Lacosamide Aurobindo

Package leaflet: Information for the user

Lacosamide Aurobindo 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 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 others, even if their symptoms are the same as yours, as 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 Aurobindo is and what it is used for
2. What you need to know before taking Lacosamide Aurobindo
3. How to take Lacosamide Aurobindo
4. Possible side effects
5. How to store Lacosamide Aurobindo
6. Contents of the pack and other information

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

What Lacosamide Aurobindo is
Lacosamide Aurobindo 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 (epileptic fits) you experience.

What Lacosamide Aurobindo is used for

• Lacosamide Aurobindo is used:
• As monotherapy or 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 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 Lacosamide Aurobindo

Do not take Lacosamide Aurobindo

• 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 are allergic to peanuts or soy.
• if you have a particular type of heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide Aurobindo 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 or pharmacist before taking Lacosamide Aurobindo:

• If you have had thoughts of harming or killing yourself. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts about self-harm or suicide. If you experience any such thoughts at any time, inform your doctor immediately.
• If 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).
• If you have severe heart disease, such as heart failure, or have had a heart attack.
• If you frequently feel dizzy or fall. Lacosamide Aurobindo 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 if you are unsure), speak to your doctor or pharmacist
before taking Lacosamide Aurobindo.
If you are taking Lacosamide Aurobindo, contact your doctor if you experience seizures of a different
type or if your existing seizures worsen.
If you are taking Lacosamide Aurobindo and develop symptoms of an abnormal heartbeat (such
as slow, rapid, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting),
contact your doctor immediately (see section 4).
Children
Lacosamide Aurobindo 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 of these age groups.
Other medicines and Lacosamide Aurobindo
Tell 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 Aurobindo 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 if you are unsure), speak to your doctor or pharmacist before
taking Lacosamide Aurobindo.
Also inform your doctor or pharmacist if you are taking any of the following medicines. This
is because they may increase or decrease the effect of Lacosamide Aurobindo 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), speak to your doctor or pharmacist
before taking Lacosamide Aurobindo.
Lacosamide Aurobindo with alcohol
As a precautionary safety measure, do not take Lacosamide Aurobindo with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss contraceptive methods with their doctor.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
It is recommended not to take Lacosamide Aurobindo during pregnancy, as the effects of
Lacosamide Aurobindo on pregnancy and the unborn baby are unknown. It is recommended not to
breastfeed while taking Lacosamide Aurobindo, as lacosamide 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 you should take Lacosamide Aurobindo.
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 Aurobindo may cause dizziness or blurred vision.
Lacosamide Aurobindo contains soybean lecithin. If you are allergic to peanuts or soy, do not use
this medicine.

3. How to take Lacosamide Aurobindo

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.
Taking Lacosamide Aurobindo

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

You will usually start on a lower daily dose, which your doctor will gradually increase over a number of weeks. Once the appropriate dose for you has been reached, this is called the “maintenance dose”, so you should continue taking the same amount every day. Lacosamide Aurobindo is used as a long-term treatment. You must continue taking Lacosamide Aurobindo until your doctor tells you to stop.
Dosage
Below are the usual recommended doses of Lacosamide Aurobindo for different age and weight groups. 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 Aurobindo alone
The initial dose of Lacosamide Aurobindo is usually 50 mg twice daily.
Your doctor may also prescribe an initial dose of 100 mg of Lacosamide Aurobindo 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 Aurobindo with other antiepileptic medicines
The initial dose of Lacosamide Aurobindo 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 Aurobindo 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

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

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

• dizziness;

• feeling unwell (nausea) or being unwell (vomiting);

• 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 Aurobindo

• If you forget to take a dose of Lacosamide Aurobindo and it is less than 6 hours since your usual time, take Lacosamide Aurobindo 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 tablet at the usual time.

• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Lacosamide Aurobindo

• Do not stop treatment with Lacosamide Aurobindo without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your treatment with Lacosamide Aurobindo, 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.
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, tremors, tingling (paraesthesia), 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;
• Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
• Reduced touch sensation or sensitivity, difficulty articulating words, attention disturbance;
• Ringing noises in the ear such as buzzing, ringing, or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness 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 the heart (cardiac conduction disorder);
• Exaggerated sense of well-being, seeing and/or hearing things that are not there;
• Allergic reaction following medicine intake, hives (urticaria);
• Blood tests may show abnormal liver function, liver damage;
• Self-harming thoughts or suicidal thoughts, suicide attempt: inform your doctor immediately;
• Feelings 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 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 that 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 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 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 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 Aurobindo

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.
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 Lacosamide Aurobindo contains

• The active substance is lacosamide. One film-coated tablet contains 50 mg of lacosamide. One film-coated tablet contains 100 mg of lacosamide. One film-coated tablet contains 150 mg of lacosamide. One film-coated tablet contains 200 mg of lacosamide.

• The other components are:
  Tablet core: microcrystalline cellulose (grade-101), hydroxypropylcellulose (low-substituted), crospovidone (type A), hydroxypropylcellulose, microcrystalline cellulose (grade-102), anhydrous colloidal silica, magnesium stearate.

Coating:
50 mg: titanium dioxide (E 171), hypromellose (6 mPa·s) (E464), talc (E553b), polyvinyl alcohol (E1203), hypromellose (15 mPa·s) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), red iron oxide (E172), indigotine (E132), black iron oxide (E172).
100 mg: titanium dioxide (E 171), hypromellose (6 mPa·s) (E464), talc (E553b), polyvinyl alcohol (E1203), hypromellose (15 mPa·s) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), yellow iron oxide (E172).
150 mg: titanium dioxide (E 171), hypromellose (6 mPa·s) (E464), talc (E553b), polyvinyl alcohol (E1203), hypromellose (15 mPa·s) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).
200 mg: titanium dioxide (E 171), hypromellose (6 mPa·s) (E464), talc (E553b), polyvinyl alcohol (E1203), hypromellose (15 mPa·s) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), indigotine [(3% - 5%) (E132)], indigotine [(11% - 14%) (E132)].

Description of the appearance of Lacosamide Aurobindo and contents of the pack
Film-coated tablet.
Lacosamide Aurobindo 50 mg film-coated tablets
Film-coated tablets, light pink to pink in colour, oval-shaped (dimensions 10.4 x 4.9 mm), engraved with '50' on one side and 'LA' on the other.
Lacosamide Aurobindo 100 mg film-coated tablets
Film-coated tablets, light yellow to yellow in colour, oval-shaped (dimensions 13.1 x 6.1 mm), engraved with '100' on one side and 'L' and 'A' on both sides of the breakline on the other. The tablet can be divided into equal doses.
Lacosamide Aurobindo 150 mg film-coated tablets
Film-coated tablets, light orange to pinkish-orange in colour, oval-shaped (dimensions 15.1 x 7.0 mm), engraved with '150' on one side and 'L' and 'A' on both sides of the breakline on the other. The tablet can be divided into equal doses.
Lacosamide Aurobindo 200 mg film-coated tablets
Film-coated tablets, blue to dark blue in colour, oval-shaped (dimensions 16.5 x 7.7 mm), engraved with '200' on one side and 'L' and 'A' on both sides of the breakline on the other. The tablet can be divided into equal doses.

Lacosamide Aurobindo film-coated tablets are available in blister packs.
Pack sizes:
50 mg and 100 mg: 14, 28, 56, 168 film-coated tablets
150 mg and 200 mg: 14, 28, 56, 168 film-coated tablets and multipack containing 168 film-coated tablets (3 packs x 56 film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047, Saronno (VA)

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica SA
Rua João de Deus, 19, 2700-487 Amadora, Portugal

This medicinal product is authorised in the European Economic Area Member States under the following names:
France: Lacosamide Arrow 50 mg comprimé pelliculé
Lacosamide Arrow 100 mg, comprimé pelliculé sécable
Lacosamide Arrow 150 mg, comprimé pelliculé sécable
Lacosamide Arrow 200 mg, comprimé pelliculé sécable
Germany: Lacosamid PUREN 50 mg/100 mg/150 mg/200 mg Filmtabletten
Italy: Lacosamide Aurobindo
Portugal: Lacosamida Generis
Spain: Lacosamida Aurovitas 50 mg/100 mg/150 mg/200 mg comprimidos recubiertos con película EFG