ESRAN 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Esran 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:

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

1. What is Esran and what is it 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 where the person has repeated seizures or fits.

This medicine is used:

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

Your doctor has prescribed Esran to reduce the number of seizures.

2. What you need to know before you take Esran

Do not take Esran:

• if you are allergic to eslicarbazepine acetate, to other carbamazepine-related compounds (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

Consult your doctor or pharmacist before taking this medicine.

Tell your doctor immediately:

• If you develop 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 experience 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 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 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 a widespread electrical discharge that affects both sides of the brain.

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

Eslicarbazepine acetate 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 with Esran

In post-marketing experience, severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome/toxic epidermal necrolysis, have been reported in patients treated with this medicine.

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 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. Your doctor may advise you on the need for such a blood test before taking Esran.

Children

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

Other medicines and Esran

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 Esran works, or Esran 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 the dose,
• carbamazepine (a medicine used to treat epilepsy), as your doctor may need to adjust the 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 the dose,
• 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 two medicines together.

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

Pregnancy and breast-feeding

Esran should not be used during pregnancy, as the effects of 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 is limited data on the use of eslicarbazepine acetate in pregnant women.

Research has shown an increased risk of birth defects and problems with brain development (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 without consulting your doctor 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 Esran. Eslicarbazepine may affect the way hormonal contraceptives work, making them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective methods of contraception while taking Esran. Talk to your doctor, who will discuss with you the most suitable contraceptive method to use while taking Esran. If treatment with eslicarbazepine is stopped, you should continue to use an effective method of contraception until the end of your current menstrual cycle. If you take Esran 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 breast-feed while taking Esran. It is not known if eslicarbazepine 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.

3. How to take Esran

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

Adults

Starting dose

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 Esran, the dose may be increased to 1,200 mg once a day. If you are taking this medicine only (monotherapy), your doctor may consider increasing the dose to 1,600 mg once a day.

Patients with kidney problems

If you have kidney problems, you will usually 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 kidney disease.

Elderly patients (over 65 years of age)

If you are an elderly patient and are 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 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 Esran, 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 form of this medicine, may be more suitable for administration in children. Consult your doctor or pharmacist.

Form and route of administration

Esran is taken by mouth. Swallow the tablet with a glass of water.

Esran can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Esran than you should

If you accidentally take more Esran 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 to hospital immediately 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 Esran

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 a forgotten dose.

If you stop taking Esran

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 need to 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 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If they occur, stop taking Esran and contact a doctor or go to hospital immediately, as you may need urgent medical treatment:

• blistering 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.

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

• dizziness or drowsiness

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

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

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

• clumsiness
• allergic reaction
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased levels of thyroid hormones (detected in blood tests), intolerance to cold, increased size of the tongue, brittle or fragile nails and hair, and low body temperature
• liver problems (such as increased liver enzymes)
• high blood pressure or sudden increase in blood pressure
• low blood pressure, or decreased blood pressure when standing up
• blood tests showing low levels of salts (including chloride), or a decrease in the number of red blood cells
• dehydration
• changes in eye movements, blurred vision or red eyes
• falls
• heat burn
• poor memory or forgetfulness
• crying, feeling depressed, nervous or confused, lack of interest or emotions
• inability to speak, write or understand spoken or written language
• agitation
• attention deficit/hyperactivity disorder
• irritability
• mood changes or hallucinations
• difficulty speaking
• nosebleeds
• chest pain
• tingling or numbness in any part of the body
• migraine
• burning sensation
• abnormal sensation to touch
• changes in sense of smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• indigestion, stomach upset, abdominal pain, bloating and abdominal discomfort or dry mouth
• black stools
• gum inflammation or toothache
• sweating or dry skin
• itching
• changes in skin (e.g. redness of the skin)
• hair loss
• urinary tract infection
• general malaise, weakness or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone protein
• redness, coldness in the limbs
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• neuromotor disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain and cramps
• drug toxicity
• anxiety

The following side effects have a frequency that cannot be estimated(cannot be estimated from the available data):

• Decrease in platelets that increases the risk of bleeding or bruising.
• Severe pain in the back or stomach (caused by pancreas inflammation).
• Decrease in white blood cells that makes infections more likely.
• Red patches or circular patches often with blisters in the centre on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes, red and inflamed eyes and which may be preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• Initially flu-like symptoms, rash on the face, generalised rash, high 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.
• Hives (itchy skin rash).
• Lethargy, confusion, muscle spasms or significantly worsening 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 abnormality in the ECG (electrocardiogram) called prolonged PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of the heart) may occur.

Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported with antiepileptic medicines structurally related to 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esran

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 pack and carton after the letters CAD. 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 packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esran

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

Appearance of the Product and Package Contents

White, capsule-shaped, biconvex tablets, scored on one side, with the "Medochemie logo" engraved on the other side, with dimensions of 19x10 mm. The tablet can be divided into equal doses.

The tablets are packaged in ALU/ALU blisters.

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

Only some package 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

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

Medochemie Iberia S.A., Branch in Spain

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

28044 Madrid

Spain

Date of the last revision of this leaflet: May 2022

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