TOPIRAMATE KERN PHARMA 100 mg FILM-COATED TABLETS

Using Topiramate Kern Pharma with food and drink

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 migraine, do not take Topiramate Kern Pharma if you are pregnant.
• in the case of migraine, 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 about 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 disease 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 developing 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 together 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 about 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 reassess your treatment and evaluate 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 evaluate if you need an 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 reassess your treatment and evaluate 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 substance 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 to stop treatment with Topiramate Kern Pharma. your doctor will take into account 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.

Important information about some of the ingredients of Topiramate Kern Pharma

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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Girls and women of childbearing age:

Treatment with Topiramato Kern Pharma 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 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 may 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 (attacks).

You may experience an overdose if you are taking another medication along 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 questions 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.

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 worsened)

Common (may affect up to 1 in 10 people)

• Seizures (attacks)
• Anxiety, irritability, mood changes, confusion, disorientation
• Concentration problems, slow thinking, memory loss, memory problems (initial, sudden change, or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased acid levels in the blood (which can cause breathing problems, including shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat)
• Decreased or lost sweating (especially in young 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 pressure in the eye, pain, or decreased vision
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling of numbness with low energy - these symptoms may be a sign of high ammonia levels in the blood (hyperammonemia), which can cause a change in brain function (hyperammonemic encephalopathy)
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may appear as skin rashes with or without blisters. Skin irritation, ulcers, or inflammation in the mouth, throat, nose, eyes, or around the genitals. Skin rashes can become widespread skin damage (desquamation of the epidermis and superficial mucous membranes) with life-threatening consequences.

Not known (cannot be estimated from available data):

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

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 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 of instability when walking
• Decreased ability to complete routine tasks
• Decreased, lost, or absent taste
• Tremors or involuntary twitches; 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 cramps, 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
• Elated 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 awareness
• Slow or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sensation of touch; altered touch
• Altered, distorted, or absent 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 elated 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

Not known (cannot be estimated from available data)

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

Other 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 acid levels in the blood
• 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 in the pharmacy's SIGRE collection 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 100 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 100 mg is presented in packages containing 60 film-coated tablets, which are round and yellow.

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