Prospect: information for the patient

Topiramato Sandoz 25 mg film-coated tablets

Topiramato Sandoz 50 mg film-coated tablets

Topiramato Sandoz 100 mg film-coated tablets

Topiramato Sandoz 200 mg film-coated tablets

This medicine is subject to additional monitoring, which will facilitate 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 prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor, pharmacist or nurse.
• This medicine has been prescribedonlyto you, and you must not give it to other people althoughtheymay havethe same symptomsas you,as it may harm them.
• If you experience adverse effects,consult your doctor, pharmacist or nurse, evenifthey are not listed in this prospect. See section 4.

1.What is Topiramato Sandoz and what is it used for

2.What you need to know beforestarting totake Topiramato Sandoz

3.How to take Topiramato Sandoz

4.Possible adverse effects

5Storage of Topiramato Sandoz

6.Contents of the pack and additional information

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

• the treatment of seizures in adults and children over 6 years old when given alone,
• the treatment of seizures in adults and children 2 or more years old when given with other medicines,
• to prevent migraine in adults.

Do not take Topiramato Sandoz:

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

Prevention of migraines

• Do not take topiramate if you are pregnant.
• If you are a fertile woman, do not take topiramate 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 topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, do not take topiramate, unless you are using a highly effective contraceptive method during your treatment. The only exception is if topiramate 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 topiramate 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 doctor or scan the QR code to obtain it (see section 6 “Other sources of information”.

A patient leaflet is provided with the packaging of Topiramato Sandoz 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 topiramate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Topiramato Sandoz if:

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

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

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

It is essential not to stop taking your medication without consulting your doctor first.

You must consult your doctor before taking any other medication that contains topiramate that is given as an alternative to topiramate.

You may lose weight if you take topiramate, 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 taking antiepileptic medicines like topiramate have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Topiramate 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”).

Topiramate may cause high levels of ammonia in the blood (seen in blood tests) which may 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 alertness or consciousness
• feeling drowsy with low energy

You may be at increased risk of developing these symptoms at higher doses of topiramate.

Other medicines and Topiramato Sandoz

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

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

• other medicines that impair or reduce your thoughts, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives),
• hormonal contraceptives. Topiramate 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 topiramate.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and topiramate. You may experience irregular menstrual 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 for the treatment of depression), warfarin used to prevent blood clotting.

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

Topiramato Sandoz with food, drinks and alcohol

You can take topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stone formation while taking topiramate.

You should avoid drinking alcohol while taking topiramate.

Pregnancy, breastfeeding and fertility

Important advice for fertile women:

Topiramate 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 topiramate if you are pregnant.
• Do not use topiramate 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 topiramate in a fertile woman.

Treatment of epilepsy

• Do not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• Do not use topiramato Sandoz if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if topiramate 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 topiramate during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• A pregnancy test should be performed before starting treatment with topiramato Sandoz in a fertile woman.

The 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 a baby during pregnancy if topiramate is used during pregnancy.

• If you take topiramate during pregnancy, your child will have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children will have birth defects. This compares with 1-3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medicine. In particular, there have been reports of cleft lip (a split in the upper lip) and cleft palate (a split in the palate). Newborn boys 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 topiramate during pregnancy, your child may be at a 2-3 times higher risk of developing autism spectrum disorders, intellectual disabilities or attention deficit hyperactivity disorder (ADHD) compared with children born to women with epilepsy who are not taking an antiepileptic medicine.
• If you take topiramate 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 who were not taking an antiepileptic medicine 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 birth defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking topiramate. If the decision is made to use topiramate, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of topiramate.

You should use a highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a hormonal contraceptive with a barrier method (such as a condom or diaphragm). Consult your doctor about the most suitable contraceptive methods for you.

• If you are taking hormonal contraceptives, there may be a reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, you should use an additional barrier method (such as a condom or diaphragm).
• Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent/caregiver of a girl treated with topiramate, 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 topiramate:

• 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 topiramate 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 topiramate during pregnancy. The doctor may also refer you to another specialist.

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

• Book an urgent appointment with your doctor.
• If you are taking topiramate for migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need an alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking it 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 topiramate during pregnancy. The doctor may also refer you to another specialist.
• If topiramate 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 or scan the QR code to obtain it (see section 6 “Other sources of information”.

A patient leaflet is provided with the packaging of Topiramato Sandoz to remind you of the risks during pregnancy. With the packaging of topiramate, a patient leaflet is provided to remind you of the risks during pregnancy.

Breastfeeding

The active ingredient topiramate passes into breast milk. There have been reports of effects in breastfed babies of mothers treated with topiramate, including diarrhea, feeling sleepy, feeling irritable and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or whether to stop taking topiramate. 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 taking topiramate should 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 with topiramate. Do not drive or operate tools or machines without talking to your doctor first.

Topiramato Sandoz contains lactose and sodium

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

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

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

Girls and fertile women:

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

• Your doctor will usually start with a low dose of topiramato and gradually increase your dose to find the best one for you.
• Topiramato tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take topiramato before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking topiramato.

If you take more Topiramato Sandoz 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 topiramato.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Topiramato Sandoz

• If you forgot to take a dose, take it as soon as you remember. However, if it is almost time to take your next dose, skip the missed dose and continue as usual. Consult your doctor if you forget 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 treatment with Topiramato Sandoz

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 using this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Consult your doctor or seek medical attention immediately if you experience the following side effects:

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

• depression (new or worsened).

Common (may affect up to 1 in 10 people)

• seizures,
• anxiety, irritability, mood changes, confusion, disorientation,
• problems with concentration, slowness of thought, memory loss, problems with memory(initial, sudden change or increase in severity),
• 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 a 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 pressure in the eye, 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 levels of ammonia in the blood (hyperammonemia), which may cause a change in brain function (encephalopathy),
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, including 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.

Not known (cannot be estimated from available data):

• inflammation of the eyes (uveitis) with symptoms such as redness and pain in the eyes, sensitivity to light, tearing, vision of small dots or blurred 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,
• tingling, 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 staying or falling asleep,
• speech or language disorders, poor pronunciation when speaking,
• clumsiness or lack of coordination, feeling of instability when walking,
• decreased ability to complete routine tasks,
• decreased, lost or absent taste,
• tremors or involuntary, uncontrolled movements of the eyes,
• vision alteration, such as double vision, blurred vision, decreased vision, difficulty focusing,
• sensation of spinning (vertigo), ringing in the ears, ear pain,
• shortness of breath,
• cough,
• nasal bleeding,
• 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 level in blood,
• increased liver enzymes, increased eosinophils (a type of white blood cell) in blood,
• swelling of lymph nodes in the neck, armpit or groin,
• increased appetite,
• exalted mood,
• hearing, seeing or feeling things that are not there, severe mental disorder (psychosis),
• not showing or feeling emotion, unusual distrust, panic attack,
• problems with reading, speech disorder, problems with writing by hand,
• restlessness, hyperactivity,
• slow thinking, decreased state of vigilance or alertness,
• slow or reduced body movements, abnormal or repetitive involuntary muscle movements,
• syncope,
• anomalous or altered sense of touch; altered touch,
• altered, distorted or absent sense of smell,
• unusual feeling that may precede a migraine or a 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 up or sitting suddenly),
• flushing or feeling hot,
• pancreatitis (inflammation of the pancreas),
• excessive gas or flatulence, acid reflux, feeling full or bloated,
• gum bleeding, increased saliva, drooling, bad breath,
• excessive fluid intake, thirst,
• skin discoloration,
• muscle stiffness, chest pain,
• blood in the urine, incontinence (loss of control) when urinating, urgency to urinate, pain in the side or kidney,
• difficulty achieving or maintaining an erection, sexual dysfunction,
• flu-like symptoms,
• cold hands and feet,
• 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,
• lazy eye,
• swelling of the eyes and around the eyes,
• numbness, tingling and color change (white, blue then red) of the fingers of the hands and feet when exposed to cold,
• inflammation of the liver, liver insufficiency,
• unusual skin odor,
• discomfort in the arms and legs,
• renal alteration.

Not known (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:

• problems with concentration,
• increased blood acidity,
• having thoughts of self-harm,
• fatigue,
• decreased or increased appetite,
• aggression, abnormal behavior,
• difficulty staying or falling asleep,
• feeling of instability when walking,
• general feeling of illness,
• decreased potassium level in blood,
• not showing or feeling emotion,
• 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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not use Topiramato Sandoz after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Container:

Once opened, do not store at a temperature above 25ºC.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Topiramato Sandoz

• The active ingredient is topiramate.

Each tablet contains 25 mg oftopiramate.

Each tablet contains 50 mg oftopiramate.

Each tablet contains 100 mg oftopiramate.

Each tablet contains 200 mg oftopiramate.

• The other components are:
• Tablet core: lactose monohydrate (lactose), microcrystalline cellulose, pregelatinized cornstarch (cornstarch), sodium carboxymethylstarch type A (potato starch), magnesium stearate.

• Tablet coating:

Topiramato Sandoz 25 mg: opadry white 13B58802 (hypromellose, titanium dioxide (E171), macrogol, and polisorbate 80).

Topiramato Sandoz 50 mg:opadry yellow 13B52425 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), and polisorbate 80).

Topiramato Sandoz 100 mg: opadry white 13B58802 (hypromellose, titanium dioxide (E171), macrogol, and polisorbate 80).

Topiramato Sandoz 200 mg:opadry yellow 13B52425 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), and polisorbate 80).

Appearance of the product and contents of the package

Topiramato Sandoz 25 mg: are white film-coated tablets, rounded and flat on both sides.

Topiramato Sandoz 50 mg:are yellow film-coated tablets, rounded and flat on both sides.

Topiramato Sandoz 100 mg: are white film-coated tablets, rounded and flat on both sides.

Topiramato Sandoz 200 mg: are yellow film-coated tablets, rounded and flat on both sides.

They are presented in HDPE bottles with a safety closure or in blisters of 60 or 500 (clinical pack) tablets in aluminum/aluminum.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Sandoz GmbH

Biochemiestrasse 10 -A- 6250

Kundl

Austria

or

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Eslovenia

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Eslovenia

Last revision date of thisleaflet:January 2024

Other sources of information

The most recent approved information from the patient guide information for this medication is available by scanning the following QR code with a smartphone. The same information is also available on the following website: https://cima.aemps.es/cima/DocsPub/16/3252:

The most recent approved information is available on the following website:http://www.aemps.gob.es/