Topiramate Kern Pharma 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Topiramate Kern Pharma 50 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine because it contains important information.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally; do not pass it on to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

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

Topiramato Kern Pharma belongs to a group of medicines called "antiepileptic drugs". It is used for:

• treating seizures in adults and children over 6 years of age, given as the only antiepileptic medicine
• treating seizures in adults and children over 2 years of age, given together with other antiepileptic medicines
• preventing migraine in adults

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

Do not take Topiramate Kern Pharma

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

Prevention of migraines

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

Treatment of epilepsy

• You must not use Topiramate Kern Pharma if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you are a woman of childbearing potential, you must not take Topiramate Kern Pharma unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramate Kern Pharma is the only treatment that provides sufficient seizure control and you are planning to become pregnant. You must 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. See below under “Pregnancy, breastfeeding and fertility – Important advice for women”.

Make sure to read the patient guide 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 unsure whether any of the above applies to you, consult your doctor or pharmacist before using 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 undergoing dialysis
• have a history of blood or body fluid disorders (metabolic acidosis)
• have liver problems
• have eye problems, especially glaucoma
• have growth problems
• are on a high-fat diet (ketogenic diet)
• are a woman who could become pregnant. Topiramate Kern Pharma may harm an unborn baby if taken 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 if taken during pregnancy.

If you are unsure whether any of the above applies to you, consult your doctor before using Topiramate Kern Pharma.

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

You should consult your doctor before taking any other medicine containing topiramate that may be prescribed as an alternative to Topiramate Kern Pharma.

You may lose weight while taking Topiramate Kern Pharma, so your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of people treated with antiepileptic medicines such as Topiramate Kern Pharma have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramate Kern Pharma may cause serious skin reactions. Contact your doctor immediately if you develop a 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 may lead to changes in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. As this may be a serious condition, contact 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
• reduced alertness or consciousness
• feeling drowsy with low energy

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

Other medicines and Topiramate Kern Pharma

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

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

• other medicines that impair or reduce mental function, concentration, or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives)
• hormonal contraceptives. Topiramate Kern Pharma may reduce the effectiveness of hormonal contraceptives. An additional barrier contraceptive method such as a condom or diaphragm should be used. Consult your doctor about the most appropriate 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 starting any new medicine. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

Other medicines you should discuss with your doctor or pharmacist 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), and warfarin used to prevent blood clotting.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Topiramate Kern Pharma.

Taking Topiramate Kern Pharma with food and drink

You may take Topiramate Kern Pharma with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation 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. 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.

Prevention of migraines

• For migraine, do not take Topiramate Kern Pharma if you are pregnant.
• For migraine, do not use Topiramate Kern Pharma if you are a woman of childbearing potential unless you are using a highly effective method of contraception.
• Before starting treatment with Topiramate Kern Pharma, a pregnancy test must be performed in women of childbearing potential.

Treatment of epilepsy

• For epilepsy, do not take Topiramate Kern Pharma if you are pregnant, unless no other treatment provides sufficient seizure control.
• For epilepsy, do not use Topiramate Kern Pharma if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Topiramate Kern Pharma is the only treatment that provides sufficient seizure control and you are planning to become pregnant. You must 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 must be performed in women of childbearing potential.

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

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

• If you take Topiramate Kern Pharma during pregnancy, your baby will have a higher chance of having congenital malformations. In women taking topiramate, about 4 to 9 out of every 100 babies will have congenital malformations. This compares with 1–3 out of every 100 babies 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 observed. Male newborns may also have a penile malformation (hypospadias). These defects may develop early in 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 medicines.

• If you take Topiramate Kern Pharma during pregnancy, your baby may be smaller and weigh less than expected at birth. In one study, 18% of babies born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medicines.

• Consult your doctor if you have questions about these risks during pregnancy.

• There may be other medicines available to treat your condition with a lower risk of congenital malformations.

Need for contraception in 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 contraceptive pill together with a barrier method such as a condom or diaphragm) should be used. Consult your doctor about the most appropriate 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.

• Inform 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 being treated with Topiramate Kern Pharma, consult your doctor immediately once she experiences her first menstrual period (menarche). The doctor will inform you about the risks to an unborn baby 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 without first discussing it with your doctor, as your condition could worsen.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramate Kern Pharma during pregnancy and may 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 whether you need an alternative treatment.

• If you are taking Topiramate Kern Pharma for epilepsy, do not stop taking this medicine until you have discussed it with your doctor, as your condition could worsen. Worsening 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 about the risks of Topiramate Kern Pharma during pregnancy and may refer you to another specialist.

• If Topiramate Kern Pharma is used during pregnancy, you will be closely monitored to check your baby’s development.

Make sure to read the patient guide you will receive from your doctor. A patient card is provided with the packaging of Topiramate Kern Pharma to remind you of the risks of topiramate during pregnancy.

Breastfeeding

The active ingredient in Topiramate Kern Pharma (topiramate) passes into breast milk. Effects have been observed in infants of treated mothers, including diarrhea, drowsiness, irritability, and poor weight gain. Therefore, your doctor will discuss with you whether you should stop breastfeeding or discontinue treatment with Topiramate Kern Pharma. Your doctor will consider the importance of the benefits for the mother and the potential risk to the infant.

Breastfeeding mothers taking Topiramate Kern Pharma should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Driving and using machines

Dizziness, fatigue, and visual disturbances may occur during treatment with Topiramate Kern Pharma. Do not drive or operate tools or machinery without first talking to your doctor.

Topiramate Kern Pharma contains soy lecithin

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

3. How to take Topiramate Kern Pharma

Follow exactly the instructions for the administration of Topiramate Kern Pharma given by your doctor. If in doubt, consult your doctor or pharmacist.

Girls and women of childbearing potential:

Treatment with Topiramate Kern Pharma should be initiated and continued under the supervision of a physician 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 Topiramate Kern Pharma and slowly increase the dose until the optimal dose for you is found.

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

• You may take Topiramate Kern Pharma before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramate Kern Pharma.

If you take more Topiramate Kern Pharma than you should

• Contact your doctor immediately. Take the medicine with you.
• You may feel drowsy, tired, or less alert; experience lack of coordination; have difficulty speaking or concentrating; experience 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 medicine together with Topiramate Kern Pharma.

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Topiramate 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 with your regular schedule. 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 a missed dose.

If you stop taking Topiramate Kern Pharma

Do not stop treatment unless your doctor tells you to. Symptoms of your condition may return. If your doctor decides you should stop taking this medicine, your dose will be gradually reduced over several days.

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

4. Possible adverse effects

Like all medicines, Topiramate Kern Pharma can have adverse effects, although not everyone experiences 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, slowed thinking, memory loss, memory problems (initial, sudden onset, or increased severity)
• Kidney stones, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

• Increased levels of acid in the blood (which may cause breathing problems including shortness of breath, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat)
• Reduced or absent sweating (especially in young children exposed to high temperatures)
• Thoughts of self-harm, attempting to cause serious injury to oneself
• Loss of part of the visual field

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

• Glaucoma – blockage of fluid in the eye causing increased pressure, eye pain, or vision loss
• Difficulty thinking, remembering information, or solving problems, decreased alertness or consciousness, feeling drowsy with low energy – these symptoms may indicate high levels of ammonia in the blood (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy)
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which 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 may progress to widespread damage to the skin (detachment of the epidermis and superficial mucous membranes), with potentially life-threatening consequences.

Not known (cannot be estimated from available data):

• Inflammation of the eyes (uveitis) with symptoms such as redness and eye pain, light sensitivity, tearing, seeing small floating spots, or blurred vision

Other adverse effects include the following. If they are severe, please consult your doctor or pharmacist:

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

• Nasal congestion, runny nose, or sore throat
• Tingling, pain, and/or numbness in various parts of the body
• Drowsiness, fatigue
• Dizziness
• Nausea, diarrhea
• Weight loss

Common (may affect up to 1 in 10 people)

• Anaemia (low blood count)
• Allergic reaction (such as skin rash, redness, itching, facial swelling, hives)
• Loss of appetite, decreased appetite
• Aggression, agitation, anger, abnormal behavior
• Difficulty falling or staying asleep
• Speech problems or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling unsteady when walking
• Reduced ability to complete routine tasks
• Reduced, lost, or absent sense of taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, reduced vision, difficulty focusing
• Sensation 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 swelling, muscle spasms or twitches, 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 (which help protect against infections), decreased blood potassium levels
• Increased liver enzymes, increased eosinophils (a type of white blood cell) in blood
• Swelling of lymph nodes in the neck, armpit, or groin
• Increased appetite
• Euphoric mood
• Hallucinations (hearing, seeing, or feeling things that are not there), severe mental disorder (psychosis)
• Lack of emotion or emotional expression, unusual distrust, panic attack
• Reading difficulties, speech disorders, handwriting problems
• Restlessness, hyperactivity
• Slowed thinking, decreased level of alertness or consciousness
• Slowed or reduced body movements, abnormal or repetitive involuntary muscle movements
• Fainting
• Abnormal sense of touch; altered touch sensation
• Impaired, distorted, or absent sense of smell
• Unusual feeling or sensation that may precede a migraine or certain types of seizures
• Dry eyes, light sensitivity, eyelid twitching, watery eyes
• Hearing loss or decreased hearing, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Decreased blood pressure, drop in blood pressure upon standing (as a result, some people may faint, feel dizzy, or lose consciousness when standing up or sitting up suddenly)
• Flushing or feeling hot
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acid, feeling full or bloated
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in urine, urinary incontinence (lack of control), urgency to urinate, side or kidney pain
• Difficulty achieving or maintaining an erection, sexual dysfunction
• Flu-like symptoms
• Cold hands and feet
• Drunken feeling
• 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 changes (white, then blue, followed by red) in fingers and toes when exposed to cold (Raynaud's phenomenon)
• Liver inflammation, liver failure
• Unusual body odor
• Discomfort in arms and legs
• Kidney impairment

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 any change or decrease in your vision.

Other adverse effects in children

In general, adverse effects observed in children are similar to those seen in adults, but the following adverse effects may be more common in children than in adults:

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

Other adverse effects that may occur in children include:

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
• Learning difficulties

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Kern Pharma

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original packaging to protect from moisture.

Do not use Topiramate Kern Pharma after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Topiramate Kern Pharma

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

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

Appearance of Topiramate Kern Pharma and contents of the pack

Topiramate Kern Pharma 50 mg is presented in packs containing 60 film-coated tablets, round and light yellow in colour.

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 most recent revision of this leaflet: December 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es