Eslicarbazepine Stada 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eslicarbazepine Stada 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Eslicarbazepina Stada is and what it is used for

Eslicarbazepina Stada 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 convulsions.

Eslicarbazepine is used:

• as a single medication (monotherapy) in adult patients with newly diagnosed epilepsy;
• together with other antiepileptic medicines (adjunctive therapy) in adult patients, adolescents, and children over 6 years of age who have 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 eslicarbazepine to reduce the number of seizures.

2. What you need to know before taking Eslicarbazepine Stada

Do not take Eslicarbazepine Stada:

• 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 starting eslicarbazepine.

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 indicate 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 disease;
• 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 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 any heart rhythm disturbances;
• if you have seizures that begin with a widespread electrical discharge affecting both sides of the brain.

A small number of people taking antiepileptic medicines have had thoughts of harming themselves or of suicide. 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.

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 descent and Han Chinese ethnic group, 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 eslicarbazepine.

Children

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

Taking Eslicarbazepine Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because some medicines may interfere with how eslicarbazepine works, or 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 required, and the following adverse 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 dose adjustment may be needed;
• 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 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 is not recommended if you are pregnant, as the effects of eslicarbazepine on pregnancy and the unborn child are unknown.

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

If you take eslicarbazepine 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. It is unknown whether eslicarbazepine passes into breast milk.

Driving and using machines

Eslicarbazepine 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.

3. How to take Eslicarbazepine Stada

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 how you respond 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 kidney problems, you are generally given a lower dose of eslicarbazepine. Your doctor will determine the correct dose for you. Eslicarbazepine is not recommended if you have severe kidney problems.

Elderly patients (over 65 years of age)

If you are an elderly patient and are taking eslicarbazepine 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 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 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 Stada 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 that 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eslicarbazepine Stada

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 Eslicarbazepine Stada

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 eslicarbazepine. If your doctor decides to stop 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 they 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.

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

• dizziness or somnolence

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

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

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

• clumsiness in movements
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased 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 decreased 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 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
• 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 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, 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, elevated body temperature, increased 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 blood due to inappropriate antidiuretic hormone (ADH) secretion).

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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Stada

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

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

No special storage conditions are required.

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. 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 Eslicarbazepine Stada

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

Appearance of the product and contents of the pack

Eslicarbazepine Stada 800 mg tablets are white to off-white, oblong and biconvex, scored on both sides, with an approximate length of 18.9 mm and an approximate thickness of 6.1 mm. The tablet can be divided into equal doses.

The tablets are packaged in transparent or opaque blisters, packed into cardboard boxes containing 20, 28, 30, 60 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

or

Delorbis Pharmaceuticals Ltd.

17 Athinon Street

Ergates Industrial Area 2643 Ergates

2081 Lefkosia

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

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

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