Lacosamide UCB
Italy
Table of Contents
- Patient Information Leaflet
- Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
- Patient information leaflet
- Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
- Patient information leaflet
- Lacosamide UCB 10 mg/mL syrup
- Instructions for use: Oral dosing syringe
- Patient information leaflet
- Lacosamide UCB 10 mg/mL solution for infusion
Patient Information Leaflet
Lacosamide UCB 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
lacosamide
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide UCB is and what it is used for
- What you need to know before taking Lacosamide UCB
- How to take Lacosamide UCB
- Possible side effects
- How to store Lacosamide UCB
- Contents of the pack and other information
1. What Lacosamide UCB is and what it is used for
What Lacosamide UCB is
Lacosamide UCB contains the active substance lacosamide. It belongs to a group of medicines called
"antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed for you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide UCB is used for
- Lacosamide UCB is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age, to treat a specific type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures initially involve only one side of your brain. However, they may then spread to broader areas on 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 seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy 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 to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether 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 any of the above apply to you. If you are unsure, speak 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 antiepileptic medicines such as lacosamide have had thoughts about harming themselves or committing suicide. If you have any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heartbeat and often experience a heartbeat that is particularly slow, fast, or irregular (e.g. AV block, atrial fibrillation, or atrial flutter).
- you have a serious heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Lacosamide UCB may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.
If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB. If you are already taking Lacosamide UCB, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide UCB and develop symptoms of abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or 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 whether it is effective and safe in children in these age groups.
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, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide UCB may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "P-R 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 types of irregular heartbeat or heart failure.
If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide UCB in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- HIV medicines 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 unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Lacosamide UCB and alcohol
As a precautionary safety measure, 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Lacosamide UCB is not recommended during pregnancy, as the effects of Lacosamide UCB on the unborn baby are unknown.
Breastfeeding is not recommended while taking Lacosamide UCB, as lacosamide passes into breast milk.
Contact your doctor immediately if you are pregnant or planning to become pregnant. Your doctor will help you decide whether or not you should take Lacosamide UCB.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide UCB may cause dizziness or blurred vision.
3. How to take Lacosamide UCB
Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more
suitable for children: please ask your doctor or pharmacist.
How to take Lacosamide UCB
- Take Lacosamide UCB twice daily, 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 may take Lacosamide UCB with or without food.
You will usually start with a lower dose each day, and your doctor will gradually increase it over
several weeks. Once the appropriate dose for you has been reached, this is called the "maintenance dose", and you should continue taking the same amount every day. Lacosamide UCB is
used as a long-term treatment. You must continue taking Lacosamide UCB until your doctor tells you to stop.
Dosage instructions
Below are the usual recommended doses of Lacosamide UCB for different age groups and weight categories. 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 taking Lacosamide UCB alone
The usual starting dose of Lacosamide UCB is 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 300 mg twice daily.
When taking Lacosamide UCB with other antiepileptic medicines
The usual starting dose of Lacosamide UCB is 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide UCB using a single "loading dose" of 200 mg. Twelve hours later, you would then start your maintenance dose.
Children and adolescents weighing less than 50 kg
For the treatment of partial-onset seizures: note that Lacosamide UCB is not recommended
in children under 2 years of age.
For the treatment of primary generalized tonic-clonic seizures: note that Lacosamide UCB
is not recommended in children under 4 years of age.
The dose depends on body weight. Treatment usually starts with the oral syrup, and patients switch to tablets only if they are able to swallow them and can receive the correct dose with the available tablet strengths. Your doctor will prescribe the most suitable formulation for the patient.
If you take more Lacosamide UCB than you should
Contact your doctor immediately if you have taken more Lacosamide UCB than prescribed.
Do not attempt to drive.
You may experience:
- dizziness;
- nausea or vomiting;
- seizures (epileptic fits), heart rhythm problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid 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 dosing time, take the missed dose as soon as you remember.
- If you forget to take a dose and more than 6 hours have passed since your usual dosing time, do not take the missed tablet. Instead, take the next dose 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 treatment with Lacosamide UCB without consulting your doctor, as epilepsy may return or worsen.
- If your doctor decides to discontinue treatment with Lacosamide UCB, you will be given instructions on how to gradually reduce the dose. If you have any questions about the use of this medicine, consult 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;
- Dizziness or nausea;
- 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 with balance, tremors, tingling (paraesthesia), muscle spasms, increased tendency to fall or bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling of drunkenness;
- Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced sense of touch or sensitivity, difficulty articulating words, attention disturbance;
- Ringing noises in the ear such as buzzing, ringing, or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present (hallucinations);
- Allergic reaction following intake of the medicine, hives (urticaria);
- Blood tests may show abnormal liver function, liver damage;
- Self-harming thoughts or suicidal thoughts, suicide attempt: 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 the available data
- Rapid heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and increased susceptibility to infections. Blood tests may show a severe decrease in the number of a specific class of white blood cells (agranulocytosis);
- Severe skin reaction which may include high fever and other influenza-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
- Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizure.
Additional side effects in children
- Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), 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 experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system referred to 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 stated on the carton after Exp. and on the blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via 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 substance is lacosamide. One tablet of Lacosamide UCB 50 mg contains 50 mg of lacosamide. One tablet of Lacosamide UCB 100 mg contains 100 mg of lacosamide. One tablet of Lacosamide UCB 150 mg contains 150 mg of lacosamide. One tablet of Lacosamide UCB 200 mg contains 200 mg of lacosamide.
- The other components are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (poliplasdone XL-10 pharmaceutical grade), magnesium stearate. Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants* * The colourants are: 50 mg tablets: red iron oxide (E172), black iron oxide (E172), indigotine (E132). 100 mg tablets: yellow iron oxide (E172). 150 mg tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). 200 mg tablets: indigotine (E132).
Description of the appearance of Lacosamide UCB and contents of the pack
- Lacosamide UCB 50 mg film-coated tablets are pink, oval-shaped, approximately 10.4 mm x 4.9 mm in size, with the imprint ‘SP’ on one side and ‘50’ on the other.
- Lacosamide UCB 100 mg film-coated tablets are dark yellow, oval-shaped, approximately 13.2 mm x 6.1 mm in size, with the imprint ‘SP’ on one side and ‘100’ on the other.
- Lacosamide UCB 150 mg film-coated tablets are salmon-coloured, oval-shaped, approximately 15.1 mm x 7.0 mm in size, with the imprint ‘SP’ on one side and ‘150’ on the other.
- Lacosamide UCB 200 mg film-coated tablets are blue, oval-shaped, approximately 16.6 mm x 7.8 mm in size, with the imprint ‘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 cartons, each with 56 tablets. Packs of 14 x 1 and 56 x 1 film-coated tablets are available in unit-dose divisible blisters sealed with aluminium foil in PVC/PVDC; all other packs are available in standard PVC/PVDC blisters sealed with aluminium foil. Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, 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, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)
България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43 (0) 1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00
Latvija United Kingdom (Northern Ireland)
UCB Pharma Oy Finland UCB (Pharma) Ireland Ltd.
Tel: + 358 9 2514 4221 (Somija) Tel: + 353 / (0)1-46 37 395
Further 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.
Patient information leaflet
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 suitable only for adolescents and children weighing 50 kg or more and for adults.
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide UCB is and what it is used for
- What you need to know before taking Lacosamide UCB
- How to take Lacosamide UCB
- Possible side effects
- How to store Lacosamide UCB
- Contents of the pack and other information
1. What Lacosamide UCB is and what it is used for
What Lacosamide UCB is
Lacosamide UCB contains the active substance lacosamide. It belongs to a group of medicines called
"antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide UCB is used for
- Lacosamide UCB is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from the age of 2 years, to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of your brain. However, they may then spread to broader areas on both sides of your brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children from the age of 4 years, to treat primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy 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 to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor
- if you have a specific type of heart rhythm problem called second- or third-degree AV block.
Do not take Lacosamide UCB if any of the above apply to you. If you are unsure, speak to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor before taking Lacosamide UCB if:
- you have had thoughts of harming or killing yourself. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming or killing themselves. If you experience any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heart rhythm and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
- you have a serious heart condition such as heart failure or have had a heart attack.
- you often feel dizzy or have falls. Lacosamide UCB may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you become accustomed to the effects of this medicine.
If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB. If you are already taking Lacosamide UCB, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide UCB and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), contact 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 whether it is effective or safe in children in these age groups.
Other medicines and Lacosamide UCB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide UCB may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "P-R 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 types of irregular heartbeat or heart failure.
If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide UCB in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- HIV medicines 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 unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Lacosamide UCB and alcohol
As a precautionary safety measure, 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Lacosamide UCB during pregnancy, as the effects of Lacosamide UCB on the unborn baby are unknown.
Breastfeeding is not recommended while taking Lacosamide UCB, as lacosamide passes into breast milk.
Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether you should take Lacosamide UCB.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (attacks). Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide UCB may cause dizziness or blurred vision.
3. How to take Lacosamide UCB
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for children: please ask your doctor or pharmacist.
How to take Lacosamide UCB
- Take Lacosamide UCB twice daily, approximately 12 hours apart.
- Try to take it at approximately the same times each day.
- Swallow the Lacosamide UCB tablet with a glass of water.
- You may take Lacosamide UCB with or without food.
You will usually start with a lower daily dose, which your doctor will gradually increase over several weeks. When the appropriate dose for you has been reached, this is called the "maintenance dose", and you should continue taking the same amount every day. Lacosamide UCB is used as a long-term treatment. You must continue taking Lacosamide UCB until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide UCB for different age groups and weight categories. 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 taking Lacosamide UCB alone:
The usual starting dose of Lacosamide UCB is 50 mg twice daily.
Your doctor may alternatively prescribe a starting dose of 100 mg of Lacosamide UCB twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 300 mg twice daily.
When taking Lacosamide UCB with other antiepileptic medicines:
Initiation of therapy (first 4 weeks)
This pack (initiation pack) is intended for starting treatment with Lacosamide UCB. The pack contains 4 different packages for the first 4 weeks of therapy, one for each week.
Each package contains 14 tablets, corresponding to 2 tablets per day for 7 days.
Each package contains a different dosage of Lacosamide UCB, allowing you to gradually increase the dose.
You will start treatment with a low dose of Lacosamide UCB, usually 50 mg twice daily, and gradually increase the dose week by week. The most commonly prescribed daily doses during the first 4 weeks of therapy are listed in the table below. Your doctor will advise you whether you need to use all 4 packages.
Table: Initiation of therapy (first 4 weeks)
| Week | Package to use | First dose (in the morning) | Second dose (in the evening) | Total daily dose | |----------|--------------------|----------------------------------|----------------------------------|-----------------------| | Week 1 | 50 mg package marked "Week 1" | 50 mg (1 tablet of Lacosamide UCB 50 mg) | 50 mg (1 tablet of Lacosamide UCB 50 mg) | 100 mg | | Week 2 | 100 mg package marked "Week 2" | 100 mg (1 tablet of Lacosamide UCB 100 mg) | 100 mg (1 tablet of Lacosamide UCB 100 mg) | 200 mg | | Week 3 | 150 mg package marked "Week 3" | 150 mg (1 tablet of Lacosamide UCB 150 mg) | 150 mg (1 tablet of Lacosamide UCB 150 mg) | 300 mg | | Week 4 | 200 mg package 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 you continue taking for long-term therapy. This is called the maintenance dose and depends on your response to Lacosamide UCB. In most patients, the maintenance dose ranges between 200 mg and 400 mg per day.
Children and adolescents weighing less than 50 kg
The initiation 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 prescribed.
Do not attempt to drive.
You may experience:
- dizziness;
- nausea or vomiting;
- seizures (epileptic fits), heart rhythm problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid 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 the missed dose 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 missed tablet. Instead, take the next dose at your usual time.
- Do not take a double dose to make up for a forgotten tablet.
If you stop taking Lacosamide UCB
- Do not stop treatment with Lacosamide UCB without consulting your doctor, as epilepsy may return or worsen.
- If your doctor decides to discontinue your treatment with Lacosamide UCB, they will provide instructions on how to gradually reduce the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor or pharmacist if you suffer from any of the following symptoms:
Very common: may affect more than 1 in 10 people
- Headache;
- Dizziness or nausea;
- 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 (paraesthesia) or muscle spasms, increased tendency to fall or bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling of drunkenness;
- Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
- Ringing or buzzing sounds in the ears (tinnitus);
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
- Excessive feeling of well-being, seeing and/or hearing things that are not there;
- Allergic reaction after taking the medicine, hives;
- Blood tests may show abnormal liver function, liver damage;
- Self-harming thoughts or suicidal thoughts, suicide attempt – inform your doctor immediately;
- Feeling angry or agitated;
- 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 the available data
- Fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever and increased number of infections compared to usual. Blood tests may show a severe decrease in the number of a specific type of white blood cells (agranulocytosis);
- Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
- Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizure.
Additional side effects in children
- Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour) 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 experience any side effects, including those not listed in this leaflet, talk to 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 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 carton after Exp. and on the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 substance is lacosamide. One tablet of Lacosamide UCB 50 mg contains 50 mg of lacosamide. One tablet of Lacosamide UCB 100 mg contains 100 mg of lacosamide. One tablet of Lacosamide UCB 150 mg contains 150 mg of lacosamide. One tablet of Lacosamide UCB 200 mg contains 200 mg of lacosamide.
- The other components are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (pharmaceutical grade poliplasdone XL-10), magnesium stearate. Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants* * The colourants are: 50 mg tablets: red iron oxide (E172), black iron oxide (E172), indigotine (E132). 100 mg tablets: yellow iron oxide (E172).
150 mg tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
200 mg tablets: indigotine (E132).
Description of the appearance of Lacosamide UCB and contents of the pack
The film-coated tablets of Lacosamide UCB 50 mg are pink, oval, approximately 10.4 mm x 4.9 mm in size, with the imprint ‘SP’ on one side and ‘50’ on the other.
- The film-coated tablets of Lacosamide UCB 100 mg are dark yellow, oval, approximately 13.2 mm x 6.1 mm in size, with the imprint ‘SP’ on one side and ‘100’ on the other.
- The film-coated tablets of Lacosamide UCB 150 mg are salmon-coloured, oval, approximately 15.1 mm x 7.0 mm in size, with the imprint ‘SP’ on one side and ‘150’ on the other.
- The film-coated tablets of Lacosamide UCB 200 mg are blue, oval, approximately 16.6 mm x 7.8 mm in size, with the imprint ‘SP’ on one side and ‘200’ on the other.
The starter pack contains 56 film-coated tablets, divided into 4 packages:
- The package labelled ‘Week 1’ contains 14 tablets of 50 mg,
- The package labelled ‘Week 2’ contains 14 tablets of 100 mg,
- The package labelled ‘Week 3’ contains 14 tablets of 150 mg,
- The package labelled ‘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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)
България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43 (0) 1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00
Latvija United Kingdom (Northern Ireland)
UCB Pharma Oy Finland UCB (Pharma) Ireland Ltd.
Tel: + 358 9 2514 4221 (Somija) 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.
Patient information leaflet
Lacosamide UCB 10 mg/mL syrup
lacosamide
Read this entire leaflet carefully before taking 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide UCB is and what it is used for
- What you need to know before taking Lacosamide UCB
- How to take Lacosamide UCB
- Possible side effects
- How to store Lacosamide UCB
- Contents of the pack and other information
1. What Lacosamide UCB is and what it is used for
What Lacosamide UCB is
Lacosamide UCB contains the active substance lacosamide. It belongs to a group of medicines called
"antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide UCB is used for
- Lacosamide UCB is used:
- alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age, to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader areas on both sides of the 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 seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy 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 to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
- if you have a specific type of heart rhythm problem called second- or third-degree AV block.
Do not take Lacosamide UCB if any of the above apply to you. If you are unsure, speak 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 ending your life. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If you experience such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heart rhythm and often experience a particularly slow, fast, or irregular heartbeat (e.g., AV block, atrial fibrillation, or atrial flutter).
- you have a severe heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Lacosamide UCB may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you become accustomed to the effects of this medicine.
If any of the above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB. If you are taking Lacosamide UCB, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide UCB and develop symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or 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 whether it is effective or safe in children in these age groups.
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, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide UCB may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "P-R 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 types of irregular heartbeat or heart failure.
If any of the above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide UCB in your body:
- antifungal medicines 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 (Hypericum perforatum).
If any of the above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Lacosamide UCB.
Lacosamide UCB and alcohol
As a precautionary safety measure, do not take Lacosamide UCB with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraception with their doctor.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Lacosamide UCB during pregnancy, as the effects of Lacosamide UCB on the unborn baby are unknown.
It is recommended not to breastfeed while taking Lacosamide UCB, as Lacosamide UCB passes into breast milk.
Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether you should take Lacosamide UCB.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide UCB may cause dizziness or blurred vision.
Lacosamide UCB contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame,
propylene glycol, and potassium
- Sorbitol (a type of sugar): this medicine contains 187 mg of sorbitol per mL. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be metabolized, contact your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
- Sodium (salt): this medicine contains 1.42 mg of sodium (the main component of table salt) per mL. This amount is equivalent to 0.07% of the maximum daily sodium intake recommended 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 mL. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot metabolize it properly.
- Propylene glycol (E1520): this medicine contains 2.14 mg of propylene glycol per 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 exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Taking Lacosamide UCB
- Take Lacosamide UCB twice daily, approximately 12 hours apart.
- Try to take it at approximately the same time each day.
- You may take Lacosamide UCB with or without food.
You will usually start with a lower daily dose, which your doctor will gradually increase over a number
of weeks. Once you reach the dose appropriate for you, this is called the "maintenance dose", so you
should take the same amount every day. Lacosamide UCB is used as a long-term treatment. You must
continue taking Lacosamide UCB until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide UCB for different age and weight groups.
Your doctor may prescribe a different dose if you have kidney or liver problems.
Use the 10 mL oral syringe (with black graduated markings) or the 30 mL dosing cup provided in the
package, depending on the required dose. See the instructions for use below.
Adolescents and children weighing 50 kg or more, and adults
When taking Lacosamide UCB alone
The initial dose of Lacosamide UCB is usually 50 mg (5 mL) twice daily.
Your doctor may also prescribe an initial dose of 100 mg (10 mL) of Lacosamide UCB twice daily.
Your doctor may increase your daily dose by 50 mg (5 mL) twice daily each week, up to a maintenance
dose ranging from 100 mg (10 mL) to 300 mg (30 mL) twice daily.
When taking Lacosamide UCB with other antiepileptic medicines
The initial dose of Lacosamide UCB is usually 50 mg (5 mL) twice daily.
Your doctor may increase your daily dose by 50 mg (5 mL) twice daily each week, up to a maintenance
dose ranging from 100 mg (10 mL) to 200 mg (20 mL) twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide UCB using a
single "loading dose" of 200 mg (20 mL). Twelve 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 taking Lacosamide UCB alone
Your doctor will determine the dose of Lacosamide UCB based on your body weight.
The usual initial dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, twice daily.
Your doctor may then increase your daily dose weekly by 1 mg (0.1 mL) per kg of body weight twice
daily, until reaching a maintenance dose.
The dosage tables below are provided, including the maximum recommended dose.
For reference only. Your doctor will calculate the appropriate dose for you.
To be taken twice daily for children from 2 years of age weighing from 10 kg to less than 40 kg
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 0.5 mL/kg | Week 6 Maximum recommended dose: 0.6 mL/kg | ||||||||
| Use the 10 mL syringe (black graduated markings) for volumes between 1 mL and 20 mL *Use a 30 mL dosing cup (black graduated markings) for volumes greater than 20 mL | ||||||||||||||
| 10 kg | 1 mL | 2 mL | 3 mL | 4 mL | 5 mL | 6 mL | ||||||||
| 15 kg | 1.5 mL | 3 mL | 4.5 mL | 6 mL | 7.5 mL | 9 mL | ||||||||
| 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL | 12 mL | ||||||||
| 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL | 15 mL | ||||||||
| 30 kg | 3 mL | 6 mL | 9 mL | 12 mL | 15 mL | 18 mL | ||||||||
| 35 kg | 3.5 mL | 7 mL | 10.5 mL | 14 mL | 17.5 mL | 21 mL* | ||||||||
To be taken twice daily for children and adolescents weighing 40 kg and less than 50 kg:
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 Maximum recommended dose: 0.5 mL/kg |
| Use the 10 mL syringe (black graduated marks) for volumes between 1 mL and 20 mL * Use the 30 mL dosing cup (black graduated marks) for volumes greater than 20 mL | |||||
| 40 kg | 4 mL | 8 mL | 12 mL | 16 mL | 20 mL |
| 45 kg | 4.5 mL | 9 mL | 13.5 mL | 18 mL | 22.5 mL* |
When taking Lacosamide UCB with other antiepileptic medicines
Your doctor will determine 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 daily.
Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of body weight twice daily each week, until a maintenance dose is reached.
Dosage tables, including the recommended maximum dose, are provided below.
For informational purposes only. Your doctor will calculate the correct dose for you:
To be taken twice daily for children from 2 years of age weighing 10 kg to less than 20 kg
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 0.5 mL/kg | Week 6 Maximum recommended dose: 0.6 mL/kg |
| Use the 10 mL syringe (black graduated markings) for volumes between 1 mL and 20 mL | ||||||
| 10 kg | 1 mL | 2 mL | 3 mL | 4 mL | 5 mL | 6 mL |
| 12 kg | 1.2 mL | 2.4 mL | 3.6 mL | 4.8 mL | 6 mL | 7.2 mL |
| 14 kg | 1.4 mL | 2.8 mL | 4.2 mL | 5.6 mL | 7 mL | 8.4 mL |
| 15 kg | 1.5 mL | 3 mL | 4.5 mL | 6 mL | 7.5 mL | 9 mL |
| 16 kg | 1.6 mL | 3.2 mL | 4.8 mL | 6.4 mL | 8 mL | 9.6 mL |
| 18 kg | 1.8 mL | 3.6 mL | 5.4 mL | 7.2 mL | 9 mL | 10.8 mL |
To be taken twice daily for children and adolescents with body weight between 20 kg and
less than 30 kg :
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 Maximum recommended dose: 0.5 mL/kg | |||||
| *Use the 10 mL syringe (black graduated marks) for volumes between 5 mL and 20 mL | ||||||||||
| 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL | |||||
| 22 kg | 2.2 mL | 4.4 mL | 6.6 mL | 8.8 mL | 11 mL | |||||
| 24 kg | 2.4 mL | 4.8 mL | 7.2 mL | 9.6 mL | 12 mL | |||||
| 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL | |||||
| 26 kg | 2.6 mL | 5.2 mL | 7.8 mL | 10.4 mL | 13 mL | |||||
| 28 kg | 2.8 mL | 5.6 mL | 8.4 mL | 11.2 mL | 14 mL | |||||
To be taken twice daily for children and adolescents with body weight between 30 kg
and less than 50 kg:
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 Maximum recommended dose: 0.4 mL/kg |
| Use the 10 mL syringe (black graduated marks) for volumes between 1 mL and 20 mL | ||||
| 30 kg | 3 mL | 6 mL | 9 mL | 12 mL |
| 35 kg | 3.5 mL | 7 mL | 10.5 mL | 14 mL |
| 40 kg | 4 mL | 8 mL | 12 mL | 16 mL |
| 45 kg | 4.5 mL | 9 mL | 13.5 mL | 18 mL |
Instructions for use
It is important to use the correct measuring device to measure the dose. Your doctor or pharmacist will
inform you which measuring device to use depending on the dose prescribed for you.
| 10 mL oral dosing syringe | 30 mL dosing cup |
| The 10 mL oral dosing syringe has black graduations every 0.25 mL. If the required dose is between 1 mL and 10 mL, use the 10 mL oral dosing syringe and the adapter provided in this package. If the required dose is between 10 mL and 20 mL, you must use the 10 mL syringe twice. | The 30 mL dosing cup has black graduations every 5 mL. If the required dose is more than 20 mL, you must use the 30 mL dosing cup provided in this package |
Instructions for use: dosing cup
- Shake the bottle well before use.
- Fill the dosing cup up to the mark indicating the dose in millilitres (mL) prescribed by your doctor.
- Swallow the dose of syrup.
- Then drink some water.
Instructions for use: Oral dosing syringe
Your doctor will show you how to use the oral dosing syringe before your first use. If you have any questions, please consult your doctor or pharmacist again.
Shake the bottle well before use.
Open the bottle by pressing down on the cap and simultaneously turning it counterclockwise (Figure 1).
Follow these steps the first time you take Lacosamide UCB:
- Remove the adapter from the oral dosing syringe (Figure 2).
- Place the adapter onto the neck of the bottle (Figure 3). Make sure it is securely attached. There is no need to remove the adapter after use.
Follow these steps every time you take Lacosamide UCB:
- Insert the oral dosing syringe into the opening of the adapter (Figure 4).
- Invert the bottle (Figure 5).
- Hold the inverted bottle in one hand and use the other hand to fill the oral dosing syringe.
- Pull the plunger downward to fill the oral dosing syringe with a small amount of solution (Figure 6).
- Push the plunger upward to remove any air bubbles (Figure 7).
- Pull the plunger downward until the prescribed dose mark in millilitres (mL) is reached (Figure 8). The plunger may move up along the syringe barrel during the first dose. Therefore, ensure that the plunger is held in place until the oral dosing syringe is disconnected from the bottle.
- Return the bottle to its upright position (Figure 9).
- Remove the oral dosing syringe from the adapter (Figure 10).
You may choose one of two ways to take the medicine:
- empty the contents of the oral dosing syringe into a small amount of water by pushing the plunger fully down (Figure 11) – then drink all the water (therefore, add only enough water to make drinking the syrup easier) or
- drink the solution directly from the oral dosing syringe, without water (Figure 12)
- drink all the contents of the oral dosing syringe.
- Close the bottle with the plastic screw cap (there is no need to remove the adapter).
- To clean the oral dosing syringe, rinse it only with cold water, moving the plunger up and down several times to draw in and expel water, without separating the two parts of the syringe (Figure 13).
- Store the bottle, the oral dosing syringe, and the instruction leaflet in the cardboard carton.
If you take more Lacosamide UCB than you should
Contact your doctor immediately if you have taken more Lacosamide UCB than prescribed.
Do not attempt to drive.
You may experience:
- dizziness;
- nausea or vomiting;
- seizures (epileptic fits), heart rhythm problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with rapid 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 dosing 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 dosing time, do not take the missed dose of syrup. Instead, take your next dose of Lacosamide UCB syrup 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 treatment with Lacosamide UCB without consulting your doctor, as epilepsy may return or worsen.
- If your doctor decides to discontinue your treatment with Lacosamide UCB, they will provide instructions on how to gradually reduce the dose. If you have any doubts about using this medicine, consult 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.
If you experience any of the following symptoms, consult your doctor or pharmacist:
Very common: may affect more than 1 in 10 people
- Headache;
- Dizziness or nausea;
- 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 (paraesthesia), or muscle spasms, increased tendency to fall or bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling drunk;
- Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
- Ringing, buzzing, or other noises in the ear (tinnitus);
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not there (hallucinations);
- Allergic reaction after taking the medicine, hives (urticaria);
- Blood tests may show abnormal liver function, liver damage;
- Suicidal thoughts or self-harming thoughts, suicide attempt – inform your doctor immediately;
- Feeling angry or agitated;
- Abnormal thoughts or loss of contact with reality;
- Severe allergic reaction causing swelling of the face, throat, hands, feet, ankles, or lower limbs;
- Fainting;
- Abnormal involuntary movements (dyskinesia).
Not known: frequency cannot be estimated from the available data
- Fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and experiencing 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 which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
- Widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizure.
Other side effects in children
- Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), 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, including ones not listed in this leaflet, talk to 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 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 stated on the carton and 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 beyond 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Lacosamide UCB contains
- The active substance is lacosamide. 1 mL of Lacosamide UCB syrup contains 10 mg of lacosamide.
- The other components are: glycerol (E422), sodium carmellose, liquid sorbitol (crystallisable) (E420), polyethylene glycol 4000, sodium chloride, anhydrous citric acid, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (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, colourless to yellow-brown.
- Lacosamide UCB is available in a 200 mL bottle.
The Lacosamide UCB syrup cartons contain a 30 mL dosing cup made of polypropylene (with black graduated markings) and a 10 mL oral dosing syringe made of polyethylene/polypropylene (with black graduated markings) with the corresponding adapter made of polyethylene.
- The dosing cup is suitable for doses greater than 20 mL. Each graduated marking (5 mL) on the dosing cup corresponds to 50 mg of lacosamide (for example, 2 graduated markings correspond to 100 mg).
- The 10 mL oral dosing syringe is suitable for doses between 5 mL and 20 mL. A full 10 mL oral dosing 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 Bruxelles, 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)
България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43 (0) 1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00
Latvija United Kingdom (Northern Ireland)
UCB Pharma Oy Finland UCB (Pharma) Ireland Ltd.
Tel: + 358 9 2514 4221 (Somija) 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.
Patient information leaflet
Lacosamide UCB 10 mg/mL solution for infusion
lacosamide
Read this leaflet carefully before taking 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide UCB is and what it is used for
- What you need to know before using Lacosamide UCB
- How to use Lacosamide UCB
- Possible side effects
- How to store Lacosamide UCB
- 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 the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide UCB is used for
- Lacosamide UCB is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age for the treatment of a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader areas on both sides of the brain;
- in combination with other antiepileptic medicines in adults, adolescents and children from 4 years of age for the treatment of primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).
2. What you should know before using Lacosamide UCB
Do not use Lacosamide UCB
- if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether 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 use Lacosamide UCB if you fall into any of the above categories. If you are unsure, speak to your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide UCB if:
- you have had thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or committing suicide. If you have any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heart rhythm and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter)
- you have a severe heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Lacosamide UCB may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.
If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide UCB. If you are taking Lacosamide UCB, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide UCB and develop symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or 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 whether it is effective or safe in children in these age groups.
Other medicines and Lacosamide UCB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide UCB may also affect your heart:
- medicines used to treat heart diseases;
- medicines that can prolong the "P-R interval" on a heart scan (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of irregular heartbeat or heart failure.
If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide UCB.
Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of Lacosamide UCB in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- an HIV medicine 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 you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide UCB.
Lacosamide UCB and alcohol
As a precautionary safety measure, 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, planning a pregnancy, or breastfeeding with breast milk, consult your doctor or pharmacist 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.
Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to use Lacosamide UCB.
Do not stop treatment without first consulting your doctor, as this could lead to an increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide UCB may cause dizziness or blurred vision.
Lacosamide UCB contains sodium
This medicine contains 59.8 mg of sodium (a key component of table salt) per vial. This amount is equivalent to 3% of the recommended maximum daily 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 unsure.
Using Lacosamide UCB
- Lacosamide UCB may be initiated:
- by taking the medicine orally, or
- by intravenous infusion (sometimes referred to as “IV infusion”), where the medicine is administered into a vein by a doctor or nurse over a period of 15 to 60 minutes.
- The IV infusion is usually used for a short period when you cannot take the medicine orally.
- Your doctor will decide for how many days you will receive infusions. Data are available for two daily infusions of Lacosamide UCB for up to 5 days. For longer-term treatment, Lacosamide UCB tablets and oral solution are available.
When switching from infusion to oral administration (or vice versa), the total daily amount
and dosing frequency remain the same.
- Use Lacosamide UCB twice daily, approximately 12 hours apart.
- Try to take it at approximately the same times each day.
How much to use
Below are the usual recommended doses of Lacosamide UCB for different age and weight groups. 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 using Lacosamide UCB alone
- The usual starting dose of Lacosamide UCB is 50 mg twice daily.
- Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice daily.
- Your doctor may increase your dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 300 mg twice daily.
When using Lacosamide UCB with other antiepileptic medicines
The usual starting dose of Lacosamide UCB is 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose of 100 mg to 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide UCB using a single 200 mg "loading dose". Twelve 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 below 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide UCB is not recommended in children below 4 years of age.
When using Lacosamide UCB alone
Your doctor will determine 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 daily.
Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of body weight twice daily each week, up to a maintenance dose.
Dosing tables are provided below, including the maximum recommended dose.
Dose when using Lacosamide UCB alone – For reference only. Your doctor will calculate the dose appropriate for you.
To be used twice daily in children from 2 years of age weighing between 10 kg and less than 40 kg
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 0.5 mL/kg | Week 6 Maximum recommended dose: 0.6 mL/kg | |
| 10 kg | 1 mL | 2 mL | 3 mL | 4 mL | 5 mL | 6 mL | |
| 15 kg | 1.5 mL | 3 mL | 4.5 mL | 6 mL | 7.5 mL | 9 mL | |
| 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL | 12 mL | |
| 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL | 15 mL | |
| 30 kg | 3 mL | 6 mL | 9 mL | 12 mL | 15 mL | 18 mL | |
| 35 kg | 3.5 mL | 7 mL | 10.5 mL | 14 mL | 17.5 mL | 21 mL | |
To be used twice daily for children and adolescents weighing 40 kg to less
than 50 kg:
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 Maximum recommended dose: 0.5 mL/kg |
| 40 kg | 4 mL | 8 mL | 12 mL | 16 mL | 20 mL |
| 45 kg | 4.5 mL | 9 mL | 13.5 mL | 18 mL | 22.5 mL |
When using Lacosamide UCB with other antiepileptic medicines
Your doctor will determine 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 daily.
- Your doctor may then increase your dose by 1 mg (0.1 mL) per kg of body weight each week for the twice-daily administration, until reaching a maintenance dose.
The following dosage tables are provided, including the recommended maximum dose.
For informational purposes only. Your doctor will calculate the correct dose for you.
To be used twice daily for children from 2 years of age weighing 10 kg to less than 20 kg
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 0.5 mL/kg | Week 6 Maximum recommended dose: 0.6 mL/kg |
| 10 kg | 1 mL | 2 mL | 3 mL | 4 mL | 5 mL | 6 mL |
| 15 kg | 1.5 mL | 3 mL | 4.5 mL | 6 mL | 7.5 mL | 9 mL |
To be used twice daily for children and adolescents with body weight between 20 kg and
less than 30 kg:
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 0.4 mL/kg | Week 5 Maximum recommended dose: 0.5 mL/kg |
| 20 kg | 2 mL | 4 mL | 6 mL | 8 mL | 10 mL |
| 25 kg | 2.5 mL | 5 mL | 7.5 mL | 10 mL | 12.5 mL |
To be used twice daily for children and adolescents with a body weight between 30 kg and
less than 50 kg:
| Weight | Week 1 Initial dose: 0.1 mL/kg | Week 2 0.2 mL/kg | Week 3 0.3 mL/kg | Week 4 Maximum recommended dose: 0.4 mL/kg |
| 30 kg | 3 mL | 6 mL | 9 mL | 12 mL |
| 35 kg | 3.5 mL | 7 mL | 10.5 mL | 14 mL |
| 40 kg | 4 mL | 8 mL | 12 mL | 16 mL |
| 45 kg | 4.5 mL | 9 mL | 13.5 mL | 18 mL |
If you stop treatment with Lacosamide UCB
If your doctor decides to discontinue treatment with Lacosamide UCB, the dose should be gradually reduced.
This is intended to prevent the recurrence or worsening of epilepsy.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nervous system side effects 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
- Dizziness or nausea
- Double vision (diplopia)
Common: may affect up to 1 in 10 people
- Brief spasms in a muscle or a group of muscles (myoclonic jerks)
- Difficulty coordinating movements or walking
- Problems maintaining balance, tremors, tingling (paraesthesia) or muscle spasms, increased tendency to fall and bruise
- Memory problems, difficulty thinking or finding words, confusion
- Rapid and uncontrolled eye movements (nystagmus), blurred vision
- Sensation of spinning (vertigo), feeling of drunkenness
- Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea
- Reduced touch sensation or numbness, difficulty articulating words, attention disturbance
- Ringing in the ears such as buzzing, ringing, or whistling sounds (tinnitus)
- Irritability, difficulty sleeping, depression
- Drowsiness, tiredness or weakness (asthenia)
- Itching, irritation
Uncommon: may affect up to 1 in 100 people
- Slowed heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder)
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present (hallucinations)
- Allergic reaction after taking the medicine, hives (urticaria)
- Blood tests may show abnormal liver function, liver damage
- Self-harming thoughts or suicidal thoughts, suicide attempt – 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 (syncope)
- Abnormal involuntary movements (dyskinesia)
Not known: frequency cannot be estimated from the available data
- Fast heartbeat (ventricular tachyarrhythmia)
- Sore throat, high fever, and experiencing more infections than usual. Blood tests may show a severe decrease in the number of a specific type of white blood cells (agranulocytosis)
- Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia)
- Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
- Seizure
Other side effects when administered as 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 include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, abnormal behaviour, 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and vial after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Each vial of Lacosamide UCB infusion solution must be used only once.
Any unused solution remaining must be discarded.
The solution should be used only if it is clear, with no colour changes and free from foreign particles.
Do not dispose of medicines via 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 substance is lacosamide. 1 mL of Lacosamide UCB infusion solution contains 10 mg of lacosamide. One vial contains 20 mL of Lacosamide UCB infusion solution, equivalent to 200 mg of lacosamide.
- The other components 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 infusion solution is a clear, colourless solution. Lacosamide UCB infusion solution 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 Bruxelles, 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, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)
България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43 (0) 1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00
Latvija United Kingdom (Northern Ireland)
UCB Pharma Oy Finland UCB (Pharma) Ireland Ltd.
Tel: + 358 9 2514 4221 (Somija) Tel: + 353 / (0)1-46 37 395
Further 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 infusion solution must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamide UCB infusion solution may 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 Ringer's lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical in-use stability 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.