LACOSAMIDE INTAS 50 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Lacosamida Intas 50 mg Effervescent Tablets EFG

Lacosamida Intas 100 mg Effervescent Tablets EFG

Lacosamida Intas 150 mg Effervescent Tablets EFG

Lacosamida Intas 200 mg Effervescent Tablet EFG

Lacosamida

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lacosamida Intas and what is it used for
2. What you need to know before you take Lacosamida Intas
3. How to take Lacosamida Intas
4. Possible side effects
5. Storing Lacosamida Intas
6. Pack contents and further information

1. What is Lacosamida Intas and what is it used for

What is Lacosamida Intas

Lacosamida Intas contains lacosamida, which belongs to a group of medicines called “antiepileptic medicines”.

These medicines are used to treat epilepsy.

• You have been prescribed this medicine to reduce the number of seizures you have.

What is Lacosamida Intas used for

• Lacosamida Intas is used in adults, adolescents, and children over 4 years of age.
• Lacosamida Intas is used:

• alone and with other antiepileptics in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of your brain. However, they can then spread to larger areas on both sides of your brain;
• with other antiepileptics in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (grand mal seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Intas

Do not take Lacosamida Intas

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

Do not take Lacosamida if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to use lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida have had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.
• you have a heart problem that affects your heartbeat and your pulse is often particularly slow, fast, or irregular (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 often feel dizzy or faint. Lacosamida may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you are used to the effects of this medicine.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Lacosamida.

If you are taking lacosamida, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking lacosamida and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamida is not recommended in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures, nor in 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 for children of this age group.

Other medicines and Lacosamida Intas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as Lacosamida may also affect the heart:

• medicines for heart problems.
• medicines that may increase the “PR interval” in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine, or pregabalin.
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking lacosamida.

Also, inform your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of Lacosamida in your body:

• medicines for fungal infections such as fluconazole, itraconazole, or ketoconazol.
• HIV medicines such as ritonavir.
• medicines for 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 applies to you (or you are not sure), talk to your doctor or pharmacist before taking lacosamida.

Taking Lacosamida Intas with alcohol

As a precaution, do not take lacosamida with alcohol.

Pregnancy and breast-feeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lacosamida is not recommended during pregnancy, as its effects on pregnancy and the fetus are not known.

It is not recommended to breast-feed while taking lacosamida, as lacosamida passes into breast milk.

Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide whether to take lacosamida or not.

Do not stop treatment without talking to your doctor first, as this may increase seizures (epilepsy). Worsening of your condition may also harm the fetus.

Driving and using machines

Do not drive, ride a bike, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Sodium benzoate

Each tablet of this medicine contains 30 mg of sodium benzoate.

Sodium benzoate may increase jaundice (yellowing of skin and eyes) in newborns (up to 4 weeks old).

3. How to take Lacosamida Intas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Taking Lacosamida Intas

• Take Lacosamida Intas twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Put it in a glass of water and let it dissolve completely before drinking.
• You can take Lacosamida Intas with or without food.

Normally, you will start by taking a low dose each day and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, called the “maintenance dose”, you will take the same amount each day. Lacosamida is used as long-term treatment. You should continue taking Lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of Lacosamida Intas 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 taking Lacosamida Intas alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of Lacosamida Intas twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When taking Lacosamida Intas with other antiepileptic medicines:

The usual starting dose is 50 mg twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, 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 start treatment with Lacosamida Intas with a single “loading dose” of 200 mg. Then you would start taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that Lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamida is not recommended for children under 4 years of age.
• The dose depends on body weight. Treatment is usually started with the syrup and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different concentrations. The doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida Intas than you should

If you have taken more Lacosamida than you should, consult your doctor immediately. Do not attempt to drive.

You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heart rate and sweating.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lacosamida Intas

• If you have forgotten to take a dose within the next 6 hours after the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after the next 6 hours after the scheduled dose, do not take the missed dose. Instead, take Lacosamida the next time you normally would.
• Do not take a double dose to make up for missed doses.

If you stop taking Lacosamida Intas

• Do not stop taking Lacosamida without telling your doctor, as epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with Lacosamida, they will give you instructions on how to gradually decrease the dose.

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

4. Possible side effects

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

Side effects on the nervous system, such as dizziness, may be greater after a single “loading dose”.

Tell your doctor or pharmacist if you get any of the following side effects:

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

• brief muscle jerks or muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems keeping balance, agitation (shaking), numbness (paresthesia), or muscle spasms, falling easily and bruising;
• memory problems, thinking or finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• decreased sensitivity, difficulty articulating words, attention disorder;
• noise in the ear like buzzing, ringing, or whistling;
• irritability, sleep problems, depression;
• drowsiness, tiredness, or weakness (asthenia);
• itching, rash.

Uncommon: may affect up to 1 in 100 people

• decreased heart rate, palpitations, irregular pulse, or other changes in heart activity (conduction disorder);
• exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• allergic reaction to taking the medicine, hives;
• blood tests may show abnormalities in liver function tests, liver damage;
• thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;
• feeling angry or agitated;
• abnormal thoughts or loss of sense of reality;
• severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;
• fainting;
• abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, elevated temperature, and infections more often than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cell (eosinophilia);
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis):
• seizures.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioral changes, not acting as they normally do (abnormal behavior), and lack of energy (lethargy). Drowsiness (somnolence) 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lacosamida Intas

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 is the last day of the month shown.

50 mg/150 mg: Store below 30°C.

100mg/200mg: This presentation does not require special storage conditions.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist or local recycling collection point. If unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Intas

• The active ingredient is lacosamide.

Each Lacosamida Intas 50 mg tablet contains 50 mg of lacosamide.

Each Lacosamida Intas 100 mg tablet contains 100 mg of lacosamide.

Each Lacosamida Intas 150 mg tablet contains 150 mg of lacosamide.

Each Lacosamida Intas 200 mg tablet contains 200 mg of lacosamide.

The other components are anhydrous citric acid, calcium carbonate, povidone, sucralose, premium orange powder, macrogol, sodium benzoate

50 mg: Erythrosine

100 mg: Quinoline Yellow

150 mg: Erythrosine and Quinoline Yellow

Product Appearance and Container Content

The Lacosamida Intas 50 mg effervescent tablets are light pink to pink, round, flat-faced and beveled-edged, smooth on both sides and with a slight orange odor. The tablet diameter is approximately 20 mm.

The Lacosamida Intas 100 mg effervescent tablets are light yellow to yellow, round, flat-faced and beveled-edged, smooth on both sides and with a slight orange odor. The tablet diameter is approximately 20 mm.

The Lacosamida Intas 150 mg effervescent tablets are light orange to orange, round, flat-faced and beveled-edged, smooth on both sides and with a slight orange odor. The tablet diameter is approximately 20 mm.

The Lacosamida Intas 200 mg effervescent tablets are white to opaque white, round, flat-faced and beveled-edged, smooth on both sides and with a slight orange odor. The tablet diameter is approximately 20 mm.

Lacosamida Intas is presented in blister strips with 56 and 168 effervescent tablets.

Lacosamida Intas 50 mg is also available in blister strips with 14 and 16 effervescent tablets. Lacosamida Intas 100 mg is also available in blister strips with 16 effervescent tablets.

Only some pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Intas Third Party Sales 2005, S.L.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona,

Spain

Date of Last Revision of this Prospectus:

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/