Leaflet: information for the user

Topiramato Kern Pharma 50 mg film-coated tablets EFG

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.

Read the leaflet carefully before starting to take the medicine, as it contains important information.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

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

2. What you need to know before starting to take Topiramato Kern Pharma

3. How to take Topiramato Kern Pharma

4. Possible adverse effects

5. Storage of Topiramato Kern Pharma

6. Contents of the package and additional information

Topiramato Kern Pharma belongs to a group of medicines called “anti-epileptic medicines”. It is used for:

• treating seizures in adults and children over 6 years old, administered alone
• treating seizures in adults and children over 2 years old, administered in combination with other medicines
• to prevent migraine in adults

Do not take Topiramato Kern Pharma

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

Prevention of migraines

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

Treatment of epilepsy

• Do not use Topiramato Kern Pharma if you are pregnant, unless no other treatment offers sufficient control of seizures.
• If you are a fertile woman, do not take Topiramato Kern Pharma unless you are using a highly effective contraceptive method during your treatment. The only exception is if Topiramato Kern Pharma 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 Topiramato Kern Pharma 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

A patient leaflet is provided with the packaging of Topiramato Kern Pharma 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 Kern Pharma.

Warnings and precautions

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

• have kidney problems, especially kidney stones, or are receiving dialysis
• have a history of blood or fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are following a high-fat diet (ketogenic diet),
• are a woman who may become pregnant. Topiramato Kern Pharma may cause harm to a baby during pregnancy when taken during pregnancy. Highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topiramato Kern Pharma. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramato Kern Pharma may cause harm to a baby during pregnancy when taken during pregnancy.

If you are unsure whether anything above applies to you, consult your doctor before using Topiramato Kern Pharma.

If you have epilepsy, 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 Kern Pharma.

You may lose weight if you take Topiramato Kern Pharma, so your weight should 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 Kern Pharma have had thoughts of harming themselves or taking their own lives. If you ever have these thoughts, contact your doctor immediately.

Topiramato Kern Pharma 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 Kern Pharma 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 alertness or consciousness

- feeling drowsy with low energy

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

Other medications and Topiramato Kern Pharma

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication. Topiramato Kern Pharma and certain medications may affect each other. Sometimes, the dose of one of the other medications or of Topiramato Kern Pharma may need to be adjusted.

Especially, inform your doctor or pharmacist if you are taking:

• other medications that impair or reduce your thoughts, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives),
• hormonal contraceptives. Topiramato Kern Pharma may make hormonal contraceptives less effective. You should use an additional barrier method such as a condom or a diaphragm. You should consult your doctor about the best contraceptive method to use while taking Topiramato Kern Pharma.

Tell your doctor if you change your menstrual bleeding while taking hormonal contraceptives and Topiramato Kern Pharma.

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

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 Kern Pharma.

Use of Topiramato Kern Pharma with food and drinks

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

Pregnancy, breastfeeding and fertility

Important advice for fertile women:

Topiramato Kern Pharma 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.

Prevention of migraines

• Do not take Topiramato Kern Pharma if you are pregnant.
• Do not use Topiramato Kern Pharma if you are a fertile woman, unless you are using a highly effective contraceptive method.
• A pregnancy test should be performed before starting treatment with Topiramato Kern Pharma in a fertile woman.

Treatment of epilepsy

• Do not take Topiramato Kern Pharma if you are pregnant, unless no other treatment offers sufficient control of seizures.
• Do not use Topiramato Kern Pharma if you are a fertile woman, unless you are using a highly effective contraceptive method. The only exception is if Topiramato Kern Pharma 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 Topiramato Kern Pharma during pregnancy and about the risks of seizures during pregnancy, which may put you or your baby during pregnancy at risk.
• A pregnancy test should be performed before starting treatment with Topiramato Kern Pharma in a fertile woman.

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 a baby during pregnancy if Topiramato Kern Pharma is used during pregnancy.

• If you take Topiramato Kern Pharma during pregnancy, your child will have a higher probability of having congenital defects. In women taking topiramate, around 4 to 9 children out of 100 will have congenital defects. This compares with 1-3 children out of 100 born to women without epilepsy and not taking an antiepileptic medication. In particular, a cleft lip (a division in the upper lip) and a cleft palate (a division in the palate) have been observed. Newborn males may also have a genital malformation (hypospadias). These defects can develop in the early stages of pregnancy, even before you know you are pregnant.

• If you take Topiramato Kern Pharma 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 Topiramato Kern Pharma 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.

Necessity of contraceptive methods for fertile women:

• If you are a fertile woman, consult your doctor about other possible treatments instead of taking Topiramato Kern Pharma. If the decision is made to use Topiramato Kern Pharma, highly effective contraceptive methods should be used during your treatment and for at least 4 weeks after the last dose of Topiramato Kern Pharma.

• Highly effective contraceptive methods (such as an intrauterine device) or two complementary contraceptive methods (such as a contraceptive pill together with a barrier method such as a condom or a 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 method (such as a condom or a diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Kern Pharma in girls:

If you are the parent/caregiver of a girl treated withTopiramato 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 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 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 Topiramato Kern Pharma 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 on the risks of Topiramato Kern Pharma during pregnancy. The doctor may also refer you to another specialist.

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

• Schedule an urgent appointment with your doctor.

• If you are taking Topiramato Kern Pharma for migraines, stop taking the medication immediately and consult your doctor to evaluate if you need an alternative treatment.

• If you are taking Topiramato Kern Pharma 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 on the risks of Topiramato Kern Pharma during pregnancy. The doctor may also refer you to another specialist.
• If Topiramato 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 leaflet that you will receive from your doctor. A patient leaflet is provided with the packaging of Topiramato Kern Pharma to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient ofTopiramato Kern Pharma(topiramate) passes into breast milk. Side effects have been observed in breastfed babies of mothers treated with, 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 treatment withTopiramato Kern Pharma. 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 Kern Pharma should 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 Kern Pharma. Do not drive or operate tools or machines without talking to your doctor first.

Topiramato Kern Pharma contains soy lecithin

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

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

Girls and fertile women:

Topiramato Kern Pharma 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 Kern Pharma and gradually increase your dose to find the best one for you.

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

• You can take Topiramato Kern Pharma before, during, or after a meal. Drink plenty of liquids during the day to prevent kidney stone formation 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; difficulty speaking or concentrating; double or blurry 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 Kern Pharma.

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

If you forgot to take Topiramato Kern Pharma

• If you forgot 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 the treatment with Topiramato Kern Pharma

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 the use of this product, ask your doctor or pharmacist.

Like all medications, Topiramato Kern Pharma may have side effects, although not everyone will 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 (attacks)

-Anxiety, irritability, mood changes, confusion, disorientation

-Difficulty concentrating, slow thinking, memory loss, problems with memory (initial, sudden change or increase in severity)

-Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

-Increased blood acidity (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)

-Decreased or loss of sweating (especially in small children exposed to high temperatures)

-Having thoughts of self-harm, attempting to cause serious injuries

-Loss of part of the visual field

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

-Glaucoma – blockage of fluid in the eye that causes increased eye pressure, pain, or decreased vision

-Difficulty thinking, remembering information, or solving problems, decreased state of alertness or consciousness, feeling of numbness with low energy – these symptoms may be a sign of high levels of ammonia in the blood (hyperammonemia), which can cause a change in brain function (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 (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Not known (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, vision of small dots or blurred vision

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

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

-Congestion, runny nose, 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 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 taste

-Tremors or involuntary movements; rapid, uncontrollable eye movements

-Alteration of vision, such as double vision, blurred vision, decreased vision, difficulty focusing

-Sensation of spinning (vertigo), ringing in the ears, ear pain

-Shortness of breath

-Cough

-Nosebleeds

-Fever, general feeling of illness, 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 cramps, 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 level in blood

-Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood

-Swelling of the lymph nodes in the neck, armpits, or groin

-Increased appetite

-Exalted mood

-Hearing, seeing, or feeling 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 vigilance or alertness

-Abnormal or repetitive involuntary muscle movements

-Fainting

-Abnormal sensation of touch; alteration of touch

-Alteration, distortion, or absence of smell

-Sensation or feeling unusual 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

-Slow or irregular heartbeat, feeling the heart beating in the chest

-Decreased blood pressure, decreased blood pressure when standing (consequently, some people may faint, feel dizzy, or lose consciousness when standing up or sitting suddenly)

-Flush or feeling hot

-Pancreatitis (inflammation of the pancreas)

-Excessive gas or flatulence, stomach acid, feeling full or bloated

-Gingival bleeding, increased saliva, drooling, bad breath

-Excessive fluid intake, thirst

-Decoloration of the skin

-Muscle stiffness, side pain

-Blood in the urine, incontinence (loss of bladder control) when urinating, urgency to urinate, side or kidney pain

-Difficulty achieving or maintaining an erection, sexual dysfunction

-Flu-like symptoms

-Cold fingers and toes

-Sensation of intoxication

-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 and toes when exposed to cold

-Inflammation of the liver, liver insufficiency

-Unusual odor of the skin

-Discomfort in the arms and legs

-Alteration of the kidney

Not known (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.

Other side effects in 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 of instability when walking

-General feeling of illness

-Decreased potassium level in blood

-Not showing or feeling emotions

-Watery eyes

-Slow or irregular heartbeat

Other side effects that may appear 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 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from humidity.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Topiramato Kern Pharma

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

• The other components of Topiramato Kern Pharma are listed below: mannitol (E-421), pregelatinized cornstarch, microcrystalline cellulose (E-460i), sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate (E-470b). Coating layer: 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 content of the packaging

Topiramato Kern Pharma 50 mg is presented in packaging containing 60 film-coated, rounded, and light yellow tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: December 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es