Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lacosamide

Document Subject

Generated Narrative: MedicinalProductDefinition mp3259b4ec962bd839a6862c2a3f8b465b

identifier: http://ema.europa.eu/identifier/EU/1/19/1383/004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lacosamide UCB 50 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3259b4ec962bd839a6862c2a3f8b465b

identifier: http://ema.europa.eu/identifier/EU/1/19/1383/004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lacosamide

Attesters

What is in 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

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

• You have been given this medicine to lower the number of fits (seizures) you have.

What Lacosamide UCB is used for

• Lacosamide UCB is used:
• on its own and in association with other antiepileptic medicines in adults, adolescents and children aged 2 years and older to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation. In this type of epilepsy, fits first affect only one side of your brain. However, these may then spread to larger areas on both sides of your brain;
• in association with other antiepileptic medicines in adults, adolescents and children aged 4 year and older to treat primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

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 whether you are allergic, please discuss with your doctor.
• if you have a certain type of heart beat problem called second- or third-degree AV block.

Do not take Lacosamide UCB if any of the above applies 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 thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, tell your doctor straight away.
• you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
• you have severe heart disease such as heart failure or have had a heart attack.
• you are often dizzy or fall over. Lacosamide UCB may make you dizzy - this could increase the risk of accidental injury or a fall. This means that you should take care until you are 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 taking Lacosamide UCB. If you are taking Lacosamide UCB, talk to your doctor if you are experiencing a new type of seizure or worsening of existing seizures. If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).

Children Lacosamide UCB is not recommended for children aged under 2 years with epilepsy characterised by the occurrence of partial-onset seizure and not recommended for children aged under 4 years with primary generalised tonic-clonic seizures. This is because we do not yet know whether it will work and whether 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 your heart - this is because Lacosamide UCB can also affect your heart:

• medicines to treat heart problems;
• medicines which can increase the PR interval on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat certain types of irregular heart beat 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 medicines - this is because they may 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 breast-feeding Fertile women should discuss the use of contraceptives with the doctor.

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Lacosamide UCB if you are pregnant, as the effects of Lacosamide UCB on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Lacosamide UCB, as Lacosamide UCB passes into breast milk. Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant. They will help you decide if you should take Lacosamide UCB or not.

Do not stop treatment without talking to your doctor first as this could increase your fits (seizures). A worsening of your disease can also harm your baby.

Driving and using machines Do not drive, cycle or use any tools or machines until you know how this medicine affects you. This is because Lacosamide UCB may make you feel dizzy or cause blurred vision.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

Taking Lacosamide UCB

• Take Lacosamide UCB twice each 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 may take Lacosamide UCB with or without food.

You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks. When you reach the dose that works for you, this is called the maintenance dose , you then take the same amount each day. Lacosamide UCB is used as a long term treatment. You should continue to take Lacosamide UCB until your doctor tells you to stop.

How much to take Listed below are the normal recommended doses of Lacosamide UCB for different age groups and weights. Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.

Adolescents and children weighing 50 kg or more and adults When you take Lacosamide UCB on its own

• The usual starting dose of Lacosamide UCB is 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 twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When you take Lacosamide UCB with other antiepileptic medicines

• The usual starting dose of Lacosamide UCB is 50 mg twice a day.
• Your doctor may increase your twice daily dose every week by 50 mg. This will be until you reach a maintenance dose between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single loading dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizure: Observe that Lacosamide UCB is not recommended for children under 2 years of age.

• In the treatment of primary generalised tonic-clonic seizures: Observe that Lacosamide UCB is not recommended for children under 4 years of age.

• The dose depends on their body weight. They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths. The doctor will prescribe the formulation that is best suited to them.

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

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• fits (seizures), heart beat problems such a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.

If you forget to take Lacosamide UCB

• If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
• If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore. Instead take Lacosamide UCB at the next time that you would normally take it.
• 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 talking to your doctor, as your epilepsy may come back again or become worse.
• If your doctor decides to stop your treatment with Lacosamide UCB, they will tell you how to decrease the dose step by step. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Nervous system side effects such as dizziness may be higher after a single loading dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Short jerks of a muscle or group of muscles (myoclonic seizures);
• Difficulties in coordinating your movements or walking;
• Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
• Troubles with your memory, thinking or finding words, confusion;
• Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
• A spinning sensation (vertigo), feeling drunk;
• Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
• Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention;
• Noise in the ear such as buzzing, ringing or whistling;
• Irritability, trouble sleeping, depression;
• Sleepiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 people

• Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
• Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
• Allergic reaction to medicine intake, hives;
• Blood tests may show abnormal liver function, liver injury;
• Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away;
• Feeling angry or agitated;
• Abnormal thinking or losing touch with reality;
• Serious allergic reaction which 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

• Abnormal rapid heartbeat (ventricular tachyarrhythmia);
• A sore throat, high temperature and getting more infections than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
• A widespread rash with blisters and peeling skin, particularly 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.

Additional side effects in children

The additional side effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, not acting like themselves (abnormal behavior) and lacking in energy (lethargy). Feeling sleepy (somnolence) 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 and 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Lacosamide UCB contains

• The active substance is lacosamide. One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide. One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide. One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide. One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide.

• The other ingredients are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate. Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*.

• The colourants are: 50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132). 100 mg tablet: yellow iron oxide (E172). 150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). 200 mg tablet: indigo carmine aluminium lake (E132).

What Lacosamide UCB looks like and contents of the pack

• Lacosamide UCB 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 4.9 mm with a debossed SP on one side and 50 on the other side.
• Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed SP on one side and 100 on the other side.
• Lacosamide UCB 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed SP on one side and 150 on the other side.
• Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed SP on one side and 200 on the other side.

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 multipacks comprising 3 cartons, each containing 56 tablets. The 14 x 1 and 56 x 1 film-coated tablets packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are available with standard PVC/PVDC blisters sealed with an aluminium foil. Not all pack sizes may be marketed.

Marketing Authorisation Holder UCB Pharma S.A., All e 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien UCB Pharma SA/NV T l/Tel: + 32 / (0)2 559 92 Lietuva UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Suomija)

Te .: + 359 (0) 2 962 30 Luxembourg/Luxemburg UCB Pharma SA/NV T l/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

esk republika UCB s.r.o. Tel: + 420 221 773 Magyarorsz g UCB Magyarorsz g Kft. Tel.: + 36-(1) 391 0Danmark UCB Nordic A/S Tlf: + 45 / 32 46 24 Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 Deutschland UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4Nederland UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 Eesti UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Soome)

Norge UCB Nordic A/S Tlf: + 47 / 67 16 5
UCB . .
: + 30 / 2109974 sterreich UCB Pharma GmbH Tel: + 43 (0)1 291 80 Espa a UCB Pharma, S.A. Tel: + 34 / 91 570 34 Polska UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel: + 48 22 696 99 France UCB Pharma S.A. T l: + 33 / (0)1 47 29 44 Portugal UCB Pharma (Produtos Farmac uticos), Lda
Tel: + 351 21 302 5Hrvatska Medis Adria d.o.o. Tel: +385 (0) 1 230 34 Rom nia UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 Slovenija Medis, d.o.o. Tel: + 386 1 589 69 sland Vistor hf. Simi: + 354 535 7Slovensk republika UCB s.r.o., organiza n zlo ka Tel: + 421 (0) 2 5920 2Italia UCB Pharma S.p.A. Tel: + 39 / 02 300 Suomi/Finland UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4
Lifepharma (Z.A.M.) Ltd : + 357 22 05 63 Sverige UCB Nordic A/S Tel: + 46 / (0) 40 29 49 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 This leaflet was last revised in {month/YYYY}.

Other sources of information

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