LACOSAMIDE JUBILANT 50 mg FILM-COATED TABLETS

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

Do not takeLacosamida Jubilant

• 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 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, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting to use Lacosamida Jubilant 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 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. This medicine 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 Jubilant.

Children

Lacosamida is not recommended in children under 4 years of age. This is because it is not yet known if it is effective and safe for children in this age group.

Other medicines andLacosamida Jubilant

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.

Tell 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 called fluconazole, itraconazole, or ketoconazole
• a medicine for HIV called ritonavir.
• medicines for bacterial infections called 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 Jubilant.

TakingLacosamida Jubilantwith alcohol

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

Pregnancy and breastfeeding

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 or breastfeeding, as the effects of this medicine on pregnancy and the fetus or newborn are not known. Additionally, it is not known if Lacosamida passes into breast milk. Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. Your doctor will help you decide whether to take Lacosamida or not.

Do not stop treatment without talking to your doctor first, as this may 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 Jubilant may cause dizziness or blurred vision.

3. How to take/use Lacosamida Jubilant

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

• Take lacosamida twice a day, once in the morning and once in the evening.
• Try to take it at about 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 will need to continue taking 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.

Use in adults, adolescents, and children from 4 years of age who weigh 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. Then you will start taking the continuous maintenance dose 12 hours later.

Children and adolescents who weigh less than 50 kg

The dose depends on body weight. Treatment is usually started with the oral solution and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different strengths. The 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 or pharmacist immediately 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 after the scheduled dose, take it as soon as you remember.

If you have forgotten to take a dose after 6 hours after 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 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 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 dizzy or sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 people

• problems with balance, agitation (shaking), tingling (paresthesia), or muscle spasms, falling easily, and bruising;
• memory problems, problems thinking or finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

decreased sensitivity, difficulty articulating words, attention problems;

• ringing in the ears 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

• 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;

passing out.

• difficulty coordinating movements or walking

Frequency not known: cannot be estimated from the available data

• abnormally fast heart rhythm (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 (lymph nodes enlarged). 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 peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

seizures.

Other side effects in children

Common: may affect up to 1 in 10 children

• runny nose (nasopharyngitis);
• fever (pyrexia);
• sore throat (pharyngitis);
• eating less than usual.

Uncommon: may affect up to 1 in 100 children

• feeling drowsy or lacking energy (lethargy).

Frequency not known: cannot be estimated from the available data

• changes in behavior, not acting as they normally do.

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 Jubilant

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 the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition ofLacosamida Jubilant

The active ingredient is lacosamida.

Each film-coated tablet contains 50 mg lacosamida.

Each film-coated tablet contains 100 mg lacosamida.

Each film-coated tablet contains 150 mg lacosamida.

Each film-coated tablet contains 200 mg lacosamida.

The other components are:

Tablet core: microcrystalline cellulose, crospovidone, hypromellose (low substituted), hypromellose, silicified microcrystalline cellulose (colloidal anhydrous silica and microcrystalline cellulose), magnesium stearate.

Film coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colorants*.

• The colorants are:

50 mg tablets: red iron oxide (E172), black iron oxide (E172), aluminum lake indigo carmine (E132).

100 mg tablets: yellow iron oxide (E172).

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

200 mg tablets: aluminum lake indigo carmine (E132).

Appearance ofLacosamida Jubilantand container content

• Lacosamida Jubilant 50 mg are film-coated tablets, light pink in color, oval in shape, engraved with ‘J4’ on one side and smooth on the other side.
• Lacosamida Jubilant 100 mg are film-coated tablets, yellow in color, oval in shape, engraved with ‘598’ on one side and smooth on the other side.
• Lacosamida Jubilant 150 mg are film-coated tablets, peach in color, oval in shape, engraved with ‘599’ on one side and smooth on the other side.
• Lacosamida Jubilant 200 mg are film-coated tablets, light blue in color, oval in shape, engraved with ‘600’ on one side and smooth on the other side.

Lacosamida Jubilant is available in packs of 12, 14, 24, 28, 36, 48, 56, 60, 72, 84, 96, 120, 168 (pack of 168 only for 50 mg and 100 mg), 14 x 1 and 56 x 1 film-coated tablets, and in a multipack of 3 packs, each containing 56 film-coated tablets (multipack only for 150 mg and 200 mg). The pack of 14 x 1 or 56 x 1 tablets is available in precut unit-dose PVC/PVDC blisters sealed with an aluminum foil, all other packs are available in standard PVC/PVDC blisters sealed with an aluminum foil.

Only some pack sizes may be marketed.

Marketing authorization holder;

Jubilant Pharmaceuticals nv.

Axxes Business Park.

Guldensporenpark 22 - Block C.

9820 Merelbeke.

Belgium.

Manufacturer:

PSI supply nv.

Axxes Business Park.

Guldensporenpark 22, Block C.

Merelbeke, Belgium.

Or.

PharmaS d.o.o.

Industrijska Cesta 5, Potok, Popovaca.

Sisacko-Moslavacka, 44317, Croatia.

This medicinal product is authorized in the EEA Member States under the following names:

Date of last revision of this leafletJune 2021.

Detailed and updated 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.