Lacosamide Mylan

Package leaflet: Information for the patient

Lacosamide Mylan 50 mg film-coated tablets

Lacosamide Mylan 100 mg film-coated tablets
Lacosamide Mylan 150 mg film-coated tablets

Lacosamide Mylan 200 mg film-coated tablets
lacosamide
Generic medicine
Please read all of this leaflet carefully before you take 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, because it may be harmful.
‐ If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

What is Lacosamide Mylan
Lacosamide Mylan 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 to you to reduce the number of seizures (convulsive fits) you experience.

What Lacosamide Mylan is used for

• Lacosamide Mylan 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 convulsive 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 Mylan

Do not take Lacosamide Mylan

• 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 Mylan 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 Lacosamide Mylan if:

• you have had thoughts of harming yourself or of suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of suicide. 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 experience dizziness or falls. Lacosamide Mylan 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 conditions apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Mylan. If you are already taking Lacosamide Mylan, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Mylan and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children
Lacosamide Mylan 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 for children in these age groups.
Other medicines and Lacosamide Mylan
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 Mylan may also affect your heart:

• medicines used to treat heart problems;
• 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 any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Mylan.

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 Mylan in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
• an HIV medicine 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 if you are unsure), consult your doctor or pharmacist before taking Lacosamide Mylan.

Lacosamide Mylan and alcohol
As a precautionary safety measure, do not take Lacosamide Mylan 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,
please consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Lacosamide Mylan during pregnancy, as the effects of Lacosamide Mylan on pregnancy and the unborn baby are unknown. It is recommended not to breastfeed while taking Lacosamide Mylan, 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 Mylan.
Do not stop treatment without first consulting your doctor, as this could 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 Mylan may cause dizziness or blurred vision.

3. How to take Lacosamide Mylan

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.
How to take Lacosamide Mylan

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

You will usually start on a lower daily dose, which your doctor will gradually increase over
a number of weeks. When you reach the dose appropriate for you, this is called your “maintenance dose”, so you will then take the same amount every day. Lacosamide Mylan is
used as a long-term treatment. You must continue taking Lacosamide Mylan until your
doctor tells you to stop.
Dosage
Below are the usual recommended doses of lacosamide 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 Mylan alone:
The initial dose of lacosamide is usually 50 mg twice daily.
Your doctor may also prescribe an initial dose of 100 mg of lacosamide 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 Mylan with other antiepileptic medicines:
The initial dose of lacosamide 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 Mylan using a single “loading dose” of 200 mg. You should then start your maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that Lacosamide is not recommended in children below 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide is not recommended in children below 4 years of age.

The dose depends on their body weight. Treatment usually starts with the syrup, and they may switch to tablets only if they are able to swallow them and receive the correct dose with the available tablet strengths. Your doctor will prescribe the most appropriate formulation for them.
If you take more Lacosamide Mylan than you should
Contact your doctor immediately if you have taken more Lacosamide Mylan than prescribed.
Do not attempt to drive. You may experience:

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

• If you forget to take a dose and less than 6 hours have passed 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 your next dose of Lacosamide Mylan at your usual time.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lacosamide Mylan

• Do not stop treatment with Lacosamide Mylan without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to discontinue your treatment with Lacosamide Mylan, 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 everyone experiences 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 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 (paraesthesia), muscle spasms, increased tendency to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Dizziness, sensation of drunkenness;
• Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced touch or sensitivity, difficulty articulating words, attention disturbances;
• Ringing noises in the ears such as buzzing, ringing, 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 (conduction disorder);
• Excessive 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 or suicidal thoughts, suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• 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

• Accelerated 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 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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 Mylan contains

• The active substance is lacosamide. One film-coated tablet of Lacosamide Mylan 50 mg contains 50 mg of lacosamide. One film-coated tablet of Lacosamide Mylan 100 mg contains 100 mg of lacosamide. One film-coated tablet of Lacosamide Mylan 150 mg contains 150 mg of lacosamide. One film-coated tablet of Lacosamide Mylan 200 mg contains 200 mg of lacosamide.
• The other components are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low-substituted), anhydrous colloidal silica, crospovidone (type A), magnesium stearate. Coating: polyvinyl alcohol, macrogol (3350), talc, talc, titanium dioxide (E171), aluminium lake containing indigo carmine (E132) (50 mg/200 mg film-coated tablets), red iron oxide (E172) (50 mg/150 mg film-coated tablets), black iron oxide (E172) (50 mg/150 mg film-coated tablets), yellow iron oxide (E172) (100 mg/150 mg film-coated tablets).

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

• Lacosamide Mylan 50 mg film-coated tablets are pink, oval-shaped, marked with "I73" on one side and smooth on the other side. The average size of the tablets is 10.4 x 4.9 mm.
• Lacosamide Mylan 100 mg film-coated tablets are dark yellow, oval-shaped, marked with "I74" on one side and smooth on the other side. The average size of the tablets is 13.0 x 6.0 mm.
• Lacosamide Mylan 150 mg film-coated tablets are peach-coloured, oval-shaped, marked with "I75" on one side and smooth on the other side. The average size of the tablets is 15.0 x 7.0 mm.
• Lacosamide Mylan 200 mg film-coated tablets are blue, oval-shaped, marked with "I76" on one side and smooth on the other side. The average size of the tablets is 16.5 x 7.7 mm.

PVC/PVDC blisters or unit dose divisible blisters sealed with an aluminium foil sheet.
Lacosamide Mylan is available in packs of 14, 14x1, 28, 56, 56x1, 168 film-coated tablets and in multiple packs containing 3 boxes, each with 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan SpA
via Vittor Pisani 20,
Milan, 20124
Italy

Manufacturer
HBM Pharma s.r.o., Sklabinska 30
03680 Martin
Slovak Republic
McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road 13, Dublin
Ireland
Medis International a.s.,
vyrobni zavod Bolatice,
Prumyslova 961/16,
Bolatice, 747 23,
Czech Republic
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe, Hessen, 61352,
Germany