will receive from your doctoror scan the codeQR to obtain it (see section6 “Other sources of information”).

A patient leaflet is provided with the Topamax packaging to remind you of the risks during pregnancy.

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using Topamax.

Warnings and precautions

Consult your doctor before starting to take Topamax if you:

• have kidney problems, especially kidney stones, or are receiving dialysis
• have a history of blood or fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are following a high-fat diet (ketogenic diet)
• are a woman who may become pregnant. Topamax may cause harm to a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods should be used during treatment and for at least 4weeks after the last dose of Topamax. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topamax may cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure whether anything above applies to your case, consult your doctor before usingTopamax.

If you have epilepsy, it is important not to stop taking your medication without consulting your doctor first.

You must consult your doctor before taking any other medicine containing topiramate that is given as an alternative to Topamax.

You may lose weight if you take Topamax, so your weight should be monitored regularly while taking this medicine. If you lose too much weight or if a child taking this medicine does not gain enough weight, you must consult your doctor.

A small number of people being treated with antiepileptic drugs such as Topamax have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Topamax may cause severe skin reactions, contact your doctor immediately if you develop a skin rash and/or blisters (see also section 4 “Possible side effects”).

Topamax may cause high levels of ammonia in the blood (seen in blood tests) which can cause a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this can be a serious condition, talk to your doctor immediately if you experience any of the following symptoms (see also section 4 “Possible side effects”):

• difficulty thinking, remembering information or solving problems
• decreased state of alertness or consciousness
• feeling drowsy with low energy

You may increase the risk of developing these symptoms at higher doses of Topamax.

Other medicines and Topamax

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine. Topamax and certain medicines may affect each other. Sometimes, the dose of one or other of the other medicines or Topamax may need to be adjusted.

Especially, inform your doctor or pharmacist if you are taking:

• other medicines that impair or decrease your thoughts, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives).
• hormonal contraceptives. Topamax may make hormonal contraceptives less effective. You should use an additional barrier method such as a condom or diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topamax.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topamax. You may experience irregular bleeding. In this case, continue taking the hormonal contraceptives and inform your doctor.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before starting a new medicine.

Other medicines that you should consult your doctor or pharmacist about include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's Wort(Hypericum perforatum)(a herbal preparation used to treat depression), warfarin used to prevent blood clotting.

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before taking Topamax.

Use of Topamax with food and drinks

You can takeTopamaxwith or without food. Drink plenty of liquid during the day to prevent kidney stone formation while takingTopamax. You should avoid drinking alcohol while takingTopamax.

Pregnancy and breastfeeding

Important advice for fertile women:

Topamax may cause harm to a baby during pregnancy. If you are a fertile woman, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Prevention of migraines

• Do not take Topamax if you are pregnant.
• Do not use Topamax if you are a fertile woman, unless you are using a highly effective contraceptive method.
• A pregnancy test should be performed before starting treatment with Topamax in a fertile woman.

Treatment of epilepsy

• Do not take Topamax if you are pregnant, unless no other treatment offers sufficient control of seizures.
• Do not use Topamax if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topamax is the only treatment that offers sufficient control of seizures and if you plan to become pregnant. You must consult your doctor to ensure that you have received information about the risks of taking Topamax during pregnancy and about the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.
• A pregnancy test should be performed before starting treatment with Topamax in a fertile woman.

Risks of topiramate when taken during pregnancy (regardless of the condition for which topiramate is used) are as follows:

There is a risk of harm to the baby during pregnancy if Topamax is used during pregnancy..

• If you take Topamax during pregnancy, your child will have a higherprobability of having congenital defects.Approximately 4 to 9children out of 100 will have congenital defects. This compares with 1‑3children out of 100 born to women with epilepsy who are not taking an antiepileptic drug.In particular, labial leporine (a cleft lip) and cleft palate have been observed. Newborn males may also have a genital malformation (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.
• If you take Topamax during pregnancy, your child may have a 2 to 3times higher risk of developing autism spectrum disorders, intellectual disabilities or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking an antiepileptic drug.
• If you take Topamax during pregnancy, your child may be smaller and weigh less than expected at birth.In a study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, while 5% of children born to mothers without epilepsy and not taking an antiepileptic drug were smaller and weighed less than expected at birth.
• Consult your doctor if you have any questions about this risk during pregnancy.
• There may be other medicines to treat your condition with a lower risk of congenital defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Topamax. If the decision is made to use Topamax,highly effective contraceptive methods should be used during treatment and for at least 4weeks after the last dose of Topamax.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together with a barrier method such as a condom or diaphragm) should be used. Consult your doctor about the most suitable contraceptive methods for you.
• If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, an additional barrier method (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topamax in girls:

If you are the father/mother or caregiver of a girl treated with Topamax,you should consult your doctor immediately once your daughter experiences her first menstrual period (menarche). The doctor will inform you about the risks to a baby during pregnancy due to exposure to topiramate during pregnancy, and about the need to use highly effective contraceptive methods.

If you want to become pregnant while taking Topamax:

• Book an appointment with your doctor.
• Do not stop using your contraceptive method until you have discussed this with your doctor.
• If you are taking Topamax for epilepsy, do not stop taking it until you have consulted with your doctor, as your condition may worsen.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topamaxduring pregnancy. The doctor may also refer you to another specialist.

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

• Book an urgent appointment with your doctor.
• If you are taking Topamax for migraines, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topamax for epilepsy, do not stop taking this medicine until you have consulted with your doctor, as your condition may worsen. A worsening of your epilepsy may put you or your baby during pregnancy at risk.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topamax during pregnancy. The doctor may also refer you to another specialist.
• If Topamax is used during pregnancy, you will be closely monitored to check how your baby is developing during pregnancy.

Make sure to read the patient leaflet that you will receive from your doctor. The patient leaflet is also available by scanning a QR code; see section6 “Other sources of information”. A patient leaflet is provided with the Topamax packaging to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in Topamax (topiramate) passes into breast milk. Adverse effects have been observed in breastfed infants of mothers treated with Topamax, including diarrhea, feeling sleepy, feeling irritable, and low weight gain. Therefore, your doctor will discuss with you whether to interrupt breastfeeding or whether to interrupt treatment with Topamax. Your doctor will take into account the importance of the benefits for the mother and the risk to the baby.

Mothers who are breastfeeding and takingTopamaxshould inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machines

You may experience dizziness, fatigue, and visual disturbances during treatment withTopamax. Do not drive or operate tools or machineswithout talking to your doctor.

Topamax contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Other excipients

This medicine contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will usually start with a low dose ofTopamaxand gradually increase your dose to find the best one for you.
• Topamaxtablets are swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can takeTopamaxbefore, during, or after a meal. Drink plenty of liquids throughout the day to prevent kidney stone formation while takingTopamax.

Girls and fertile women:

Topamax treatment should begin and continue under the supervision of an experienced doctor in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

If you take more Topamax than you should:

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy, tired, or less attentive; lack of coordination; difficulty speaking or concentrating; double or blurred vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain, or seizures.

You may experience an overdose if you are taking another medication with Topamax.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, Phone 91 5620420.

If you forgot to take Topamax:

• If you forgot to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Consult your doctor if you miss two or more doses.
• Do not take a double dose (two doses at the same time) to compensate for the missed dose.

If you interrupt the treatment with Topamax:

Do not stop treatment without your doctor's instructions. Your symptoms may reappear. If your doctor decides that you should stop taking this medication, they will gradually reduce your dose over several days.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Consult your doctor or seek medical attention immediately if you have 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)(may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Difficulty concentrating, slowness of thought, memory loss, problems with memory (initial, sudden change or worsening)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased blood acidity (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or loss of sweating (especially in young children exposed to high temperatures)
• Having thoughts of self-harm, attempting to cause serious injuries
• Loss of part of the visual field

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

• Glaucoma – blockage of fluid in the eye that causes increased eye pressure, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (encephalopathy)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin eruptions with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin eruptions can become generalized skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Unknown (cannot be estimated from available data):

• Inflammation of the eyes (uveitis) with symptoms such as redness and pain, sensitivity to light, tearing, seeing small dots or blurry vision

Other side effects include the following, if severe, please consult your doctor or pharmacist:

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

• Congestion, runny nose, or sore throat
• Tickling, pain, and/or numbness in several parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, swelling of the face, urticaria)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling or staying asleep
• Speech or language disorders, poor pronunciation when speaking
• Clumsiness or lack of coordination, feeling unstable when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary, uncontrolled movements of the eyes
• Alteration of vision, such as double vision, blurry vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Shortness of breath
• Cough
• Nosebleeds
• Fever, general feeling of illness, weakness
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection
• Dry mouth
• Hair loss
• Itching
• Joint pain or inflammation, muscle spasms or cramps, muscle pain or weakness, chest pain
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Decreased platelets (blood cells that help prevent bleeding), decreased white blood cells that help protect against infections, decreased potassium levels in blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpits, or groin
• Increased appetite
• Exalted mood
• Seeing, hearing, or feeling things that are not there, severe mental disorder (psychosis)
• Not showing or feeling emotions, unusual distrust, panic attack
• Difficulty reading, speech disorder, difficulty writing by hand
• Restlessness, hyperactivity
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Alteration, distortion, or absence of smell
• Unusual feeling that may precede a migraine or certain type of seizure
• Dry eyes, sensitivity of the eyes to light, eyelid tremor, watery eyes
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing (consequently, some people may faint, feel dizzy, or lose consciousness when standing or sitting suddenly)
• Flush or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excessive gas or flatulence, stomach acid, feeling full or bloated
• Nosebleeds, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Decoloration of the skin
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss of bladder control), urgency to urinate, side or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Hands and feet cold
• Sensation of intoxication
• Difficulty learning

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

• Abnormally exalted mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Wandering eye
• Swelling of the eyes and around the eyes
• Numbness, tingling, and color change (white, blue, then red) of the fingers and toes when exposed to cold
• Inflammation of the liver, liver insufficiency
• Unusual skin odor
• Discomfort in the arms and legs
• Alteration of the kidney

Unknown (cannot be estimated from available data)

• Maculopathy is a disease of the macula, a small area in the retina where vision is more acute. Consult your doctor if you notice a change or decrease in your vision.

Other side effects in children

Generally, side effects observed in children are similar to those observed in adults, but the following side effects may be more common in children than in adults:

• Difficulty concentrating
• Increased blood acidity
• Having thoughts of self-harm
• Fatigue
• Increased or decreased appetite
• Aggression, abnormal behavior
• Difficulty falling or staying asleep
• Feeling unstable when walking
• General feeling of illness
• Decreased potassium levels in blood
• Not showing or feeling emotions
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• Sensation of spinning (vertigo)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in blood
• Hyperactivity
• Feeling hot
• Difficulty learning

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister/packaging/container after CAD. The expiration date is the last day of the month indicated.

Do not store above25ºC.

Blister packs: Store in the original packaging to protect the tablets from moisture.

Bottles: Store in the original packaging and keep the bottle perfectly closed to protect the tablets from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at theSIGREpharmacy drop-off point. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Topamax

• The active ingredient is topiramate.
• Each coated tablet of Topamax contains 50 mg of topiramate.
• The other components of Topamax are:

• tablet core: lactose monohydrate 62 mg, cornstarch pregelatinized, microcrystalline cellulose, sodium starch glycolate (Type A),magnesium stearate
• film coating:OPADRY®Yellow1, carnauba wax

1 OPADRY contains: hypromellose, macrogol, polisorbate 80 and as a colorant, titanium dioxide E171 and iron oxide yellow E172.

Appearance of the product and contents of the package

50 mg: yellowish round tablets, 7 mm in diameter, with the inscription "TOP" on one face and "50" on the other face.

Transparent plastic bottle with a child-resistant closure containing 20, 28, 30, 50, 56, 60, 100 or 200 (2x100) coated tablets. Each bottle includes a desiccant that should not be swallowed.

Aluminum/aluminum blister pack. Package sizes: 10, 20, 28, 30, 50, 56, 60, 100 or 200 (2x100) coated tablets. Each blister pack (alu/alu) is contained within a protective pouch.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

JANSSEN-PHARMA, S.L.

Pº de las Doce Estrellas, 5-7

28042 Madrid

Spain

Responsible for manufacturing

Janssen Pharmaceutica NV

Turnhoutseweg 30,

Beerse, 2340

Belgium

or

Janssen-Cilag SpA

Via C. Janssen,

Borgo San Michele

04100

Latina

Italy

or

Lusomedicamenta – Sociedade Técnica Farmacêutica S.A.

Estrada Consiglieri Pedroso nº 69 B

Queluz de Baixo

2730-055 Barcarena

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:March 2024.

Other sources of information

The most recent approved patient guide information for this medicine is available by scanning the following QR code with a smartphone. The same information is also available on the following website (URL):

https://cima.aemps.es/cima/DocsPub/16/3252

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).