Lacosamide Olpha: detailed information

Package leaflet: information for the patient

Lacosamide Olpha 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

lacosamide
Generic medicine
Please 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.
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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Lacosamide Olpha is and what it is used for
What you need to know before taking Lacosamide Olpha
How to take Lacosamide Olpha
Possible side effects
How to store Lacosamide Olpha
Contents of the pack and other information

1. What Lacosamide Olpha is and what it is used for

What Lacosamide Olpha is
Lacosamide Olpha 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 Olpha is used for
Lacosamide Olpha 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 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 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 Olpha

Do not take Lacosamide Olpha

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 Olpha if you fall into any of the above categories. If you are unsure, speak to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Lacosamide Olpha if:

you have had thoughts of harming or killing yourself. A small number of people taking antiepileptic medicines such as lacosamide have had suicidal thoughts. 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 frequently experience dizziness or falls. Lacosamide Olpha may cause dizziness – this may increase the risk of accidental injury or falls. This means you should exercise caution until you become accustomed to the effects of this medicine. If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Lacosamide Olpha.

If you are taking Lacosamide Olpha, contact your doctor if you experience seizures of a different type or if your existing seizures worsen.

If you are taking Lacosamide Olpha 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 Olpha is not recommended for children under 2 years of age with partial-onset epilepsy, 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 the medicine is effective or safe in children within these age groups.

Other medicines and Lacosamide Olpha

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: because Lacosamide Olpha 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 medicines for epilepsy or pain 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), consult your doctor or pharmacist before taking Lacosamide Olpha.

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 Olpha 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 you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before taking Lacosamide Olpha.

Lacosamide Olpha and alcohol

As a precautionary safety measure, do not take Lacosamide Olpha with alcohol.

Pregnancy and breastfeeding

Women of childbearing age 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 Olpha is not recommended during pregnancy, as the effects of Lacosamide Olpha on the unborn baby are unknown.

Breastfeeding is not recommended while taking Lacosamide Olpha, as lacosamide passes into breast milk.

Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not you should take Lacosamide Olpha.

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 Olpha may cause dizziness or blurred vision.

3. How to take Lacosamide Olpha

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for children: please ask your doctor or pharmacist.

Taking Lacosamide Olpha

Take Lacosamide Olpha twice daily, approximately 12 hours apart.
Try to take it at approximately the same time each day.
Swallow the Lacosamide Olpha tablet with a glass of water.
You may take Lacosamide Olpha with or without food.

You will usually start on a lower daily dose, which your doctor will gradually increase over several weeks. Once you reach the dose that is right for you, this is called the "maintenance dose", so you should continue taking the same amount every day. Lacosamide Olpha is used as a long-term treatment. You must continue taking Lacosamide Olpha until your doctor tells you to stop.

Dosage

Below are the usual recommended doses of Lacosamide Olpha 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 Olpha alone:

The usual starting dose of Lacosamide Olpha is 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Olpha 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 Olpha with other antiepileptic medicines:

The usual starting dose of Lacosamide Olpha is 50 mg 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 200 mg twice daily.
If you weigh 50 kg or more, your doctor may decide to start treatment with a single "loading dose" of 200 mg of Lacosamide Olpha. 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 Olpha is not recommended in children under 2 years of age.
For the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Olpha is not recommended in children under 4 years of age.

The dose depends on body weight. Treatment usually starts with the oral syrup, and tablets are used only if the child can swallow them and receive the correct dose with the available tablet strengths. Your doctor will prescribe the most appropriate formulation for the patient.

If you take more Lacosamide Olpha than you should

Contact your doctor immediately if you have taken more Lacosamide Olpha 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 Olpha

If you forget to take a dose and it is less than 6 hours past your usual time, take it as soon as you remember.
If you forget to take a dose and it is more than 6 hours past your usual time, do not take the missed tablet. Instead, take your next dose of Lacosamide Olpha at the usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lacosamide Olpha

Do not stop taking Lacosamide Olpha without consulting your doctor, as seizures may return or worsen.
If your doctor decides to discontinue treatment with Lacosamide Olpha, they will give you 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.
Contact 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 maintaining balance, tremors, tingling (paraesthesia), muscle spasms, increased tendency to fall and bruising;
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, trills 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;
Allergic reaction following medicine intake, hives;
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 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 of a type of white blood cells (eosinophilia);
Widespread skin rash with blisters and skin peeling, 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, 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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lacosamide Olpha

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 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 Olpha contains

The active substance is lacosamide. One tablet of Lacosamide Olpha 50 mg contains 50 mg of lacosamide. One tablet of Lacosamide Olpha 100 mg contains 100 mg of lacosamide. One tablet of Lacosamide Olpha 150 mg contains 150 mg of lacosamide. One tablet of Lacosamide Olpha 200 mg contains 200 mg of lacosamide.
The other components are: Tablet core: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, polyvinyl alcohol, macrogol, lecithin (soy), colourants*. * The colourants are: 50 mg tablets: red iron oxide (E172), black iron oxide (E172). 100 mg tablets: yellow iron oxide (E172). 150 mg tablets: red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172). 200 mg tablets: indigo carmine (E132).

Description of the appearance of Lacosamide Olpha and contents of the pack

Lacosamide Olpha 50 mg are film-coated pink tablets, biconvex, oval, with "L50" engraved on one side and smooth on the other side (length 9.7 mm; width 5 mm).
Lacosamide Olpha 100 mg are film-coated yellow tablets, biconvex, oval, with "L100" engraved on one side and smooth on the other side (length 13 mm; width 6.5 mm).
Lacosamide Olpha 150 mg are film-coated light brown tablets, biconvex, oval, with "L150" engraved on one side and smooth on the other side (length 14.7 mm; width 7.7 mm).
Lacosamide Olpha 200 mg are film-coated blue tablets, biconvex, oval, with "L200" engraved on one side and smooth on the other side (length 16 mm; width 7.5 mm).

Lacosamide Olpha 50 mg film-coated tablets and Lacosamide Olpha 100 mg film-coated tablets
Packs of 14, 56 and 168 film-coated tablets in PVC/PVDC blisters sealed with an aluminium foil.
Lacosamide Olpha 150 mg film-coated tablets and Lacosamide Olpha 200 mg film-coated tablets
Packs of 56 and 168 film-coated tablets in PVC/PVDC blisters sealed with an aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorised in the European Economic Area countries under the following names:
Latvia: Lacosamide Olpha 50 mg, 100 mg, 150 mg, 200 mg apvalkotās tabletes
Germany: Lacosamid Olpha 50 mg, 100 mg, 150 mg, 200 mg Filmtabletten
Italy: Lacosamide Olpha
France: LACOSAMIDE OLPHA 50 mg, 100 mg, 150 mg, 200 mg, comprimé pelliculé