LACOSAMIDE 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. LACOSAMIDE DOC 50 mg film-coated tablets, 100 mg film-coated tablets with
   1. What is LACOSAMIDE DOC and what it is used for
   2. What you need to know before taking LACOSAMIDE DOC
   3. How to take LACOSAMIDE DOC
2. LACOSAMIDE DOC is not recommended in children under 4 years of age.
   1. Possible side effects
   2. How to store LACOSAMIDE DOC
   3. Package Contents and Other Information

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

film LACOSAMIDE DOC 150 mg film-coated tablets with
film LACOSAMIDE DOC 200 mg film-coated tablets with
film
“Equivalent medicinal product”

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 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 DOC is and what it is used for
• 2. What you need to know before you take 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 is LACOSAMIDE DOC and what it is used for

What is LACOSAMIDE DOC
LACOSAMIDE DOC 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 is LACOSAMIDE DOC used for
LACOSAMIDE DOC 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 characterized by the occurrence of seizures with partial onset 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 generalized tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).

2. What you need to know before taking LACOSAMIDE DOC

Do not take LACOSAMIDE DOC

• 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, consult your doctor.
• if you have a particular type of heart rhythm problem called second or third degree AV block

Do not take LACOSAMIDE DOC if you fall into one of the above cases. If you are not sure, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor before taking LACOSAMIDE DOC if:

• you have thought about harming yourself or committing suicide. A small number of people treated with antiepileptic medicines like lacosamide have thought about harming themselves or committing suicide. If you should have any of these thoughts at any time, tell your doctor immediately.
• 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)
• you have a serious heart condition such as heart failure or have had a heart attack.
• you often feel dizzy or fall. LACOSAMIDE DOC can cause dizziness - this may increase the risk of accidental injuries or falls. This means you should be careful until you get used to the effects of this medicine. If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist before taking LACOSAMIDE DOC.

If you are taking LACOSAMIDE DOC, talk to your doctor if you have a seizure
of a different type or your existing seizures get worse.
If you are taking LACOSAMIDE DOC and experience symptoms of 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 DOC 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 if it works and is safe for children in this age group.

Other medicines and LACOSAMIDE DOC
Tell your doctor or pharmacist if you are taking, have recently taken or
may 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 DOC can also
affect your heart:

• medicines to treat heart disease;
• medicines that can prolong the “PR interval” in a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
• medicines used to treat certain forms of irregular heartbeat or heart failure. If you fall into one of the above cases (or are not sure) ask your doctor or pharmacist before taking LACOSAMIDE DOC.

Also tell your doctor or pharmacist if you are taking any of the following drugs -
because they can increase or decrease the effect of LACOSAMIDE DOC on your
body:

• medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
• medicines for HIV such as ritonavir;
• medicines used to treat bacterial infections such as clarithromycin or rifampicin;
• an herbal medicine used to treat mild anxiety and depression called St. John's wort.

If you fall into one of the above cases (or are not sure), ask your doctor or pharmacist
before taking LACOSAMIDE DOC.

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

Pregnancy and breastfeeding
Women of childbearing potential should discuss contraceptive measures with their doctor.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice 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 DOC 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 DOC or not.
Do not stop treatment without consulting your doctor first, as this may
cause an increase in seizures (fits). 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 machinery until you have checked
how this medicine affects you. This is because LACOSAMIDE DOC can
cause dizziness or blurred vision.

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

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

3. How to take LACOSAMIDE DOC

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 DOC

• Take LACOSAMIDE DOC twice every day, 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 can be divided into two equal doses.
• You can take LACOSAMIDE DOC with or without food.

Usually you will start by taking a reduced dose each day and your doctor will increase it
slowly 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 DOC is used as a long-term treatment.
You must continue to take LACOSAMIDE DOC until your doctor tells you to
stop.

How much to take
Below are listed the usual recommended doses of LACOSAMIDE DOC 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 DOC alone:
The starting dose of LACOSAMIDE DOC is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of LACOSAMIDE DOC twice
a day.
Your doctor may increase your daily dose by 50 mg twice a day each
week, until you reach a maintenance dose, between 100 mg and
300 mg twice a day.
When you take LACOSAMIDE DOC with other antiepileptic medicines
The starting dose of LACOSAMIDE DOC is usually 50 mg twice a day.
Your doctor may increase the daily dose by 50 mg twice a day each week. This
until you reach a maintenance dose, 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 DOC
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 DOC is not

recommended in children under 2 years of age.

• In the treatment of primary generalized tonic-clonic seizures:it should be noted that

LACOSAMIDE DOC is not recommended in children under 4 years of age.

The dose depends on body weight. Usually, treatment is started with the syrup and switched to
tablets only if they are able to take them and receive the correct dose with the different
tablet dosages. The doctor will prescribe the most suitable formulation for them.

If you take more LACOSAMIDE DOC than you should
Contact your doctor immediatelyif you have taken more LACOSAMIDE DOC than
you should. Do not attempt to drive.
You may experience:

• dizziness;
• nausea or vomiting;
• seizures, heart problems such as slow, fast or irregular heartbeat, coma or a drop in blood pressure with a rapid heartbeat and sweating.

If you forget to take LACOSAMIDE DOC

• If you have forgotten to take a dose of LACOSAMIDE DOC and less than 6 hours have passed since the usual time of taking it, take LACOSAMIDE DOC as soon as you remember.
• If you have forgotten to take a dose and more than 6 hours have passed since the usual time of taking it, do not take the forgotten tablet. Instead, take the next tablet of LACOSAMIDE DOC at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking LACOSAMIDE DOC

• Do not stop treatment with LACOSAMIDE DOC without consulting your doctor as epilepsy may recur or worsen.
• If your doctor decides to stop therapy with LACOSAMIDE DOC, they will provide you with instructions on how to gradually reduce the 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 of 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 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;
• Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or sensitivity, difficulty articulating words, attention deficit; Noises in the ear such as ringing, trilling or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, skin rash.

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 sense of well-being, seeing and/or hearing things that are not present;
• Allergic reaction after 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 tachycardia);
• Sore throat, high fever and suffering from a greater number of 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, 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 skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling 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 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 which is stated on the carton or on the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Package Contents and Other Information

information
What LACOSAMIDE DOC contains
The active ingredient is lacosamide.
One LACOSAMIDE DOC 50 mg tablet contains 50 mg of lacosamide.
One LACOSAMIDE DOC 100 mg tablet contains 100 mg of lacosamide.
One LACOSAMIDE DOC 150 mg tablet contains 150 mg of lacosamide.
One LACOSAMIDE DOC 200 mg tablet contains 200 mg of lacosamide.
The other ingredients are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (with
low substitution), 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 contents of the pack
LACOSAMIDE DOC 50 mg film-coated tablets are pink, oval-shaped,
biconvex with the inscription "50" on one side and plain on the other. Approximate
dimensions of 4.3 x 9.7 mm.
LACOSAMIDE DOC 100 mg film-coated tablets are yellow in color, oval in
shape, biconvex with the inscription "100" on one side and plain on the other. Approximate
dimensions of 5.4 x 12.1 mm.
LACOSAMIDE DOC 150 mg film-coated tablets are orange in color, of
oval shape, biconvex with the inscription "150" on one side and plain on the other.
Approximate dimensions of 6.6 x 14.0 mm.
LACOSAMIDE DOC 200 mg film-coated tablets are blue in color, of
oval shape, biconvex with the inscription "200" on one side and plain on the other. Dimensions
approximately 7.8 x 15.6 mm.
LACOSAMIDE DOC 50 mg, 100 mg, 150 mg and 200 mg is available in packs of 14, 56
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl - Via Turati 40 - 20121 Milan, Italy

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