ESLICARBAZEPINE STADA 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Eslicarbazepina 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 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 and other information

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

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

Eslicarbazepina Stada contains the active substance eslicarbazepine acetate.

Eslicarbazepina belongs to a group of medicines called antiepileptics, used to treat epilepsy, a condition where the person has repeated seizures or fits.

Eslicarbazepina is used:

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

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

2. What you need to know before you take Eslicarbazepina Stada

Do not take Eslicarbazepina Stada:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking eslicarbazepina.

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 suffer from 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. Eslicarbazepina is not recommended in patients with severe kidney disease;
• if you have liver problems. Eslicarbazepina 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 suicide. If this happens while you are taking eslicarbazepina, contact your doctor immediately.

Eslicarbazepina may make you feel dizzy and/or drowsy, particularly at the start of treatment. Be particularly careful while taking eslicarbazepina to avoid accidental injury, such as falls.

Be particularly careful with eslicarbazepina.

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

If you develop a severe rash or other sign of skin reaction (see section 4), stop taking eslicarbazepina 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 in these patients. Your doctor may advise you on the need for such a blood test before taking eslicarbazepina.

Children

Eslicarbazepina should not be given to children under 6 years of age.

Taking Eslicarbazepina Stada with other medicines

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 eslicarbazepina works, or eslicarbazepina 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 eslicarbazepina may occur more frequently: double vision, abnormal coordination and dizziness;
• hormonal contraceptives (such as the pill), as eslicarbazepina 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 inhibitors (MAOIs), antidepressants;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with eslicarbazepina, as it is not known if it is safe to take these two medicines together.

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

Pregnancy and breast-feeding

Eslicarbazepina should not be used if you are pregnant, as the effects of eslicarbazepina on pregnancy and the unborn child are not known.

If you are planning to become pregnant, talk to your doctor before stopping your contraceptive method and before becoming pregnant. Your doctor may decide to change your treatment.

There are limited data on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital malformations and neurodevelopmental problems (brain development) in the children of women who take antiepileptic medicines, particularly when more than one antiepileptic medicine is taken 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 suddenly may cause seizures, which could be harmful for 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 eslicarbazepina. Eslicarbazepina may affect the way hormonal contraceptives work, making them less effective in preventing pregnancy. Therefore, you are advised to use other forms of safe and effective contraception while taking eslicarbazepina. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while taking eslicarbazepina. If you stop taking eslicarbazepina, you should continue to use an effective method of contraception until the end of your current menstrual cycle.

If you take eslicarbazepina during pregnancy, your baby is 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 you are taking eslicarbazepina. It is not known if eslicarbazepina passes into breast milk.

Driving and using machines

Eslicarbazepina may cause dizziness, drowsiness and affect your vision, particularly at the start of treatment. If this happens, do not drive or use any tools or machines.

3. How to take Eslicarbazepina Stada

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

Adults

Initial dose

400 mg once a day 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 a day.

Depending on how you respond to eslicarbazepina, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepina only (monotherapy), your doctor may consider increasing the dose to 1,600 mg once a day.

Patient with kidney problems

If you have kidney problems, you will usually be given a lower dose of eslicarbazepina. Your doctor will determine the correct dose for you. Eslicarbazepina is not recommended if you have severe kidney disease.

Elderly patients (above 65 years of age)

If you are an elderly patient and are taking eslicarbazepina in monotherapy, the dose of 1,600 mg is not suitable for you.

Children over 6 years of age

Initial dose

The initial dose is 10 mg per kg of body weight once a day for one or two weeks, before increasing to the maintenance dose.

Maintenance dose

Depending on the response to eslicarbazepina, the dose may be increased by 10 mg per kg of body weight, at intervals of one or two weeks, up to 30 mg per kg 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 pharmaceutical form of the medicine, may be more suitable for administration in children. Talk to your doctor or pharmacist.

Form and route of administration

Eslicarbazepina is taken by mouth. Swallow the tablet with a glass of water. Eslicarbazepina can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Eslicarbazepina Stada than you should

If you accidentally take more eslicarbazepina 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Eslicarbazepina Stada

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 forgotten doses.

If you stop taking Eslicarbazepina Stada

Do not stop taking the tablets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide for how long you should take eslicarbazepina. If your doctor decides to stop your treatment with eslicarbazepina, your dose will usually be reduced gradually. It is important that you complete the treatment as your doctor tells you; 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects may be very serious. If they appear, discontinue the administration of eslicarbazepine and inform a doctor or go to a hospital immediately, as you may need urgent medical treatment:

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

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

• dizziness or drowsiness

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

• feeling of instability, or spinning or floating
• nausea or vomiting
• headache
• diarrhea
• double vision or blurred vision
• difficulty concentrating
• feeling of fatigue or decreased energy
• tremors
• skin rash
• blood tests showing low sodium levels
• decreased appetite
• difficulty sleeping
• difficulty with movement coordination (ataxia)
• weight gain

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

• clumsiness
• allergy
• constipation
• seizures
• underactive thyroid gland. Symptoms include decreased thyroid hormone levels (detected in blood tests), intolerance to cold, enlarged tongue, thin and brittle nails and hair, and low body temperature
• liver problems (such as increased liver enzymes);
• high blood pressure or intense 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
• suffering from falls
• thermal burn
• poor memory or forgetfulness
• crying, feeling of depression, nervousness, or confusion, 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
• alterations in smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• acidity, stomach discomfort, abdominal pain, bloating, and abdominal discomfort or dry mouth
• black stools
• gum inflammation or tooth pain
• sweating or dry skin
• itching
• changes in skin (e.g., redness of the skin)
• hair loss
• urinary tract infection
• general discomfort, weakness, or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone proteins
• flushing (redness), coldness in the extremities
• slower or irregular heartbeats
• extreme drowsiness
• sedation
• motor neurological disorder where muscles contract, causing twisting and repetitive movements or abnormal postures. Symptoms include tremors, pain, and cramps
• drug toxicity
• anxiety.

The adverse effects of unknown frequency(cannot be estimated from the available data) are:

• Reduction of platelets that increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Reduction of white blood cells that makes infections more likely.
• Reddish spots or circular patches often with central blisters on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes that may be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome / toxic epidermal necrolysis).

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• Initially symptoms similar to the flu, rash on the face, generalized rash, elevated 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.
• Urticaria (skin rash with itching).
• Lethargy, confusion, muscle spasms, or significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of the antidiuretic hormone (ADH)).

The use of eslicarbazepine is associated with an ECG (electrocardiogram) anomaly called an increase in the PR interval. Adverse effects associated with this ECG anomaly may occur (e.g., fainting and slowing of heartbeats).

Bone disorders, including osteopenia and osteoporosis (thinning of the bones), and fractures have been reported with antiepileptic drugs 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 take steroids.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the blister pack, bottle, and carton after the letters CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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 Eslicarbazepine Stada

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

Appearance of the Product and Package Contents

The 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, boxed in cardboard boxes of 20, 28, 30, 60, or 90 tablets.

Only certain package 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 Last Revision of this Prospectus:June 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/.