LACOSAMIDE 10 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Lacosamide UCB and what is it used for
   2. What you need to know before taking Lacosamide UCB
   3. How to take Lacosamide UCB
   4. Possible side effects
   5. How to store Lacosamide UCB
   6. Package contents and other information
2. Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Lacosamide UCB and what is it used for
   2. What you need to know before taking Lacosamide UCB
   3. How to take Lacosamide UCB
   4. Possible side effects
   5. How to store Lacosamide UCB
   6. Contents of the pack and other information
3. Lacosamide UCB 10 mg/mL syrup
   1. What is Lacosamide UCB and what is it used for
   2. What you need to know before taking Lacosamide UCB
   3. How to take Lacosamide UCB
   4. Possible side effects
   5. How to store Lacosamide UCB
   6. Contents of the pack and other information
4. Lacosamide UCB 10 mg/mL solution for infusion
   1. What is Lacosamide UCB and what is it used for
   2. What you need to know before you use Lacosamide UCB
   3. How to use Lacosamide UCB
   4. Possible side effects
   5. How to store Lacosamide UCB
   6. Package contents and other information

Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Lacosamide UCB and what is it used for

What is Lacosamide UCB
Lacosamide UCB contains lacosamide. It belongs to a group of medicines called
“antiepileptic medicines”. These medicines are used to treat epilepsy.

• This medicine has been given to you to reduce the number of seizures (epileptic fits) you experience.

What is Lacosamide UCB used for

• Lacosamide UCB is used:
• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age, to treat a specific form of epilepsy characterized by the occurrence of seizures with partial onset with or without secondary generalization. In this type of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas of both sides of your brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age, to treat primary generalized tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before taking Lacosamide UCB

Do not take Lacosamide UCB

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, consult your doctor.
• if you have a particular type of heart rhythm problem called second or third degree AV block.

Do not take Lacosamide UCB if you fall into one of the above cases. If you are not sure, ask your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Lacosamide UCB if:

• you have thought about harming or killing yourself. A small number of people treated with antiepileptic medicines like lacosamide have thought about harming or killing themselves. If you should have any of these thoughts at any time, tell your doctor immediately.
• you have a heart problem that affects your heartbeat and often have a particularly slow, fast or irregular heartbeat (e.g. AV block, atrial fibrillation and flutter)
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamide UCB can cause dizziness - this may increase the risk of accidental injury or falls. This means you should be careful until you get used to the effects of this medicine. If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist before taking Lacosamide UCB. If you are taking Lacosamide UCB, talk to your doctor if you have a seizure that is different from your usual seizures or if your existing seizures get worse. If you are taking Lacosamide UCB and experience symptoms of an abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy and fainting), consult your doctor immediately (see section 4).

Children
Lacosamide UCB is not recommended for children under 2 years of age with epilepsy
characterized by partial-onset seizures and is not recommended for children under 4 years of
age with primary generalized tonic-clonic seizures. This is because it is not yet known if it works and if it is
safe for children in this age group.

Other medicines and Lacosamide UCB
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
affect the heart: this is because Lacosamide UCB can also affect your heart:

• medicines to treat heart disease;
• medicines that can prolong the “PR interval” on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat certain forms of irregular heartbeat or heart failure. If you fall into one of the above cases (or are not sure) ask your doctor or pharmacist before taking Lacosamide UCB.

Also tell your doctor or pharmacist if you are taking any of the following drugs - this is because they
can increase or decrease the effect of Lacosamide UCB on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• medicines for HIV such as ritonavir;
• medicines used to treat bacterial infections such as clarithromycin or rifampicin;
• an herbal medicine used to treat mild anxiety and depression called St. John's wort If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist before taking Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution, do not take Lacosamide UCB with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended not to take Lacosamide UCB during pregnancy, as the effects of
Lacosamide UCB on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide UCB, as Lacosamide UCB
passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you
decide whether to take Lacosamide UCB or not.
Do not stop treatment without consulting your doctor first, as this may cause an
increase in seizures (fits). A worsening of your condition can also be harmful to your
baby.

Driving and operating machinery
Do not drive vehicles, ride a bicycle, use tools or machinery until you have checked how this medicine affects you. This is because Lacosamide UCB can cause dizziness or
blurred vision.

3. How to take Lacosamide UCB

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. Other forms of this medicine may be more
suitable for children: ask your doctor or pharmacist.

Taking Lacosamide UCB

• Lacosamide UCB twice a day, approximately 12 hours apart.
• Try to take it at about the same time each day.
• Swallow the Lacosamide UCB tablet with a glass of water.
• You can take Lacosamide UCB with or without food.

Usually you will start by taking a reduced dose each day and your doctor will increase it slowly over
a number of weeks. When you reach the dose that is right for you, this is
called a "maintenance dose", so take the same amount each day. Lacosamide UCB is
used as a long-term treatment. You must continue to take Lacosamide UCB until your
doctor tells you to stop.

How much to take
Below are listed the usual recommended doses of Lacosamide UCB for the different age
groups and weight ranges. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults
When you take Lacosamide UCB alone
The starting dose of Lacosamide UCB is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day.
Your doctor may increase your daily dose by 50 mg twice a day each week, up to
a maintenance dose of between 100 mg and 300 mg twice a day.
When you take Lacosamide UCB with other antiepileptic medicines
The starting dose of Lacosamide UCB is usually 50 mg twice a day.
Your doctor may increase the daily dose by 50 mg twice a day each week. This is up to
a maintenance dose of between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide UCB with a
single “loading” dose of 200 mg. 12 hours later you would then start your maintenance dose.

Children and adolescents weighing less than 50 kg

In the treatment of partial-onset seizures: it should be noted that Lacosamide UCB is not recommended
in children under 2 years of age.

In the treatment of primary generalized tonic-clonic seizures: it should be noted that Lacosamide UCB
is not recommended in children under 4 years of age.
The dose depends on their body weight. Usually they start treatment with the syrup and switch to
tablets only if they are able to take them and receive the correct dose with the different tablet strengths. The doctor will prescribe the most suitable formulation for them.

If you take more Lacosamide UCB than you should
Contact your doctor immediately if you have taken more Lacosamide UCB than you should.
Do not drive.
You may experience:

• dizziness;
• nausea or vomiting;
• seizures, heart problems such as slow, fast or irregular heartbeat, coma or a drop in blood pressure with a fast heartbeat and sweating.

If you forget to take Lacosamide UCB

• If you forget to take a dose of Lacosamide UCB and less than 6 hours have passed since your usual time, take Lacosamide UCB as soon as you remember.
• If you forget to take a dose and more than 6 hours have passed since your usual time, do not take the forgotten tablet. Instead, take your next Lacosamide UCB tablet at your usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Lacosamide UCB

• Do not stop taking Lacosamide UCB without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your treatment with Lacosamide UCB, they will give you instructions on how to gradually reduce your dose. If you have any questions about using 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.
Side effects involving the nervous system, such as dizziness, may be more frequent
after a single “loading” dose.

Talk to your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people

• Headache;
• Feeling dizzy or nauseous;
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, increased risk of falls and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling of “spinning” (vertigo), drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or sensitivity, difficulty articulating words, attention disorder;
• Noises in the ear such as ringing, trilling or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, attempt to commit suicide: inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting.;
• Abnormal involuntary movements (dyskinesia).

Not known:frequency cannot be estimated from available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever and having more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis);
• Severe skin reaction that may include high fever and other flu-like symptoms, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.

Other side effects in children

• Additional side effects in children have been fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, different than normal behavior (abnormal behavior) and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store Lacosamide UCB

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 pack after Scad. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide UCB contains

• The active ingredient is lacosamide. One Lacosamide UCB 50 mg tablet contains 50 mg of lacosamide. One Lacosamide UCB 100 mg tablet contains 100 mg of lacosamide. One Lacosamide UCB 150 mg tablet contains 150 mg of lacosamide. One Lacosamide UCB 200 mg tablet contains 200 mg of lacosamide.
• Other ingredients are: Tablet core:microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substitution), anhydrous colloidal silica, crospovidone (polyplasdone XL-10 pharmaceutical grade), magnesium stearate. Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colorants* *The colorants are: 50 mg tablets: iron oxide red (E172), iron oxide black (E172), indigotine (E132). 100 mg tablets: iron oxide yellow (E172). 150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172). 200 mg tablets: indigotine (E132).

Description of the appearance of Lacosamide UCB and package contents

• Lacosamide UCB 50 mg film-coated tablets are pink, oval, approximately 10.4 mm x 4.9 mm in size and with the inscription ‘SP’ on one side and ‘50’ on the other.
• Lacosamide UCB 100 mg film-coated tablets are dark yellow, oval, approximately 13.2 mm x 6.1 mm in size and with the inscription ‘SP’ on one side and ‘100’ on the other.
• Lacosamide UCB 150 mg film-coated tablets are salmon-colored, oval, approximately 15.1 mm x 7.0 mm in size and with the inscription ‘SP’ on one side and ‘150’ on the other.
• Lacosamide UCB 200 mg film-coated tablets are blue, oval, approximately 16.6 mm x 7.8 mm in size and with the inscription ‘SP’ on one side and ‘200’ on the other.

Lacosamide UCB is available in packs of 14, 28, 56, 14 x 1 and 56 x 1 film-coated tablets. Lacosamide UCB 50 mg and Lacosamide UCB 100 mg are available in packs of 168 film-coated tablets and Lacosamide UCB 150 mg and Lacosamide UCB 200 mg are available in multiple packs containing 3 blisters, each of 56 tablets. The packs of 14 x 1 and 56 x 1 film-coated tablets are available in divisible unit-dose blisters made of PVC/PVDC sealed with an aluminum foil, all other packs are available in standard blisters made of PVC/PVDC sealed with an aluminum foil. Not all pack sizes may be marketed.

Marketing authorization holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
For further information on this medicine, please contact the local representative of the marketing authorization holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0) 1 291 80 00

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 48 22 696 99 20

France
UCB Pharma S.A.
Tél: + 33 / (0)1 47 29 44 35

España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
Vistor hf.
Simi: + 354 535 7000

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: + 421 (0) 2 5920 2020

Italia
UCB Pharma S.p.A.
Tel: + 39 / 02 300 791

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4221

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 357 22 05 63 00

Sverige
UCB Nordic A/S
Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide

The starter pack is only suitable for adolescents and children weighing 50 kg or more, and for adults.
Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Lacosamide UCB and what is it used for

What is Lacosamide UCB
Lacosamide UCB contains lacosamide. It belongs to a group of medicines called
“antiepileptic medicines”. These medicines are used to treat epilepsy.

• This medicine has been given to you to reduce the number of seizures (epileptic fits) you experience.

What is Lacosamide UCB used for

• Lacosamide UCB is used:
• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age to treat a specific form of epilepsy characterised by the occurrence of seizures with partial onset with or without secondary generalization. In this type of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas of both sides of your brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age to treat primary generalised tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before taking Lacosamide UCB

Do not take Lacosamide UCB

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, ask your doctor
• if you have a particular type of heartbeat problem called second or third degree AV block.

Do not take Lacosamide UCB if any of the above apply to you. If you are not sure, talk to your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Lacosamide UCB if:

• you have thought about harming yourself or committing suicide. A small number of people treated with anti-epileptic medicines like lacosamide have thought about harming themselves or committing suicide. If you have these thoughts at any time, tell your doctor immediately.
• you have a heart problem that affects your heartbeat and often have a particularly slow, fast or irregular heartbeat (e.g. AV block, atrial fibrillation and atrial flutter).
• you have a serious heart condition such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamide UCB can cause dizziness - this may increase the risk of accidental injury or falls. This means you should be careful until you know how this medicine affects you. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide UCB. If you are taking Lacosamide UCB, talk to your doctor if you have a seizure that is different from usual or if your existing seizures get worse. If you are taking Lacosamide UCB and develop symptoms of an abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling faint or lightheaded, and fainting), see your doctor immediately (see section 4).

Children
Lacosamide UCB is not recommended for children under 2 years of age with epilepsy
characterised by partial-onset seizures and is not recommended for children under 4 years of
age with primary generalised tonic-clonic seizures. This is because it is not yet known if it works and if it is
safe for children in this age group.

Other medicines and Lacosamide UCB
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
affect the heart: this is because Lacosamide UCB can also affect your heart:

• medicines to treat heart disease;
• medicines that can prolong the “PR interval” on a heart scan (ECG or electrocardiogram) such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat some types of irregular heartbeat or heart failure. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide UCB.

Also tell your doctor or pharmacist if you are taking any of the following drugs - this is because they
can increase or decrease the effect of Lacosamide UCB on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• medicines for HIV such as ritonavir;
• medicines used to treat bacterial infections, such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression, called St John's Wort. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution, do not take Lacosamide UCB with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
It is recommended not to take Lacosamide UCB during pregnancy, as the effects of
Lacosamide UCB on the fetus are not known.
It is recommended not to breastfeed while taking Lacosamide UCB, as Lacosamide UCB
passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you
decide whether to take Lacosamide UCB or not.
Do not stop treatment without consulting your doctor first, as this may cause an
increase in seizures (fits). A worsening of your condition can also be harmful to
your baby.

Driving and using machines
Do not drive, ride a bicycle, use tools or machinery until you have checked how this medicine affects you. This is because Lacosamide UCB can cause dizziness or
blurred vision.

3. How to take Lacosamide UCB

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. Other forms of this medicine may be more
suitable for children: ask your doctor or pharmacist.

Taking Lacosamide UCB

• Take Lacosamide UCB twice every day, approximately 12 hours apart.
• Try to take it at about the same time each day.
• Swallow the Lacosamide UCB tablet with a glass of water.
• You can take Lacosamide UCB with or without food.

Usually you will start by taking a reduced dose each day and your doctor will slowly increase it over
a number of weeks. When you reach the dose that is right for you, this is
called a "maintenance dose", so take the same amount each day. Lacosamide UCB is
used as a long-term treatment. You must continue to take Lacosamide UCB until your
doctor tells you to stop.

How much to take
Below are listed the usual recommended doses of Lacosamide UCB for different age
groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults
When you take Lacosamide UCB alone
The starting dose of Lacosamide UCB is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day.
Your doctor may increase your daily dose by 50 mg twice a day each week, up to
a maintenance dose, between 100 mg and 300 mg twice a day.
When you take Lacosamide UCB with other anti-epileptic medicines
Start of therapy (first 4 weeks)
This pack (start of therapy pack) is for you to start your treatment with Lacosamide UCB.
The pack contains 4 different packs for the first 4 weeks of therapy, one for each
week.
Each pack contains 14 tablets, which corresponds to 2 tablets a day for 7 days.
Each pack contains a different dosage of Lacosamide UCB, to allow you to increase the
dose gradually.
You will start treatment with a low dose of Lacosamide UCB, usually 50 mg twice a
day, and will increase the dose gradually week by week. The dose that you can most commonly
take each day for the first 4 weeks of therapy is shown in the following table. Your
doctor will tell you if you need to use all 4 packs.

Table: start of therapy (the first 4 weeks)

WeekTOTAL
daily dose
Week 1Pack
marked
"Week 1"

Pack to useFirst dose (in the
morning)
Second dose
(in the evening)
50 mg
(1 tablet of
Lacosamide
UCB 50 mg)
50 mg
(1 tablet of
Lacosamide
UCB 50 mg)
100 mg

Week 2Pack
marked
"Week 2"
100 mg
(1 tablet of
Lacosamide
UCB 100 mg)
100 mg
(1 tablet of
Lacosamide
UCB 100 mg)
200 mg

Week 3Pack
marked
"Week 3"
150 mg
(1 tablet of
Lacosamide
UCB 150 mg)
150 mg
(1 tablet of
Lacosamide
UCB 150 mg)
300 mg

Week 4Pack
marked
"Week 4"
200 mg
(1 tablet of
Lacosamide
UCB 200 mg)
200 mg
(1 tablet of
Lacosamide
UCB 200 mg)
400 mg

• Maintenance therapy (after the first 4 weeks) After the first 4 weeks of treatment, your doctor may adjust the dose that you will continue to take for long-term therapy. This dose is called a maintenance dose, and depends on your response to Lacosamide UCB. In most patients, the maintenance dose is between 200 mg and 400 mg a day.

Children and adolescents weighing less than 50 kg
The start of therapy pack is not suitable for children and adolescents weighing less than 50 kg.

If you take more Lacosamide UCB than you should
Contact your doctor immediately if you have taken more Lacosamide UCB than you should.
Do not drive.
You may experience:

• dizziness;
• nausea or vomiting;
• seizures, heart problems such as slow, fast or irregular heartbeat, coma or a drop in blood pressure with a fast heartbeat and sweating.

If you forget to take Lacosamide UCB

• If you forget to take a dose of Lacosamide UCB and less than 6 hours have passed since your usual time for taking it, take Lacosamide UCB as soon as you remember.
• If you forget to take a dose and more than 6 hours have passed since your usual time for taking it, do not take the forgotten dose. Instead, take your next Lacosamide UCB tablet at your usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Lacosamide UCB

• Do not stop taking Lacosamide UCB without consulting your doctor, as epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with Lacosamide UCB, they will give you instructions on how to gradually reduce your dose. If you have any questions about using 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.

Contact your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people

• Headache;
• Feeling dizzy or nauseous;
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, easy bruising and falling;
• Memory problems, difficulty thinking or finding the right words, confusion;
• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling of “spinning” (vertigo), drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or sensation, difficulty articulating words, attention deficit;
• Noises in the ear such as ringing, buzzing or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
• Exaggerated sense of well-being, seeing and/or hearing things that are not present;
• Allergic reaction after taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, attempt to commit suicide, inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known:frequency cannot be estimated from available data

• Fast heartbeat (ventricular tachycardia);
• Sore throat, high fever and suffering from more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific type of white blood cells (agranulocytosis);
• Severe skin reaction that may include high fever and other flu-like symptoms, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.

Other side effects in children

• Additional side effects observed in children have been fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, behavior different from normal (abnormal behavior) and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lacosamide UCB

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 package after Scad. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lacosamide UCB contains

• The active ingredient is lacosamide. One Lacosamide UCB 50 mg tablet contains 50 mg of lacosamide. One Lacosamide UCB 100 mg tablet contains 100 mg of lacosamide. One Lacosamide UCB 150 mg tablet contains 150 mg of lacosamide. One Lacosamide UCB 200 mg tablet contains 200 mg of lacosamide.
• Other ingredients are: Tablet core:microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substitution), anhydrous colloidal silica, crospovidone (crospovidone XL-10 pharmaceutical grade), magnesium stearate. Coating:polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colorants* *Colorants are: 50 mg tablets: iron oxide red (E172), iron oxide black (E172), indigotine (E132). 100 mg tablets: iron oxide yellow (E172).

150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
200 mg tablets: indigotine (E132).

Description of Lacosamide UCB and contents of the pack
Lacosamide UCB 50 mg film-coated tablets are pink, oval, approximately 10.4 mm x 4.9 mm in size and with the inscription ‘SP’ on one side and ‘50’ on the other.

• Lacosamide UCB 100 mg film-coated tablets are dark yellow, oval, approximately 13.2 mm x 6.1 mm in size and with the inscription ‘SP’ on one side and ‘100’ on the other.
• Lacosamide UCB 150 mg film-coated tablets are salmon-colored, oval, approximately 15.1 mm x 7.0 mm in size and with the inscription ‘SP’ on one side and ‘150’ on the other.
• Lacosamide UCB 200 mg film-coated tablets are blue, oval, approximately 16.6 mm x 7.8 mm in size and with the inscription ‘SP’ on one side and ‘200’ on the other.

The starter pack contains 56 film-coated tablets, divided into 4 packs:

• The pack labeled ‘Week 1’ contains 14 tablets of 50 mg,
• The pack labeled ‘Week 2’ contains 14 tablets of 100 mg,
• The pack labeled ‘Week 3’ contains 14 tablets of 150 mg,
• The pack labeled ‘Week 4’ contains 14 tablets of 200 mg.

Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0) 1 291 80 00

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 48 22 696 99 20

France
UCB Pharma S.A.
Tél: + 33 / (0)1 47 29 44 35

España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
Vistor hf.
Simi: + 354 535 7000

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: + 421 (0) 2 5920 2020

Italia
UCB Pharma S.p.A.
Tel: + 39 / 02 300 791

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4221

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 357 22 05 63 00

Sverige
UCB Nordic A/S
Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Lacosamide UCB 10 mg/mL syrup

lacosamide

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Lacosamide UCB and what is it used for

What is Lacosamide UCB
Lacosamide UCB contains lacosamide. It belongs to a group of medicines called
“antiepileptic medicines”. These medicines are used to treat epilepsy.

• This medicine has been given to you to reduce the number of seizures (epileptic fits) you experience.

What is Lacosamide UCB used for

• Lacosamide UCB is used:
• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age, to treat a specific form of epilepsy characterised by the occurrence of seizures with partial onset with or without secondary generalization. In this type of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas of both sides of your brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age, to treat primary generalised tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is believed to have a genetic cause).

2. What you need to know before taking Lacosamide UCB

Do not take Lacosamide UCB

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, consult your doctor.
• if you have a particular type of heart rhythm problem called second or third degree AV block.

Do not take Lacosamide UCB if you fall into one of the above cases. If you are not sure, ask your doctor
or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Lacosamide UCB if:

• you have thought about harming yourself or committing suicide. A small number of people treated with antiepileptic medicines like lacosamide have thought about harming themselves or committing suicide. If you should have any of these thoughts at any time, tell your doctor immediately.
• you have a heart problem that affects your heartbeat and often have a particularly slow, fast or irregular heartbeat (e.g. AV block, atrial fibrillation and flutter)
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamide UCB can cause dizziness - this can increase the risk of accidental injuries or falls. This means you should be careful until you get used to the effects of this medicine. If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist before taking Lacosamide UCB. If you are taking Lacosamide UCB, talk to your doctor if you should have a seizure that is different from your usual seizures or if your existing seizures should get worse. If you are taking Lacosamide UCB and experience symptoms of an abnormal heartbeat (such as a slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy and fainting), consult your doctor immediately (see section 4).

Children
Lacosamide UCB is not recommended for children under 2 years of age with epilepsy
characterized by partial-onset seizures and is not recommended for children under 4 years of
age with primary generalized tonic-clonic seizures. This is because it is not yet known if it works and if it is
safe for children in this age group.

Other medicines and Lacosamide UCB
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
affect the heart: this is because Lacosamide UCB can also affect your heart:

• medicines to treat heart disease;
• medicines that can prolong the “PR interval” in a heart scan (ECG or electrocardiogram) such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat some forms of irregular heartbeat or heart failure. If you fall into one of the above cases (or are not sure) ask your doctor or pharmacist before taking Lacosamide UCB.

Also tell your doctor or pharmacist if you are taking any of the following drugs - this is because they
can increase or decrease the effect of Lacosamide UCB on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• medicines for HIV such as ritonavir;
• medicines used to treat bacterial infections such as clarithromycin or rifampicin;
• an herbal medicine used to treat mild anxiety and depression called St. John's wort. If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist before taking Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution, do not take Lacosamide UCB with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended not to take Lacosamide UCB during pregnancy, as the effects of
Lacosamide UCB on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide UCB, as Lacosamide UCB
passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you
decide whether or not to take Lacosamide UCB.
Do not stop treatment without consulting your doctor first, as this can cause an
increase in seizures (fits). A worsening of your condition can also be harmful to
your baby.

Driving and using machines
Do not drive vehicles, ride a bicycle, use tools or machinery until you have checked how this medicine affects you. This is because Lacosamide UCB can cause dizziness or
blurred vision.

Lacosamide UCB contains sorbitol, sodium, sodium methyl parahydroxybenzoate and aspartame ,
propylene glycol and potassium

• Sorbitol (a type of sugar): this medicine contains 187 mg of sorbitol per each mL. Sorbitol is a source of fructose. If your doctor has found that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which people are unable to metabolize fructose, contact them before you (or your child) take or receive this medicine. Sorbitol can cause intestinal discomfort and mild laxative effect.
• Sodium (salt): this medicine contains 1.42 mg of sodium (the main component of table salt) per each mL. This amount is equivalent to 0.07 % of the recommended daily intake of sodium for an adult.
• Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (including delayed reactions).
• Aspartame (E951): this medicine contains 0.032 mg of aspartame per each mL. Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to metabolize it properly.
• Propylene glycol (E1520): this medicine contains 2.14 mg of propylene glycol per each mL.
• Potassium: this medicine contains potassium, less than 1 mmol (39 mg) per 60 mL, i.e. essentially “potassium-free”.

3. How to take Lacosamide UCB

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Taking Lacosamide UCB

• Take Lacosamide UCB twice every day, approximately 12 hours apart.
• Try to take it around the same time each day.
• You can take Lacosamide UCB with or without food.

Usually you will start by taking a reduced dose each day and your doctor will slowly increase it over
a number of weeks. When you reach the dose that is right for you, this is
called a "maintenance dose", so take the same amount each day. Lacosamide UCB is
used as a long-term treatment. You must continue to take Lacosamide UCB until your
doctor tells you to stop.

How much to take
Below are listed the usual recommended doses of Lacosamide UCB for different age
groups and weights. Your doctor may prescribe a different dose if you have kidney or liver
problems. Use the 10 mL oral syringe (black graduated markings) or the 30 mL measuring
cup provided in the pack, depending on the dose needed. See the instructions for use below.

Adolescents and children weighing 50 kg or more and adults
When you take Lacosamide UCB alone
The starting dose of Lacosamide UCB is usually 50 mg (5 mL) twice a day.
Your doctor may also prescribe a starting dose of 100 mg (10 mL) of Lacosamide UCB twice a
day.
Your doctor may increase your daily dose by 50 mg (5 mL) twice a day each week,
until you reach a maintenance dose, between 100 mg (10 mL) and 300 mg (30 mL) twice
a day.
When you take Lacosamide UCB with other antiepileptic medicines
The starting dose of Lacosamide UCB is usually 50 mg (5 mL) twice a day.
Your doctor may increase the daily dose by 50 mg (5 mL) twice a day each week, until you
reach a maintenance dose, between 100 mg (10 mL) and 200 mg (20 mL) twice a
day.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide UCB with a
single “loading” dose of 200 mg (20 mL). 12 hours later you would then start your maintenance dose.

Children and adolescents weighing less than 50 kg

In the treatment of partial-onset seizures: note that Lacosamide UCB is not recommended
in children under 2 years of age.

In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide UCB
is not recommended in children under 4 years of age.
When you take Lacosamide UCB alone
Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Usually the starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice a
day.
Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of
body weight twice a day each week, until you reach a maintenance dose.
Below are dosage tables, including the maximum recommended dose.
For reference only. Your doctor will calculate the dose that is right for you.

To be taken twice a dayfor children from 2 years of age weighing from 10 kg to less
than 40 kg
To be taken twice a dayfor children and adolescents weighing between 40 kg and less
than 50 kg:

When you take Lacosamide UCB with other antiepileptic medicines
Your doctor will decide the dose of Lacosamide UCB based on your body weight.
The usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice a
day.
Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of
body weight twice a day each week, until you reach a maintenance dose.
Below are dosage tables, including the maximum recommended dose.
For informational purposes only. Your doctor will calculate the right dose for you:

To be taken twice a dayfor children from 2 years of age and weighing between 10 kg
and less than 20 kg

To be taken twice a dayfor children and adolescents weighing between 20 kg and
less than 30 kg:

To be taken twice a dayfor children and adolescents weighing between 30 kg
and less than 50 kg:

Instructions for use
It is important to use the correct measuring device. Your doctor or pharmacist will
tell you which measuring device to use depending on the dose prescribed.

Instructions for use: measuring cup

• 1. Shake the bottle well before use.
• 2. Fill the measuring cup to the mark for the dose in milliliters (mL) prescribed by your doctor.

• 3. Swallow the dose of syrup.
• 4. Then drink some water.

Instructions for use: oral administration syringe
The doctor will show you how to use the oral administration syringe before the first use. If you have any questions, ask your doctor or pharmacist again.
Shake the bottle well before use.
Open the bottle by pressing and rotating the cap counterclockwise simultaneously (figure 1).

Follow these steps the first time you take Lacosamide UCB:

• Remove the adapter from the oral administration syringe (figure 2).
• Place the adapter into the neck of the bottle (figure 3). Make sure it is securely attached. It is not necessary to remove the adapter after use.

Follow these steps each time you take Lacosamide UCB:

• Insert the oral administration syringe into the opening of the adapter (figure 4).
• Turn the bottle upside down (figure 5).

• Hold the inverted bottle with one hand and use the other hand to fill the oral administration syringe.
• Pull the plunger down to fill the oral administration syringe with a small amount of solution (figure 6).
• Push the plunger up to eliminate any air bubbles (figure 7).
• Pull the plunger down to the mark of the dose in milliliters (mL) prescribed by the doctor (figure 8). The plunger may rise along the syringe cylinder at the first dosage. Therefore, make sure that the plunger is held in place until the oral administration syringe is disconnected from the bottle.

• Return the bottle to its initial position (figure 9).
• Remove the oral administration syringe from the adapter (figure 10).

You can choose two ways to drink the medicine:

• empty the contents of the oral administration syringe into a small amount of water by pushing the syringe plunger all the way down (figure 11) - then you will need to drink all the water (so only add the amount of water that makes it easier to drink the syrup) or
• drink the solution directly from the oral administration syringe, without water (figure 12)
• drink all the contents of the oral administration syringe.

• Close the bottle with the plastic screw cap (it is not necessary to remove the adapter).
• To clean the oral administration syringe, rinse only with cold water, moving the plunger up and down several times to draw and expel the water, without separating the two parts of the syringe (figure 13).

of cardboard.

If you take more Lacosamide UCB than you should
Contact your doctor immediately if you have taken more Lacosamide UCB than you should.
Do not try to drive.
You may experience:

• dizziness;
• nausea or vomiting;
• seizures, heart problems such as slow, fast or irregular heartbeat, coma or a drop in blood pressure with a fast heartbeat and sweating.

If you forget to take Lacosamide UCB

• If you have forgotten to take a dose of Lacosamide UCB and less than 6 hours have passed since the usual time of taking it, take Lacosamide UCB as soon as you remember.
• If you have forgotten to take a dose and more than 6 hours have passed since the usual time of taking it, do not take the forgotten dose of syrup. Instead, take the next dose of Lacosamide UCB syrup at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Lacosamide UCB

• Do not stop taking Lacosamide UCB without consulting your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop the therapy with Lacosamide UCB, he will give you instructions on how to gradually reduce the dose. If you have any doubts about 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.
Side effects affecting the nervous system, such as dizziness, may be more frequent
after a single “loading” dose.

Talk to your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people

• Headache;
• Feeling dizzy or nauseous;
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, easy bruising and getting cuts;
• Memory problems, difficulty thinking or finding the right words, confusion;
• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling of “spinning” (vertigo), drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or feeling, difficulty articulating words, attention disorder;
• Noises in the ear such as ringing, trilling or whistling;
• Irritability, difficulty sleeping, depression;
• Sleepiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
• Exaggerated sense of well-being, seeing and/or hearing things that are not present;
• Allergic reaction after taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, attempt to commit suicide, tell your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known:frequency cannot be estimated based on available data

• Fast heartbeat (ventricular tachycardia);
• Sore throat, high fever and suffering from more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis);
• Severe skin reaction that may include high fever and other flu-like symptoms, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling skin in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.

Other side effects in children

• Additional side effects observed in children have been fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, different than normal behavior (abnormal behavior) and lack of energy (lethargy). Sleepiness is a very common side effect in children and may affect more than 1 in 10 children.

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lacosamide UCB

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 package and the bottle after
Exp. The expiry date refers to the last day of that month.
Do not refrigerate.
Once the syrup bottle has been opened, do not use it for more than 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lacosamide UCB contains

• The active ingredient is lacosamide. 1 mL of Lacosamide UCB syrup contains 10 mg of lacosamide.
• The other ingredients are: glycerol (E422), sodium carboxymethylcellulose, liquid sorbitol (crystallizable) (E420), polyethylene glycol 4000, sodium chloride, anhydrous citric acid, potassium acesulfame (E950), sodium methylparaben (E219), strawberry aroma (contains propylene glycol, maltol), masking aroma (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionized water), purified water.

Description of the appearance of Lacosamide UCB and contents of the pack

• Lacosamide UCB 10 mg/mL syrup is a clear, slightly viscous liquid, from colorless to yellow-brown.
• Lacosamide UCB is available in a 200 mL bottle.

The packs of Lacosamide UCB syrup contain a 30 mL polypropylene measuring cup
(with black graduated markings) and a 10 mL polyethylene/polypropylene oral administration syringe
(with black graduated markings) with the respective polyethylene adapter.

• The measuring cup is suitable for doses greater than 20 mL. Each graduated marking (5 mL) on the measuring cup corresponds to 50 mg of lacosamide (for example, 2 graduated markings correspond to 100 mg).
• The 10 mL oral administration syringe is suitable for doses between 5 mL and 20 mL. One full 10 mL oral administration syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 mL, i.e. 10 mg of lacosamide. After this, each graduated marking (0.25 mL) corresponds to 2.5 mg of lacosamide (for example, 4 graduated markings correspond to 10 mg).

Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany
or
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0) 1 291 80 00

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 48 22 696 99 20

France
UCB Pharma S.A.
Tél: + 33 / (0)1 47 29 44 35

España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
Vistor hf.
Simi: + 354 535 7000

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: + 421 (0) 2 5920 2020

Italia
UCB Pharma S.p.A.
Tel: + 39 / 02 300 791

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4221

Κύπρος
Lifepharma (Z.A.M.) Ltd

Sverige
UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Lacosamide UCB 10 mg/mL solution for infusion

lacosamide

Read this leaflet carefully before you start to use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Lacosamide UCB is and what it is used for
• 2. What you need to know before you use Lacosamide UCB
• 3. How to use Lacosamide UCB
• 4. Possible side effects
• 5. How to store Lacosamide UCB
• 6. Contents of the pack and other information

1. What is Lacosamide UCB and what is it used for

What is Lacosamide UCB
Lacosamide UCB contains lacosamide. It belongs to a group of medicines called
“antiepileptic medicines”. These medicines are used to treat epilepsy.

• This medicine has been given to you to reduce the number of seizures (epileptic fits) you experience.

What is Lacosamide UCB used for

• Lacosamide UCB is used:
• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age to treat a specific form of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas of both sides of your brain;
• in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age to treat primary generalized tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).

2. What you need to know before you use Lacosamide UCB

Do not use Lacosamide UCB

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, ask your doctor
• if you have a particular type of heart rhythm problem called second or third degree AV block.

Do not use Lacosamide UCB if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions
Talk to your doctor before using Lacosamide UCB if:

• you have thought about harming yourself or committing suicide. A small number of people treated with anti-epileptic medicines like lacosamide have thought about harming themselves or committing suicide. If you should have any

of these thoughts at any time, tell your doctor immediately.

• you have a heart problem that affects your heartbeat and often have a particularly slow, fast or irregular heartbeat (e.g. AV block, atrial fibrillation and flutter)
• you have a serious heart condition, such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamide UCB can cause dizziness - this can increase the risk of accidental injury or falls. This means you should be careful until you get used to the effects of this medicine. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Lacosamide UCB. If you are taking Lacosamide UCB, talk to your doctor if you experience a different type of seizure or your existing seizures get worse. If you are taking Lacosamide UCB and develop symptoms of an abnormal heartbeat (such as a slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy and fainting), see your doctor immediately (see section 4).

Children
Lacosamide UCB is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known if it works and if it is safe for children in this age group.

Other medicines and Lacosamide UCB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide UCB can also affect your heart:

• medicines to treat heart disease;
• medicines that can prolong the “PR interval” on a heart scan (ECG or electrocardiogram) such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat some forms of irregular heartbeat or heart failure. If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before using Lacosamide UCB.

Also tell your doctor or pharmacist if you are taking any of the following drugs - this is because they can increase or decrease the effect of Lacosamide UCB on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• a medicine for HIV such as ritonavir;
• medicines used to treat bacterial infections such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St John's Wort. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Lacosamide UCB.

Lacosamide UCB with alcohol
As a safety precaution, do not take Lacosamide UCB with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
It is recommended not to use Lacosamide UCB during pregnancy, as the effects of Lacosamide UCB on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide UCB, as Lacosamide UCB passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you decide whether to use Lacosamide UCB or not.
Do not stop treatment without consulting your doctor first, as this may cause an increase in seizures (fits). A worsening of your condition can also be harmful to your baby.

Driving and using machines
Do not drive vehicles, ride a bicycle, use tools or operate machinery until you have checked how this medicine affects you. This is because Lacosamide UCB can cause dizziness or blurred vision.

Lacosamide UCB contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt) per vial. This amount is equivalent to 3% of the maximum daily recommended intake of sodium for an adult.

3. How to use Lacosamide UCB

Always use this medicine exactly as your doctor or pharmacist has told you. Consult your
doctor or pharmacist if you are not sure.

Using Lacosamide UCB

• Lacosamide UCB can be started:
• by taking the medicine by mouth or
• with administration as an intravenous infusion (sometimes called an “IV infusion”) in which the medicine is given to you in a vein by a doctor or a nurse. It is given over a period of time between 15 and 60 minutes.
• The IV infusion is usually used for a short period when you cannot take the medicine by mouth.
• The doctor will decide for how many days you will receive infusions. There is data on two daily infusions of Lacosamide UCB for up to 5 days. For treatments for longer periods, Lacosamide UCB tablets and syrup are available.

When you switch from the infusion to taking the medicine by mouth (or vice versa) the total amount
you take each day and the frequency of the doses remain the same.

• Use Lacosamide UCB twice every day, approximately 12 hours apart.
• Try to use it at about the same time each day.

How much to use
Below are listed the normal recommended doses of Lacosamide UCB for the different age
groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50kg or more and adults
When you use Lacosamide UCB alone

• The starting dose of Lacosamide UCB is usually 50 mg twice a day.
• The doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day.
• The doctor may increase your daily dose by 50 mg twice a day each week, up to a maintenance dose between 100 mg and 300 mg twice a day.

When you use Lacosamide UCB with other antiepileptic medicines
The starting dose of Lacosamide UCB is usually 50 mg twice a day.
The doctor may increase your daily dose by 50 mg twice a day each week. This until
reaching a maintenance dose between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, the doctor may decide to start treatment with Lacosamide UCB with a
single “loading” dose of 200 mg. 12 hours later, you would then start your maintenance dose.

Children and adolescents weighing less than 50kg

• In the treatment of partial-onset seizures: note that Lacosamide UCB is not recommended in children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide UCB is not recommended in children under 4 years of age.

When you use Lacosamide UCB alone
The doctor will decide on the dose of Lacosamide UCB based on your body weight.
The usual starting dose is 1 mg (0.1 mL) for each kilogram (kg) of body weight, twice a
day.
The doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of
body weight twice a day each week, up to a maintenance dose.
Below are the dosage tables, including the recommended maximum dose.
Dose when using Lacosamide UCB alone – For reference only. The doctor
will calculate the appropriate dose for you.

To be used twice a dayfor children starting from 2 years of age weighing between 10 kg
and less than 40 kg
To be used twice a dayfor children and adolescents weighing between 40 kg and less
than 50 kg:

When you use Lacosamide UCB with other antiepileptic medicines
The doctor will decide on the dose of Lacosamide UCB based on your body weight.

• The usual starting dose is 1 mg (0.1 mL) for each kilogram (kg) of body weight, twice a day.
• The doctor may then increase your dose taken twice a day by 1 mg (0.1 mL) per kg of body weight each week, up to a maintenance dose.

The dosage tables are provided below, including the recommended maximum dose.
For informational purposes only. The doctor will calculate the right dose for you.

To be used twice a dayfor children starting from 2 years of age weighing between 10 kg and
less than 20 kg
To be used twice a dayfor children and adolescents with a body weight between 20 kg and
less than 30 kg:

To be used twice a dayfor children and adolescents with a body weight between 30 kg and
less than 50 kg:

If you stop taking Lacosamide UCB
If the doctor decides to stop the therapy with Lacosamide UCB, the dose will have to be reduced
gradually. This is to prevent the return or worsening of epilepsy.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects affecting the nervous system, such as dizziness, may be more frequent
after a single “loading” dose.

Consult your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people

• Headache
• Feeling dizzy or nauseous;
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief spasms in a muscle or group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, easy bruising and getting cuts;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling of “spinning” (vertigo), drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or sensation, difficulty articulating words, attention deficit;
• Noises in the ear such as ringing, trilling or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
• Exaggerated sense of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, attempt to commit suicide, inform your doctor immediately;
• Feeling of anger or agitation;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Not known:frequency cannot be estimated based on available data

• Fast heartbeat (ventricular tachycardia);
• Sore throat, high fever and suffering from more infections than usual. Blood tests may show a severe decrease in the number of cells of a specific class of white blood cells (agranulocytosis);
• Severe skin reaction that may include high fever and other flu-like symptoms, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.

Other side effects when administered as an intravenous infusion
Local side effects may occur.

Common: may affect up to 1 in 10 people

• Pain, discomfort or irritation at the injection site.

Uncommon: may affect up to 1 in 100 people

• Redness at the injection site.

Other side effects in children

• Additional side effects observed in children have been fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, abnormal behavior (abnormal behavior) and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Lacosamide UCB

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 package and vial after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Each vial of Lacosamide UCB solution for infusion must be used only once.
Any unused solution remaining should be discarded.
The solution should only be used if it is clear, without any colour changes and free from foreign particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lacosamide UCB contains

• The active ingredient is lacosamide. 1 mL of Lacosamide UCB solution for infusion contains 10 mg of lacosamide. 1 vial contains 20 mL of Lacosamide UCB solution for infusion, equivalent to 200 mg of lacosamide.
• The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Lacosamide UCB and contents of the pack

• Lacosamide UCB 10 mg/mL solution for infusion is a clear and colourless solution. Lacosamide UCB solution for infusion is available in packs of 1 vial and 5 vials. Each vial contains 20 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00

Lietuva
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Suomija)

България
Ю СИ БИ България ЕООД
Teл.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg
UCB Pharma SA/NV
Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika
UCB s.r.o.
Tel: + 420 221 773 411

Magyarország
UCB Magyarország Kft.
Tel.: + 36-(1) 391 0060

Danmark
UCB Nordic A/S
Tlf: + 45 / 32 46 24 00

Malta
Pharmasud Ltd.
Tel: + 356 / 21 37 64 36

Deutschland
UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4848

Nederland
UCB Pharma B.V.
Tel.: + 31 / (0)76-573 11 40

Eesti
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge
UCB Nordic A/S
Tlf: + 47 / 67 16 5880

Ελλάδα
UCB Α.Ε.
Τηλ: + 30 / 2109974000

Österreich
UCB Pharma GmbH
Tel: + 43 (0) 1 291 80 00

Polska
UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 48 22 696 99 20

France
UCB Pharma S.A.
Tél: + 33 / (0)1 47 29 44 35

España
UCB Pharma, S.A.
Tel: + 34 / 91 570 34 44

Portugal
UCB Pharma (Produtos Farmacêuticos), Lda
Tel: + 351 21 302 5300

România
UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 04

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Hrvatska
Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 46

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
Vistor hf.
Simi: + 354 535 7000

Slovenská republika
UCB s.r.o., organizačná zložka
Tel: + 421 (0) 2 5920 2020

Italia
UCB Pharma S.p.A.
Tel: + 39 / 02 300 791

Suomi/Finland
UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4221

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: + 357 22 05 63 00

Sverige
UCB Nordic A/S
Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

United Kingdom (Northern Ireland)
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:
Each vial of Lacosamide UCB solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamide UCB solution for infusion can be administered without further dilution, or it may be diluted with the following solutions: sodium chloride 9 mg/mL (0.9 %), glucose 50 mg/mL (5 %), or in Ringer’s lactate solution.
From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical stability during use has been demonstrated for 24 hours at temperatures up to 25°C for the product mixed with these diluents and stored in glass containers or PVC bags.