Ollat

Package leaflet: Information for the patient

Ollat 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, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Ollat is and what it is used for
  2. What you need to know before taking Ollat
  3. How to take Ollat
  4. Possible side effects
  5. How to store Ollat
  6. Contents of the pack and other information

1. What Ollat is and what it is used for

What Ollat is
Ollat contains lacosamide. It belongs to a group of medicines called "antiepileptic medicines".
These medicines are used to treat epilepsy.

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

What Ollat is used for
Ollat is used:

• alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a specific type of epilepsy characterized by partial-onset seizures with or without secondary generalization. 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 for the treatment of primary generalized tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Ollat Do not take Ollat

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are not sure 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 Ollat if you fall into either of the above categories. If you are unsure, speak with your doctor before taking this medicine.

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Warnings and precautions
Talk to your doctor before taking Ollat if:

• you have had thoughts about harming or killing yourself. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming or killing themselves. If you have 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. Ollat may cause dizziness—this may increase the risk of accidental injury or falls. This means you should be cautious until you have become accustomed to the effects of this medicine. If you fall into any of the above categories (or are unsure), speak with your doctor or pharmacist before taking Ollat. If you are taking Ollat, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Ollat and develop symptoms of an abnormal heartbeat (such as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children
Ollat is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, 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 it is effective and safe in children in these age groups.

Other medicines and Ollat
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: this is because Ollat 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), speak with your doctor or pharmacist before taking Ollat.

Also inform your doctor or pharmacist if you are taking any of the following medicines—because they may increase or decrease the effect of Ollat 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), speak with your doctor or pharmacist before taking Ollat.

Ollat and alcohol
As a precautionary safety measure, do not take Ollat with alcohol.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Ollat is not recommended during pregnancy, as the effects of Ollat on pregnancy and the fetus are unknown.

Breastfeeding is not recommended while taking Ollat, as Ollat 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 Ollat.

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 Ollat may cause dizziness or blurred vision.

3. How to take Ollat

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for
children: ask your doctor or pharmacist.
How to take Ollat

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

Usually, you will start with a lower dose each day, and your doctor will slowly increase it over several
weeks. When you reach the dose that is right for you, this is called the "maintenance dose"; from then on, take the same amount every day. Ollat is used as a long-term treatment. You must continue taking Ollat until your doctor tells you to stop.

Dosage
Below are the usual recommended doses of Ollat for different age groups and body weights. 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 Ollat alone:

• The usual starting dose of Ollat is 50 mg twice daily.
• Your doctor may also prescribe a starting dose of 100 mg of Ollat twice daily.
• Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 300 mg twice daily.

When taking Ollat with other antiepileptic medicines:

• The usual starting dose of Ollat is 50 mg twice daily.
• Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose between 100 mg and 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 Ollat. 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 Ollat is not recommended in children under 2 years of age.
• For the treatment of primary generalized tonic-clonic seizures: note that Ollat is not recommended in children under 4 years of age.
• The dose depends on body weight. Treatment usually starts with syrup, and patients switch to tablets only if they are able to swallow them and can receive the correct dose using the available tablet strengths.
  Your doctor will prescribe the most appropriate formulation for you.

If you take more Ollat than you should
Contact your doctor immediately if you have taken more Ollat than you should. Do not attempt to drive.
You may experience:

• dizziness;
• nausea or vomiting;
• seizures (epileptic fits), heart problems such as slow, fast or irregular heartbeat, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Ollat

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

If you stop taking Ollat

• Do not stop taking Ollat without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your treatment with Ollat, they will give you instructions on how to gradually reduce the dose.
  If you have any doubts about how to use 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 a group of muscles (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paraesthesia) or muscle spasms, increased tendency to fall and bruise;
• 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 touch or sensitivity, difficulty articulating words, attention disturbance;
• Ringing in the ears such as buzzing, ringing, or whistling sounds;
• 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 there;
• Allergic reaction after taking the medicine, 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

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever, and experiencing a higher number of infections than usual. Blood tests may show a severe decrease in the number of cells of a specific class 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 rash with blisters and peeling of the skin, 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, behaviour different from normal (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 website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Ollat

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 any medicine 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 Ollat contains
The active substance is lacosamide.
One Ollat 50 mg tablet contains 50 mg of lacosamide.
One Ollat 100 mg tablet contains 100 mg of lacosamide.
One Ollat 150 mg tablet contains 150 mg of lacosamide.
One Ollat 200 mg tablet contains 200 mg of lacosamide.
The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), silicified microcrystalline cellulose, crospovidone (type B), magnesium stearate
Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*
* The colourants are:
50 mg tablets: iron oxide red (E172), iron oxide black (E172), indigo carmine aluminium lake (E132)
100 mg tablets: iron oxide yellow (E172)
150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172)
200 mg tablet: indigo carmine aluminium lake (E132)

Description of the appearance of Ollat and contents of the pack
Ollat 50 mg are pink, film-coated, oval tablets.
Ollat 100 mg are dark yellow, film-coated, oval tablets.
Ollat 150 mg are salmon-coloured, film-coated, oval tablets.
Ollat 200 mg are blue, film-coated, oval tablets.
Ollat is available in packs of 14, 56 and 84 film-coated tablets in transparent, colourless PVC/PVDC blisters sealed with an aluminium foil.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Marketing Authorised Representative
Istituto Luso Farmaco d’Italia S.p.A.
Milanofiori, Strada 6, Edificio L
20089 Rozzano (MI)
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
IT: Ollat