TOPIRAMATE SANDOZ 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Topiramate Sandoz 25 mg film-coated tablets EFG

Topiramate Sandoz 50 mg film-coated tablets EFG

Topiramate Sandoz 100 mg film-coated tablets EFG

Topiramate Sandoz 200 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Topiramate Sandoz and what is it used for
2. What you need to know before you take Topiramate Sandoz
3. How to take Topiramate Sandoz
4. Possible side effects

5 Storage of Topiramate Sandoz

1. Contents of the pack and other information

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

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

• treatment of seizures in adults and children over 6 years of age given alone,
• treatment of seizures in adults and children over 2 years of age given together with other medicines,
• to prevent migraine headaches in adults.

2. What you need to know before you take Topiramate Sandoz

Do not take Topiramate Sandoz:

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

Migraine prevention

• Do not take topiramate if you are pregnant.
• If you are a woman of childbearing potential, do not take topiramate unless you are using a highly effective method of contraception during treatment. See below under “Pregnancy, breastfeeding and fertility”, Important advice for women.

Epilepsy treatment

• Do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• If you are a woman of childbearing potential, do not take Topiramate Sandoz unless you are using a highly effective method of contraception during treatment. The only exception is if topiramate is the only treatment that provides sufficient control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 unborn baby at risk.

Make sure to read the patient guide that you will receive from your doctor or scan the QR code to get it (see section 6 “Other sources of information”.

A patient card is provided with the pack of Topiramate Sandoz to remind you of the risks during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking topiramate.

Warnings and precautions

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

• you have kidney problems, especially kidney stones, or are on dialysis,
• you have a history of blood or body fluid disorders (metabolic acidosis),
• you have liver problems,
• you have eye problems, especially glaucoma,
• you have growth problems,
• you follow a high-fat diet (ketogenic diet),
• you are a woman who may become pregnant. Topiramate may harm an unborn baby during pregnancy. Highly effective contraceptive methods must be used during 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 harm an unborn baby during pregnancy.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking topiramate.

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

It is important that you do not stop taking your medication without consulting your doctor first.

You should consult your doctor before taking any other medicine that contains topiramate that is given to you as an alternative to topiramate.

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

A small number of people who were being treated with antiepileptic medicines like topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

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

Topiramate may rarely 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 disease, 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 of numbness with low energy

The risk of developing these symptoms may increase with higher doses of topiramate.

Other medicines and Topiramate Sandoz

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

In particular, tell 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. Topiramate may make hormonal contraceptives less effective. You should use an additional barrier contraceptive 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 your menstrual bleeding changes while you are taking hormonal contraceptives and topiramate. You may experience irregular bleeding. In this case, keep taking your hormonal contraceptives and tell your doctor.

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

Other medicines that you should tell 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 not sure if any of the above applies to you, consult your doctor or pharmacist before taking topiramate.

Taking Topiramate Sandoz with food, drinks, and alcohol

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

You should avoid drinking alcohol while taking topiramate.

Pregnancy, breastfeeding, and fertility

Important advice for women of childbearing potential:

Topiramate may harm an unborn baby during pregnancy. If you are a woman of childbearing potential, consult your doctor about other possible treatments. Visit your doctor to review your treatment and discuss the risks at least once a year.

Migraine prevention

• In the case of migraine, do not take topiramate if you are pregnant.
• In the case of migraine, do not take topiramate if you are a woman of childbearing potential, unless you are using a highly effective method of contraception.
• Before starting treatment with topiramate, a pregnancy test should be performed in a woman of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• In the case of epilepsy, do not take Topiramate Sandoz if you are a woman of childbearing potential, unless you are using a highly effective method of contraception. The only exception is if topiramate is the only treatment that provides sufficient control of your seizures and if you plan to become pregnant. You should consult your doctor to ensure 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 unborn baby at risk.
• Before starting treatment with Topiramate Sandoz, a pregnancy test should be performed in a woman of childbearing potential.

The risks of topiramate when taken during pregnancy (regardless of the disease for which topiramate is used) are as follows:

There is a risk of harm to the unborn 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 to 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a division in the upper lip) and cleft palate (a division in the palate) have been seen. Newborn boys may also have a malformation of the penis (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 have a 2 to 3 times higher risk of having autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medication.
• If you take topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one 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 antiepileptic medication were smaller and weighed less than expected at birth.
• Consult your doctor if you have 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 women of childbearing potential:

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

Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods such as a hormonal contraceptive together with a barrier contraceptive 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 contraceptive (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent or 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 an unborn baby during pregnancy due to exposure to topiramate during pregnancy and about the need for highly effective contraceptive methods.

If you wish to become pregnant while taking topiramate:

• Schedule 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 discussed this with your doctor, as your condition may worsen.
• Your doctor will reassess 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 become pregnant or think you may be pregnant while taking topiramate:

• Schedule an urgent appointment with your doctor.
• If you are taking topiramate to prevent migraines, stop taking the medicine immediately and consult your doctor to evaluate if you need alternative treatment.
• If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed this with your doctor, as your condition may worsen. Worsening of your epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess 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 guide that you will receive from your doctor or scan the QR code to get it (see section 6 “Other sources of information”.

A patient card is provided with the pack of Topiramate Sandoz to remind you of the risks during pregnancy. A patient card is provided with the pack of topiramate to remind you of the risks in pregnancy.

Breastfeeding

Topiramate passes into human milk. Effects in breastfed babies of mothers treated with topiramate have been seen, including diarrhea, drowsiness, irritability, and low weight gain. Therefore, your doctor will discuss with you whether to stop breastfeeding or to stop treatment with topiramate. Your doctor will take into account the importance of the benefits for the mother and the risk for the baby.

Mothers who are breastfeeding while taking topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, fatigue, and vision disturbances may occur during treatment with topiramate. Do not drive or operate tools or machines without talking to your doctor first.

Topiramate Sandoz contains lactose and sodium

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

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

3. How to take Topiramato Sandoz

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

Girls and women of childbearing age:

Treatment with topiramate should begin and continue under the supervision of a doctor with experience in the treatment of 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 topiramate and slowly increase your dose until they find the best one for you.
• Topiramate tablets should be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• You can take topiramate before, during, or after a meal. Drink plenty of liquids during the day to avoid the formation of kidney stones while taking topiramate.

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 alert; lack of coordination; have difficulty speaking or concentrating; have double or blurred vision; feel dizzy due to a drop in blood pressure; feel depressed or restless; or have abdominal pain or seizures (attacks).

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

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

If you forget to take Topiramato Sandoz

• If you forget 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 forget two or more doses.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop treatment with Topiramato Sandoz

Do not stop treatment without your doctor telling you to do so. Your disease symptoms may return. If your doctor decides that you should stop taking this medication, they will gradually decrease your dose over several days.

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

4. Possible side effects

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

Consult your doctor or seek medical attention immediately if you have 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 (attacks),
• anxiety, irritability, mood changes, confusion, disorientation,
• concentration problems, slow thinking, memory loss, memory problems (initial, sudden change, or increased severity),
• kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• increased acid levels in the blood (which can cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat),
• decreased or lost sweating (especially in small children who are exposed to high temperatures)
• having thoughts of self-harm, attempting to cause serious harm to oneself,
• 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 pressure in the eye, pain, or decreased vision,
• difficulty thinking, remembering information, or solving problems, decreased 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 (hyperammonemic encephalopathy),
• severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin rashes with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become widespread skin damage (shedding 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 eye pain, sensitivity to light, tearing, blurred vision

Other side effects include the following; if they are 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 of 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, hives),
• loss of appetite, decreased appetite,
• aggression, agitation, anger, abnormal behavior,
• difficulty staying or falling asleep,
• speech problems or speech 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 sense of taste,
• tremors or involuntary shaking; rapid, uncontrolled eye movements,
• vision changes, such as double vision, blurred vision, decreased vision, difficulty focusing,
• feeling of spinning (vertigo), ringing in the ears, ear pain,
• shortness of breath,
• cough,
• nosebleeds,
• fever, general malaise, weakness,
• vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection,
• dry mouth,
• hair loss,
• itching,
• joint pain or inflammation, muscle spasms or twitches, muscle pain or weakness, chest pain,
• weight gain.

Uncommon (may affect up to 1 in 100 people)

• decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count that helps protect against infections, decreased potassium levels in the blood,
• increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood,
• swelling of the neck, armpit, or groin lymph nodes,
• increased appetite,
• elated mood,
• hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis),
• not showing and/or feeling emotion, unusual distrust, panic attack,
• reading problems, speech disorder, handwriting problems,
• restlessness, hyperactivity,
• slow thinking, decreased alertness or vigilance,
• slow or reduced body movements, abnormal or repetitive involuntary muscle movements,
• fainting,
• abnormal sense of touch; altered touch,
• altered, distorted, or absent sense of smell,
• unusual feeling or sensation that may precede a migraine or a certain type of seizure,
• dry eyes, eye sensitivity to light, eyelid twitching, tearing,
• 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 up (consequently, some people taking topiramate may faint, feel dizzy, or lose consciousness when standing up or sitting down suddenly),
• flushing or feeling hot,
• pancreatitis (inflammation of the pancreas),
• excess gas or bloating, stomach acid, feeling full or bloated,
• gum bleeding, increased saliva, drooling, bad breath,
• excessive fluid intake, thirst,
• skin discoloration,
• muscle stiffness, side pain,
• blood in the urine, incontinence (loss of bladder control), urgency to urinate, side or kidney pain,
• difficulty getting or maintaining an erection, sexual dysfunction,
• flu-like symptoms,
• cold hands and feet,
• feeling of drunkenness,
• learning difficulties.

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

• abnormally elated 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,
• liver inflammation, liver failure,
• abnormal skin odor,
• discomfort in the arms and legs,
• kidney disorder.

Not known (cannot be estimated from available data)

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

Other side effects in children

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

• concentration problems,
• increased acid levels in the blood,
• having thoughts of self-harm,
• fatigue,
• decreased or increased appetite,
• aggression, abnormal behavior,
• difficulty staying or falling asleep,
• feeling of instability when walking,
• general malaise,
• decreased potassium levels in the blood,
• not showing and/or feeling emotion,
• tearing,
• slow or irregular heartbeat.

Other side effects that may occur in children are:

Common (may affect up to 1 in 10 people)

• feeling of spinning (vertigo),
• vomiting,
• fever.

Uncommon (may affect up to 1 in 100 people)

• increased eosinophils (a type of white blood cell) in the blood,
• hyperactivity,
• feeling hot,
• learning difficulties.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Topiramato Sandoz

Keep this medication out of sight and reach of children.

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

Do not store above 25°C.

Bottle:

Once opened, do not store above 25°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Topiramato Sandoz

• The active ingredient is topiramate.

Each tablet contains 25 mg of topiramate.

Each tablet contains 50 mg of topiramate.

Each tablet contains 100 mg of topiramate.

Each tablet contains 200 mg of topiramate.

• The other ingredients are:
• Core of the tablet: lactose monohydrate (lactose), microcrystalline cellulose, pregelatinized corn starch (corn starch), sodium carboxymethylcellulose type A (potato starch), magnesium stearate.

• Coating of the tablet:

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

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

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

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

Appearance and packaging of the product

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

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

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

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

They are available in packs of 60 tablets in HDPE bottles with child-resistant closures or in packs of 60 or 500 (clinical packaging) tablets in aluminum/aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse 10 -A- 6250

Kundl

Austria

or

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Slovenia

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

Date of the last revision of this leaflet:January 2024

Other sources of information

The most recent approved information on the patient guide 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/