OLLAT 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. Ollat 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Ollat and what is it used for
   2. What you need to know before taking Ollat Do not take Ollat
   3. How to take Ollat
   4. Possible side effects
   5. How to store Ollat
   6. Contents of the pack and other information

Ollat 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

Lacosamide
Generic medicine

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 they have the same symptoms as you, as it may 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 Ollat is and what it is used for
• 2. What you need to know before you take Ollat
• 3. How to take Ollat
• 4. Possible side effects
• 5. How to store Ollat
• 6. Contents of the pack and other information

1. What is Ollat and what is it used for

What is Ollat
Ollat 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 Ollat used for
Ollat is used:

• alone and in combination with other antiepileptic medicines in adults, adolescents and children from 2 years of age for the treatment of 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 for the treatment of 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 Ollat Do not take Ollat

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

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Warnings and precautions
Talk to your doctor before taking Ollat if:

• you have thought about harming or killing yourself. A small number of people treated with antiepileptic medicines like lacosamide have thought about harming or killing themselves. 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 atrial flutter).
• you have a serious heart condition such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Ollat can cause dizziness - this can increase the risk of accidental injury 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 Ollat. If you are taking Ollat, 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 Ollat 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
Ollat 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 Ollat
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 Ollat can also affect your heart:

• medicines to treat heart disease;
• 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 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 Ollat. Also tell your doctor or pharmacist if you are taking any of the following drugs - this is because they can increase or decrease the effect of Ollat 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 Ollat.

Ollat with alcohol
As a safety precaution, do not take Ollat 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 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 Ollat during pregnancy, as the effects of Ollat on pregnancy and the fetus are unknown.
It is recommended not to breastfeed while taking Ollat, as Ollat passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you decide whether or not to take Ollat.
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 Ollat can cause dizziness or blurred vision.

3. How to take Ollat

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

TakingOllat

• Take Ollat twice every day, approximately 12 hours apart.
• Try to take it at about the same time each day.
• Swallow the Ollat tablet with a glass of water.
• You can take Ollat 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. Ollat is used as a long-
term treatment. You must continue to take Ollat until your doctor tells you to stop.

How much to take
Below are listed the normal recommended doses of Ollat for the different age and weight groups. Your
doctor may prescribe a different dose if you have problems with your kidneys or liver.

Adolescents and children weighing 50 kg or more and adults
When you take Ollat alone

• The starting dose of Ollat is usually 50 mg twice a day.
• Your doctor may also prescribe a starting dose of 100 mg of Ollat 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 Ollat with other antiepileptic medicines

• The starting dose of Ollat is usually 50 mg twice a day.
• Your doctor may increase the daily dose by 50 mg twice a day each week. This is 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 Ollat 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 Ollat is not recommended in children under 2 years of age.
• In the treatment of primary generalised tonic-clonic seizures: it should be noted that Ollat is not recommended in children under 4 years of age.
• The dose depends on their body weight. They usually start treatment with the syrup and switch to tablets only if they are able to take them and receive the correct dose with the different strengths of

tablets. The doctor will prescribe the most suitable formulation for them.

If you take more Ollat than you should
Contact your doctor immediately if you have taken more Ollat than you should. Do not drive.
You may experience:

• dizziness;
• nausea or 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 Ollat
• If you forget to take a dose of Ollat, and less than 6 hours have passed since the usual time of taking it, take Ollat as soon as you remember.
• If you forget 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 your next Ollat tablet at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Ollat

• Do not stop taking Ollat without consulting your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your treatment with Ollat, they will provide you with instructions on how to gradually reduce the dose. If you have any questions about 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 everybody gets them.
Side effects involving the nervous system, such as dizziness, may be more frequent after
a single “loading” dose. See 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, easy bruising and getting cuts;
• Memory problems, difficulty thinking or finding the right 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, irritation.

Uncommon:may affect up to 1 in 100 people

• Decreased heart rate, palpitations, irregular heartbeat or other changes in the electrical activity of your heart (cardiac conduction disorder);

Not known:frequency cannot be estimated from available data

• Fast heartbeat (ventricular tachycardia);
• 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 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the system
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.
Reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Ollat

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. and 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.
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. Contents of the pack and other information

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

Tablet core:microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low
substitution), silicified microcrystalline cellulose, crospovidone (Type B), magnesium stearate

Coating:polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colorants*

*The colorants are:
50 mg tablets: iron oxide red (E172), iron oxide black (E172), indigotine aluminium lake (E132)
100 mg tablets: iron oxide yellow (E172)
150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black
(E172)
200 mg tablets: indigotine aluminium lake (E132)
Description of the appearance of Ollat and contents of the pack
Ollat 50 mg are pink film-coated oval tablets.
Ollat 100 mg are dark yellow film-coated oval tablets.
Ollat 150 mg are salmon-colored film-coated oval tablets.
Ollat 200 mg are blue film-coated oval tablets.
Ollat is available in packs of 14, 56 and 84 film-coated tablets in transparent, colorless PVC/PVDC
blisters sealed with aluminum foil.
Marketing authorization holder and manufacturer

Marketing authorization holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Sales concessionaire
Istituto Luso Farmaco d’Italia S.p.A.
Milanofiori, Strada 6, Edificio L
20089 Rozzano (MI)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IT: Ollat