Stutan

PACKAGE LEAFLET

Package leaflet: information for the patient

STUTAN 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 side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What STUTAN is and what it is used for
2. What you need to know before taking STUTAN
3. How to take STUTAN
4. Possible side effects
5. How to store STUTAN
6. Contents of the pack and other information

1. What STUTAN is and what it is used for

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

• This medicine has been prescribed to reduce the number of seizures (epileptic fits) you experience.

What STUTAN is used for

• STUTAN is used in adults, adolescents, and children from the age of 4 years.
• It is used:
  • alone or in combination with other antiepileptic medicines to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures start in 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 to treat primary generalized tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking STUTAN

Do not take STUTAN

• 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 STUTAN if any of the above apply to you. If you are unsure, speak to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking STUTAN if:

• you have had thoughts of harming yourself or of suicide. A small number of patients taking antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of suicide. If you have any such thoughts at any time, inform your doctor immediately.
• you have a heart condition affecting your heartbeat 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 feel dizzy or fall. STUTAN may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you become accustomed to the effects of this medicine.

If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking STUTAN. If you are taking STUTAN and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, or fainting), consult your doctor immediately (see section 4).

Children under 4 years of age

STUTAN is not recommended for children under 4 years of age.
This is because it is not yet known whether it is effective or safe in children in this age group.

Other medicines and STUTAN

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 your heart: this is because STUTAN may also affect your heart:

• medicines used to treat heart diseases;
• medicines that can prolong the "PR interval" on a heart scan (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking STUTAN.

Also inform your doctor or pharmacist if you are taking any of the following medicines – because they may increase or decrease the effect of STUTAN in your body:

• antifungal medicines called fluconazole, itraconazolo, or ketoconazole;
• an HIV medicine called ritonavir;
• medicines used to treat bacterial infections called clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John's wort (Hypericum perforatum).

If any of the above apply to you (or you are unsure), speak to your doctor or pharmacist before taking STUTAN.

STUTAN and alcohol

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

Pregnancy and breastfeeding

Women of childbearing potential 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, consult your doctor or pharmacist before taking this medicine.

STUTAN is not recommended during pregnancy, as the effects of STUTAN on the unborn baby are unknown.

Breastfeeding is not recommended while taking STUTAN, as STUTAN passes into breast milk. Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to take STUTAN.

Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (epileptic fits). 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 STUTAN may cause dizziness or blurred vision.

STUTAN 100 mg and 150 mg contains Sunset Yellow FCF (E110)
May cause allergic reactions.

STUTAN 200 mg contains Ponceau 4R (E124)
May cause allergic reactions.

3. How to take STUTAN

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How to take STUTAN

• Take STUTAN twice daily – once in the morning and once in the evening.
• Try to take it at approximately the same time each day.
• Swallow the STUTAN tablet with a glass of water.
• You may take STUTAN with or without food.

Usually, you will start with a low daily dose, and your doctor will gradually increase it over a number of weeks. Once the appropriate dose for you has been reached, this is called the “maintenance dose”, so you will then take the same amount every day. STUTAN is used as a long-term treatment. You must continue taking STUTAN unless your doctor tells you to stop.

Dosage
Below are the usual recommended doses of STUTAN 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 STUTAN alone:
The usual starting dose of STUTAN is 50 mg twice daily.
Your doctor may also prescribe a starting dose of 100 mg of STUTAN twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching the maintenance dose, which ranges between 100 mg and 300 mg twice daily.

When taking STUTAN with other antiepileptic medicines:
The usual starting dose of STUTAN is 50 mg twice daily.
Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching the maintenance dose, which ranges between 100 mg and 200 mg twice daily.

If you weigh 50 kg or more, your doctor may decide to start treatment with STUTAN using a single “loading dose” of 200 mg. Twelve hours later, you would then begin your maintenance dose.

Children and adolescents weighing less than 50 kg
The dose depends on body weight. Treatment usually starts with the oral syrup, switching to tablets only if the child is 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 STUTAN than you should
Contact your doctor immediately if you have taken more STUTAN than prescribed. Do not attempt to drive.
You may experience:

• dizziness;
• feeling unwell (nausea) or being unwell (vomiting);
• seizures (convulsive 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 STUTAN

• If you forget to take a dose of STUTAN and it is less than 6 hours since your usual time, take it 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 STUTAN

• Do not stop treatment with STUTAN without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue STUTAN treatment, they will give you instructions on how to gradually reduce the dose.
  If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent after a single "loading" dose.
If you experience any of the following symptoms, consult your doctor or pharmacist:
Very common: may affect more than 1 in 10 people

• Headache;
• Dizziness or feeling unwell (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, tremor, tingling (paresthesia), or muscle spasms, increased tendency to fall or bruise easily;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of spinning (vertigo), feeling of drunkenness;
• Nausea (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;
• Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
• Ringing, buzzing, or whistling noise in the ear (tinnitus);
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, skin rash.

Uncommon: may affect up to 1 in 100 people

• Slow heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction after taking the medicine, hives (urticaria);
• Blood tests may show abnormal liver function, liver damage;
• Self-harming thoughts or suicidal thoughts or 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

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, high fever, and increased susceptibility to infections. Blood tests may show a severe decrease in the number of a specific class of white blood cells (agranulocytosis);
• A serious skin reaction that may include high fever and other flu-like symptoms, facial rash, widespread rash, and 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.

Other side effects in children
Common: may affect up to 1 in 10 children

• Runny nose (nasopharyngitis);
• Fever (pyrexia);
• Sore throat (pharyngitis);
• Decreased appetite.

Uncommon: may affect up to 1 in 100 children

• Feeling drowsy or lacking energy (lethargy).

Not known: frequency cannot be estimated from the available data

• Changes in behaviour, not acting like themselves.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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.

5. How to store STUTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the blister, following "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Store in the original packaging to protect the medicine from light.
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. Contents of the pack and other information

What STUTAN contains

• The active substance is lacosamide. Each STUTAN 50 mg tablet contains 50 mg of lacosamide. Each STUTAN 100 mg tablet contains 100 mg of lacosamide. Each STUTAN 150 mg tablet contains 150 mg of lacosamide. Each STUTAN 200 mg tablet contains 200 mg of lacosamide.
• The other components are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone and magnesium stearate. Coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 4000, talc. The 50 mg tablets also contain red iron oxide (E172), black iron oxide (E172) and yellow iron oxide (E172). The 100 mg tablets also contain yellow iron oxide (E172), quinoline yellow (E104), sunset yellow FCF (E110). The 150 mg tablets also contain yellow iron oxide (E172), sunset yellow FCF (E110). The 200 mg tablets also contain brilliant blue FCF (E133), ponceau 4R (E124).

Description of the appearance of STUTAN and contents of the pack
STUTAN 50 mg film-coated tablets are pink, oval-shaped, biconvex tablets with the number "50" engraved on one side and plain on the other. Dimensions: approximately 4.3 x 9.7 mm.
STUTAN 100 mg film-coated tablets are yellow, oval-shaped, biconvex tablets with the number "100" engraved on one side and plain on the other. Dimensions: approximately 5.4 x 12.1 mm.
STUTAN 150 mg film-coated tablets are orange, oval-shaped, biconvex tablets with the number "150" engraved on one side and plain on the other. Dimensions: approximately 6.6 x 14.0 mm.
STUTAN 200 mg film-coated tablets are blue, oval-shaped, biconvex tablets with the number "200" engraved on one side and plain on the other. Dimensions: approximately 7.8 x 15.6 mm.
STUTAN 50 mg, 100 mg, 150 mg and 200 mg are available in packs of 14 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milan
Italy

Manufacturer
TEVA Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen
Hungary
Merckle GmbH
Ludwig-Merckle-Strasse 3, Blaubeuren
Baden-Wuerttemberg, 89143
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Stutan