Topiramate Normon 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Topiramate Normon 50 mg film-coated tablets EFG

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end includes information on how to report adverse reactions.

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Topiramate Normon belongs to a group of medicines called "antiepileptic medicines". It is used for:

• treating seizures in adults and children over 6 years of age, used alone
• treating seizures in adults and children over 2 years of age, used in combination with other medicines
• preventing migraine in adults

2. What you need to know before taking Topiramato Normon

Do not take Topiramato Normon

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

Migraine prevention

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

Epilepsy treatment

• Do not use Topiramato Normon if you are pregnant, unless no other treatment provides sufficient seizure control.
• If you are a woman of childbearing potential, you must not take Topiramato Normon unless you are using a highly effective method of contraception during treatment. The only exception is if Topiramato Normon 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 Topiramato Normon 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 guide you will receive from your doctor.

A patient card is provided with the Topiramato Normon packaging 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 Topiramato Normon.

Warnings and precautions

Consult your doctor before starting Topiramato Normon if you:

• have kidney problems, especially kidney stones, or are undergoing dialysis
• have a history of blood or fluid imbalances in the body (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. Topiramato Normon may harm an unborn baby when taken during pregnancy. Highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Normon. See section “Pregnancy and breastfeeding” for more information.
• are pregnant. Topiramato Normon may harm an unborn baby when taken during pregnancy.

If you are unsure whether any of the above applies to you, consult your doctor before using Topiramato Normon.

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

It is important that you do not 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 Topiramato Normon.

You may lose weight while taking Topiramato Normon, 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 Topiramato Normon have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.

Topiramato Normon may cause serious skin reactions. Contact your doctor immediately if you develop a rash and/or blisters (see also section 4 “Possible side effects”).

Topiramato Normon may rarely cause high levels of ammonia in the blood (detected 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. Since this may be a serious condition, speak 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
• reduced alertness or consciousness
• feeling drowsy with low energy

The risk of developing these symptoms may increase at higher doses of Topiramato Normon.

Other medicines and Topiramato Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Topiramato Normon and certain medicines may affect each other. Sometimes, the dose of one or both 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. Topiramato Normon 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 Topiramato Normon.

Tell your doctor if you experience changes in your menstrual bleeding while taking hormonal contraceptives and Topiramato Normon. Irregular bleeding may occur. In this case, continue taking the hormonal contraceptives and inform your doctor.

Keep a list of all the medicines you are taking. Show this list to your doctor and pharmacist before starting any new medicine.

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 Topiramato Normon.

Use of Topiramato Normon with food and drink

You may take Topiramato Normon with or without food. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramato Normon. You should avoid drinking alcohol while taking Topiramato Normon.

Pregnancy and breastfeeding

Important advice for women of childbearing potential:

Topiramato Normon 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.

Migraine prevention

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

Epilepsy treatment

• For epilepsy, do not take Topiramato Normon if you are pregnant, unless no other treatment provides sufficient seizure control.
• For epilepsy, do not use Topiramato Normon if you are a woman of childbearing potential unless you are using a highly effective method of contraception. The only exception is if Topiramato Normon 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 Topiramato Normon during pregnancy and about the risks of seizures during pregnancy, which may endanger you or your unborn baby.
• A pregnancy test must be performed in women of childbearing potential before starting treatment with Topiramato Normon.

Risks of taking topiramate during pregnancy (regardless of the condition for which topiramate is used):

There is a risk of harm to the unborn baby if Topiramato Normon is used during pregnancy.

• If you take Topiramato Normon during pregnancy, your child has a higher chance of having congenital malformations. In women taking topiramate, approximately 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 medication. In particular, cleft lip (a split in the upper lip) and cleft palate (a split in the roof of the mouth) have been observed. Newborn boys may also have a penile malformation (hypospadias). These defects may develop early in pregnancy, even before you know you are pregnant.
• If you take Topiramato Normon 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 Topiramato Normon during pregnancy, your child 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, compared to 5% of babies born to mothers without epilepsy who were not taking antiepileptic medication.
• 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 Topiramato Normon. If the decision is made to use Topiramato Normon, highly effective contraceptive methods must be used during treatment and for at least 4 weeks after the last dose of Topiramato Normon.
• A highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods (such as a combined oral 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 contraceptive effectiveness due to topiramate. Therefore, an additional barrier contraceptive (such as a condom or diaphragm) should be used.
• Inform your doctor if you experience irregular menstrual bleeding.

Use of Topiramato Normon in girls:

If you are the parent or caregiver of a girl being treated with Topiramato Normon, 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 plan to become pregnant while taking Topiramato Normon:

• 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 Normon for epilepsy, do not stop taking it until you have discussed this 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 Topiramato Normon during pregnancy. The doctor may also refer you to another specialist.

If you become pregnant or think you may be pregnant while taking Topiramato Normon:

• Schedule an urgent appointment with your doctor.
• If you are taking Topiramato Normon for migraine prevention, stop taking the medicine immediately and consult your doctor to evaluate whether you need an alternative treatment.
• If you are taking Topiramato Normon for epilepsy, do not stop taking this medicine until you have discussed it with your doctor, as your condition could worsen. Worsening epilepsy may endanger you or your unborn baby.
• Your doctor will reassess your treatment and evaluate alternative treatment options. The doctor will advise you about the risks of Topiramato Normon during pregnancy. The doctor may also refer you to another specialist.
• If Topiramato Normon is used during pregnancy, you will be closely monitored to check your baby’s development during pregnancy.

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

Driving and using machines

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

Topiramato Normon contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Topiramate Normon

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose for you is found.

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

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

Girls and women of childbearing potential:

Treatment with topiramate 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.

If you take more Topiramate Normon 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).

An overdose may occur if you are taking another medicine together with topiramate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Topiramate Normon

• 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 Normon

Do not stop treatment without first consulting your doctor. Your symptoms may return. If your doctor decides that 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Topiramate Normon may have adverse effects, although not everyone experiences them.

Consult your doctor or seek immediate medical attention if you experience any of the following adverse 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
• Difficulty concentrating, slowed 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 level 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)
• Decreased or absent sweating (especially in young children exposed to high temperatures)
• Thoughts of self-harm, attempting to cause serious harm 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 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 signs of high levels of ammonia in the blood (hyperammonemia), which may lead to changes in brain function (hyperammonemic encephalopathy)
• Severe 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 of 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 eye redness and 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 behaviour
• Difficulty falling or staying asleep
• Problems with speech or speech disorders, poor pronunciation
• Clumsiness or lack of coordination, feeling of unsteadiness when walking
• Reduced ability to complete routine tasks
• Decreased, lost or absent sense of taste
• Tremors or involuntary shaking; rapid, uncontrollable eye movements
• Vision disturbances, such as double vision, blurred vision, decreased vision, difficulty focusing
• Sensation of spinning (dizziness), 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 that 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
• Elevated mood
• Hearing, seeing or feeling things that are not there, severe mental disorder (psychosis)
• Lack of emotional expression and/or feeling, unusual distrust, panic attack
• Reading difficulties, speech disorder, handwriting problems
• Restlessness, hyperactivity
• Slowed thinking, decreased level of wakefulness or alertness
• 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
• Decreased or lost hearing, hearing loss in one ear
• Slow or irregular heartbeat, awareness of heartbeat in the chest
• Decreased blood pressure, decreased blood pressure upon standing (as a result, some people taking Topamax may faint, feel dizzy or lose consciousness when standing up or sitting up suddenly)
• Flushing or feeling of warmth
• Pancreatitis (inflammation of the pancreas)
• Excess gas or flatulence, stomach acidity, feeling of fullness or bloating
• Bleeding gums, increased saliva, drooling, bad breath
• Excessive fluid intake, thirst
• Skin discoloration
• Muscle stiffness, side pain
• Blood in the urine, incontinence (lack of control) when urinating, urgency to urinate, side or kidney pain
• Difficulty achieving 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) in fingers and toes when exposed to cold
• Liver inflammation, liver failure
• Unusual odour of the skin
• 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 a 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:

• Difficulty concentrating
• Increased level of acid in the blood
• Thoughts of self-harm
• Tiredness
• Decreased or increased appetite
• Aggression, abnormal behaviour
• Difficulty falling or staying asleep
• Feeling of unsteadiness when walking
• General malaise
• Decreased blood potassium levels
• Lack of emotional expression and/or feeling
• 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 (dizziness)
• Vomiting
• Fever

Uncommon (may affect up to 1 in 100 people)

• Increased eosinophils (a type of white blood cell) in blood
• Hyperactivity
• Feeling of warmth
• Learning difficulties

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topiramate Normon

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

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

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

6. Contents of the pack and other information

Composition of Topiramate Normon

• The active substance is topiramate.

• Topiramate Normon 50 mg: each tablet contains 50 mg of topiramate.

• The other components (excipients) are:

  • Core: lactose, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate and colloidal anhydrous silica.

• Coating: hypromellose, titanium dioxide (E-171) and macrogol 6000. Colouring excipients: yellow iron oxide (E-172).

Appearance of Topiramate Normon and contents of the pack

Topiramate Normon 50 mg is presented in packs containing 60 film-coated tablets, yellow, round, biconvex and printed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 – Tres Cantos – Madrid, Spain

The most recent revision of this leaflet: June 2024

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

The most recently approved information; educational material (patient guide) for this medicinal product is available by scanning the following QR code with a smartphone. The same information is also available at the following web address (URL): https://cima.aemps.es/cima/DocsPub/16/3252.