Lacosamide Doc Generici

Patient Information Leaflet

LACOSAMIDE DOC 50 mg film-coated tablets, 100 mg film-coated tablets,

150 mg film-coated tablets,
200 mg film-coated tablets
“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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What LACOSAMIDE DOC is and what it is used for

What LACOSAMIDE DOC is
LACOSAMIDE DOC contains the active substance 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 LACOSAMIDE DOC is used for
LACOSAMIDE DOC 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 the brain. However, they may then spread to broader areas on both sides of the 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 should know before taking LACOSAMIDE DOC

Do not take LACOSAMIDE DOC

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

Warnings and precautions

Talk to your doctor before taking LACOSAMIDE DOC if:

• you have had thoughts of harming or killing yourself. A small number of people treated with 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 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 have falls. LACOSAMIDE DOC may cause dizziness – this may increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine. If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking LACOSAMIDE DOC.

If you are taking LACOSAMIDE DOC, consult your doctor if you experience seizures of a different type or if your existing seizures worsen.

If you are taking LACOSAMIDE DOC 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 DOC is not recommended for children under 2 years of age with 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 or safe in children within these age groups.

Other medicines and LACOSAMIDE DOC

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 LACOSAMIDE DOC may also affect your heart:

• medicines used to treat heart diseases;
• medicines that may 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 any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking LACOSAMIDE DOC.

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 DOC 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 any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking LACOSAMIDE DOC.

LACOSAMIDE DOC and alcohol

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

Pregnancy and breastfeeding

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

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.

It is recommended not to take LACOSAMIDE DOC during pregnancy, as the effects of LACOSAMIDE DOC on pregnancy and the fetus are unknown.

It is recommended not to breastfeed while taking LACOSAMIDE DOC, 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 to take LACOSAMIDE DOC.

Do not stop treatment without first consulting your doctor, as this may cause an increase in seizures (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 LACOSAMIDE DOC may cause dizziness or blurred vision.

LACOSAMIDE DOC 100 mg and 150 mg contains Sunset Yellow FCF (E 110).
It may cause allergic reactions.

LACOSAMIDE DOC 200 mg contains Ponceau 4R (E 124).
It may cause allergic reactions.

3. How to take LACOSAMIDE DOC

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: please ask your doctor or pharmacist.
How to take LACOSAMIDE DOC

• Take LACOSAMIDE DOC twice daily, approximately 12 hours apart.
• Try to take it at about the same time each day.
• Swallow the LACOSAMIDE DOC tablet with a glass of water.
• 100 mg and 200 mg: The tablet may be divided into two equal doses.
• You may take LACOSAMIDE DOC with or without food.

Usually, you will start with a lower daily dose, which your doctor will gradually increase over several weeks. Once the appropriate dose for you has been reached, this is called the “maintenance dose”, and you should continue taking the same amount every day. LACOSAMIDE DOC is intended for long-term treatment.
You must continue taking LACOSAMIDE DOC until your doctor tells you to stop.
Dosage instructions
Below are the usual recommended doses of LACOSAMIDE DOC 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 DOC alone:
The initial dose of LACOSAMIDE DOC is usually 50 mg twice daily.
Your doctor may also prescribe an initial dose of 100 mg of LACOSAMIDE DOC 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 LACOSAMIDE DOC with other antiepileptic medicines:
The initial dose of LACOSAMIDE DOC is usually 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 LACOSAMIDE DOC using a single “loading dose” of 200 mg. 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 DOC is not recommended in children below 2 years of age.

• For the treatment of primary generalized tonic-clonic seizures: note that LACOSAMIDE DOC is not recommended in children below 4 years of age. The dose depends on body weight. Treatment is usually started with the oral syrup, and tablets are used only when the child is able to swallow them and can receive the correct dose with the available tablet strengths. Your doctor will prescribe the most appropriate formulation for the child.

If you take more LACOSAMIDE DOC than you should
Contact your doctor immediately if you have taken more LACOSAMIDE DOC than you should. 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 DOC

• If you forget to take a dose of LACOSAMIDE DOC and less than 6 hours have passed since your usual time, take LACOSAMIDE DOC 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 your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking LACOSAMIDE DOC

• Do not stop treatment with LACOSAMIDE DOC without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your treatment with LACOSAMIDE DOC, 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 everybody 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, speak to your doctor or pharmacist:

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 with balance, tremors, tingling (paraesthesia), 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 drunk;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced touch or sensitivity, difficulty speaking clearly, attention disturbance;
• Ringing in the ears such as buzzing, ringing or whistling sounds (tinnitus);
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, skin rash.

Uncommon: may affect up to 1 in 100 people

• Slower heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder);
• Excessive feeling of well-being, seeing and/or hearing things that are not there (hallucinations);
• Allergic reaction after taking the medicine, hives (urticaria);
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, 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 suffering more infections than usual. Blood tests may show a severe decrease in the number 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 a type of white blood cells (eosinophilia);
• Widespread skin 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, 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 get any side effects, 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 available at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LACOSAMIDE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack, 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 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 DOC contains
The active substance is lacosamide.
One tablet of LACOSAMIDE DOC 50 mg contains 50 mg of lacosamide.
One tablet of LACOSAMIDE DOC 100 mg contains 100 mg of lacosamide.
One tablet of LACOSAMIDE DOC 150 mg contains 150 mg of lacosamide.
One tablet of LACOSAMIDE DOC 200 mg contains 200 mg of lacosamide.

The other components are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), anhydrous colloidal silica, crospovidone and magnesium stearate.
Coating: polyvinyl alcohol, 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 LACOSAMIDE DOC and package contents
Film-coated tablets of LACOSAMIDE DOC 50 mg are pink, oval-shaped, biconvex, with the imprint "50" on one side and flat on the other. Approximate dimensions: 4.3 x 9.7 mm.
Film-coated tablets of LACOSAMIDE DOC 100 mg are yellow, oval-shaped, biconvex, with the imprint "100" on one side and flat on the other. Approximate dimensions: 5.4 x 12.1 mm.
Film-coated tablets of LACOSAMIDE DOC 150 mg are orange, oval-shaped, biconvex, with the imprint "150" on one side and flat on the other. Approximate dimensions: 6.6 x 14.0 mm.
Film-coated tablets of LACOSAMIDE DOC 200 mg are blue, oval-shaped, biconvex, with the imprint "200" on one side and flat on the other. Approximate dimensions: 7.8 x 15.6 mm.

LACOSAMIDE DOC 50 mg, 100 mg, 150 mg and 200 mg is available in packs of 14 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl - Via Turati 40 - 20121 Milano, Italy

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