Eslicarbazepine Cinfa 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

1. What eslicarbazepine cinfa is and what it is used for

This medicine contains the active substance eslicarbazepine acetate.

It belongs to a group of medicines called antiepileptic drugs, which are 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;
• in combination with other antiepileptic medicines (adjunctive therapy) in adult, adolescent, and children over 6 years of age who experience epileptic seizures (convulsions) 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 eslicarbazepine cinfa to reduce the number of seizures.

2. What you need to know before taking eslicarbazepine cinfa

Do not take eslicarbazepine cinfa

• 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 certain type of heart rhythm disorder (second- or third-degree atrioventricular (AV) block).

Warnings and precautions

Talk to your doctor or pharmacist before taking eslicarbazepine cinfa.

Tell 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.

Tell your doctor:

• if you have kidney problems. Your doctor may need to adjust your dose. Eslicarbazepine is not recommended in patients with severe renal disease;
• if you have liver problems. Eslicarbazepine is not recommended in patients with severe liver problems;
• 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 suicidal thoughts or thoughts about self-harm. If this happens to you while taking eslicarbazepine, contact your doctor immediately.

Eslicarbazepine may cause dizziness and/or drowsiness, especially at the beginning of treatment. Take special care while taking eslicarbazepine to avoid accidental injury, such as falls.

Take special care with eslicarbazepine cinfa.

In post-marketing experience, serious and potentially life-threatening skin reactions have been reported in patients treated with eslicarbazepine, 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 eslicarbazepine and consult your doctor or seek immediate medical attention.

In patients of Thai origin and in the Han Chinese ethnic group, 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 about the need for such a blood test before starting eslicarbazepine.

Children

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

Taking eslicarbazepine cinfa 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 eslicarbazepine works, or eslicarbazepine 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 eslicarbazepine may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as the contraceptive pill), as eslicarbazepine 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 eslicarbazepine, as it is not known whether it is safe to take these two medicines together.

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

Pregnancy and breastfeeding

Use of eslicarbazepine acetate is not recommended if you are pregnant, as the effects of eslicarbazepine acetate 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 problems with neurological development (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 pregnant or think you might 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 potential and are not planning to become pregnant, you must use an effective method of contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate 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. Talk to your doctor, who will discuss with you the most appropriate type of contraception to use while taking eslicarbazepine acetate. If treatment with eslicarbazepine acetate is stopped, you should continue to use an effective method of contraception until the end of the current menstrual cycle. If you take eslicarbazepine acetate 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 eslicarbazepine acetate. It is not known whether it passes into breast milk.

Driving and using machines

Eslicarbazepine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction time. These effects, as well as the underlying disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Eslicarbazepine cinfa contains sodium.

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

Eslicarbazepine cinfa contains hydrogenated castor oil.

This medicine may cause stomach upset and diarrhoea because it contains castor oil.

3. How to take eslicarbazepine cinfa

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist. If in doubt, 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 recommended maintenance dose is 800 mg once daily.

Depending on your response to eslicarbazepine, 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 renal problems, you will generally be given a lower dose of eslicarbazepine. Your doctor will determine the correct dose for you. Eslicarbazepine is not recommended if you have severe renal impairment.

Elderly patients (over 65 years of age)

If you are elderly and are taking eslicarbazepine as monotherapy, the 1,600 mg dose is not suitable for you.

Use in children

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 the response to eslicarbazepine, 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. Consult your doctor or pharmacist.

Method and route of administration

Eslicarbazepine cinfa is administered orally. Swallow the tablet with a glass of water. Eslicarbazepine may be taken with or without food.

The tablet may be divided into equal doses.

If you take more eslicarbazepine cinfa 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. Contact your doctor or go immediately to a hospital if you experience any of these symptoms. Take the medicine package with you so the doctor knows what you have taken.

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

If you forget to take eslicarbazepine cinfa

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

If you stop taking eslicarbazepine cinfa

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 eslicarbazepine. If your doctor decides to discontinue your treatment with eslicarbazepine, 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 eslicarbazepine and contact a doctor or go to a hospital immediately, 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 very common adverse effects (may affect more than 1 in 10 people) are:

• dizziness or drowsiness.

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

• feeling unsteady, or of 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.

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

• clumsiness of movement
• 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 decreased blood pressure upon standing
• blood tests showing low levels of salts (including chloride), or a reduction in the number of red blood cells
• dehydration
• changes in eye movements, blurred vision, or red eyes
• falls
• thermal burn
• memory problems 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
• changes in mood 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
• 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
• flushing, cold extremities
• slower or irregular heartbeat
• extreme drowsiness
• sedation
• motor neurological disorder where muscles contract, causing twisting movements, repetitive movements, or abnormal postures. Symptoms 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
• reddish spots or circular lesions often with central blisters on the trunk, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals and eyes, 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, widespread 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 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 the blood due to inappropriate secretion of antidiuretic hormone (ADH)).

The use of eslicarbazepine 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 slowing of the heartbeat).

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 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 cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". 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 unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of eslicarbazepine cinfa

• The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other components are croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose, colloidal anhydrous silica, hydrogenated castor oil and magnesium stearate.

Appearance of the product and contents of the pack

Eslicarbazepine cinfa tablets are oblong, biconvex, white in colour, scored on one side and marked with the letter “E” on the other side.

The tablets are packed in PVC-PVDC/ALU blisters, in cardboard boxes containing 20, 30, 60 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: April 2022

Detailed 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/)

You can access detailed and up-to-date information on this medicinal product by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84717/P_84717.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84717/P_84717.html