Prospect: Information for the user

Topiramato ratiopharm 100 mg film-coated tablets

topiramato

This medicine is subject to additional monitoring, which will facilitate 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.

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

2.What you need to knowbefore starting to take Topiramato ratiopharm

3.How to takeTopiramato ratiopharm

4.Possible adverse effects

5.Storage ofTopiramato ratiopharm

6.Contents of the package and additional information

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

• treating seizures in adults and children over 6 years old when taken alone
• treating seizures in adults and children 2 years old or older, when taken with other medicines
• preventing migraine in adults

Do not take Topiramato ratiopharm

- if you are allergic to topiramate or any of the other components of this medication (listed in section 6).

Migraine prevention

• Do not take topiramate if you are pregnant.
• If you are a fertile woman, do 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”.

Epilepsy treatment

• Do not use topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, do 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 must 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 ratiopharm to remind you of the risks during pregnancy.

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using Topiramato ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Topiramato ratiopharm 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)
• if you are a woman who may become pregnant. Topiramate may cause harm to a baby during pregnancy when taken during pregnancy. You must use highly effective contraceptive methods during your treatment and for at least 4 weeks after your last dose of topiramate. See section “Pregnancy and breastfeeding” for more information
• if 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.

It is essential not to stop taking your medication without consulting your doctor first.

You must consult your doctor before taking any other medication containing topiramate that is given as an alternative to Topiramato ratiopharm.

You may lose weight if you take Topiramato ratiopharm, so your weight must be monitored regularly while taking this medication. If you lose too much weight or if a child taking this medication does not gain enough weight, you must consult your doctor.

A small number of people being treated with antiepileptic medications such as Topiramato ratiopharm have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.

Topiramato ratiopharm 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”).

Topiramato ratiopharm may cause 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 medication called valproic acid or valproate sodium. Since this can be a serious condition, 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 state of alertness or consciousness
• feeling drowsy with low energy

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

Other medications and Topiramato ratiopharm

Consult your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Topiramato ratiopharm and certain medications may affect each other. Sometimes, you may need to adjust the dose of one or both medications.

Especially inform your doctor or pharmacist if you are taking:

• other medications 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 must use an additional barrier method such as a condom or diaphragm. You must 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 medications you take. Show this list to your doctor and pharmacist before using Topiramato ratiopharm.

Other medications that you should consult your doctor or pharmacist about include other antiepileptic medications, 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 unsure whether anything above applies to you, consult your doctor or pharmacist before taking Topiramato ratiopharm.

Topiramato ratiopharm with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Important advice for fertile 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.

Migraine prevention

• During migraine, do not take topiramate if you are pregnant.
• During migraine, do not use topiramate if you are a fertile woman, unless you are using a highly effective contraceptive method.
• Before starting treatment with topiramate, a pregnancy test should be performed in a fertile woman.

Epilepsy treatment

• During epilepsy, do not take topiramate if you are pregnant, unless no other treatment offers sufficient control of seizures.
• During epilepsy, do 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 must 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.
• Before starting treatment with topiramate, a pregnancy test should be performed in a fertile woman.

Risks of topiramate 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 probability of having congenital defects. In women taking topiramate, around 4 to 9 out of 100 children will have congenital defects. This compares with 1-3 children out of 100 born to women with epilepsy who are not taking an antiepileptic medication. In particular, a cleft lip (a division in the upper lip) and cleft palate (a division in the palate) have been observed. Newborn males 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 2-3 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 medication.
• 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 and not taking an antiepileptic medication were smaller and weighed less than expected at birth.
• Consult your doctor if you have questions about this risk during pregnancy.
• There may be other medications to treat your condition with a lower risk of congenital defects.

Need for contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking topiramate. If you decide to use topiramate, highly effective contraceptive methods must be used during your treatment and for at least 4 weeks after your last dose of topiramate.
• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a hormonal contraceptive pill together with a barrier method such as a condom or diaphragm) must be used. Consult your doctor about the most suitable contraceptive method for you.
• There is a possibility of reduced effectiveness of hormonal contraceptives due to topiramate. Therefore, an additional barrier method (such as a condom or diaphragm) must be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato ratiopharm in girls:

If you are the father/mother or caregiver of a girl treated with topiramate, you must 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 ratiopharm:

• 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.
• Your doctor will re-evaluate your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of topiramate during pregnancy.

Your doctor may also refer you to another specialist.

If you have become pregnant or think you may be pregnant while taking Topiramato ratiopharm:

• Book an urgent appointment with your doctor.
• If you are taking topiramate for migraines, stop taking the medication 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 medication 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.

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 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 ratiopharm to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient of Topiramato ratiopharm (topiramate) passes into human breast milk. Adverse effects have been observed in breastfed infants of mothers treated with topiramate, including diarrhea, feeling sleepy, feeling irritable, and low weight gain. Therefore, your doctor will discuss with you whether to interrupt breastfeeding or whether to interrupt the treatment with Topiramato ratiopharm. 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 Topiramato ratiopharm must inform their doctor as soon as possible if the baby experiences anything unusual.

Driving and operating machines

You may experience dizziness, fatigue, and visual disturbances during treatment with Topiramato ratiopharm.

Do not drive or operate tools or machines without talking to your doctor first.

Topiramato ratiopharm contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Topiramato ratiopharm contains sodium

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

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

Girls and fertile women:

Topiramato treatment should begin and continue under the supervision of a doctor experienced in treating 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 topiramato and gradually increase your dose to find the best one for you.
• Topiramato tablets should be swallowed whole. Avoid chewing the tablets as it may leave a bitter taste.
• You can take topiramato before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation while taking topiramato.

IfYou Take MoreTopiramato ratiopharmThan 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 with topiramato.

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 Forget to Take Topiramato ratiopharm

• If you forget 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 forget 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 Treatment withTopiramato ratiopharm

Do not stop treatment without your doctor's instructions. Your symptoms may reappear. If your doctor decides that you should stop taking this medication, they will gradually reduce your dose over several days.

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

Like all medicines, this medicine can have 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 worsening)

Common (may affect up to 1 in 10 people):

• Seizures (attacks)
• Anxiety, irritability, mood swings, confusion, disorientation
• Difficulty concentrating, slowness of thought, memory loss, memory problems (new onset, sudden change, or worsening)
• Kidney stones, frequent desire to urinate or painful urination

Uncommon (may affect up to 1 in 100 people):

• Increased blood acidity (may cause breathing problems, including difficulty breathing, loss of appetite, nausea, vomiting, excessive fatigue, and irregular or rapid heartbeat)
• Decreased sweating (particularly in children exposed to high temperatures)
• Having severe thoughts of self-harm, leading to severe self-harm
• 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 eye pressure, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling extremely sleepy with low energy – these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can lead to brain dysfunction (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 (epidermal detachment and superficial mucous membrane membranes) with life-threatening consequences.

Frequency not known (the frequency cannot be estimated from available data):

• Uveitis (inflammation of the eyes) with symptoms such as redness and pain in the eyes, sensitivity to light, tearing, seeing small dots or blurred vision

Other side effects include the following, if severe, please inform your doctor or pharmacist:

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

• Congestion, nasal secretion, 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 staying or falling 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 movements; rapid, uncontrollable eye movements
• Visual disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Labored breathing
• Cough
• Nasal bleeding
• Fever, general malaise, 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 pulls, 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
• Exalted mood
• Heard, seen, or felt things that are not there, severe mental disorder (psychosis)
• Not showing or feeling emotions, unusual distrust, panic attack
• Difficulty reading, speech disorder, difficulty writing by hand
• Restlessness, hyperactivity
• Slow thinking, decreased state of alertness or consciousness
• Abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent sense of smell
• Unusual feeling that may precede a migraine or a 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
• Irregular or slow heartbeat, feeling the heart beating in the chest
• Decreased blood pressure, decreased blood pressure when standing (consequently, some people taking topiramato ratiopharm 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
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (loss 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
• Feeling drunk
• Difficulty learning

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

• Abnormally exalted 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 of the hands and feet when exposed to cold
• Inflammation of the liver, liver insufficiency
• Unusual odor of the skin
• Discomfort in the arms and legs
• Renal alteration

Unknown (the frequency 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.

Children

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

• Difficulty concentrating
• Increased blood acidity
• Having thoughts of self-harm
• Fatigue
• Increased or decreased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling unstable when walking
• General malaise
• Decreased potassium levels in the blood
• Not showing or feeling emotions
• Watery eyes
• Irregular heartbeat

Other side effects that may occur in children are:

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 the blood
• Hyperactivity
• Feeling hot
• Difficulty learning

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website: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 bottle and on the packaging, after CAD. The expiration date is the last day of the month indicated.

Bottle: Keep the container perfectly closed to protect it from moisture.

Blister: Store below 30 °C. Store in the original packaging to protect it from moisture

humidity

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofTopiramato ratiopharm

The active ingredient is topiramate.

One film-coated tablet of Topiramato ratiopharm contains 100 mg of topiramate.

The other components of Topiramato ratiopharm are listed below:Core of the tablet:lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, microcrystalline cellulose, sodium carboxymethyl starch from potato and magnesium stearate.Covering: Opadry II yellow containing hypromellose, polydextrose, triacetin, macrogol 8000, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance ofTopiramato ratiopharm and packaging contentsof the packaging

Topiramato ratiopharm is presented as film-coated tablets, yellow, round, biconvex, and beveled edge.

Package sizes:

Topiramato ratiopharm 100 mg film-coated tablets: 10, 20, 30, 50, 60, 100, 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B 1st floor

28108 Alcobendas, Madrid Spain

Responsible manufacturer:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren Germany

This medicine is authorized in the member states of the European Economic Area with the following names

Finland:Topiramat ratiopharm 100 mg tabletti, kalvopäällysteinen

Austria:Topiramat ratiopharm 100 mg Filmtabletten

Germany:Topiramat ratiopharm 100 mg Filmtabletten

Spain:Topiramato ratiopharm 100 mg comprimidos recubiertos con película EFG

Sweden:Topiramat ratiopharm 100 mg filmdragerade tabletter

Last review date of this leaflet:February 2024

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

The latest approved information (patient guide) on this medicine 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/cima/DocsPub/16/3252

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