ARUPSAN 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Arupsan 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

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

1. What is Eslicarbazepine Accord and what is it used for

Arupsan 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.

Eslicarbazepine is used:

• as the only medicine (monotherapy) in adult patients with newly diagnosed epilepsy;
• 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 eslicarbazepine to reduce the number of seizures.

2. What you need to know before you take Eslicarbazepine Accord

Do not take Arupsan:

• 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 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 Arupsan.

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 your dose. Eslicarbazepine 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 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 suicidal thoughts. If at any time you have these thoughts, contact your doctor immediately.

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

Be extra careful with eslicarbazepine.

In the post-marketing experience, in patients treated with eslicarbazepine, 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 eslicarbazepine and contact your doctor or seek medical attention immediately.

In patients of Thai and Chinese Han ethnic origin, 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 the need for such a blood test before taking this medicine.

Children

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

Other medicines and Arupsan

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 eslicarbazepine works, or eslicarbazepine may affect the way other medicines work. Tell your doctor if you are taking:

• phenytoin (a medicine used to treat epilepsy), as you may need to have your dose adjusted;
• carbamazepine (a medicine used to treat epilepsy), as you may need to have your dose adjusted, and the following side effects of eslicarbazepine may occur more frequently: double vision, abnormal coordination and dizziness;
• hormonal contraceptives (such as the pill) as eslicarbazepine may reduce their effectiveness;
• simvastatin (a medicine used to lower cholesterol levels), as you may need to have your dose adjusted;
• rosuvastatin, a medicine used to lower cholesterol levels;
• the anticoagulant warfarin;
• tricyclic antidepressants, e.g. amitriptyline;
• do not take oxcarbazepine (a medicine used to treat epilepsy) with eslicarbazepine, as it is not known if it is safe to take these two medicines together.

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

Pregnancy and breast-feeding

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

If you are planning to become pregnant, talk to your doctor before stopping your contraceptive 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.

Research has shown an increased risk of birth defects and problems with brain development (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 suddenly 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 eslicarbazepine. Eslicarbazepine may affect the way hormonal contraceptives work, such as the pill, and make them less effective in preventing pregnancy. Therefore, you are advised to use other safe and effective methods of contraception while taking eslicarbazepine. Talk to your doctor, who will discuss with you the most suitable contraceptive method to use while taking eslicarbazepine. If you stop taking eslicarbazepine, you should continue to use an effective method of contraception until the end of your current menstrual cycle.

If you take eslicarbazepine 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 eslicarbazepine. It is not known if eslicarbazepine passes into breast milk.

Driving and using machines

Arupsan 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.

Arupsan contains sodium

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

3. How to take Eslicarbazepine Accord

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

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 eslicarbazepine, the dose may be increased to 1,200 mg once a day. If you are taking eslicarbazepine only (monotherapy), your doctor may consider increasing your 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 eslicarbazepine. Your doctor will determine the correct dose for you. This medicine is not recommended if you have severe kidney disease.

Elderly patients (over 65 years of age)

If you are an elderly patient and are taking eslicarbazepine in 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 the 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.

The oral suspension, another form of the medicine, may be more suitable for administration in children. Talk to your doctor or pharmacist.

Form and route of administration

Arupsan is taken by mouth. Swallow the tablet with a glass of water.

This medicine can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Arupsan than you should

If you accidentally take more eslicarbazepine 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.

If you forget to take Arupsan

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 Arupsan

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 eslicarbazepine, your dose will usually be reduced gradually. It is important that you complete the treatment as instructed by your doctor; 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 Arupsan and contact a doctor or go to a hospital immediately, as you may need urgent medical attention:

• 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.

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 unsteady or spinning, or feeling as if you are floating
• nausea or vomiting
• headache
• diarrhoea
• double vision or blurred vision
• difficulty concentrating
• feeling tired or lacking energy
• tremor
• skin rash
• blood tests showing low levels of sodium
• loss of 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
• high blood pressure or severe 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
• falling
• heat burn
• poor memory or forgetfulness
• crying, feeling depressed, nervous or confused, 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 sense of smell
• ringing in the ears
• difficulty hearing
• swelling of legs and arms
• heartburn, stomach upset, abdominal pain, bloating and stomach discomfort or dry mouth
• black stools
• gum inflammation or toothache
• 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), cold hands and feet
• slow or irregular heartbeat
• extreme drowsiness
• sedation
• neuromotor disorder where the 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 cannot be estimated(cannot be estimated from the available data):

• reduction in platelets that increases the risk of bleeding or bruising.
• severe back or stomach pain (caused by pancreas inflammation).
• reduction in white blood cells that makes infections more likely.
• red patches or spots, often with blisters in the centre, on the trunk, peeling of the skin, ulcers in the mouth, 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, rash on the face, generalised 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).

The use of eslicarbazepine is associated with an abnormality in the ECG (electrocardiogram) called prolonged PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slow heart rate) 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eslicarbazepina Accord

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 and on the carton after the letters CAD. The expiry 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. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Arupsan

• The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.
• The other ingredients are sodium croscarmellose (E468), magnesium stearate (E572), povidone (E1201), microcrystalline cellulose (E460), colloidal anhydrous silica (E551).

Appearance of the Product and Package Contents

The Arupsan 800 mg tablets are oblong, uncoated, white to off-white, engraved with “V7” on one side and a break line on the other. The tablet size is approximately 19.00 x 9.80 mm.

The tablet can be divided into equal doses.

The tablets are packaged in blisters, in cardboard boxes of 20, 30, or 60 tablets, and in HDPE bottles with child-resistant closures, in cardboard boxes of 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

Moll de Barcelona s/n.

World Trade Center. Edifici Est 6ª planta

08039 Barcelona

Spain

Manufacturer

Laboratori Fundacio Dau

C/c 12-14 Poligon Industrial Zona Franca

Barcelona, 08040

Spain

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Accord Healthcare Polska Sp. z.o.o.

Ul.Lutomierska 50,

95-200, Pabianice

Poland

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

Date of the last revision of this leaflet: August 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/