Eslicarbazepine Zentiva 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eslicarbazepine Zentiva 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, 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 only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Eslicarbazepine Zentiva is and what it is 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 in which affected individuals experience repeated seizures or fits.

This medicine is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• in combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent and pediatric patients over 6 years of age who have epileptic seizures (fits) originating in one part of the brain (partial seizures). These seizures may or may not be followed by a seizure affecting 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 Zentiva

Do not take Eslicarbazepine Zentiva:

• if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (for example, carbamazepine or oxcarbazepine, medicines used to treat epilepsy), or to any of the other components 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 starting this medicine.

Inform your doctor immediately:

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

Inform your doctor:

• if you have kidney problems. Your doctor may need to adjust the dose. This medicine is not recommended in patients with severe renal impairment;
• if you have liver problems. This medicine is not recommended in patients with severe hepatic impairment;
• if you are taking any medicine that may cause an abnormality in the ECG (electrocardiogram) known as PR interval prolongation. If you are unsure whether 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 disturbances;
• if you have seizures that begin with a generalized electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medicines have had thoughts of self-harm or suicide. If this happens to you while taking this medicine, contact your doctor immediately.

This medicine may cause dizziness and/or drowsiness, particularly at the start of treatment. Take special care while taking this medicine to avoid accidental injury, such as falls.

Take special care with Eslicarbazepine Zentiva

In post-marketing experience, serious and potentially life-threatening skin reactions have been reported in patients treated with this medicine, including Stevens-Johnson syndrome/toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

If you develop a severe rash or other skin symptoms (see section 4), stop taking this medicine and consult your doctor or seek immediate medical attention.

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

Children

This medicine must not be given to children aged 6 years or younger.

Taking Eslicarbazepine Zentiva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This recommendation is because some medicines may interfere with how this medicine works, or because eslicarbazepine may interfere with the effects of other medicines. Inform your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as dose adjustment may be needed;
• carbamazepine (a medicine used to treat epilepsy), as dose adjustment may be needed, and the following adverse 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 dose adjustment may be needed;
• rosuvastatin, a medicine used to lower cholesterol levels;
• the anticoagulant warfarin;
• monoamine oxidase inhibitor (MAOI) antidepressants, other antidepressants;
• do not take oxcarbazepine (a medicine used to treat epilepsy) together with this medicine, as it is unknown whether it is safe to take these two medicines together.

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

Pregnancy and breastfeeding

Use of Eslicarbazepine Zentiva is not recommended if you are pregnant, as the effects of Eslicarbazepine Zentiva on pregnancy and the unborn child are unknown.

If you plan to become pregnant, speak with your doctor before stopping contraception and before becoming pregnant. Your doctor may decide to change your treatment.

There is limited data on the use of eslicarbazepine acetate in pregnant women.

Studies have shown an increased risk of congenital malformations and neurological development problems (brain development) in children of women taking antiepileptic medicines, particularly when more than one antiepileptic medicine is taken at the same time.

If you are or think you may be pregnant, inform your doctor immediately. You must not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor may cause seizures, which could be dangerous for you and your unborn child. Your doctor may decide to change your treatment.

If you are a woman of childbearing age and are not planning to become pregnant, you should use an effective method of contraception during treatment with Eslicarbazepine Zentiva. Eslicarbazepine Zentiva may affect the effectiveness of hormonal contraceptives, such as the contraceptive pill, making them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective forms of contraception while taking Eslicarbazepine Zentiva. Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking Eslicarbazepine Zentiva. If treatment with Eslicarbazepine Zentiva is stopped, you should continue using an effective method of contraception until the end of the current menstrual cycle.

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

Do not breast-feed while taking this medicine. It is unknown whether the drug passes into breast milk.

Driving and using machines

This medicine may cause dizziness, drowsiness, and affect your vision, particularly at the beginning of treatment. If this occurs, do not drive or operate any tools or machinery.

Eslicarbazepine Zentiva contains sodium.

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

3. How to take Eslicarbazepine Zentiva

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Adults

Starting dose

400 mg once daily for one or two weeks before increasing to the maintenance dose. Your doctor will decide whether you should take this dose for one or two weeks.

Maintenance dose

The usual maintenance dose is 800 mg once daily.

Depending on your response to this medicine, the dose may be increased to 1,200 mg once daily. If you are taking eslicarbazepine alone (monotherapy), your doctor may consider increasing your dose to 1,600 mg once daily.

Patients with renal problems

If you have kidney problems, you will generally 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 elderly and taking this medicine as monotherapy, the 1,600 mg dose is not suitable for you.

Children over 6 years of age

Starting dose

The starting dose is 10 mg per kg of body weight once daily for one or two weeks before increasing to the maintenance dose.

Maintenance dose

Depending on your 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 a maximum of 30 mg per kg of body weight. The maximum dose is 1,200 mg once daily.

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. Please consult your doctor or pharmacist.

Method and route of administration

This medicine is taken orally.

Swallow the tablet with a glass of water.

This medicine may be taken with or without food.

The tablet may be divided into equal doses.

If you take more Eslicarbazepine Zentiva than you should

If you accidentally take more eslicarbazepine than you should, you may be at risk of having more seizures; or you may feel that your heartbeat is irregular or faster than normal.

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

If you forget to take Eslicarbazepine Zentiva

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

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

If you stop taking Eslicarbazepine Zentiva

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

If you have any further questions about 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 everyone will experience them.

The following adverse effects may be very serious. If any of these occur, stop taking this medicine immediately and contact a doctor or go to a hospital straight away, as you may require urgent medical treatment:

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

Very common adverse effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness

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

• feeling unsteady, or as if spinning or floating
• nausea or vomiting
• headache
• diarrhoea
• double or blurred vision
• difficulty concentrating
• feeling tired or lacking energy
• tremor
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• problems with coordination of movement (ataxia)
• weight gain

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

• clumsiness of movement
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include reduced levels of thyroid hormones (detected in blood tests), intolerance to cold, enlarged tongue, brittle nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or sudden, severe increase in blood pressure
• low blood pressure, or reduced blood pressure upon standing
• blood tests showing low levels of salts (including chloride), or reduced number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• falls
• thermal burns
• poor memory or forgetfulness
• crying, feeling depressed, 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
• nosebleeds
• chest pain
• tingling or numbness sensation anywhere in the body
• migraine
• burning sensation
• abnormal sensation to touch
• changes in sense of smell
• ringing in the ears
• hearing difficulty
• swelling of arms and legs
• heartburn, stomach discomfort, abdominal pain, bloating and abdominal discomfort, or dry mouth
• black stools
• swollen gums or toothache
• sweating or dry skin
• itching
• skin changes (e.g., skin redness)
• hair loss
• urinary tract infection
• general malaise, weakness or chills
• weight loss
• muscle pain, limb pain, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing, cold extremities
• slower or irregular heartbeat
• extreme drowsiness
• sedation
• motor neurological disorder involving muscle contractions causing twisting movements, repetitive movements, or abnormal postures. Symptoms may include tremors, pain, and cramps
• drug toxicity
• anxiety

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Reduction in platelets, increasing the risk of bleeding or bruising.
• Severe back or stomach pain (caused by inflammation of the pancreas).
• Reduction in white blood cells, making infections more likely.
• Red spots or circular lesions often with central blisters on the trunk, skin peeling, mouth ulcers, sores in the throat, nose, genitals and eyes, red and inflamed eyes, possibly preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis).
• Initially flu-like symptoms, facial rash, widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic conditions (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower legs.
• Urticaria (itchy skin rash).
  • Lethargy, confusion, muscle spasms, or a significant worsening of seizures (possible symptoms of low sodium levels in blood due to inappropriate antidiuretic hormone (ADH) secretion).

Use of this medicine is associated with an ECG (electrocardiogram) abnormality called PR interval prolongation. Adverse effects related to this ECG abnormality may occur (e.g., fainting and slowed heart rate).

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with structurally related antiepileptic medicines such as carbamazepine and oxcarbazepine. Speak with 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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Eslicarbazepine Zentiva

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

Do not use this medicine after the expiry date stated on the blister and on the carton, following the letters CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Eslicarbazepine Zentiva

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

Nature of the product and pack contents

Eslicarbazepine Zentiva tablets are white to off-white, oval, biconvex, 19 mm in length, with an "IC" mark engraved on one side and a score line on the other. The tablet can be divided into equal doses.

The tablets are packaged in transparent blisters in cardboard boxes containing 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

For further information about this medicinal product, please contact 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 most recent review of this leaflet: May 2022

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