TOPIRAMATE KERN PHARMA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Topiramate Kern Pharma 50 mg film-coated tablets EFG

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. The last section of section 4 will tell you 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 Kern Pharma and what is it used for
2. What you need to know before you take Topiramate Kern Pharma
3. How to take Topiramate Kern Pharma
4. Possible side effects
5. Storage of Topiramate Kern Pharma
6. Contents of the pack and further information

1. What is Topiramate Kern Pharma and what is it used for

Topiramate Kern Pharma 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 together with other medicines
• prevent migraine headaches in adults

2. What you need to know before you take Topiramate Kern Pharma

Do not take Topiramate Kern Pharma

• if you are allergic (hypersensitive) to topiramate, soybean lecithin, or any of the other ingredients of Topiramate Kern Pharma (listed in section 6).

Migraine prevention

• Do not take Topiramate Kern Pharma if you are pregnant.
• If you are a woman of childbearing potential, do not take Topiramate Kern Pharma unless you are using a highly effective contraceptive method during treatment. See below under “Pregnancy, breastfeeding, and fertility – Important advice for women”.

Epilepsy treatment

• Do not take Topiramate Kern Pharma 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 Kern Pharma unless you are using a highly effective contraceptive method during treatment. The only exception is if Topiramate Kern Pharma 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 Kern Pharma during pregnancy and 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

A patient card is provided with the packaging of Topiramate Kern Pharma 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 taking Topiramate Kern Pharma.

Warnings and precautions

Consult your doctor before starting to take Topiramate Kern Pharma if you:

• have kidney problems, especially kidney stones, or are receiving dialysis
• have a history of blood or body fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• follow a high-fat diet (ketogenic diet),
• are a woman who may become pregnant. Topiramate Kern Pharma 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 Kern Pharma. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramate Kern Pharma 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 Kern Pharma.

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 Topiramate Kern Pharma.

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

Topiramate Kern Pharma 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 Kern Pharma 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 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

The risk of these symptoms may increase with higher doses of Topiramate Kern Pharma.

Other medicines and Topiramate Kern Pharma

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

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

• other medicines that impair or decrease your thoughts, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives),
• hormonal contraceptives. Topiramate Kern Pharma 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 Kern Pharma.

Tell your doctor if your menstrual bleeding changes while you are taking hormonal contraceptives and Topiramate Kern Pharma.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you take a new medicine. You may experience irregular bleeding. In this case, continue taking your hormonal contraceptives and inform your doctor.

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 Kern Pharma.

Using Topiramate Kern Pharma with food and drinks

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

Pregnancy, breastfeeding, and fertility

Important advice for women of childbearing potential:

Topiramate Kern Pharma 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 the case of migraines, do not take Topiramate Kern Pharma if you are pregnant.
• In the case of migraines, do not take Topiramate Kern Pharma if you are a woman of childbearing potential, unless you are using a highly effective contraceptive method.
• Before starting treatment with Topiramate Kern Pharma, a pregnancy test should be performed in a woman of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, do not take Topiramate Kern Pharma if you are pregnant, unless no other treatment provides sufficient control of your seizures.
• In the case of epilepsy, do not take Topiramate Kern Pharma if you are a woman of childbearing potential, unless you are using a highly effective contraceptive method. The only exception is if Topiramate Kern Pharma 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 Kern Pharma during pregnancy and the risks of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before starting treatment with Topiramate Kern Pharma, a pregnancy test should be performed in a woman of childbearing potential.

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

There is a risk of harm to the unborn baby during pregnancy if Topiramate Kern Pharma is used during pregnancy.

• If you take Topiramate Kern Pharma 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 seen. 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 Kern Pharma 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 Kern Pharma 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 Kern Pharma. If the decision is made to use Topiramate Kern Pharma, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramate Kern Pharma.

• 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 Kern Pharma in girls

If you are the parent or caregiver of a girl treated with Topiramate Kern Pharma, 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 the need to use highly effective contraceptive methods.

If you wish to become pregnant while taking Topiramate Kern Pharma

• 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 Kern Pharma 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 on the risks of Topiramate Kern Pharma during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.

• If you are taking Topiramate Kern Pharma to prevent migraines, stop taking the medicine immediately and consult your doctor to assess if you need alternative treatment.

• If you are taking Topiramate Kern Pharma 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 on the risks of Topiramate Kern Pharma during pregnancy. The doctor may also refer you to another specialist.
• If Topiramate Kern Pharma 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. A patient card is provided with the packaging of Topiramate Kern Pharma to remind you of the risks during pregnancy.

Breastfeeding

The active ingredient of Topiramate Kern Pharma (topiramate) passes into breast milk. Effects have been seen 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 stop treatment with Topiramate Kern Pharma. Your doctor will consider the benefits for the mother and the risk for the baby.

Breastfeeding mothers taking Topiramate Kern Pharma 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 Kern Pharma. Do not drive or operate tools or machines without talking to your doctor first.

Topiramate Kern Pharma contains soybean lecithin

Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Topiramato Kern Pharma

Follow the administration instructions of Topiramato Kern Pharma indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist.

Girls and women of childbearing age:

Treatment with Topiramato Kern Pharma should begin and continue under the supervision of a doctor experienced in the treatment of epilepsy or migraine. Visit your doctor to review your treatment at least once a year.

• Your doctor will usually start with a low dose of Topiramato Kern Pharma and slowly increase your dose until they find the best one for you.

• Topiramato Kern Pharma tablets should be swallowed whole. Avoid chewing the tablets as they can leave a bitter taste.

• You can take Topiramato Kern Pharma before, during, or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking Topiramato Kern Pharma.

If you take more Topiramato Kern Pharma than 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 a drop in 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 Kern Pharma.

In case of overdose or accidental ingestion, you can also consult the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Topiramato Kern Pharma

• 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 miss 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 interrupt treatment with Topiramato Kern Pharma

Do not interrupt treatment without your doctor telling you to do so. Your disease symptoms may reappear. If your doctor decides that you should stop taking this medication, they will gradually decrease your dose over several days.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Topiramato Kern Pharma can have side effects, although not all people experience them.

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

• Depression (new or worsened)

Common (may affect up to 1 in 10 people)

• Seizures
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration problems, slowness of thought, 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 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 small children exposed to high temperatures)
• 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 can 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, can 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.

Unknown (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 consult your doctor or pharmacist:

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

• Congestion, runny nose, or sore throat
• Numbness, pain, and/or tingling of 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, 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 twitches; rapid, uncontrollable eye movements
• Visual disturbances, 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 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)
• Lack of emotion, unusual distrust, panic attack
• Reading problems, speech disorders, handwriting problems
• Restlessness, hyperactivity
• Slow thinking, decreased alertness or awareness
• 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 Topiramato 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
• Nosebleeds, 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 hands and feet
• Feeling of drunkenness
• 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) of the fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Abnormal skin odor
• Discomfort in the arms and legs
• Kidney disorder

Unknown (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 side effects in 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 of instability when walking
• General malaise
• Decreased potassium levels 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 Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Topiramato Kern Pharma

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Do not use Topiramato Kern Pharma after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Topiramato Kern Pharma

• The active ingredient is topiramate. Each Topiramato Kern Pharma film-coated tablet contains 50 mg of topiramate.

• The other components of Topiramato Kern Pharma are listed below: mannitol (E-421), pregelatinized maize starch, microcrystalline cellulose (E-460i), sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate (E-470b). Coating: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, soy lecithin (E-322), and yellow iron oxide (E-172).

Appearance of Topiramato Kern Pharma and package contents

Topiramato Kern Pharma 50 mg is presented in packages containing 60 film-coated tablets, round and light yellow in color.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Coripharma ehf.

Reykjavikurvegi, 78, P.O. Box

420 – IS-220 Hafnarfjordur (Iceland)

or

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas - Madrid (Spain)

or

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: December 2023.

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