LACOSAMIDE 10 mg /Ml Инфузионный Раствор

Содержание инструкции

1. Lacosamide Dr. Reddy’s 10 mg/ml solution for infusion
   1. What is Lacosamide Dr. Reddy’s and what it is used for
   2. What you need to know before you use Lacosamide Dr. Reddy’s
   3. How to use Lacosamide Dr. Reddy’s
   4. Possible side effects
   5. How to store Lacosamide Dr. Reddy’s
   6. Package Contents and Other Information

Lacosamide Dr. Reddy’s 10 mg/ml solution for infusion

Generic medicine

Read this leaflet carefully before you start to use 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.
• 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 Dr. Reddy’s is and what it is used for
• 2. What you need to know before you use Lacosamide Dr. Reddy’s
• 3. How to use Lacosamide Dr. Reddy’s
• 4. Possible side effects
• 5. How to store Lacosamide Dr. Reddy’s
• 6. Contents of the pack and other information

1. What is Lacosamide Dr. Reddy’s and what it is used for

What is Lacosamide Dr. Reddy’s
Lacosamide Dr. Reddy’s 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 (convulsive seizures) you experience.

What Lacosamide Dr. Reddy’s is used for

• Lacosamide Dr. Reddy’s 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 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 generalized tonic-clonic seizures (major seizures, 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 you use Lacosamide Dr. Reddy’s

Do not use Lacosamide Dr. Reddy’s

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

Do not use Lacosamide Dr. Reddy’s if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.

Warnings and precautions
Talk to your doctor before using Lacosamide Dr. Reddy’s 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 should have 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 Dr. Reddy’s can cause dizziness - this may increase the risk of accidental injury or falling. This means you should be careful until you get used to the effects of this medicine. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Lacosamide Dr. Reddy’s. If you are taking Lacosamide Dr. Reddy’s, 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 Dr. Reddy’s and develop symptoms of an abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded and fainting), see your doctor immediately (see section 4).

Children
Lacosamide Dr. Reddy’s 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 if it is safe for children in this age group.

Other medicines and Lacosamide Dr. Reddy’s
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
have an effect on the heart: this is because Lacosamide Dr. Reddy’s can also affect the 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 forms 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 using Lacosamide Dr. Reddy’s.

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 Dr. Reddy’s 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 using Lacosamide Dr. Reddy’s.

Lacosamide Dr. Reddy’s and alcohol
As a safety precaution, do not take Lacosamide Dr. Reddy’s 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 using this medicine.
It is recommended not to use Lacosamide Dr. Reddy’s during pregnancy, as the effects of
Lacosamide Dr. Reddy’s on pregnancy and the foetus are not known.
It is recommended not to breastfeed while taking Lacosamide Dr. Reddy’s, as Lacosamide Dr. Reddy’s passes into breast milk.
See your doctor immediately if you are pregnant or planning a pregnancy. They will help you
decide whether to use Lacosamide Dr. Reddy’s or not.
Do not stop your treatment without consulting your doctor first, as this may cause an
increase in seizures (convulsions). 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 Dr. Reddy’s can cause dizziness
or blurred vision.

Lacosamide Dr. Reddy’s contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt) per
vial. This amount is equivalent to 3% of the recommended maximum daily intake of sodium
for an adult.

3. How to use Lacosamide Dr. Reddy’s

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Using Lacosamide Dr. Reddy’s

• Lacosamide Dr. Reddy’s can be started:
• by taking the medicine by mouth or
• with administration as an intravenous infusion (sometimes called an “IV infusion”) in which the medicine is given to you in a vein by a doctor or nurse. It is given over a period of time between 15 and 60 minutes.
• The IV infusion is usually used for a short period when you cannot take the medicine by mouth.
• The doctor will decide for how many days you will receive infusions. There is data on two daily infusions of Lacosamide Dr. Reddy’s for up to 5 days. For treatments for longer periods, lacosamide tablets and syrup are available.

When you switch from the infusion to taking the medicine by mouth (or vice versa), the total amount
you take each day and the frequency of the doses remain the same.

• Use Lacosamide Dr. Reddy’s twice every day, approximately 12 hours apart.
• Try to use it at about the same time each day.

How much to use
Below are listed the normal recommended doses of Lacosamide Dr. Reddy’s for the different
age and weight groups.
The 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 use Lacosamide Dr. Reddy’s alone

• The initial dose of Lacosamide Dr. Reddy’s is usually 50 mg twice a day.
• Treatment may also start with an initial dose of 100 mg of Lacosamide Dr. Reddy’s twice a day.
• The doctor may increase your daily dose by 50 mg twice a day each week, up to reaching the maintenance dose, between 100 mg and 300 mg twice a day.

When you use Lacosamide Dr. Reddy’s with other antiepileptic medicines

• The initial dose of Lacosamide Dr. Reddy’s is usually 50 mg twice a day.
• The doctor may increase your daily dose by 50 mg twice a day each week. This until reaching a maintenance dose between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, the doctor may decide to start treatment with Lacosamide Dr. Reddy’s with a single “loading” dose of 200 mg. Then 12 hours later, you would start your maintenance dose.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: please note that Lacosamide Dr. Reddy’s is not recommended in children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: please note that Lacosamide Dr. Reddy’s is not recommended in children under 4 years of age.

When you use Lacosamide Dr. Reddy’s alone

• The doctor will decide the dose of Lacosamide Dr. Reddy’s based on your body weight.
• The usual initial dose is 1 mg (0.1 mL) for each kilogram (kg) of body weight, twice a day.
• The doctor may then increase your daily dose by 1 mg (0.1 mL) for each kg of body weight twice a day each week, up to reaching a maintenance dose.
• Below are the dosage tables, including the recommended maximum dose. To be considered only as reference information. The doctor will calculate the dose suitable for you.

To be used twice a dayfor children starting from 2 years of age weighing between 10 kg and
less than 40 kg
To be used twice a dayfor children and adolescents weighing between 40 kg and less than 50
kg:

When you use Lacosamide Dr. Reddy’s with other antiepileptic medicines

• The doctor will decide the dose of Lacosamide Dr. Reddy’s based on your body weight.
• For children and adolescents with a body weight between 10 kg and less than 50 kg, the usual initial dose is 1 mg (0.1 mL) for each kilogram (kg) of body weight, twice a day.
• The doctor may then increase your dose taken twice a day by 1 mg (0.1 mL) for each kg of body weight each week, up to reaching a maintenance dose.
• Below are the dosage tables, including the recommended maximum dose. To be considered only for informational purposes. The doctor will calculate the right dose for you.

To be used twice a dayfor children starting from 2 years of age weighing between 10 kg and
less than 20 kg
To be used twice a dayfor children and adolescents with a body weight between 20 kg and
less than 30 kg
To be used twice a dayfor children and adolescents with a body weight between 30 kg and
less than 50 kg
If you stop treatment with Lacosamide Dr. Reddy’s
If the doctor decides to stop therapy with Lacosamide Dr. Reddy’s, the dose must be
gradually reduced. This is to prevent the return or worsening
of epilepsy.
If you have any doubts about the use of this medicine, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects affecting 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 dizzy or nauseous;
• 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, being prone to falls and bruising;
• Memory problems, difficulty thinking or finding the right words, confusion;

• Rapid and uncontrollable eye movements (nystagmus), blurred vision;
• Feeling dizzy (vertigo), drunkenness;
• Vomiting, dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Reduced sense of touch or sensation, difficulty articulating words, difficulty concentrating;
• Ringing in the ears, or hearing buzzing, trills 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 your heart’s electrical activity (cardiac conduction disturbance);
• Feeling 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: tell your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts or loss of contact with reality;
• Severe allergic reaction that causes swelling of the face, throat, hands, feet, ankles or lower legs;
• Fainting;
• Involuntary abnormal movements (dyskinesia).

Not known:frequency cannot be estimated from available data

• Fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high temperature 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 temperature 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 that causes peeling of the skin in more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsions.

Other side effects when given as an intravenous infusion
Local side effects may occur.

Common: may affect up to 1 in 10 people

• Pain or discomfort or irritation at the injection site. Uncommon: may affect up to 1 in 100 people
• Redness at the injection site.

Other side effects in children
Additional side effects observed in children have been fever (pyrexia), runny nose (naso-
pharyngitis), 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 side effects not listed
in this leaflet. 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 Dr. Reddy’s

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 package and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Each vial of Lacosamide Dr. Reddy’s infusion solution must be used only once.
Any unused solution remaining should be discarded.
The solution should only be used if it is clear, without any colour changes and free from foreign particles.
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 protect the environment.

6. Package Contents and Other Information

What Lacosamide Dr. Reddy’s contains

• The active ingredient is lacosamide. 1 mL of Lacosamide Dr. Reddy’s solution for infusion contains 10 mg of lacosamide. 1 vial contains 20 mL of Lacosamide Dr. Reddy’s solution for infusion, equivalent to 200 mg of lacosamide.
• The other ingredients are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Lacosamide Dr. Reddy’s and package contents

• Lacosamide Dr. Reddy’s 10 mg/mL solution for infusion is a clear and colorless solution in a transparent glass vial, closed with a gray rubber stopper and sealed with a green cap. Lacosamide Dr. Reddy’s solution for infusion is available in packs of 1 vial and 5 vials. Each vial contains 20 mL. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1
20123 Milan (MI), Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95, Kriegshaber
86156 Augsburg,
Germany
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
PLA 3000, Paola
Malta
Rual Laboratories S.R.L.,
Building H, 1st Floor, Sector 3, Splaiul Unirii 313,
030138 Bucharest,
Romania

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
The following information is intended only for healthcare professionals.
Each vial of Lacosamide Dr. Reddy’s solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamide Dr. Reddy’s solution for infusion can be administered without further dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/mL (0.9 %), glucose 50 mg/mL (5 %), or in Ringer’s lactate solution.
From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times during use and the conditions prior to use are the responsibility of the user and should not exceed 24 hours between 2 and 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical stability during use has been demonstrated for 24 hours at temperatures up to 25 °C for the product mixed with these diluents and stored in glass containers or PVC bags.