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Exalief (eslicarbazepine acetate) – Package leaflet - N03AF04

Updated on site: 06-Oct-2017

Medication nameExalief
ATC CodeN03AF04
Substanceeslicarbazepine acetate
ManufacturerBIAL - Portela

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet:

Exalief 400 mg tablets

authorised

 

 

Eslicarbazepine acetate

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others. It may harm them, even if their

-

symptoms are the same as yours.

 

If any of the side effects gets serious, or if you notice any side effects not listed in is leaflet, please tell

 

your doctor or pharmacist.

 

1.

What Exalief is and what it is used for

longer

2.

Before you take Exalief

3.

How to take Exalief

 

4.

Possible side effects

 

5.

How to store Exalief

 

6.

Further information

 

1. WHAT EXALIEF IS AND WHAT IT IS USED FOR

Exalief belongs to a group of medicines called anti-epi eptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

no

 

Exalief is used in adult patients who are already taking ther anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be

2. BEFORE YOU TAKE EXALIEF

followed by a seizure affecting all of the brain (seco dary generalisation). Exalief has been given to youproductby your do or o reduce your number of seizures.

Do not take Exalief if:

you are allergic (hype sensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients

you suffer from a certain ty e of heart rhythm disorder (second or third degree atrioventricular (AV) block)

Take special care with Ex lief

Contact your doctor immediately if:

you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be s gns of an allergic reaction.

you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels

Pl ase t ll your doctor if:

you have kidney problems. Your doctor may need to adjust the dose. Exalief is not recommended in patients with severe renal disease.

you have liver problems. Exalief is not recommended in patients with severe liver problems.Medicinal

• you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.

• you suffer from a heart disease such as heart failure or heart attack.

• you suffer from seizures that begin with a widespread electric discharge that involves both sid s of the brain

Exalief may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Exalief to avoid accidental injury (fall).

A small number of people being treated with anti-epileptics have had thoughts of arming killing themselves. If at any time you have these thoughts, when taking Exalief, contact your doctor immediately.

Children

Exalief is not to be given to children and adolescents.

Taking other medicines

• Tell your doctor if you are taking phenytoin (a medicine used to t eat epilepsy) since your dose may

 

need to be adjusted.

 

longer

authorised

 

 

 

 

 

Tell your doctor if you are taking carbamazepine (a medicine us d to tr at epilepsy) since your dose may

 

have to be adjusted and the following side effects of Exalief may occur in higher frequency: seeing

double, abnormal coordination and dizziness.

 

 

 

Tell your doctor if you are taking simvastatin (a medici used to lower cholesterol levels) since your

 

dose may have to be adjusted.

 

 

 

• Tell your doctor if you are taking the blood thinner - warfarin.

 

• Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.

 

no

 

 

Tell your doctor if you are taking hormonal/oral contraceptives. Exalief may make hormonal

 

contraceptives such as the contraceptive pill less effective. Therefore it is recommended that you use

 

other forms of safe and effective contraceptio

, when taking Exalief up to the end of the current

 

product

 

 

 

menstrual cycle after stopping treatment.

 

 

 

Do not take oxcarbazepine (a medicine used

o reat epilepsy) with Exalief, as it is not known whether it

 

is safe to take these medicines together.

 

 

 

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is just in case any of them interfere with how Exalief works or how Exalief interferes with their effect.

Taking Exalief with food and drink

Exalief tablets may be taken with without food.

PregnancyMedicinaland breast-feeding

Tell your doctor immediate y if you are pregnant or planning to become pregnant. You must only take Exalief during pregnancy if your doctor tells you.

Research has shown i creased risk of birth defects in children of women taking anti-epileptic medicines. On the other ha effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Do not breast-feed while you are taking Exalief. It is not known whether it passes into breast milk. See Taking other medicines’ section for advice about contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Exalief may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

3. HOW TO TAKE EXALIEF

Always take Exalief exactly as your doctor has told you. You should check with your doctor pharmacist if you are not sure.

Adults

There are two dosing regimes for adults:

Dose when you start treatment

400 mg dose once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Elderly (over 65 years of age)

Maintenance dose

 

authorised

The usual maintenance dose is 800 mg once daily.

 

Depending on how you respond to Exalief, your dose may be increased to 1200 mg once daily.

Patients with liver problems

longer

 

If you are elderly your doctor will decide the suitable dose for you.

Patients with kidney problems

 

 

If you have kidney problems you will usually be given a l

wer d se of Exalief. Your doctor will work out

the correct dose for you. Exalief is not recommended if y

u have severe kidney problems.

 

no

t recommended if you have severe liver problems.

The dose is the same as for adults. However, Exalief is n

Please talk to your doctor if you are unsure about the dose you should be taking.

product

 

 

Method and route of administration

 

 

Swallow the tablet with a glass of water.

If you take more Exalief than you sho ld

If you accidently take more Exalief than you should, tell a doctor or go to a hospital accident and emergency department immediately. Take the me icine pack with you. This is so the doctor knows what you have taken.

If you forget to take Exalief

If you forget to take a tablet, take it as soon as you remember and carry on as usual. Do not take a double dose to make up for the one you have missed.

IfMedicinalyou stop taking Exa ief

Do not stop taking your t b ets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take Exalief for. Should your doctor decide to stop your treatment with Exalief your dose will usually be reduced gradually. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Exalief can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined as using the very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

The following side effects can be very serious. If they happen to you stop taking Exalief and tell a doctor or

go to a hospital immediately, as you may need urgent medical treatment:

authorised

 

• Rash, swallowing or breathing problems, swelling of your lips, face, throat tongue. These could be signs of an allergic reaction

following convention:

Very common side effects are:

• Feeling dizzy or sleepy

Common side effects are:

 

 

 

 

• Feeling unsteady or having a sensation of spinning or floating

Feeling sick or vomiting

 

 

 

longer

Headache

 

 

 

 

 

Diarrhoea

 

 

 

 

 

• Seeing double or blurred vision

 

 

Difficulty in concentration

 

 

 

• Feeling low in energy or tired

 

 

Shaking

 

 

 

 

 

Clumsiness

 

 

 

no

 

Skin rash

 

 

 

 

Numbness and tingling in hands and feet

 

 

 

Uncommon side effects are:

 

 

 

 

Hypersensitivity

product

 

 

Having falls

 

 

 

Worsening of seizures

 

 

 

 

Underactive thyroid gland. Symptoms in lude cold intolerance, large tongue, thin and brittle fingernails

or hair and low body temperature.

 

 

Increased levels of circulating fats in yo r blood

 

Difficulty in sleeping

 

 

 

 

Liver problems

 

 

 

 

High or low blood pressure

a fall in blood pressure on standing up

Blood tests showing that y

have l w levels of salts or sodium in your blood or a reduction in red blood

cells

 

 

 

 

 

 

Dehydration

 

 

 

 

 

• Eye movement changes, fuzzy vision, red eye or eye pain

Medicinal

 

 

 

 

Poor memory or forgetfulness

 

 

• Crying, feeling depressed, nervous or confused, lack of interest or emotion

• Inability to speak or write or understand spoken or written language

Agitated

 

 

 

 

 

Irritab

ty

 

 

 

 

 

Mood

hanges or hallucinations

 

 

Difficulty

speaking

 

 

 

 

Nosebleed

 

 

 

 

 

Ch st pain

 

 

 

 

 

• Weight loss and general ill health (Cachexia)

 

 

• Feeling numb in any part of your body

 

 

Burning sensation

 

 

 

 

Disturbances in the sense of smell and/or tasting

• Ear pain or ringing in the ears

Swelling in your legs and arms

 

 

 

 

authorised

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort dry mouth

Blood in faeces

 

 

 

 

• Inflamed gums, mouth inflammation or toothache

 

 

 

Painful swallowing

 

 

 

 

• Sweating or having dry skin

 

 

 

 

• Nail or skin changes (e.g. red skin)

 

 

 

 

Hair loss

 

 

 

 

Having irregular periods

 

 

 

 

• Increased urine production during night time

 

 

 

 

Urinary tract infection

 

 

 

 

• Feeling generally unwell or having chills

 

 

 

 

• Increased or decreased appetite

 

 

 

 

• Weight loss or extreme weight gain

 

longer

 

Muscle pain

 

 

• Back pain or neck pain

 

 

 

 

Cold limbs

 

 

 

 

• Faster, slower or irregular heart beat

 

 

 

 

Feeling sleepy

 

 

 

 

Neurological movement disorder where your muscles co

tract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pai , cramping.

Irritable Bowel Syndrome (IBS). Symptoms include chr

 

nic abdominal cramps and diarrhoea or

 

constipation.

no

 

 

 

Rare side effects are:

 

 

 

Reduction in blood platelets which increases risk f bleeding or bruising

 

• Severe pain in the back and stomach

 

 

 

 

Keep out of the reach and sightproductof children.

 

 

 

 

Reduction in white blood cells which makes infections more likely

 

The use of Exalief is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE EXALIEF

DoMedicinalnot use Exalief fter the expiry date, which is stated on the blister package and the carton after EXP. The expiry date refers to the last day of that month.

This medi ine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of me icines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Exalief contains

Not all pack sizes may be marketed.

The active substance is eslicarbazepine acetate. Each tablet contains 400 mg of eslicarbazepine acetate.

authorised

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Exalief looks like and contents of the pack

Exalief 400 mg tablets are white, circular and biconvex. The tablets have ‘ESL 400’engraved on one side and are scored on the other side. The scoreline is only to facilitate breaking the tablet into two for ea of swallowing, and it does not divide the tablet into two equal doses.

The tablets are packaged in blisters in cardboard boxes containing 7, 14 or 28 tablets.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com

For any information about this medicine, please contact the Marketing Authorisation Holder.

Detailed information on this medicine is available on the Eur pean Medicines Agency web site: http://www.ema.europa.eu/.

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet:

Exalief 600 mg tablets

authorised

 

 

Eslicarbazepine acetate

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others. It may harm them, even if their

-

symptoms are the same as yours.

 

If any of the side effects gets serious, or if you notice any side effects not listed in is leaflet, please tell

 

your doctor or pharmacist.

 

1.

What Exalief is and what it is used for

 

2.

Before you take Exalief

 

1.

WHAT EXALIEF IS AND WHAT IT IS USED FORlonger

3.

How to take Exalief

 

4.

Possible side effects

 

5.

How to store Exalief

 

6.

Further information

 

Exalief belongs to a group of medicines called anti-epi eptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

no

 

Exalief is used in adult patients who are already taking ther anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be

2. BEFORE YOU TAKE EXALIEF

Do not take Exalief if:

followed by a seizure affecting all of the brain (seco dary generalisation). Exalief has been given to youproductby your do or o reduce your number of seizures.

you are allergic (hype sensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients

you suffer from a certain ty e of heart rhythm disorder (second or third degree atrioventricular (AV) block)

Take special care with Ex lief

Contact your doctor immediately if:

you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be s gns of an allergic reaction.

you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels

Pl ase t ll your doctor if:

you have kidney problems. Your doctor may need to adjust the dose. Exalief is not recommended in patients with severe renal disease.

you have liver problems. Exalief is not recommended in patients with severe liver problems.Medicinal

• you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.

• you suffer from a heart disease such as heart failure or heart attack.

• you suffer from seizures that begin with a widespread electric discharge that involves both sid s of the brain

Exalief may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Exalief to avoid accidental injury (fall).

A small number of people being treated with anti-epileptics have had thoughts of arming killing themselves. If at any time you have these thoughts, when taking Exalief, contact your doctor immediately.

Children

Exalief is not to be given to children and adolescents.

Taking other medicines

• Tell your doctor if you are taking phenytoin (a medicine used to t eat epilepsy) since your dose may

 

need to be adjusted.

 

longer

authorised

 

 

 

 

 

Tell your doctor if you are taking carbamazepine (a medicine us d to tr at epilepsy) since your dose may

 

have to be adjusted and the following side effects of Exalief may occur in higher frequency: seeing

double, abnormal coordination and dizziness.

 

 

 

Tell your doctor if you are taking simvastatin (a medici used to lower cholesterol levels) since your

 

dose may have to be adjusted.

 

 

 

• Tell your doctor if you are taking the blood thinner - warfarin.

 

• Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.

 

no

 

 

Tell your doctor if you are taking hormonal/oral contraceptives. Exalief may make hormonal

 

contraceptives such as the contraceptive pill less effective. Therefore it is recommended that you use

 

other forms of safe and effective contraceptio

, when taking Exalief up to the end of the current

 

product

 

 

 

menstrual cycle after stopping treatment.

 

 

 

Do not take oxcarbazepine (a medicine used

o reat epilepsy) with Exalief, as it is not known whether it

 

is safe to take these medicines together.

 

 

 

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is just in case any of them interfere with how Exalief works or how Exalief interferes with their effect.

Taking Exalief with food and drink

Exalief tablets may be taken with without food.

PregnancyMedicinaland breast-feeding

Tell your doctor immediate y if you are pregnant or planning to become pregnant. You must only take Exalief during pregnancy if your doctor tells you.

Research has shown i creased risk of birth defects in children of women taking anti-epileptic medicines. On the other ha effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Do not breast-feed while you are taking Exalief. It is not known whether it passes into breast milk. See Taking other medicines’ section for advice about contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Exalief may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

3. HOW TO TAKE EXALIEF

Always take Exalief exactly as your doctor has told you. You should check with your doctor pharmacist if you are not sure.

Adults

There are two dosing regimes for adults:

Dose when you start treatment

400 mg dose once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Elderly (over 65 years of age)

Maintenance dose

 

authorised

The usual maintenance dose is 800 mg once daily.

 

Depending on how you respond to Exalief, your dose may be increased to 1200 mg once daily.

Patients with liver problems

longer

 

If you are elderly your doctor will decide the suitable dose for you.

Patients with kidney problems

 

 

If you have kidney problems you will usually be given a l

wer d se of Exalief. Your doctor will work out

the correct dose for you. Exalief is not recommended if y

u have severe kidney problems.

 

no

t recommended if you have severe liver problems.

The dose is the same as for adults. However, Exalief is n

Please talk to your doctor if you are unsure about the dose you should be taking.

product

 

 

Method and route of administration

 

 

Swallow the tablet with a glass of water.

If you take more Exalief than you sho ld

If you accidently take more Exalief than you should, tell a doctor or go to a hospital accident and emergency department immediately. Take the me icine pack with you. This is so the doctor knows what you have taken.

If you forget to take Exalief

If you forget to take a tablet, take it as soon as you remember and carry on as usual. Do not take a double dose to make up for the one you have missed.

IfMedicinalyou stop taking Exa ief

Do not stop taking your t b ets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take Exalief for. Should your doctor decide to stop your treatment with Exalief your dose will usually be reduced gradually. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Exalief can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined as using the very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

The following side effects can be very serious. If they happen to you stop taking Exalief and tell a doctor or

go to a hospital immediately, as you may need urgent medical treatment:

authorised

 

• Rash, swallowing or breathing problems, swelling of your lips, face, throat tongue. These could be signs of an allergic reaction

following convention:

Very common side effects are:

• Feeling dizzy or sleepy

Common side effects are:

 

 

 

 

• Feeling unsteady or having a sensation of spinning or floating

Feeling sick or vomiting

 

 

 

longer

Headache

 

 

 

 

 

Diarrhoea

 

 

 

 

 

• Seeing double or blurred vision

 

 

Difficulty in concentration

 

 

 

• Feeling low in energy or tired

 

 

Shaking

 

 

 

 

 

Clumsiness

 

 

 

no

 

Skin rash

 

 

 

 

Numbness and tingling in hands and feet

 

 

 

Uncommon side effects are:

 

 

 

 

Hypersensitivity

product

 

 

Having falls

 

 

 

Worsening of seizures

 

 

 

 

Underactive thyroid gland. Symptoms in lude cold intolerance, large tongue, thin and brittle fingernails

or hair and low body temperature.

 

 

Increased levels of circulating fats in yo r blood

 

Difficulty in sleeping

 

 

 

 

Liver problems

 

 

 

 

High or low blood pressure

a fall in blood pressure on standing up

Blood tests showing that y

have l w levels of salts or sodium in your blood or a reduction in red blood

cells

 

 

 

 

 

 

Dehydration

 

 

 

 

 

• Eye movement changes, fuzzy vision, red eye or eye pain

Medicinal

 

 

 

 

Poor memory or forgetfulness

 

 

• Crying, feeling depressed, nervous or confused, lack of interest or emotion

• Inability to speak or write or understand spoken or written language

Agitated

 

 

 

 

 

Irritab

ty

 

 

 

 

 

Mood

hanges or hallucinations

 

 

Difficulty

speaking

 

 

 

 

Nosebleed

 

 

 

 

 

Ch st pain

 

 

 

 

 

• Weight loss and general ill health (Cachexia)

 

 

• Feeling numb in any part of your body

 

 

Burning sensation

 

 

 

 

Disturbances in the sense of smell and/or tasting

• Ear pain or ringing in the ears

Swelling in your legs and arms

 

 

 

 

authorised

Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort dry mouth

Blood in faeces

 

 

 

 

• Inflamed gums, mouth inflammation or toothache

 

 

 

Painful swallowing

 

 

 

 

• Sweating or having dry skin

 

 

 

 

• Nail or skin changes (e.g. red skin)

 

 

 

 

Hair loss

 

 

 

 

Having irregular periods

 

 

 

 

• Increased urine production during night time

 

 

 

 

Urinary tract infection

 

 

 

 

• Feeling generally unwell or having chills

 

 

 

 

• Increased or decreased appetite

 

 

 

 

• Weight loss or extreme weight gain

 

longer

 

Muscle pain

 

 

• Back pain or neck pain

 

 

 

 

Cold limbs

 

 

 

 

• Faster, slower or irregular heart beat

 

 

 

 

Feeling sleepy

 

 

 

 

Neurological movement disorder where your muscles co

tract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pai , cramping.

Irritable Bowel Syndrome (IBS). Symptoms include chr

 

nic abdominal cramps and diarrhoea or

 

constipation.

no

 

 

 

Rare side effects are:

 

 

 

Reduction in blood platelets which increases risk f bleeding or bruising

 

• Severe pain in the back and stomach

 

 

 

 

Keep out of the reach and sightproductof children.

 

 

 

 

Reduction in white blood cells which makes infections more likely

 

The use of Exalief is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE EXALIEF

DoMedicinalnot use Exalief fter the expiry date, which is stated on the blister package, bottle and the carton after EXP. The exp ry date refers to the last day of that month.

This medi ine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of me icines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Exalief contains

Not all pack sizes may be marketed.

The active substance is eslicarbazepine acetate. Each tablet contains 600 mg of eslicarbazepine acetate.

authorised

The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Exalief looks like and contents of the pack

Exalief 600 mg tablets are white and oblong. The tablets have ‘ESL 600’engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.

The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com

For any information about this medicine, please contact the Marketing Authorisation Holder.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

 

no

longer

 

 

 

product

 

Medicinal

 

 

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet:

Exalief 800 mg tablets

authorised

 

 

Eslicarbazepine acetate

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others. It may harm them, even if their

-

symptoms are the same as yours.

 

If any of the side effects gets serious, or if you notice any side effects not listed in is leaflet, please tell

 

your doctor or pharmacist.

 

1.

What Exalief is and what it is used for

 

2.

Before you take Exalief

 

1.

WHAT EXALIEF IS AND WHAT IT IS USED FORlonger

3.

How to take Exalief

 

4.

Possible side effects

 

5.

How to store Exalief

 

6.

Further information

 

Exalief belongs to a group of medicines called anti-epi eptics used to treat epilepsy, a condition where

someone has repeated seizures or fits.

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Exalief is used in adult patients who are already taking ther anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure). These seizures may or may not be

2. BEFORE YOU TAKE EXALIEF

followed by a seizure affecting all of the brain (seco dary generalisation). Exalief has been given to youproductby your do or o reduce your number of seizures.

Do not take Exalief if:

you are allergic (hype sensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients

you suffer from a certain ty e of heart rhythm disorder (second or third degree atrioventricular (AV) block)

Take special care with Ex lief

Contact your doctor immediately if:

you have rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. These could be s gns of an allergic reaction.

you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels

Pl ase t ll your doctor if:

you have kidney problems. Your doctor may need to adjust the dose. Exalief is not recommended in patients with severe renal disease.

you have liver problems. Exalief is not recommended in patients with severe liver problems.Medicinal

• you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval. If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.

• you suffer from a heart disease such as heart failure or heart attack.

• you suffer from seizures that begin with a widespread electric discharge that involves both sid s of the brain

Exalief may make you feel dizzy and/or drowsy, particularly at the beginning of treatment. Take special care when taking Exalief to avoid accidental injury (fall).

A small number of people being treated with anti-epileptics have had thoughts of arming killing themselves. If at any time you have these thoughts, when taking Exalief, contact your doctor immediately.

Children

Exalief is not to be given to children and adolescents.

Taking other medicines

• Tell your doctor if you are taking phenytoin (a medicine used to t eat epilepsy) since your dose may

 

need to be adjusted.

 

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Tell your doctor if you are taking carbamazepine (a medicine us d to tr at epilepsy) since your dose may

 

have to be adjusted and the following side effects of Exalief may occur in higher frequency: seeing

double, abnormal coordination and dizziness.

 

 

 

Tell your doctor if you are taking simvastatin (a medici used to lower cholesterol levels) since your

 

dose may have to be adjusted

 

 

 

• Tell your doctor if you are taking the blood thinner - warfarin.

 

• Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.

 

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Tell your doctor if you are taking hormonal/oral contraceptives. Exalief may make hormonal

 

contraceptives such as the contraceptive pill less effective. Therefore it is recommended that you use

 

other forms of safe and effective contraceptio

, when taking Exalief up to the end of the current

 

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menstrual cycle after stopping treatment.

 

 

 

Do not take oxcarbazepine (a medicine used

o reat epilepsy) with Exalief, as it is not known whether it

 

is safe to take these medicines together.

 

 

 

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is just in case any of them interfere with how Exalief works or how Exalief interferes with their effect.

Taking Exalief with food and drink

Exalief tablets may be taken with without food.

PregnancyMedicinaland breast-feeding

Tell your doctor immediate y if you are pregnant or planning to become pregnant. You must only take Exalief during pregnancy if your doctor tells you.

Research has shown i creased risk of birth defects in children of women taking anti-epileptic medicines. On the other ha effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Do not breast-feed while you are taking Exalief. It is not known whether it passes into breast milk. See Taking other medicines’ section for advice about contraception.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Exalief may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.

3. HOW TO TAKE EXALIEF

Always take Exalief exactly as your doctor has told you. You should check with your doctor pharmacist if you are not sure.

Adults

There are two dosing regimes for adults:

Dose when you start treatment

400 mg dose once daily for one or two weeks, before increasing to the maintenance dose. Your doctor will decide whether you will be given this dose for one or two weeks.

Elderly (over 65 years of age)

Maintenance dose

 

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The usual maintenance dose is 800 mg once daily.

 

Depending on how you respond to Exalief, your dose may be increased to 1200 mg once daily.

Patients with liver problems

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If you are elderly your doctor will decide the suitable dose for you.

Patients with kidney problems

 

 

If you have kidney problems you will usually be given a l

wer d se of Exalief. Your doctor will work out

the correct dose for you. Exalief is not recommended if y

u have severe kidney problems.

 

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t recommended if you have severe liver problems.

The dose is the same as for adults. However, Exalief is n

Please talk to your doctor if you are unsure about the dose you should be taking.

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Method and route of administration

 

 

Swallow the tablet with a glass of water.

If you take more Exalief than you sho ld

If you accidently take more Exalief than you should, tell a doctor or go to a hospital accident and emergency department immediately. Take the me icine pack with you. This is so the doctor knows what you have taken.

If you forget to take Exalief

If you forget to take a tablet, take it as soon as you remember and carry on as usual. Do not take a double dose to make up for the one you have missed.

IfMedicinalyou stop taking Exa ief

Do not stop taking your t b ets suddenly. If you do, you are at risk of having more seizures. Your doctor will decide how long you should take Exalief for. Should your doctor decide to stop your treatment with Exalief your dose will usually be reduced gradually. It is important that your treatment is completed as advised by your doctor or your symptoms may get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Exalief can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined as using the very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

The following side effects can be very serious. If they happen to you stop taking Exalief and tell a doctor or

go to a hospital immediately, as you may need urgent medical treatment:

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• Rash, swallowing or breathing problems, swelling of your lips, face, throat tongue. These could be signs of an allergic reaction

following convention:

Very common side effects are:

• Feeling dizzy or sleepy

Common side effects are:

 

 

 

 

• Feeling unsteady or having a sensation of spinning or floating

Feeling sick or vomiting

 

 

 

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Headache

 

 

 

 

 

Diarrhoea

 

 

 

 

 

• Seeing double or blurred vision

 

 

Difficulty in concentration

 

 

 

• Feeling low in energy or tired

 

 

Shaking

 

 

 

 

 

Clumsiness

 

 

 

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Skin rash

 

 

 

 

Numbness and tingling in hands and feet

 

 

 

Uncommon side effects are:

 

 

 

 

Hypersensitivity

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Having falls

 

 

 

Worsening of seizures

 

 

 

 

Underactive thyroid gland. Symptoms in lude cold intolerance, large tongue, thin and brittle fingernails

or hair and low body temperature.

 

 

Increased levels of circulating fats in yo r blood

 

Difficulty in sleeping

 

 

 

 

Liver problems

 

 

 

 

High or low blood pressure

a fall in blood pressure on standing up

Blood tests showing that y

have l w levels of salts or sodium in your blood or a reduction in red blood

cells

 

 

 

 

 

 

Dehydration

 

 

 

 

 

• Eye movement changes, fuzzy vision, red eye or eye pain

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Poor memory or forgetfulness

 

 

• Crying, feeling depressed, nervous or confused, lack of interest or emotion

• Inability to speak or write or understand spoken or written language

Agitated

 

 

 

 

 

Irritab

ty

 

 

 

 

 

Mood

hanges or hallucinations

 

 

Difficulty

speaking

 

 

 

 

Nosebleed

 

 

 

 

 

Ch st pain

 

 

 

 

 

• Weight loss and general ill health (Cachexia)

 

 

• Feeling numb in any part of your body

 

 

Burning sensation

 

 

 

 

Disturbances in the sense of smell and/or tasting

• Ear pain or ringing in the ears

Swelling in your legs and arms

 

 

 

 

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Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort dry mouth

Blood in faeces

 

 

 

 

• Inflamed gums, mouth inflammation or toothache

 

 

 

Painful swallowing

 

 

 

 

• Sweating or having dry skin

 

 

 

 

• Nail or skin changes (e.g. red skin)

 

 

 

 

Hair loss

 

 

 

 

Having irregular periods

 

 

 

 

• Increased urine production during night time

 

 

 

 

Urinary tract infection

 

 

 

 

• Feeling generally unwell or having chills

 

 

 

 

• Increased or decreased appetite

 

 

 

 

• Weight loss or extreme weight gain

 

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Muscle pain

 

 

• Back pain or neck pain

 

 

 

 

Cold limbs

 

 

 

 

• Faster, slower or irregular heart beat

 

 

 

 

Feeling sleepy

 

 

 

 

Neurological movement disorder where your muscles co

tract causing twisting and repetitive

movements or abnormal postures. Symptoms include tremors, pai , cramping.

Irritable Bowel Syndrome (IBS). Symptoms include chr

 

nic abdominal cramps and diarrhoea or

 

constipation.

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Rare side effects are:

 

 

 

Reduction in blood platelets which increases risk f bleeding or bruising

 

• Severe pain in the back and stomach

 

 

 

 

Keep out of the reach and sightproductof children.

 

 

 

 

Reduction in white blood cells which makes infections more likely

 

The use of Exalief is associated with an abnormality in ECG (electrocardiogram) called increase in

PR interval. Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE EXALIEF

DoMedicinalnot use Exalief fter the expiry date, which is stated on the blister package, bottle and the carton after EXP. The exp ry date refers to the last day of that month.

This medi ine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of me icines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Exalief contains

Not all pack sizes may be marketed.

The active substance is eslicarbazepine acetate. Each tablet contains 800 mg of eslicarbazepine acetate.

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The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.

What Exalief looks like and contents of the pack

Exalief 800 mg tablets are white and oblong. The tablets have ‘ESL 800’engraved on one side and are scored on the other side, enabling the tablets to be divided into equal halves.

The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and n HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.

Marketing Authorisation Holder and Manufacturer

BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado

Portugal

tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com

For any information about this medicine, please contact the Marketing Authorisation Holder.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.

 

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