LACOSAMIDE 50 mg Film-Coated Tablets

Зміст інструкції

1. Lacosamide Aurobindo 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Lacosamide Aurobindo 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. Package contents and other information

Lacosamide Aurobindo 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Lacosamide Aurobindo and what it is used for

What is Lacosamide Aurobindo
Lacosamide Aurobindo contains lacosamide. It belongs to a group of medicines called
“antiepileptic medicines”. These medicines are used to treat epilepsy.

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

What Lacosamide Aurobindo is used for

• Lacosamide Aurobindo is used:
• Alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age, to treat a specific form of epilepsy characterised by the occurrence of “partial-onset seizures with or without secondary generalization”. In this type of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas of both sides of your 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 fits, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought 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 any of the other ingredients of this medicine (listed in section 6). If you are not sure if you are allergic, ask your doctor.
• if you are allergic to peanuts or soya.
• 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 not sure, talk 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 thought about harming yourself or committing suicide. A small number of people treated with anti-epileptic medicines like lacosamide have thought about harming themselves or committing suicide. If you have these thoughts at any time, tell your doctor immediately.
• If you have a heart problem that affects your heartbeat and often have a particularly slow, fast or irregular heartbeat (e.g. AV block, atrial fibrillation and flutter)
• If you have a serious heart condition, such as heart failure or have had a heart attack.
• If you often feel dizzy or fall. Lacosamide Aurobindo can cause dizziness - this can increase the risk of accidental injury or falls. This means you should be careful until you know how this medicine affects you.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Aurobindo.
If you are taking Lacosamide Aurobindo, talk to your doctor if you have a seizure that is different from your usual seizures or if your existing seizures get worse.
If you are taking Lacosamide Aurobindo and experience symptoms of an abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy and fainting), consult your doctor immediately (see section 4).

Children
Lacosamide Aurobindo is not recommended for children under 2 years of age with epilepsy characterised by partial-onset seizures and is not recommended for children under 4 years of age with primary generalised tonic-clonic seizures. This is because it is not yet known if it works and is safe for children in this age group.

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, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart. This is because Lacosamide Aurobindo can also affect your heart:

• medicines to treat heart conditions;
• medicines that can prolong the “PR interval” on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat some types of irregular heartbeat or heart failure.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Aurobindo.
Also tell your doctor or pharmacist if you are taking any of the following medicines. This is because they can increase or decrease the effect of Lacosamide Aurobindo on your body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• a medicine for HIV 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 not sure), talk to your doctor or pharmacist before taking Lacosamide Aurobindo.

Lacosamide Aurobindo with alcohol
As a safety precaution, do not take Lacosamide Aurobindo 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 to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended not to take Lacosamide Aurobindo if you are pregnant, as the effects of Lacosamide Aurobindo on pregnancy and the fetus are not known. It is recommended not to breastfeed while taking Lacosamide Aurobindo, as Lacosamide Aurobindo passes into breast milk. Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you decide whether to take Lacosamide Aurobindo or not.
Do not stop your treatment without consulting your doctor first, as this may cause your seizures to increase. A worsening of your condition can also be harmful to your baby.

Driving and using machines
Do not drive vehicles, ride a bicycle, use tools or operate machinery until you have checked how this medicine affects you. This is because Lacosamide Aurobindo can cause dizziness or blurred vision.
Lacosamide Aurobindo contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Lacosamide Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Taking Lacosamide Aurobindo

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

Usually you will start by taking a reduced dose each day and your doctor will slowly increase it over a number of weeks. When you reach the dose that is right for you, this is called a “maintenance dose”, so take the same amount each day. Lacosamide Aurobindo is used as a long-term treatment. You must continue to take Lacosamide Aurobindo until your doctor tells you to stop.

How much to take
Below are listed the normal recommended doses of Lacosamide Aurobindo for the different age groups and 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 you take Lacosamide Aurobindo alone
The starting dose of Lacosamide Aurobindo is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Aurobindo twice a day.
Your doctor may increase your daily dose by 50 mg twice a day each week, up to a maintenance dose of between 100 mg and 300 mg twice a day.
When you take Lacosamide Aurobindo with other antiepileptic medicines
The starting dose of Lacosamide Aurobindo is usually 50 mg twice a day.
Your doctor may increase the daily dose by 50 mg twice a day each week. This is up to a maintenance dose of between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Aurobindo with a single “loading” dose of 200 mg. 12 hours later you would then start your maintenance dose.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: it should be noted that Lacosamide Aurobindo is not recommended in children under 2 years of age.
• In the treatment of primary generalised tonic-clonic seizures: it should be noted that Lacosamide Aurobindo is not recommended in children under 4 years of age.

The dose depends on their body weight. Usually they start treatment with the syrup and only switch to tablets if they are able to take them and receive the correct dose with the different tablet strengths. Your doctor will prescribe the most suitable formulation for them.

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 drive. You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• fits (seizures), heart problems such as slow, fast

or irregular heartbeat, coma or a drop in blood pressure with a fast heartbeat and sweating.

If you forget to take Lacosamide Aurobindo

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

If you stop taking Lacosamide Aurobindo

• Do not stop taking Lacosamide Aurobindo without consulting your doctor, as your epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with Lacosamide Aurobindo, they will give you instructions on how to gradually reduce your dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects affecting the nervous system, such as dizziness, may be more
frequent after a single “loading” dose.

Consult your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people

• Headache;
• Feeling dizzy or unwell (nausea);
• Double vision (diplopia).

Common:may affect up to 1 in 10 people

• Brief spasms in a muscle or muscle group (myoclonic jerks);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, tendency to fall and bruise easily;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling of “spinning” (vertigo), drunkenness;
• Feeling unwell (vomiting), dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;
• Reduced touch or sensitivity, difficulty articulating words, attention disorder;
• Noises in the ear such as ringing, trilling or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in your heart's electrical activity (cardiac conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
• Allergic reaction following taking the medicine, hives;
• Blood tests may show abnormal liver function, liver damage;
• Thoughts of self-harm or suicide, attempt to commit suicide: 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 based on available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high fever and suffering from 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 symptoms similar to the flu, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
• A widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing peeling of the skin in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion.

Other side effects in children
Additional side effects in children have been fever (pyrexia), runny nose
(nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes
in behavior, behavior different from normal (abnormal behavior) 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient 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.
• Other ingredients are: Tablet core:microcrystalline cellulose (grade-101), hypropopylcellulose (low substitution), crospovidone (Type A), hypropopylcellulose, microcrystalline cellulose (grade-102), anhydrous colloidal silica, magnesium stearate.

Coating:

50 mg:titanium dioxide (E 171), hypromellose (6mPas) (E464), talc (E553b), polyvinyl alcohol
(E1203), hypromellose (15mPas) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), iron oxide red (E172), indigotine (E132), iron oxide black (E172).

100 mg:titanium dioxide (E 171), hypromellose (6mPas) (E464), talc (E553b), polyvinyl alcohol
(E1203), hypromellose (15mPas) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), iron oxide yellow (E172).

150 mg:titanium dioxide (E 171), hypromellose (6mPas) (E464), talc (E553b), polyvinyl alcohol
(E1203), hypromellose (15mPas) (E464), macrogol 3350 (E1521), lecithin (soy) (E322), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)

200 mg:titanium dioxide (E 171), hypromellose (6mPas) (E464), talc (E553b), polyvinyl alcohol
(E1203), hypromellose (15mPas) (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 of light pink to pink color, oval shaped (dimensions 10.4 x 4.9
mm) and with ‘50’ engraved on one side and ‘LA’ on the other.

Lacosamide Aurobindo 100 mg film-coated tablets
Film-coated tablets of light yellow to yellow color, oval shaped (dimensions 13.1 x
6.1 mm) and with ‘100’ engraved on one side and ‘L’ and ‘A’ on both sides of the score line
on the other side. The tablet can be divided into equal doses.

Lacosamide Aurobindo 150 mg film-coated tablets
Film-coated tablets of light orange to pinkish orange color, oval shaped
(dimensions 15.1 x 7.0 mm) and with ‘150’ engraved on one side and ‘L’ and ‘A’ on both sides of the score line
on the other side. The tablet can be divided into equal doses.

Lacosamide Aurobindo 200 mg film-coated tablets
Film-coated tablets of light blue to blue color, oval shaped (dimensions 16.5 x 7.7
mm) and with ‘200’ engraved on one side and ‘L’ and ‘A’ on both sides of the score line on the other
side. The tablet can be divided into equal doses.
Lacosamide Aurobindo film-coated tablets is available in blister packs.
Packs:
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 Authorisation 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 Member States of the European Economic Area with the
following denominations:
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