ESLICARBAZEPINE ZENTIVA 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Zentiva Eslicarbazepine 800 mg Tablets EFG

eslicarbazepine acetate

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

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

This medicine contains the active substance eslicarbazepine acetate.

Eslicarbazepine belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition where the person has repeated seizures or fits.

This medicine is used:

• as the only medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• in combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent and child patients (from 6 years of age) who have partial seizures (seizures that affect only a part of the brain). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalisation).

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

2. What you need to know before you take Zentiva Eslicarbazepine

Do not takeZentiva Eslicarbazepine:

• if you are allergic to eslicarbazepine acetate, to other carbazepine 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 a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

Tell your doctor immediately:

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

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust your 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 prolonged PR interval. If you are not sure if the medicines you are taking may cause this effect, discuss this with your doctor;
• if you have any heart disease such as heart failure or heart attack, or have any heart rhythm disorder;
• if you have seizures that start with an electrical discharge that spreads to both sides of the brain.

A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

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

Be extra careful withZentiva Eslicarbazepine

In the 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 sign of skin reaction (see section 4), stop taking this medicine and contact your doctor or seek medical attention immediately.

In Thai and Chinese Han ethnic patients, 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.

Taking Zentiva Eslicarbazepine with other medicines

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:

• phenytoin (a medicine used to treat epilepsy), as your doctor may need to adjust your dose;
• carbamazepine (a medicine used to treat epilepsy), as your doctor may need to adjust your dose, and the following side effects of this medicine may occur more frequently: double vision, abnormal coordination and dizziness;
• hormonal contraceptives (such as the pill) as this medicine may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as your doctor may need to adjust your dose;
• rosuvastatin, a medicine used to lower cholesterol levels;
• the anticoagulant warfarin;
• monoamine oxidase inhibitors (MAOIs), 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 two medicines together.

See the section “Pregnancy and breast-feeding” for recommendations on contraception.

Pregnancy and breast-feeding

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

If you are planning to become pregnant, talk to your doctor before stopping your contraceptive 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 problems with brain development (brain development) in children of women who take antiepileptic medicines, particularly when more than one antiepileptic medicine is taken 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 for 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 Zentiva Eslicarbazepine. Zentiva Eslicarbazepine may affect the effectiveness of hormonal contraceptives, such as the pill, and make them less effective in preventing pregnancy. Therefore, you are advised to use other forms of safe and effective contraception while taking Zentiva Eslicarbazepine. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while taking Zentiva Eslicarbazepine. If treatment with Zentiva Eslicarbazepine is stopped, you should continue to use an effective method of contraception until the end of your current menstrual cycle.

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

Do not breast-feed while you are taking this medicine. It is not known if the medicine passes into breast milk.

Driving and using machines

This medicine may cause dizziness, drowsiness and affect your vision, particularly at the start of treatment. If this happens to you, do not drive or use any tools or machines.

Zentiva Eslicarbazepine contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Zentiva Eslicarbazepine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Dose at the start of treatment

400 mg once a day for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you should 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, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine 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 disease.

Patient over 65 years of age

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

Children over 6 years of age

Dose at the start of treatment

The starting dose is 10 mg per kg 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 kg of body weight, at intervals of one or two weeks, up to 30 mg per kg 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

This medicine is taken by mouth.

Swallow the tablet with a glass of water.

This medicine can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Zentiva Eslicarbazepine 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 heart is beating irregularly or faster.

Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Take the medicine pack with you, so that the doctor knows what you have taken.

If you forget to take Zentiva Eslicarbazepine

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

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

If you stop taking Zentiva Eslicarbazepine

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, your dose will usually be reduced gradually. It is important that you complete the treatment as your doctor tells you; 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 adverse effects may be very serious. If they appear, stop administering this medicine 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, rash, swallowing or breathing problems, swelling of the lips, face, eyelids, throat or tongue. These could be signs of an allergic reaction.

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

• dizziness or drowsiness

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

• feeling of instability, or spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double vision or blurred vision
• difficulty concentrating
• feeling of fatigue or decreased energy
• tremors
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• difficulty in movement coordination (ataxia).
• weight gain.

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

• clumsiness
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, enlarged tongue, fine and brittle nails and hair, and low body temperature
• liver problems (such as increased liver enzymes);
• high blood pressure or intense increase in blood pressure
• low blood pressure, or decreased blood pressure when standing up
• blood tests showing low salt levels (including chloride), or a decrease in the number of red blood cells
• dehydration
• changes in eye movements, blurred vision or red eyes
• suffering from falls
• thermal burn
• poor memory or forgetfulness
• crying, feeling of depression, nervousness or confusion, lack of interest or emotions
• inability to speak, write or understand spoken or written language
• agitation
• attention deficit/hyperactivity
• irritability
• mood changes or hallucinations
• difficulty speaking
• nasal bleeding
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning
• abnormal sensation to touch
• alterations in smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• acidity, stomach discomfort, abdominal pain, bloating and abdominal discomfort or dry mouth
• black stools
• gum inflammation or tooth pain
• sweating or dry skin
• itching
• changes in skin (e.g., skin redness)
• hair loss
• urinary tract infection
• general malaise, weakness or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing (blushing), cold in the extremities
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• motor neurological disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain and cramps
• drug toxicity
• anxiety.

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

• Reduction of platelets that increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Reduction of white blood cells that makes infections more likely.
• Reddish spots or circular patches often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, red and inflamed eyes that may be preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / toxic epidermal necrolysis).
• Initially flu-like symptoms, rash on the face, generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and other body conditions (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 the antidiuretic hormone (ADH)).

The use of this medicine is associated with an ECG (electrocardiogram) anomaly called an increase in the PR interval. Adverse effects associated with this ECG anomaly may occur (e.g., fainting and slowing of heartbeats).

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

Reporting of Adverse Effects

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

5. Storage of Eslicarbazepina Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the blister and on the carton after the letters EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Eslicarbazepina Zentiva

• Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are povidone K29/32, sodium croscarmellose and magnesium stearate.

Appearance of the Product and Package Contents

Eslicarbazepina Zentiva tablets are white to off-white, oval and biconvex, 19 mm long with an IC engraved on one face and a break line on the other face. The tablet can be divided into equal doses.

The tablets are packaged in transparent blisters in cardboard boxes of 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.,

U kabelovny 130,

Dolni Mecholupy,

102 37 Prague 10,

Czech Republic

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

Date of the Last Revision of this Leaflet: May 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/