TOPIRAMATE AUROVITAS 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Aurovitas 200 mg Film-Coated Tablets EFG

This medication is subject to additional monitoring, which will make it easier to detect new information on its safety. You can contribute by reporting any side effects you may have. The last part of section 4 includes information on 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

? treat seizures in adults and children over 6 years old given alone.

? treat seizures in adults and children over 2 years old given with other medicines.

? prevent migraine in adults.

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

Do not take Topiramate Aurovitas

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

Migraine prevention

? 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”.

Epilepsy treatment

? You must not take topiramate if you are pregnant unless no other treatment provides adequate control of your seizures.

? 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 adequate 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.

See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

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 Aurovitas 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 using this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Topiramate Aurovitas 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 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 during pregnancy when taken during pregnancy.

If you are not sure if any of the above applies to your case, consult your doctor before using topiramate.

If you have epilepsy, it is important 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 to you as an alternative to this medicine.

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 being treated with antiepileptic drugs such as topiramate have had thoughts of harming themselves or taking their own lives. 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, in rare cases, 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 illness, 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.

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

Other medicines and Topiramate Aurovitas

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

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

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

? hormonal contraceptives. Topiramate may make hormonal contraceptives less effective. You should use an additional barrier 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 to treat 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 this medicine.

Taking Topiramate Aurovitas with food and drinks

You can take this medicine 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 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, you should 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:

? You must not take topiramate if you are pregnant.

? You must 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 must be performed in a woman of childbearing potential.

Epilepsy treatment:

? You must not take topiramate if you are pregnant unless no other treatment provides adequate control of your seizures.

? You must not take 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 adequate 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, a pregnancy test must be performed in a woman of childbearing potential.

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

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 children 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. Male newborns 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.

? Ask your doctor if you have any questions about this risk during pregnancy.

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

Need for contraceptive methods for women of childbearing potential:

? If you are a woman of childbearing potential, you should 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.

? You should use a highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods such as a contraceptive pill along with a barrier contraceptive 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 is a possibility of reduced effectiveness of the hormonal contraceptive due to topiramate. Therefore, you should use an additional barrier contraceptive (such as a condom or diaphragm).

? Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Aurovitas 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 to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate Aurovitas:

? 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 re-evaluate your treatment and assess alternative treatment options. Your doctor will advise you on the risks of topiramate during pregnancy. Your doctor may also refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Topiramate Aurovitas:

? 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 assess 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 re-evaluate your treatment and assess alternative treatment options. Your doctor will advise you on the risks of topiramate during pregnancy. Your 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. 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 pack of Topiramate Aurovitas to remind you of the risks during pregnancy.

Breastfeeding

The active substance of this medicine (topiramate) passes into human milk. Effects have been observed in breastfed babies of mothers treated with topiramate, 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.

Breastfeeding mothers taking this medicine 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 Aurovitas contains lactose

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

Topiramate Aurovitas contains sodium

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

3. How to take Topiramate Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Girls and women of childbearing potential:

Treatment with topiramate should be started and continued 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 until they find the best dose for you.

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

? You can take this medicine before, during, or after a meal. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking topiramate.

If you take more Topiramate Aurovitas than you should

? Consult your doctor immediately. Take the medicine with you.

? You may feel drowsy, tired, or less alert; lack of coordination; have difficulty speaking or concentrating; have double vision or blurred vision; feel dizzy due to low blood pressure; feel depressed or restless; or have abdominal pain or seizures (attacks).

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 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 taking Topiramate Aurovitas

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

If you have any other 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 all people suffer from them.

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

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

? Depression (new or worsened).

Frequent (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.

Infrequent (may affect up to 1 in 100 people)

? Increased blood acid levels (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats).

? Decreased or lost sweating (especially in young children exposed to high temperatures).

? Having thoughts of self-harm, attempting to cause serious harm.

? Loss of part of the visual field.

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

? Glaucoma - fluid blockage in the eye that causes increased eye pressure, 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.

Frequency Not Known (cannot be estimated from available data)

? Eye inflammation (uveitis) with symptoms such as eye redness and pain, sensitivity to light, tearing, blurred vision, or seeing small dots.

Other Adverse Effects Include the Following; if Severe, Please Consult Your Doctor or Pharmacist:

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

? Congestion, runny nose, or sore throat.

? Tingling, pain, and/or numbness of various parts of the body.

? Drowsiness, fatigue.

? Dizziness.

? Nausea, diarrhea.

? Weight loss.

Frequent (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 twitching; rapid, uncontrollable 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.

Infrequent (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.

? Elevated 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, 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 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 acidity, feeling of fullness or bloating.

? 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 fingers and toes.

? 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.

? 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 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 sharpest. Consult your doctor if you notice a change or decrease in your vision.

Other Adverse Effects in Children

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

? Concentration problems.

? Increased blood acid levels.

? 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.

? Watery eyes.

? Slow or irregular heartbeat.

Other adverse effects that may occur in children are:

Frequent (may affect up to 1 in 10 people)

? Feeling of spinning (vertigo).

? Vomiting.

? Fever.

Infrequent (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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Topiramate Aurovitas

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Topiramate Aurovitas

• The active ingredient is topiramate. Each film-coated tablet contains 200 mg of topiramate.
• The other ingredients are:

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

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

Appearance of the Product and Package Contents

Film-coated tablets are pink, round, biconvex with beveled edges, 10.41 mm in diameter, with the mark "E" on one face and "24" on the other.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 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, n o 19

2700-487 Amadora,

Portugal

Date of Last Revision of this Prospectus: January 2024

Other Sources of Information

The most recently approved product information and educational material on this medicine are 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/84610.

Include QR code +

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