TOPIRAMATE RATIOPHARM 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Ratiopharm 50 mg Film-Coated Tablets EFG

topiramate

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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 signs of illness are the same as yours.
• If you get 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 pack and other information:

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

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

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

• treat seizures in adults and children over 6 years of age, given alone
• treat seizures in adults and children over 2 years of age, given with other medicines
• prevent migraine headaches in adults

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

Do not take Topiramate Ratiopharm

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

Migraine prevention

• Do not take topiramate if you are pregnant.
• If you are a woman of childbearing potential, do 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

• Do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• If you are a woman of childbearing potential, do 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 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.

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 Ratiopharm 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 Topiramate Ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Topiramate Ratiopharm 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)
• if you are a woman who can become pregnant. Topiramate may harm an unborn baby 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.
• if you are pregnant. Topiramate may harm an unborn baby during pregnancy.

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

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

It is important that you do not 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 Topiramate Ratiopharm.

You may lose weight if you take Topiramate Ratiopharm, 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 medicines like Topiramate Ratiopharm have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

Topiramate Ratiopharm 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 Ratiopharm may rarely 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 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 of numbness with low energy

The risk of developing these symptoms may increase with higher doses of Topiramate Ratiopharm.

Other medicines and Topiramate Ratiopharm

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

Especially 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 depressant medicines such as muscle relaxants and sedatives).
• hormonal contraceptives. Topiramate may make hormonal contraceptives less effective. You should use an additional barrier contraceptive 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 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 inform your doctor.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you take Topiramate Ratiopharm.

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 Topiramate Ratiopharm.

Taking Topiramate Ratiopharm with food, drinks, and alcohol

You can take Topiramate Ratiopharm with or without food. Drink plenty of fluids during the day to prevent the formation of kidney stones while taking Topiramate Ratiopharm. You should avoid drinking alcohol while taking Topiramate Ratiopharm.

Pregnancy and breastfeeding

Pregnancy

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 the risks at least once a year.

Migraine prevention

• In case of migraine, do not take topiramate if you are pregnant.
• In case of migraine, do 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 should be performed in a woman of childbearing potential.

Epilepsy treatment

• In case of epilepsy, do not take topiramate if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• In case of epilepsy, do 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 sufficient 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 should be performed in a woman of childbearing potential.

The risks of topiramate when taken during pregnancy (regardless of the disease for which topiramate is used) are as follows:

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 division in the upper lip) and cleft palate (a division in the palate) have been observed. Newborn boys 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.
• 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 contraceptive methods for 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 hormonal contraceptive with a barrier contraceptive method (such as a condom or diaphragm) should be used. 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, an additional barrier contraceptive method (such as a condom or diaphragm) should be used.
• Tell your doctor if you experience irregular menstrual bleeding.

Use of Topiramate Ratiopharm 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 Ratiopharm:

• 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. The doctor will advise you about 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 Ratiopharm:

• 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. 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 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 Ratiopharm to remind you of the risks during pregnancy.

Breastfeeding

The active substance of Topiramate Ratiopharm (topiramate) passes into human breast 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 Ratiopharm. Your doctor will take into account the importance of the benefits for the mother and the risk for the baby.

Breastfeeding mothers taking Topiramate Ratiopharm 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 Ratiopharm.

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

Topiramate Ratiopharm contains lactose

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

Topiramate Ratiopharm contains sodium

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

3. How to take Topiramato ratiopharm

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

Girls and women of childbearing age:

Treatment with topiramate should begin and continue under the supervision of a doctor with experience 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 your dose until they find the best one for you.
• Topiramate tablets should be swallowed whole. Avoid chewing the tablets as they can leave a bitter taste.
• You can take topiramate before, during, or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking topiramate.

If you take more Topiramato ratiopharm than you should

• Consult your doctor immediately. Bring the medication with you.
• You may feel drowsy, tired, or less attentive, have difficulty coordinating, 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 (attacks).

You may experience an overdose if you are taking another medication 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 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 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 treatment with Topiramato ratiopharm

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 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.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

Consult your doctor or seek medical attention immediately if you have 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 changes, confusion, disorientation
• Concentration problems, slowness of thought, memory loss, memory problems (new onset, sudden change, or increased severity)
• Kidney stones, frequent urination or painful urination

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

• Increased blood acid levels (may cause breathing problems, including difficulty breathing, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeats)
• Decreased or lost sweating (especially in children exposed to high temperatures)
• Having serious thoughts of self-harm, leading to serious self-harm
• Loss of part of the field of vision

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

• Glaucoma, blockage of fluid in the eye that causes increased pressure in the eye, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling very drowsy with low energy – these symptoms may be a sign of high ammonia levels 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, 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 (desquamation and superficial mucous membranes) with life-threatening consequences.

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

• Eye inflammation (uveitis) with symptoms such as eye redness and pain, sensitivity to light, tearing, blurred vision

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

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

• Nasal congestion, runny nose, or sore throat
• Numbness, pain, and/or tingling of various 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, 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 unsteady when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent sense of taste
• Tremors or involuntary movements; rapid, uncontrollable eye movements
• Visual disturbance, 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

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

• Decreased platelet count (blood cells that help prevent bleeding), decreased white blood cell count (which helps protect against infections), decreased potassium level in the blood
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in the blood
• Swollen neck, armpit, or groin lymph nodes
• Increased appetite
• Elevated mood
• Hearing, seeing, or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotion, unusual distrust, panic attack
• Reading problems, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or consciousness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent sense of smell
• Feeling or sensation that may precede a migraine or a certain type of seizure
• Dry eyes, eye sensitivity to light, eyelid twitching, watery eyes
• Hearing loss, 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 ratiopharm 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 acid, feeling full or bloated
• Gum bleeding, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Discoloration of the skin
• 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 hands and feet
• Feeling of intoxication
• Learning difficulties

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

• Abnormally elevated mood
• Loss of consciousness
• Blindness in one eye, temporary blindness, night blindness
• Lazy eye
• Swollen eyes and surrounding 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 damage

Not known (frequency cannot be estimated from available data):

• Maculopathy is a disease of the macula, a small area in the retina where vision is most acute. Consult your doctor if you notice a change or decrease in your vision.

Children

Generally, the 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:

• Concentration problems
• Increased blood acid levels
• Thoughts of self-harm
• Fatigue
• Decreased or increased appetite
• Aggression, abnormal behavior
• Difficulty staying or falling asleep
• Feeling unsteady when walking
• General malaise
• Decreased potassium level in the blood
• Lack of emotion
• Watery eyes
• Slow or irregular heartbeat

Other side effects that may occur in children are:

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

• Feeling 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
• Learning difficulties

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Topiramato ratiopharm

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 packaging, after EXP. 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. Keep in the original packaging to protect it from moisture.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Topiramato ratiopharm

The active ingredient is topiramate.

One film-coated tablet of Topiramato ratiopharm contains 50 mg of topiramate.

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

Appearance of Topiramato ratiopharm and package contents

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

Package sizes:

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid Spain

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren Germany

This medication is authorized in the Member States of the European Economic Area under the following names

Finland: Topiramat ratiopharm 50 mg tabletti, kalvopäällysteinen

Austria: Topiramat ratiopharm 50 mg Filmtabletten

Germany: Topiramat ratiopharm 50 mg Filmtabletten

Spain: Topiramato ratiopharm 50 mg comprimidos recubiertos con película EFG

Sweden: Topiramat ratiopharm 50 mg filmdragerade tabletter

Date of the last revision of this leaflet:February 2024

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

The latest approved information (patient guide) about 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/cima/DocsPub/16/3252

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