Topiramate Aurovitas 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Aurovitas 100 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 side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read this entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Topiramate Aurovitas is and what it is used for
2. What you need to know before taking Topiramate Aurovitas
3. How to take Topiramate Aurovitas
4. Possible side effects
5. How to store Topiramate Aurovitas
6. Contents of the pack and other information

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

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

? to treat seizures in adults and children over 6 years of age when given alone.

? to treat seizures in adults and children aged 2 years and older when given together with other medicines.

? to prevent migraine in adults.

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

Do not take Topiramato Aurovitas

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

Prevention of migraines

• 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 access it (see section 6 “Other sources of information”).

A patient card is provided with the Topiramato Aurovitas packaging 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 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 undergoing 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 and breastfeeding” 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 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 this medicine.

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 treated with 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 lead to changes in 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 level of alertness or consciousness.

• feeling drowsy with low energy.

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

Other medicines and Topiramato Aurovitas

Inform 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 either topiramate or the other medicine may need to be adjusted.

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

• other medicines that impair or reduce your 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 contraceptive method such as a condom or diaphragm should be used. Consult your doctor about the most appropriate 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 about which you should consult 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 this medicine.

Taking Topiramato Aurovitas with food and drink

You may take this medicine 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 this medicine.

Pregnancy and breastfeeding

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 migraines:

• 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 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 endanger you or your unborn baby.

• Before starting treatment with topiramate, 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, approximately 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1 to 3 out of every 100 babies born to women who do not have epilepsy and do not take antiepileptic medicines. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Male newborns may also have a penile malformation (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 do not take antiepileptic medicines.

• If you take topiramate during pregnancy, your baby 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 method (such as a condom or diaphragm) should be used.

• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Aurovitas in girls:

If you are the parent or caregiver of a girl being treated with topiramate, you must 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 Topiramato Aurovitas:

• 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 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 Topiramato Aurovitas:

• 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 evaluate 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 may worsen. Worsening epilepsy may endanger you or your unborn baby.

• 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 your baby’s development during pregnancy.

Make sure to read the patient guide you will receive from your doctor. The patient guide is also available by scanning a QR code; see section 6 “Other sources of information”. A patient card is provided with the Topiramato Aurovitas packaging to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active substance of this medicine (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 for the infant.

Breastfeeding mothers taking this medicine should inform their doctor as soon as possible if the infant shows any unusual symptoms.

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 speaking to your doctor.

Topiramato Aurovitas contains lactose

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.

Topiramato Aurovitas contains sodium

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

3. How to take Topiramate Aurovitas

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

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.

? Your doctor will usually start with a low dose of topiramate and slowly increase the dose until the optimal dose for you is reached.

? The tablets of this medicine should be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.

? You may take this medicine before, during, or after meals. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking topiramate.

If you take more Topiramate Aurovitas than you should

? Contact your doctor immediately. Take 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 a drop in blood pressure; feel depressed or agitated; or have abdominal pain or seizures (fits).

An overdose may occur 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Topiramate Aurovitas

? 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 forget 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 Aurovitas

Do not stop treatment without being instructed to do so by your doctor. Your symptoms may return. If your doctor decides that you should stop taking this medicine, the 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 will experience 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 change 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).

? Decreased or loss of 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 level of alertness or consciousness, feeling of drowsiness with low energy – these symptoms may be signs of high levels of ammonia in the blood (hyperammonemia), which can lead to a change in brain function (hyperammonemic encephalopathy).

? Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which may appear as skin rash 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 damage to the skin (detachment of the epidermis and superficial mucous membranes) with potentially life-threatening consequences.

Frequency not known (cannot be estimated from available data)

? Inflammation of the eyes (uveitis) with symptoms such as redness and pain in the eye, sensitivity to light, 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.

? Problems with speech or speech disorders, poor pronunciation.

? Clumsiness or lack of coordination, feeling unsteady when walking.

? Reduced ability to perform routine tasks.

? Decreased, lost or absent sense of taste.

? Tremors or involuntary shaking; rapid, uncontrollable eye movements.

? Vision disturbances, such as double vision, blurred vision, decreased 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, armpit or groin.

? Increased appetite.

? Euphoric mood.

? Hallucinations (hearing, seeing or feeling things that are not there), severe mental disorder (psychosis).

? Lack of emotional expression, unusual distrust, panic attack.

? Problems with reading, speech disorder, difficulty writing by hand.

? Restlessness, hyperactivity.

? Slowed thinking, decreased level of wakefulness or alertness.

? Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements.

? Fainting.

? Abnormal sense of touch; altered touch sensation.

? Impaired, distorted or absent sense of smell.

? Unusual feeling or sensation that may precede a migraine or certain types of seizures.

? Dry eyes, sensitivity of eyes to light, 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, decreased blood pressure upon standing (as a result, some people taking topiramate may faint, feel dizzy or lose consciousness when standing up or sitting up suddenly).

? Flushing or feeling hot.

? Pancreatitis (inflammation of the pancreas).

? Excess gas or flatulence, stomach acidity, feeling full or bloated.

? Bleeding gums, increased saliva, drooling, bad breath.

? Excessive fluid intake, thirst.

? Skin discoloration.

? Muscle stiffness, side pain.

? Blood in urine, incontinence (lack of control) when urinating, urgency to urinate, side or kidney pain.

? Difficulty achieving or maintaining an erection, sexual dysfunction.

? Flu-like symptoms.

? Cold hands and feet.

? Drunken feeling.

? 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.

? Abnormal odour of the skin.

? Discomfort in arms and legs.

? Kidney impairment.

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 sharpest. Consult your doctor if you notice any 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.

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

5. Storage of Topiramate Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topiramate Aurovitas

• The active substance is topiramate. Each film-coated tablet contains 100 mg of topiramate.
• The other components are:

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

Coating: Opadry Yellow (hydroxypropylmethylcellulose 2910/hypromellose 3cP, hydroxypropylmethylcellulose 2910/hypromellose 6cP, titanium dioxide E171, polyethylene glycol 400, polysorbate 80, yellow iron oxide E172).

Appearance of the product and contents of the pack

Dark yellow, round, biconvex film-coated tablets with bevelled edges, 9.62 mm in diameter, marked with "E" on one side and "23" on the other.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

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

Date of the most recent review of this Patient Information Leaflet: January 2024

Other sources of information

The most recently approved product information and educational material for this medicine is available by scanning the following QR code with a smartphone. The same information is also available at the following website (URL): https://cima.aemps.es/info/84609.

Include QR code +

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