ESCARPILO 1200 mg TABLETS

Introduction

Package Leaflet: Information for the User

Escarpilo 1,200 mg tablets

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

1. What is Escarpilo and what is it used for

This medicine contains the active substance eslicarbazepine acetate.

This medicine 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 adults with newly diagnosed epilepsy;
• with other antiepileptic medicines (adjunctive therapy) in adults, adolescents, and children over 6 years of age who have epileptic seizures (seizures) that affect part of the brain (partial seizures). These seizures may or may not be followed by a seizure that affects the whole brain (secondary generalization).

Your doctor has prescribed this medicine to reduce the number of seizures.

2. What you need to know before you take Escarpilo

Do not take Escarpilo:

• if you are allergic to eslicarbazepine acetate, to other carbamide derivatives (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

Talk to your doctor or pharmacist before you start taking this medicine

Tell your doctor immediately:

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

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 an increased PR interval. If you are not sure if the medicines you are taking may cause this effect, talk to your doctor;

(electrocardiogram) called an increased PR interval. If you are not sure if the medicines you are taking may cause this effect, talk to 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 to you while taking this medicine, contact your doctor immediately.

This medicine may make you feel dizzy and/or drowsy, particularly at the start of treatment. Be extra careful while taking this medicine to avoid accidental injuries, such as falls.

Be extra careful with this medicine

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

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 patients of Thai origin and Chinese Han ethnic group, the risk of serious skin reactions associated with carbamazepine or chemically related compounds can be predicted by a blood test for these patients. Your doctor may advise you on the need for such a blood test before taking this medicine.

Children

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

Other medicines and Escarpilo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because some of them may affect the way this medicine works, or this medicine may affect the way they 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;
• tricyclic antidepressants, such as amitriptyline;
• 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 recommendations on contraception.

Pregnancy and breast-feeding

Do not take Escarpilo if you are pregnant, as the effects of this medicine 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 is limited data on the use of eslicarbazepine acetate in pregnant women. Studies have shown an increased risk of congenital defects and neurodevelopmental problems (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 talking to 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 Escarpilo.

This medicine may affect the way hormonal contraceptives work, making them less effective in preventing pregnancy.

Therefore, you are recommended to use other safe and effective methods of contraception while taking Escarpilo.

Talk to your doctor, who will discuss with you the most suitable contraceptive method to use while taking this medicine. If you stop taking this medicine, you should continue to use an effective method of contraception until the end of your current menstrual cycle.

If you take Escarpilo 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 this medicine. It is not known if it 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.

This medicine contains sodium

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

3. How to take Escarpilo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults

Dose at the start of treatment

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 this medicine, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine alone (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 this medicine. Your doctor will determine the correct dose for you. This medicine 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 this medicine as monotherapy, the dose of 1,600 mg is not suitable for you.

Children over 6 years of age

Dose at the start of treatment

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 this medicine, 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.

Form and method of administration

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

If you have difficulty swallowing the tablet whole, you can crush it and mix it with water or apple sauce, and take it immediately.

The tablet can be divided into equal doses.

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If you accidentally take more Escarpilo than you should, you are at risk of having more seizures; or you may feel that your heartbeat is irregular or faster. Contact your doctor or go to the hospital immediately if you experience any of these symptoms. Take the medicine package with you, so the doctor knows what you have taken.

You can also call the Toxicology Information Service, Tel: 915620420, indicating the medicine and the amount taken.

If you forget to take Escarpilo

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.

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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 should take this medicine. If your doctor decides to stop your treatment with this medicine, they will usually reduce the dose 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 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 this medicine and tell a doctor or go to the 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 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 of instability, or spinning or floating
  • nausea or vomiting
  • headache
  • diarrhea
  • double vision or blurred vision
  • difficulty concentrating
  • feeling of tiredness or lack of energy
  • tremor
  • 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
• allergy
• 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 nails or 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
• falls
• heat 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
• changes in smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• acid reflux, stomach upset, 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 malaise, weakness, or chills
• weight loss
• muscle pain, pain in limbs, muscle weakness
• bone metabolism disorder
• increased bone protein
• flushing (redness of the skin), coldness in the extremities
• slow or irregular heartbeat
• 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 is not known(cannot be estimated from the available data):

• Decrease in platelets that increases the risk of bleeding or bruising.
• Severe back or stomach pain (caused by pancreas inflammation).
• Decrease in white blood cells that makes infections more likely.
• Red patches or circular spots often with blisters in the center on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, red and inflamed eyes, and may be preceded by fever and/or flu-like symptoms (Stevens-Johnson Syndrome/toxic epidermal necrolysis).
• Initially flu-like symptoms, rash on the face, generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen 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 significant worsening of seizures (possible symptoms of low sodium levels in the blood due to inadequate secretion of antidiuretic hormone (ADH)).

The use of eslicarbazepine is associated with an abnormality in the ECG (electrocardiogram) called an increased 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.

Adverse Reaction Reporting

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that is not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Storage of Escarpilo

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

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

This medicine does not require special storage conditions.

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 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 Escarpilo

• The active ingredient is eslicarbazepine acetate. Each tablet contains 1,200 mg of eslicarbazepine acetate (corresponding to 1,029.84 mg of eslicarbazepine).
• The other components are povidone K30, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Package Contents

Escarpilo 1,200 mg tablets are white to off-white, oblong, biconvex (23 x 10 mm), scored on one side.

The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes containing 28 or 30 tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

Langenfeld 40764

Germany

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Escarpilo

Spain: Escarpilo 1,200 mg tablets

Date of the Last Revision of this Leaflet:

December 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.