ESLICARBAZEPINE MEDITOP 800 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Eslicarbazepine Meditop 800 mg tablets EFG

eslicarbazepine, acetate

Read the entire package leaflet carefully before you or your child start taking this medicine, as it contains important information.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Eslicarbazepine Meditop and what is it used for
2. What you need to know before taking Eslicarbazepine Meditop
3. How to take Eslicarbazepine Meditop
4. Possible side effects
5. Storage of Eslicarbazepine Meditop
6. Package contents and further information

1. What is Eslicarbazepine Meditop and what is it used for

This medicine contains the active substance eslicarbazepine acetate.

This medicine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition where the person affected has repeated seizures or convulsions.

This medicine is used:

• as the only medicine (monotherapy) in adults with newly diagnosed epilepsy;
• in combination with other antiepileptic medicines (adjunctive therapy) in adults, adolescents, and children over 6 years of age who suffer from epileptic seizures (convulsions) that affect a part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the entire brain (secondary generalization).

Your doctor has prescribed this medicine to reduce the number of seizures.

2. What you need to know before taking Eslicarbazepine Meditop

Do not takeEslicarbazepine Meditop

• if you are allergic to eslicarbazepine acetate, to other carbamazepine derivatives (e.g., carbamazepine or oxcarbazepine, medicines used to treat epilepsy), or to any of the other ingredients of this medicine (listed in section 6);
• if you have any heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Tell your doctor immediately:

• if you have blisters or peeling of the skin and/or mucous membranes, skin rash, swallowing or breathing problems, swelling of the lips, face, eyelids, throat, or tongue. These could be symptoms of an allergic reaction.
• if you experience confusion, worsening of seizures, or decreased consciousness, which may be signs of low blood sodium levels.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. This medicine is not recommended in patients with severe kidney disease.
• if you have liver problems. This medicine is not recommended in patients with severe liver problems.
• if you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) called a prolonged PR interval. If you are not sure if the medicines you are taking may have this effect, talk to your doctor.
• if you have any heart disease, such as heart failure or myocardial infarction, or have any heart rhythm disorder.
• if you have seizures that start with a generalized electrical discharge that affects both sides of the brain.

A small number of people taking antiepileptics have had thoughts of self-harm or suicide. If at any time you have these thoughts while taking this medicine, contact your doctor immediately.

This medicine may make you feel dizzy and/or drowsy, especially at the start of treatment. Be careful when taking this medicine to avoid accidental injuries, such as falls.

Be careful with this medicine:

In post-marketing experience, in patients treated with this medicine, serious and potentially life-threatening skin reactions have been reported, including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). If you develop a severe rash or other skin symptom (see section 4), stop taking this medicine and contact your doctor or seek medical attention immediately.

In patients of Thai and Chinese Han ethnic origin, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by a blood test in these patients. Your doctor may advise you on the need for such a blood test before taking this medicine.

Children

This medicine must not be given to children under 6 years of age.

Other medicines andEslicarbazepine Meditop

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because some medicines may affect the way this medicine works, or this medicine may affect the way other medicines work. Tell your doctor if you are taking:

Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as your dose may need to be adjusted;
• carbamazepine (a medicine used to treat epilepsy), as your dose may need to be adjusted, and the following side effects of this medicine may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as the contraceptive pill), as this medicine may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as your dose may need to be adjusted;
• rosuvastatin, a medicine used to lower cholesterol levels;
• the anticoagulant warfarin;
• monoamine oxidase inhibitor (MAOI) antidepressants;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with this medicine, as it is not known if it is safe to take these medicines together.

See the section “Pregnancy and breastfeeding” for recommendations on contraception.

Pregnancy and breastfeeding

Eslicarbazepine Meditop should not be used during pregnancy, as the effects of Eslicarbazepine Meditop on pregnancy and the unborn child are not known.

If you are planning to become pregnant, talk to your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There are limited data on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations and neurodevelopmental problems (brain development) in children of women taking antiepileptic medicines, particularly when taking more than one antiepileptic medicine at the same time. If you are pregnant or think you may be pregnant, tell your doctor immediately. Do not stop taking your medicine until you have talked to your doctor. Stopping your medicine suddenly may cause seizures, which could be harmful to you and your unborn child. Your doctor may decide to change your treatment.

If you are a woman of childbearing age and not planning to become pregnant, you must use an effective method of contraception during treatment with Eslicarbazepine Meditop. Eslicarbazepine Meditop may affect the functioning of hormonal contraceptives, such as the contraceptive pill, and make them less effective in preventing pregnancy.

Therefore, you are advised to use other safe and effective methods of contraception while taking Eslicarbazepine Meditop.

Talk to your doctor, who will discuss with you the most suitable type of contraceptive to use while taking Eslicarbazepine Meditop. If you stop taking Eslicarbazepine Meditop, you should continue to use an effective method of contraception until the end of your current menstrual cycle.

If you take Eslicarbazepine Meditop during pregnancy, your baby is also at risk of having bleeding problems immediately after birth. Your doctor may give you and your baby a medicine to prevent this.

Do not breastfeed while taking Eslicarbazepine Meditop. It is not known if it passes into breast milk.

Driving and using machines

This medicine may make you feel dizzy, drowsy, and affect your vision, particularly at the start of treatment. If this happens, do not drive or use tools or machines.

3. How to take Eslicarbazepine Meditop

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults

Initial dose

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once a day.

Depending on how you respond to this medicine, your dose may be increased to 1,200 mg once a day. If you are taking Eslicarbazepine Meditop only (monotherapy), your doctor may consider increasing your dose to 1,600 mg once a day.

Patient with kidney problems

If you have kidney problems, you will usually be given a lower dose of this medicine. Your doctor will determine the correct dose for you. This medicine is not recommended if you have severe kidney problems.

Elderly patients (over 65 years of age)

If you are an elderly patient and are taking this medicine alone, the dose of 1,600 mg is not suitable for you.

Children over 6 years of age

Initial dose

The initial dose is 10 mg per kilogram of body weight once a day for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

Depending on the response to this medicine, the dose may be increased by 10 mg per kilogram of body weight, at intervals of one or two weeks, up to 30 mg per kilogram of body weight. The maximum dose is 1,200 mg once a day.

Children ≥60 kg

Children with a body weight of 60 kg or more should take the same dose as adults.

The oral suspension, another pharmaceutical form of the medicine, may be more suitable for administration in children. Talk to your doctor or pharmacist.

Form and route of administration

Eslicarbazepine Meditop is taken by mouth.

Swallow the tablet with a glass of water.

Eslicarbazepine Meditop can be taken with or without food.

If you have difficulty swallowing the tablet whole, you can crush it and add it to a small amount of water or apple sauce to take immediately.

The tablet can be divided into equal doses.

If you take more Eslicarbazepine Meditop than you should

If you accidentally take more eslicarbazepine than you should, you are at risk of having more seizures; or you may feel that your heartbeats are irregular or faster. Contact a doctor or go to a hospital immediately if you experience any of these symptoms. Take the medicine package with you. This is so that the doctor knows what you have taken.

If you forget to take Eslicarbazepine Meditop

If you forget to take a tablet, take it as soon as you remember and continue as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Eslicarbazepine Meditop

Do not stop taking the tablets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take this medicine. If your doctor decides to stop your treatment with this medicine, they will usually reduce your dose gradually. It is important that you complete the treatment as instructed by your doctor; otherwise, your symptoms may get worse.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following side effects may be very serious. If they appear, stop taking Eslicarbazepina Meditop and inform a doctor or go to a hospital immediately, as you may need urgent medical treatment:

• Blisters or peeling of the skin and/or mucous membranes, skin rash, swallowing or breathing problems, swelling of the lips, face, eyelids, throat or tongue. These could be symptoms of an allergic reaction.

The very frequent adverse effects (may affect more than 1 in 10 people) are:

• Feeling of dizziness or sleepiness.

The frequent adverse effects (may affect up to 1 in 10 people) are:

• Feeling of instability or having a feeling of spinning or floating;
• Nausea or vomiting;
• Headache;
• Diarrhea;
• Double vision or blurred vision;
• Difficulty concentrating;
• Feeling of fatigue or decreased energy;
• Tremor;
• Skin rash;
• Blood tests showing low sodium levels;
• Decreased appetite;
• Difficulty sleeping;
• Difficulty in movement coordination (ataxia);
• Weight gain.

The infrequent adverse effects (may affect up to 1 in 100 people) are:

• Clumsiness;
• Allergy;
• Constipation;
• Seizures;
• Underactive thyroid gland. Symptoms include reduced thyroid hormone levels (observed in blood tests), intolerance to cold, large tongue, thin and brittle nails and hair, and low body temperature;
• Liver problems (such as increased liver enzymes);
• High blood pressure or severe increase in blood pressure;
• Low blood pressure or drop in blood pressure when standing up;
• Blood tests showing low salt levels (including chloride) or a decrease in red blood cells;
• Dehydration;
• Changes in eye movement, blurred vision, or red eyes;
• Having falls;
• Heat burn;
• Bad memory or forgetfulness;
• Crying, feeling depressed, nervous, or confused, lack of interest or emotion;
• Inability to speak or write or understand spoken or written language;
• Agitation;
• Hyperactive disorder and attention deficit;
• Irritability;
• Mood changes or hallucinations;
• Difficulty speaking;
• Nosebleeds;
• Chest pain;
• Numbness and/or tingling sensation in any part of the body;
• Migraine;
• Burning sensation;
• Abnormal sense of touch;
• Alterations in the sense of smell;
• Ringing in the ears;
• Hearing difficulty;
• Swelling in the legs and arms;
• Acidity, stomach discomfort, abdominal pain, abdominal distension, and mouth discomfort or dryness;
• Black stools (dark-colored);
• Inflamed gums or toothache;
• Sweating or having dry skin;
• Itching;
• Changes in skin (e.g., red skin);
• Hair loss;
• Urinary tract infection;
• Feeling of weakness, general discomfort, or chills;
• Weight loss;
• Muscle pain, pain in the limbs, muscle weakness;
• Bone metabolism disorder;
• Increased bone protein;
• Redness, cold extremities;
• Slower or irregular heartbeats;
• Feeling of excessive sleepiness;
• Sedation;
• Neurological movement disorder in which muscles contract and cause twisted and repetitive movements or abnormal postures. Symptoms include tremors, pain, cramps;
• Drug toxicity;
• Anxiety.

The adverse effects of Unknown Frequency (frequency cannot be estimated from the available data) are:

• Reduction of platelets in the blood that increases the risk of bleeding or bruising;
• Severe back and stomach pain (caused by pancreas inflammation);
• Reduction of white blood cells that increases the likelihood of infections;
• Reddish patches or circular patches often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, red and swollen eyes, and may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
• Symptoms initially similar to those of the flu, rash on the face, then generalized rash, high temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and affectation of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome);
• Severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles, or lower legs;
• Urticaria (skin rash with itching).
• Lethargy, confusion, muscle spasms, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of antidiuretic hormone (ADH)).

The use of this medicine is associated with an ECG (electrocardiogram) anomaly called an increased PR interval. Side effects associated with this ECG anomaly may occur (e.g., fainting and slowing of the heart rate).

Bone disorders have been reported, including osteopenia and osteoporosis (thinning of the bone) and fractures with antiepileptic drugs structurally related to carbamazepine and oxcarbazepine. Consult your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or are taking steroids.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaram.es By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Eslicarbazepina Meditop

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month that begins.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Eslicarbazepina Meditop

• The active ingredient is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are low-substituted hydroxypropyl cellulose, magnesium stearate.

Appearance of the Product and Package Contents

White or almost white, oblong, biconvex tablets, with the mark '800' on one face and scored on the other face.

The tablet can be divided into equal doses.

30, 60, or 90 tablets in transparent and colorless PVC/PVDC//Al blister packs, in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Meditop Pharmaceutical Ltd.

H-2097 Pilisborosjeno

Ady Endre u. 1.

Hungary

This Medicine is Authorized in the EEA Member States with the Following Names:

France:Eslicarbazepine Meditop 800 mg, scored tablet

Germany:EslicarbazepinMeditop800 mg Tablets

Hungary:EslicarbazepineMeditop800 mg tablet

Italy:EslicarbazepinaMeditop

Portugal:Eslicarbazepine acetate Meditop

Spain:Eslicarbazepina Meditop 800 mg tablets EFG

Date of the Last Revision of this Prospectus: February 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)