LACOSAMIDE OLPHA 50 mg FILM-COATED TABLETS

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

Do not take Lacosamida

• if you are allergic to lacosamida or any of the other ingredients of this medicine

(listed in section 6). If you are not sure, talk to your doctor.

• if you have a heart rhythm problem called second or third degree AV block.

Do not take this medicine 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 you start taking this medicine if:

• you have thoughts of harming yourself or suicide. A small number of people taking antiepileptics such as lacosamida have had thoughts of harming themselves or suicide. If at any time you have these thoughts, 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 can 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), talk to your doctor or pharmacist before taking this medicine.

If you are taking this medicine, talk to your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking this medicine and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), contact 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 if it is effective and safe for children in this age group.

Other medicines and lacosamida

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. The reason is that lacosamida can also affect the heart.

• medicines for heart problems.
• medicines that can 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 this medicine.

Tell your doctor or pharmacist if you are taking any of the following medicines. The reason is that they can also increase or decrease the effect of lacosamida in your body.

• medicines for fungal infections such as fluconazole, itraconazole, or ketoconazole.

• medicines for HIV 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 with alcohol

As a precaution, do not take this medicine with alcohol.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, 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 if you are pregnant, as it is not known what effect it may have on the pregnancy or the fetus.

It is not recommended to breastfeed while taking this medicine, as it passes into breast milk. Ask your doctor for advice if you are pregnant or planning 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 could increase the risk of seizures (fits). 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 can cause dizziness or blurred vision.

3. How to take/use Lacosamida Olpha

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida 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 to take lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamida for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adults, adolescents, and children weighing 50 kg or more

When taking lacosamida alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 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 lacosamida treatment with a single "loading dose" of 200 mg. You would then 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 this medicine is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that this medicine is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment is usually started with the oral solution and only switched to tablets if the patient is able to take them and to get the correct dose with tablets of different strengths. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Lacosamida than you should

If you have taken more lacosamida than you should, talk to 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, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lacosamida

• If you have forgotten to take a dose within the next 6 hours of the scheduled dose, take it as soon as you remember.

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

If you stop taking Lacosamida

• Do not stop taking lacosamida without talking to your doctor first, 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 reduce 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, lacosamida 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 sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 people

• brief muscle jerks or muscle groups (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems keeping balance, shaking (tremor), tingling (paresthesia), or muscle spasms, falling easily and getting bruises;
• memory problems, difficulty thinking or finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;

• decreased sensitivity, difficulty articulating words, altered attention;
• ringing in the ear like buzzing, whistling, or hissing;
• irritability, sleep problems, depression;
• drowsiness, 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 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: tell 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 rate (ventricular tachyarrhythmia);
• sore throat, high temperature, and getting infections more often than usual. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);

• severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased levels of liver enzymes 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 peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

• seizures.

Other side effects in children

Additional side effects seen 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida Olpha

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 CAD/EXP. The expiry date is the last day of the month shown.

Do not store above 30°C

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Olpha

• The active ingredient is lacosamide.

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

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

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

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

• The other components are:

Core of the tablet: microcrystalline cellulose (101), microcrystalline cellulose (102), crospovidone type A, colloidal silicon dioxide, hypromellose (low substituted), hypromellose, magnesium stearate.

Coating:

50 mg:

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), red iron oxide (E172), black iron oxide (E172)

100 mg:

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), yellow iron oxide (E172)

150 mg:

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)

200 mg

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171)

talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521)

lecithin (E322), aluminum lake indigo carmine (E132)

Appearance of the Product and Package Contents

• Lacosamida Olpha 50 mg are film-coated, oval, biconvex tablets, pink in color, marked with “L50” on one side and smooth on the other.

• Lacosamida Olpha 100 mg are film-coated, oval, biconvex tablets, yellow in color, marked with “L100” on one side and smooth on the other.

• Lacosamida Olpha 150 mg are film-coated, oval, biconvex tablets, salmon in color, marked with “L150” on one side and smooth on the other.

• Lacosamida Olpha 200 mg are film-coated, oval, biconvex tablets, blue in color, marked with “L200” on one side and smooth on the other.

Lacosamida Olpha is available in packs of 14, 28, 56, 98, and 168 film-coated tablets, in aluminum blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Manufacturer

Macleods Pharma UK Limited.

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Date of the Last Revision of thisLeaflet:

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/)