Eslicarbazepine Tarbis 800 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eslicarbazepine Tarbis 200 mg tablets EFG

Eslicarbazepine Tarbis 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, 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 other people, 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.

Contents of this leaflet:

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

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

Eslicarbazepina Tarbis 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.

Eslicarbazepine acetate 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 pediatric patients 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 to reduce the number of seizures you have.

2. What you need to know before taking Eslicarbazepine Tarbis

Do not take Eslicarbazepine Tarbis:

• 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 acetate.

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;
• if you experience confusion, worsening of seizures, or decreased level of consciousness, which could be signs of low blood levels of salts.

Inform your doctor:

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

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

Take special care with Eslicarbazepine Tarbis

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

In patients of Thai origin and Han Chinese ethnicity, 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 whether such a blood test is needed before starting eslicarbazepine acetate.

Children

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

Taking Eslicarbazepine Tarbis 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 important because some medicines may interfere with how eslicarbazepine acetate works, or eslicarbazepine acetate may interfere with the effect 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 your dose may need to be adjusted, and the following side effects of eslicarbazepine acetate may occur more frequently: double vision, abnormal coordination, and dizziness;
• hormonal contraceptives (such as the contraceptive pill), as eslicarbazepine acetate 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 acetate, 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 eslicarbazepine acetate during pregnancy is not recommended, 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 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 pregnant or think you may be pregnant, inform your doctor immediately. Do not stop taking your medicine without first discussing it with your doctor. Stopping your medication without medical advice 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 acetate. 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 discontinued, you should continue using 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 acetate 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.

Eslicarbazepine Tarbis contains sodium

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

3. How to take Eslicarbazepine Tarbis

Follow exactly the instructions for using 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 eslicarbazepine acetate, the dose may be increased to 1,200 mg once daily. If you are taking eslicarbazepine acetate 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 acetate. Your doctor will determine the correct dose for you. Eslicarbazepine acetate 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 acetate 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 acetate, 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. Please consult your doctor or pharmacist.

Method and route of administration

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

Eslicarbazepine acetate may be taken with or without food.

If you have difficulty swallowing the tablet whole, you may crush it and mix it with a small amount of water or apple sauce, and take it immediately.

The tablet may be divided into equal doses.

If you take more Eslicarbazepine Tarbis than you should

If you accidentally take more eslicarbazepine acetate than you should, you may be at risk of having more seizures; or you may feel that your heartbeat is irregular or faster than normal. 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Eslicarbazepine Tarbis

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 Tarbis

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 continue taking eslicarbazepine acetate. If your doctor decides to discontinue your treatment with eslicarbazepine acetate, 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 experiences them.

The following adverse effects may be very serious. If any of these occur, stop taking eslicarbazepine acetate 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 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 lack of energy;
• tremor;
• skin rash;
• blood tests showing low sodium levels;
• decreased appetite;
• difficulty sleeping;
• difficulty coordinating movements (ataxia);
• weight gain.

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

• 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 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;
• 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;
• disturbances in smell;
• tinnitus (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;
• slow or irregular heartbeat;
• extreme drowsiness;
• sedation;
• motor neurological disturbance 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 pain in the back or stomach (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 ulcers, 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, generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other systemic 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 acetate is associated with an ECG (electrocardiogram) abnormality called 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 effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eslicarbazepine Tarbis

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

Do not use this medicine after the expiry date which is stated on the blister pack, the bottle, and the outer carton after the letters EXP. 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 unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eslicarbazepine Tarbis

The active substance is eslicarbazepine acetate.

Eslicarbazepine Tarbis 200 mg tablets EFG

Each tablet contains 200 mg of eslicarbazepine acetate.

Eslicarbazepine Tarbis 800 mg tablets EFG

Each tablet contains 800 mg of eslicarbazepine acetate.

The other components are

Povidone K30, sodium croscarmellose, glycerol monostearate, and stearic acid and sodium fumarate.

Appearance of the product and contents of the pack

Eslicarbazepine Tarbis 200 mg tablets EFG

White to off-white, oblong tablets of 11.1 mm x 5.7 mm, with a score line on both sides and engraved with 'E31' on one side and 'H' on the other. The tablets may be mottled.

The tablet can be divided into equal doses.

Eslicarbazepine Tarbis 800 mg tablets EFG

White to off-white, oblong tablets of 19.1 mm x 9.9 mm, with a score line on both sides and engraved with 'E34' on one side and 'H' on the other. The tablets may be mottled.

The tablet can be divided into equal doses.

PVC/Al/OPA//Al blister packs

Eslicarbazepine Tarbis 200 mg tablets EFG: 60 tablets.

Eslicarbazepine Tarbis 800 mg tablets EFG: 30 and 90 tablets.

High-density polyethylene bottle with child-resistant polypropylene cap.

Eslicarbazepine Tarbis 200 mg tablets EFG: 30 tablets

Eslicarbazepine Tarbis 800 mg tablets EFG: 30 and 90 tablets

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Eslicarbazepin Amarox 200 mg/800 mg Tabletten

Spain: Eslicarbazepina Tarbis 200 mg/800 mg comprimidos EFG

Date of the most recent revision of this leaflet: February 2023

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/