Topiramate Sandoz 25 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

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 quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What Topiramate Sandoz is and what it is used for
What you need to know before taking Topiramate Sandoz
How to take Topiramate Sandoz
Possible adverse effects
Storage of Topiramate Sandoz
Contents of the pack and other information

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

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

the treatment of seizures in adults and children over 6 years of age when used alone,
the treatment of seizures in adults and children aged 2 years and older when used in combination with other medicines,
the prevention of migraine in adults.

2. What you need to know before taking 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).

Prevention of migraine

You must not take topiramate if you are pregnant.
If you are a woman of childbearing potential, you must 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”.

Treatment of epilepsy

You must not use topiramate if you are pregnant, unless no other treatment provides sufficient seizure control.
If you are a woman of childbearing potential, you must not take topiramate 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 seizure control and you are planning to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and the risks of seizures during pregnancy. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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

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

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

Warnings and precautions

Talk to your doctor before starting to take Topiramate Sandoz if:

you have kidney problems, especially kidney stones, or are receiving 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 are on a high-fat diet (ketogenic diet),
you are a woman who could become pregnant. Topiramate may harm an unborn baby when taken 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 when taken during pregnancy.

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

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

You should consult your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to Topiramate Sandoz.

You may lose weight while taking topiramate, so your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of people taking antiepileptic medicines such as topiramate have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramate may cause serious skin reactions. Contact your doctor immediately if you develop a 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 may affect brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a serious condition, speak 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
reduced alertness or consciousness
feeling drowsy with low energy

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

Other medicines and Topiramate Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topiramate and certain medicines may affect each other. Sometimes, the dose of one or both medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives),
hormonal contraceptives. Topiramate may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception such as a condom or diaphragm should be used. Consult your doctor about the best contraceptive method to use while taking topiramate.

Tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and topiramate. Irregular bleeding may occur. 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 any new medicine.

Other medicines you should discuss with your doctor or pharmacist 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), and warfarin used to prevent blood clotting.

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

Taking Topiramate Sandoz with food, drinks and alcohol

You may take topiramate with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation 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 risks at least once a year.

Prevention of migraine

For migraine, you must not take topiramate if you are pregnant.
For migraine, you must not use 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 must be performed in women of childbearing potential.

Treatment of epilepsy

For epilepsy, you must not take topiramate if you are pregnant, unless no other treatment provides sufficient seizure control.
For epilepsy, you must not use 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 seizure control and you are planning to become pregnant. You must consult your doctor to ensure you have received information about the risks of taking topiramate during pregnancy and 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 must be performed in women of childbearing potential.

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

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

If you take topiramate during pregnancy, your baby has a higher chance of having congenital malformations. In women taking topiramate, about 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1–3 out of every 100 babies born to women who do not have epilepsy and are not taking antiepileptic treatment. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Newborn boys may also have a malformation of the penis (hypospadias). These defects may develop early in 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 developing autism spectrum disorders, intellectual disabilities, or attention deficit hyperactivity disorder (ADHD) compared to children born to women with epilepsy who are not taking antiepileptic medicines.
If you take topiramate during pregnancy, your child may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared with 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.
Consult your doctor if you have questions about these pregnancy risks.
There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in 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.
A highly effective contraceptive method (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 appropriate contraceptive methods for you.
If you are taking hormonal contraceptives, there is a possibility of reduced effectiveness due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
Inform your doctor if you experience irregular menstrual bleeding.

Use of topiramate in girls:

If you are the parent or caregiver of a girl being treated with topiramate, you should consult your doctor immediately once she experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby due to exposure to topiramate during pregnancy and the need to use 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 take topiramate for epilepsy, do not stop taking it until you have discussed this with your doctor, as your condition could worsen.
Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy and may 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 for migraine prevention, stop taking the medicine immediately and consult your doctor to assess whether you need an alternative treatment.
If you are taking topiramate for epilepsy, do not stop taking this medicine until you have discussed it with your doctor, as your condition could worsen. Worsening 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 and may refer you to another specialist.
If topiramate is used during pregnancy, you will be closely monitored to check your baby’s development during pregnancy.

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

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

Breastfeeding

The active ingredient topiramate passes into human milk. Effects have been observed in breastfed infants of treated mothers, including diarrhoea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether to discontinue breastfeeding or to discontinue treatment with topiramate. Your doctor will consider the importance of the benefits for the mother and the risk to the infant.

Breastfeeding mothers taking topiramate should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

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

Topiramate Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has informed 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 film-coated tablet; this is essentially “sodium-free”.

3. How to take Topiramate Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will usually start with a low dose of topiramate and slowly increase your dose until the best dose for you is found.
Topiramate tablets are swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
You may take topiramate before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking topiramate.

Girls and women of childbearing potential:

Treatment with topiramate should be initiated and continued under the supervision of a physician experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

If you take more Topiramate Sandoz than you should

Contact your doctor immediately. Bring the medicine with you.
You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; experience double or blurred vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain or seizures (fits).

You may experience an overdose if you are taking another medicine together with topiramate.

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

If you forget to take Topiramate 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 with your regular schedule. Consult your doctor if you miss two or more doses.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Topiramate Sandoz

Do not stop treatment without being told to do so by your doctor. Your symptoms may return. If your doctor decides you should stop taking this medicine, your dose will be gradually reduced over several days.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor or seek immediate medical attention if you experience any of the following adverse 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,
difficulty concentrating, slowed thinking, memory loss, memory problems (initial, sudden onset, or increased severity),
kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

increased level of acid in the blood (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat),
reduced or absent sweating (especially in young children exposed to high temperatures),
thoughts of self-harm, attempting to cause serious injury 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 causing increased pressure in the eye, eye pain or vision loss,
difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy – these symptoms may indicate high levels of ammonia in the blood (hyperammonemia), which may lead to altered brain function (hyperammonemic encephalopathy),
severe skin reactions may occur, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, including skin rashes with or without blisters. Skin irritation, ulcers or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes may progress to widespread skin damage (detachment of the epidermis and superficial mucous membranes), with potentially life-threatening consequences.

Not known (cannot be estimated from available data):

inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred vision.

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

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

nasal congestion, runny nose or sore throat,
tingling, pain and/or numbness in various parts of the body,
drowsiness, fatigue,
dizziness,
nausea, diarrhea,
weight loss.

Common (may affect up to 1 in 10 people)

anaemia (low blood count),
allergic reaction (such as skin rash, redness, itching, facial swelling, hives),
loss of appetite, decreased appetite,
aggression, agitation, anger, abnormal behaviour,
difficulty falling or staying asleep,
speech difficulties or speech disorders, poor pronunciation,
clumsiness or lack of coordination, feeling unsteady when walking,
reduced ability to complete routine tasks,
reduced, lost or absent taste,
tremors or involuntary shaking; rapid, uncontrollable eye movements,
vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing,
sensation 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 swelling, muscle spasms or twitches, 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 blood potassium levels,
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,
elevated mood,
hallucinations (seeing, hearing or feeling things that are not there), severe mental disorder (psychosis),
lack of emotional expression and/or feeling, unusual distrust, panic attack,
reading difficulties, speech disorder, handwriting problems,
restlessness, hyperactivity,
slowed thinking, decreased level of wakefulness or alertness,
slow or reduced body movements, abnormal or repetitive involuntary muscle movements,
fainting,
abnormal sense of touch; altered touch sensation,
altered, distorted or absent sense of smell,
unusual feeling or sensation that may precede a migraine or certain types of seizures,
dry eyes, light sensitivity, eyelid twitching, watery eyes,
decreased or lost hearing, hearing loss in one ear,
slow or irregular heartbeat, awareness of heartbeat in the chest,
decreased blood pressure, drop in blood pressure upon standing (as a result, 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 flatulence, stomach acidity, feeling of fullness or bloating,
bleeding gums, increased saliva, drooling, bad breath,
excessive fluid intake, thirst,
skin discoloration,
muscle stiffness, side pain,
blood in urine, incontinence (lack of bladder control), urgency to urinate, side or kidney pain,
difficulty achieving or maintaining an erection, sexual dysfunction,
flu-like symptoms,
cold hands and feet,
feeling of intoxication,
learning difficulties.

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

abnormally elevated 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) in fingers and toes when exposed to cold,
liver inflammation, liver failure,
unusual odour of the skin,
discomfort in arms and legs,
kidney impairment.

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 adverse effects in children

In general, adverse effects observed in children are similar to those seen in adults, but the following adverse effects may be more common in children than in adults:

difficulty concentrating,
increased level of acid in the blood,
thoughts of self-harm,
tiredness,
decreased or increased appetite,
aggression, abnormal behaviour,
difficulty falling or staying asleep,
feeling unsteady when walking,
general malaise,
decreased blood potassium levels,
lack of emotional expression and/or feeling,
watery eyes,
slow or irregular heartbeat.

Other adverse effects that may occur in children include:

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,
learning difficulties.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Sandoz

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

Do not use Topiramate Sandoz after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Bottle:

After opening, do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Topiramate Sandoz

The active substance 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 components are:
Tablet core: monohydrate lactose (lactose), microcrystalline cellulose, pregelatinized corn starch (corn starch), sodium carboxymethylstarch type A (from potato) (potato starch), magnesium stearate.
Tablet coating:

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

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

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

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

Appearance of the product and contents of the container

Topiramate Sandoz 25 mg: white film-coated tablets, rounded in shape and flat on both sides.

Topiramate Sandoz 50 mg: yellow film-coated tablets, rounded in shape and flat on both sides.

Topiramate Sandoz 100 mg: white film-coated tablets, rounded in shape and flat on both sides.

Topiramate Sandoz 200 mg: yellow film-coated tablets, rounded in shape and flat on both sides.

Presented in containers of 60 tablets in HDPE bottles with child-resistant closure or in containers of 60 or 500 (hospital pack) tablets in aluminum/aluminum blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Parque Norte Business Park Roble Building C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer

Sandoz GmbH Biochemiestrasse 10 - A-6250 Kundl Austria

Lek Pharmaceuticals d.d. Trimlini 2d 9220 Lendava Slovenia

Lek Pharmaceuticals d.d. Verovškova ulica 57 1526 Ljubljana Slovenia

Date of the most recent revision of this summary: June 2025

Other sources of information

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

Black square QR code on a white background enclosed in a thin black rectangular border

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).