Leaflet: information for the user

Topiramato Aurovitas 25 mg film-coated tablets EFG

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 leaflet carefully before you start taking this medicine, because 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 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 leaflet. See section 4.

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

2.What you need to know before starting to take Topiramato Aurovitas

3.How to take Topiramato Aurovitas

4.Possible adverse effects

5.Storage of Topiramato Aurovitas

6.Contents of the pack and additional information

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

?treating seizures in adults and children over 6 years old when administered alone.

?treating seizures in adults and children 2 or more years old when administered with other medicines.

?to prevent migraine in adults.

Do not take Topiramato Aurovitas

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

Prevention of Migraines

?You should not take topiramate if you are pregnant.

?If you are a fertile woman, you should 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

?You should not use topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.

?If you are a fertile woman, you should 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 should 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 Aurovitas to remind you of the risks during pregnancy.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Topiramato Aurovitas 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. You should use highly effective contraceptive methods during your treatment and for at least 4 weeks after the last dose of topiramate. See section “Pregnancy and breastfeeding” 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 your case, consult your doctor before using topiramate.

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

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

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 should consult your doctor.

A small number of people being treated with 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, in rare cases, 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 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 drowsy with low energy.

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

Other Medicines and Topiramato Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 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 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 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 plant-based preparation used to treat depression), warfarin used to prevent blood clotting.

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

Taking Topiramato Aurovitas with Food and Drink

You can take this medicine with or without food. Drink plenty of liquid during the day to prevent kidney stone formation while taking topiramate. You should avoid drinking alcohol while taking this medicine.

Pregnancy and Breastfeeding

Important Advice for 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:

?You should not take topiramate if you are pregnant.

?You should 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:

?You should not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.

?You should not use topiramate 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 should 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 topiramate 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 a baby during pregnancy if topiramate is used during pregnancy.

?If you take topiramate during pregnancy, your child may have a higher chance of having birth defects. In women taking topiramate, about 4 to 9 out of 100 children may have birth defects. This compares with 1 to 3 out of 100 children born to women with epilepsy who are not taking an antiepileptic medicine. In particular, a cleft lip (a division in the upper lip) and cleft palate (a division in the palate) have been observed. Newborn boys may also have a genital malformation (hypospadias). These defects may 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 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 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 questions about this risk during pregnancy.

?There may be other medicines to treat your condition with a lower risk of birth defects.

Need for Contraceptives 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 contraceptive pill together 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 Topiramato Aurovitas in Girls:

If you are the father/mother 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 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 Topiramato Aurovitas:

?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. 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 you have become pregnant or think you may be pregnant while taking Topiramato Aurovitas:

?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. The patient leaflet is also available by scanning a QR code; see section 6 “Other sources of information”. A patient leaflet is provided with the packaging of Topiramato Aurovitas to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient of this medicine (topiramate) passes into breast milk. Side effects have been observed 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 this medicine should inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and Using Machines

You may experience dizziness, tiredness, and vision disturbances during treatment with topiramate. Do not drive or operate tools or machines without talking to your doctor first.

Topiramato Aurovitas contains Lactose

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

Topiramato Aurovitas contains Sodium

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

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

Girls and fertile women:

The treatment with topiramate should begin and continue under the supervision of a doctor experienced 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 gradually increase your dose to find the best one for you.

?You should swallow the tablets whole. Avoid chewing the tablets as they may leave a bitter taste.

?You can takethis medicationbefore, during or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while takingtopiramate.

If you take moreTopiramato Aurovitasthan you should

?Consult your doctor immediately. Bring the medication with you.

?You may feel drowsy, tired, or less attentive; lack of coordination; have difficulty speaking or concentrating; have 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 along with topiramate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Topiramato Aurovitas

?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 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 Topiramato Aurovitas

Do not stop treatment without your doctor telling you to do so. Your symptoms may reappear. 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.

Like all medicines, this medicine can 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)(may affect up to 1 in 10 people)

?Seizures.

?Anxiety, irritability, mood changes, confusion, disorientation.

?Difficulty concentrating, slow thinking, 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 lost sweating (especially in small 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 levels of ammonia 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.

Frequency not known (cannot be estimated from available data)

?Uveitis – inflammation of the eyes 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 (dizziness), 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.

?Pain or inflammation of the joints, muscle spasms or tugs, 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 the blood.

?Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood.

?Swelling of the lymph nodes in the neck, armpits, or groin.

?Increased appetite.

?Abnormally elevated 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 disorders, writing difficulties.

?Restlessness, hyperactivity.

?Slow thinking, decreased state of alertness or consciousness.

?Abnormal or repetitive involuntary muscle movements.

?Fainting.

?Abnormal sensation of touch; alteration of touch.

?Alteration, distortion, or absence of smell.

?Sensation or 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 taking topiramate 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.

?Nasal bleeding, 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.

?Cold hands and feet.

?Sensation of intoxication.

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

?Abnormally elevated 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 body odor.

?Discomfort in the arms and legs.

?Renal alteration.

Frequency 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:

?Difficulty concentrating.

?Increased blood acidity.

?Having thoughts of self-harm.

?Fatigue.

?Decreased or increased appetite.

?Aggression, abnormal behavior.

?Difficulty falling or staying asleep.

?Feeling unstable when walking.

?General feeling of illness.

?Decreased potassium levels in the 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 (dizziness).

?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.

?Difficulty learning.

Reporting 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 leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at theSIGREpoint of the pharmacy. In case of doubt,ask 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 Topiramato Aurovitas

-The active ingredient is topiramate. Each film-coated tablet contains 25 mg of topiramate.

-The other components are:

Core:microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, sodium carboxymethyl starch (Type A), magnesium stearate.

Covering:Opadry white (hydroxypropylmethylcellulose 2910/hipromelosa 3cP, hydroxypropylmethylcellulose 2910/hipromelosa 6cP, titanium dioxide E171, polyethylene glycol 400, polisorbate 80).

Appearance of the product and content of the container

White film-coated tablets, round, biconvex, 6.10 mm in diameter, with the mark “E” on one face and “22” on the other.

Bottle with 60 tablets. Each bottle contains 1 g of silica gel.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19

2700-487 Amadora

Portugal

Last review date of this leaflet: January 2024

Other sources of information

The most recent approved information on the product information and educational materials on this medication 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/info/84611.

Include QR code +

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