Esran 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esran 800 mg tablets EFG

eslicarbazepine, acetate

Read the 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, 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.

Leaflet contents:

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

1. What Esran is and what it is used for

This medicine contains the active substance eslicarbazepine acetate.

Eslicarbazepine acetate belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition in which affected individuals experience repeated seizures or convulsions.

This medicine is used:

• as a single medicine (monotherapy) in adult patients with newly diagnosed epilepsy,
• together with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and pediatric patients over 6 years of age who experience epileptic seizures (convulsions) affecting 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 Esran to reduce the number of seizures.

2. What you need to know before taking Esran

Do not take Esran:

• 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 ingredients of this medicine (listed in section 6),
• if you have a specific 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.

Contact 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,
• you experience confusion, worsening of seizures, or decreased level of 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 for patients with severe renal disease.
• if you have liver problems. This medicine is not recommended for patients with severe liver problems.
• if you are taking any medicine that may cause an abnormality on the ECG (electrocardiogram) called PR interval prolongation. If you are unsure whether your medicines may cause this effect, discuss it 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 about self-harm or suicide. If this happens to you while taking this medicine, contact your doctor immediately.

Eslicarbazepine acetate may make you feel dizzy and/or drowsy, especially at the beginning of treatment. Take special care while taking this medicine to avoid accidental injuries, such as falls.

Take special care with Esran

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, 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 origin and Han Chinese ethnic group, the risk of severe 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 taking Esran.

Children

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

Other medicines and Esran

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 this medicine may interfere with the effect of other medicines.

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) 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

The use of Esran is not recommended if you are pregnant, as the effects of eslicarbazepine on pregnancy and the unborn child are unknown.

If you are planning to become pregnant, talk to 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 developmental 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 without first discussing it 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 potential and not planning to become pregnant, you must use an effective method of contraception during treatment with Esran. Eslicarbazepine 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 Esran. Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking Esran. If treatment with eslicarbazepine is discontinued, you should continue using an effective method of contraception until the end of the current menstrual cycle. If you take Esran 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 Esran. It is unknown whether it passes into breast milk.

Driving and using machines

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

3. How to take Esran

Follow exactly the instructions for administration of this medicine as given by your doctor. 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 Esran, the dose may be increased to 1,200 mg once daily. If you are taking this medicine 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 eslicarbazepine. Your doctor will determine the correct dose for you. This medicine is not recommended if you have severe renal impairment.

Elderly patients (over 65 years of age)

If you are elderly and taking Esran 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 body weight once daily for one or two weeks before increasing to the maintenance dose.

Maintenance dose

Depending on the response to Esran, the dose may be increased by 10 mg per kg body weight at intervals of one or two weeks, up to a maximum of 30 mg per kg 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

Esran is administered orally. Swallow the tablet with a glass of water.

Esran may be taken with or without food.

The tablet may be divided into equal doses.

If you take more Esran than you should

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

If you forget to take Esran

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 forgotten doses.

If you stop taking Esran

Do not suddenly stop taking the tablets. If you do, you may be at risk of having more seizures. Your doctor will decide for 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 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 experiences them.

The following adverse effects may be very serious. If they occur, stop taking Esran immediately and consult 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.

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

• dizziness or drowsiness

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

• feeling unsteady, or of spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double or blurred vision
• difficulty concentrating
• feeling tired or lacking energy
• tremor
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• difficulty coordinating movements (ataxia)
• weight gain

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

• clumsiness of movements
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, enlarged tongue, brittle and thin nails or hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or marked 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
• difficulty hearing
• swelling of arms and legs
• heartburn, stomach discomfort, abdominal pain, bloating and abdominal discomfort, or dry mouth
• black stools
• gum inflammation 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
• redness, coldness in extremities
• slower or irregular heartbeats
• 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, throat, nose, genital or eye ulcers, red and inflamed eyes, which may be preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis).
• Initially flu-like symptoms, facial rash, generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic manifestations (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 marked worsening of seizures (possible symptoms of low blood sodium levels due to inappropriate antidiuretic hormone (ADH) secretion).

Use of this medicine is associated with an ECG (electrocardiogram) abnormality known as 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 effect, talk to 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 national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esran

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esran

• The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are: sodium croscarmellose, povidone K30, magnesium stearate.

Appearance of the product and contents of the pack

White, capsule-shaped, biconvex tablets, with a score line on one side and the "Medochemie logo" engraved on the other side, measuring 19x10 mm. The tablet can be divided into equal doses.

The tablets are packaged in ALU/ALU blisters.

Pack sizes: 20, 30, 60, 90 and 180 tablets are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Medochemie Ltd.,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Manufacturer:

MEDOCHEMIE LTD (FACTORY AZ)

2 - Michael Erakleous, Agios Athanassios Industrial ST

Limassol, 4101, Cyprus

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch office in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

Spain

Date of the most recent review of this leaflet: May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.