LACOSAMIDE 50 mg Film-Coated Tablets

Зміст інструкції

1. Lacosamide Accord 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Lacosamide Accord and what is it used for
   2. What you need to know before you take Lacosamide Accord
   3. How to take Lacosamide Accord
   4. Possible side effects
   5. How to store Lacosamide Accord
   6. Package Contents and Other Information
2. Lacosamide Accord 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Lacosamide Accord and what it is used for
   2. What you need to know before taking Lacosamide Accord
   3. How to take Lacosamide Accord
   4. Possible side effects
   5. How to store Lacosamide Accord
   6. Package Contents and Other Information
3. Lacosamide Accord 10 mg/mL solution for infusion
   1. What is Lacosamide Accord and what it is used for
   2. What you need to know before using Lacosamide Accord
   3. How to use Lacosamide Accord
   4. Possible side effects
   5. How to store Lacosamide Accord
   6. Package contents and other information

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

lacosamide

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 Accord is and what it is used for
• 2. What you need to know before you take Lacosamide Accord
• 3. How to take Lacosamide Accord
• 4. Possible side effects
• 5. How to store Lacosamide Accord
• 6. Contents of the pack and other information

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

What is Lacosamide Accord
Lacosamide Accord 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 Accord is used for

• Lacosamide Accord 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 (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 you take Lacosamide Accord

Do not take Lacosamide Accord

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

degree.
Do not take Lacosamide Accord if you fall into any 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 Accord 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 atrial flutter)
• you have a serious heart condition, such as heart failure or have had a heart attack
• you often feel dizzy or fall. Lacosamide Accord can cause dizziness, this can 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 any of the above cases (or are not sure), ask your doctor or pharmacist before
taking Lacosamide Accord.
If you are taking Lacosamide Accord, talk to your doctor if you have a seizure of a
different type or your existing seizures get worse.
If you are taking Lacosamide Accord and experience symptoms of abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy and
fainting), see your doctor immediately (see section 4).

Children
Lacosamide Accord 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 if it is
safe for children in this age group.

Other medicines and Lacosamide Accord
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 Accord 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 any of the above cases (or are not sure) ask your doctor or pharmacist before
taking Lacosamide Accord.

• 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 Lacosamide Accord on your body: medicines for fungal infections, called fluconazole, itraconazole or ketoconazole;
• a medicine for HIV called ritonavir;
• medicines used to treat bacterial infections, called clarithromycin or rifampicin;
• an herbal medicine used to treat mild anxiety and depression, called St. John's wort.

If you fall into any of the above cases (or are not sure), ask your doctor or pharmacist before
taking Lacosamide Accord.

Lacosamide Accord with alcohol
As a precautionary measure, do not take Lacosamide Accord 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, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Lacosamide Accord during pregnancy, as the effects of
lacosamide on the fetus. It is not recommended to breastfeed while taking Lacosamide Accord, as Lacosamide Accord
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 Accord 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 Accord can cause dizziness or
blurred vision.

3. How to take Lacosamide Accord

Take this medicine following the instructions of your doctor or pharmacist exactly as they have told you. If
you have any doubts, ask your doctor or pharmacist.

Taking Lacosamide Accord

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

How much to take
Below are listed the usual recommended doses of Lacosamide Accord for 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 Accord alone:
The starting dose of Lacosamide Accord is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice a day.
Your doctor may increase your daily dose by 50 mg twice a day each week, up to
a maintenance dose, between 100 mg and 200 mg twice a day.
When you take Lacosamide Accord with other antiepileptic medicines:
The starting dose of Lacosamide Accord is usually 50 mg twice a day.
Your doctor may increase the daily dose by 50 mg twice a day each week. This up to
a maintenance dose, between 100 mg and 200 mg twice.
If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Accord 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 Accord 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 Accord 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 tablet strengths. The doctor will prescribe the most suitable formulation for them.

If you take more Lacosamide Accord than you should
Contact your doctor immediately if you have taken more Lacosamide Accord than you should.
Do not 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 fast heartbeat and sweating.

If you forget to take Lacosamide Accord

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

If you stop taking Lacosamide Accord

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

If you have any questions about using 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 affecting the nervous system, such as dizziness, may be more frequent
after a single “loading” dose.

Talk to 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, easy bruising and getting cuts;
• 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 disorder;
• Noises in the ear such as buzzing, 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 disturbance);
• Exaggerated feeling 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, suicide attempt: 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 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 skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing peeling skin on more than 30% of the body surface (toxic epidermal necrolysis);
• Convulsion

Other side effects in children
Additional side effects observed 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 side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Accord

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 Scad. and on the
blister 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 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 Accord contains
The active ingredient is lacosamide.
One Lacosamide Accord 50 mg tablet contains 50 mg of lacosamide.
One Lacosamide Accord 100 mg tablet contains 100 mg of lacosamide.
One Lacosamide Accord 150 mg tablet contains 150 mg of lacosamide.
One Lacosamide Accord 200 mg tablet contains 200 mg of lacosamide.
The other ingredients are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose (L), hydroxypropylcellulose (low
substitution), anhydrous colloidal silica, crospovidone and magnesium stearate.

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

*The colorants are:
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine (E132)
100 mg tablet: yellow iron oxide (E172)
150 mg tablet: red iron oxide (E172), black iron oxide (E172), yellow iron oxide
(E172)
200 mg tablet: indigo carmine (E132)

Description of the appearance of Lacosamide Accord and contents of the pack
Lacosamide Accord 50 mg film-coated tablets are pink, oval-shaped, with
approximate dimensions of 10.3 x 4.8 mm and the inscription "L" embossed on one side and the inscription
"50" on the other.
Lacosamide Accord 100 mg film-coated tablets are dark yellow, oval-shaped, with
approximate dimensions of 13.0 x 6.0 mm and the inscription "L" embossed on one side and the inscription "100"
on the other.
Lacosamide Accord 150 mg film-coated tablets are salmon-colored, oval-shaped,
with approximate dimensions of 15.0 x 6.9 mm and the inscription "L" embossed on one side and the inscription "150"
on the other.
Lacosamide Accord 200 mg film-coated tablets are blue, oval-shaped, with
approximate dimensions of 16.4 x 7.6 mm and the inscription "L" embossed on one side and the inscription "200"
on the other.
Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.
Packs of 14 x 1 and 56 x 1 tablets are available in divisible blister packs for unit doses in
PVC-PVDC/ALU sealed with an aluminum foil, all other packs are available in the
standard blister in PVC-PVDC/ALU sealed with an aluminum foil.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
or
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
or
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

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

lacosamide

The starter pack is only suitable for adolescents and children weighing 50 kg or more, and for adults.
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lacosamide Accord is and what it is used for
• 2. What you need to know before you take Lacosamide Accord
• 3. How to take Lacosamide Accord
• 4. Possible side effects
• 5. How to store Lacosamide Accord
• 6. Contents of the pack and other information

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

What is Lacosamide Accord
Lacosamide Accord 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 Accord is used for
Lacosamide Accord 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 thought to have a genetic cause).

2. What you need to know before taking Lacosamide Accord

Do not take Lacosamide Accord

• 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 Accord 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 before taking Lacosamide Accord 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.
• you have a heart problem affecting 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. Lacosamide Accord can cause dizziness, this may increase the risk of accidental injuries 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 Accord. If you are taking Lacosamide Accord, talk to your doctor if you have a different type of seizure or your existing seizures get worse. If you are taking Lacosamide Accord and experience symptoms of an abnormal heartbeat (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling faint or lightheaded, and fainting), consult your doctor immediately (see section 4).

Children
Lacosamide Accord 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 Accord
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 Accord can also affect your heart:

• medicines to treat heart conditions;
• medicines that can 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 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 taking Lacosamide Accord.

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 Accord on your body:

• medicines for fungal infections, called fluconazole, itraconazole or ketoconazole;
• a medicine used to treat HIV infections called ritonavir;
• medicines used to treat bacterial infections, called clarithromycin or rifampicin;
• an 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 Accord.

Lacosamide Accord with alcohol
As a safety precaution, do not take Lacosamide Accord 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, 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 Accord during pregnancy, as the effects of
lacosamide on the foetus are not known. It is recommended not to breastfeed while taking Lacosamide
Accord, as Lacosamide Accord 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 Accord 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, ride a bicycle, use tools or machinery until you have checked how this medicine affects you. This is because Lacosamide Accord can cause dizziness or
blurred vision.

Lacosamide Accord contains soya lecithin.
If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Lacosamide Accord

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 Accord

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

How much to take
Below are listed the normal recommended doses of Lacosamide Accord 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 Accord alone
The starting dose of Lacosamide Accord is usually 50 mg twice a day.
Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice a
day.
Your doctor may increase your daily dose by 50 mg twice a day each week, up to
a maintenance dose, between 100 mg and 300 mg twice a day.
When you take Lacosamide Accord with other antiepileptic medicines
Start of therapy (first 4 weeks)
This pack (start of therapy pack) is for you to start your treatment with Lacosamide
Accord.
The pack contains 4 different packs for the first 4 weeks of therapy, one for each
week.
Each pack contains 14 tablets, which corresponds to 2 tablets a day for 7 days.
Each pack contains a different dosage of Lacosamide Accord, to allow you to increase the
dose gradually.
You will start treatment with a low dose of Lacosamide Accord, usually 50 mg twice a
day, and increase the dose gradually week by week. The dose that you can most commonly
take each day for the first 4 weeks of therapy is shown in the following table. Your
doctor will tell you if you need to use all 4 packs.

Table: start of therapy (first 4 weeks)

WeekTOTAL
daily dose
Week 1Pack
marked
"Week 1"

Pack to useFirst dose (in the
morning)
Second dose
(in the evening)
50 mg
(1 tablet of
Lacosamide
Accord 50 mg)
50 mg
(1 tablet of
Lacosamide
Accord 50 mg)
100 mg

Week 2Pack
marked
"Week 2"
100 mg
(1 tablet of
Lacosamide
Accord 100 mg)
100 mg
(1 tablet of
Lacosamide
Accord 100 mg)
200 mg

Week 3Pack
marked
"Week 3"
150 mg
(1 tablet of
Lacosamide
Accord 150 mg)
150 mg
(1 tablet of
Lacosamide
Accord 150 mg)
300 mg

Week 4Pack
marked
"Week 4"
200 mg
(1 tablet of
Lacosamide
Accord 200 mg)
200 mg
(1 tablet of
Lacosamide
Accord 200 mg)
400 mg
Maintenance therapy (after the first 4 weeks)
After the first 4 weeks of treatment, your doctor may adjust the dose you will continue to
take for long-term therapy. This dose is called a maintenance dose, and depends on
your response to Lacosamide Accord. In most patients, the maintenance dose is
between 200 mg and 400 mg per day.

Children and adolescents weighing less than 50 kg
The start of therapy pack is not suitable for children and adolescents weighing less than 50 kg.

If you take more Lacosamide Accord than you should
Contact your doctor immediately if you have taken more Lacosamide Accord than you should.
Do not 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 fast heartbeat and sweating.

If you forget to take Lacosamide Accord

• If you forget to take a dose of Lacosamide Accord, and less than 6 hours have passed since the usual time of taking it, take Lacosamide Accord 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. Take the next Lacosamide Accord tablet at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Lacosamide Accord

• Do not stop taking Lacosamide Accord without consulting your doctor as epilepsy may come back or get worse.
• If your doctor decides to stop your therapy with Lacosamide Accord, they will give you 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 everybody gets them.

Contact 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, 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

• Reduced 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 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 from 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 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 that causes 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.

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 national reporting system
indicated in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lacosamide Accord

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 Scad. and on the
blister 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 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 Accord contains
The active ingredient is lacosamide.
One Lacosamide Accord 50 mg tablet contains 50 mg of lacosamide.
One Lacosamide Accord 100 mg tablet contains 100 mg of lacosamide.
One Lacosamide Accord 150 mg tablet contains 150 mg of lacosamide.
One Lacosamide Accord 200 mg tablet contains 200 mg of lacosamide.
The other ingredients are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose (L), hydroxypropylcellulose (low substitution), anhydrous colloidal silica, crospovidone and magnesium stearate.

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

*The colorants are:
50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigotine (E132)
100 mg tablet: yellow iron oxide (E172)
150 mg tablet: red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172)
200 mg tablet: indigotine (E132)

Description of the appearance of Lacosamide Accord and package contents
Lacosamide Accord 50 mg film-coated tablets are pink, oval-shaped, with approximate dimensions of
10.3 x 4.8 mm and the inscription "L" embossed on one side and the inscription "50" on the other.
Lacosamide Accord 100 mg film-coated tablets are dark yellow, oval-shaped, with approximate
dimensions of 13.0 x 6.0 mm and the inscription "L" embossed on one side and the inscription "100"
on the other.
Lacosamide Accord 150 mg film-coated tablets are salmon-colored, oval-shaped, with approximate
dimensions of 15.0 x 6.9 mm and the inscription "L" embossed on one side and the inscription "150"
on the other.
Lacosamide Accord 200 mg film-coated tablets are blue, oval-shaped, with approximate dimensions of
16.4 x 7.6 mm and the inscription "L" embossed on one side and the inscription "200"
on the other.
The starter pack contains 56 film-coated tablets, divided into 4 packs:

• The pack labeled ‘Week 1’ contains 14 tablets of 50 mg,
• The pack labeled ‘Week 2’ contains 14 tablets of 100 mg,
• The pack labeled ‘Week 3’ contains 14 tablets of 150 mg,
• The pack labeled ‘Week 4’ contains 14 tablets of 200 mg.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
or
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain
or
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu.

Lacosamide Accord 10 mg/mL solution for infusion

lacosamide

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 Accord is and what it is used for
• 2. What you need to know before you use Lacosamide Accord
• 3. How to use Lacosamide Accord
• 4. Possible side effects
• 5. How to store Lacosamide Accord
• 6. Contents of the pack and other information

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

What is Lacosamide Accord
Lacosamide Accord 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 Accord is used for

• Lacosamide Accord 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 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 using Lacosamide Accord

Do not use Lacosamide Accord

• 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 use Lacosamide Accord if you fall into any of the above cases. If you are not sure, ask your doctor or
pharmacist before using this medicine.

Warnings and precautions
Talk to your doctor before using Lacosamide Accord 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 Accord 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 any of the above cases (or are not sure), ask your doctor or pharmacist before using Lacosamide Accord. If you are taking Lacosamide Accord, talk to your doctor if you have a seizure that is different from usual or if existing seizures get worse. If you are taking Lacosamide Accord 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 Accord 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 if it is
safe for children in this age group.

Other medicines and Lacosamide Accord
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 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 certain forms of irregular heartbeat or heart failure. If you fall into any of the above cases (or are not sure) ask your doctor or pharmacist before using Lacosamide Accord.

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 Lacosamide Accord on your body:

• medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
• a medicine for HIV called ritonavir;
• medicines used to treat bacterial infections called clarithromycin or rifampicin;
• an herbal medicine used to treat mild anxiety and depression called St John's wort. If you fall into any of the above cases (or are not sure), ask your doctor or pharmacist before using Lacosamide Accord.

Lacosamide Accord with alcohol
As a safety precaution, do not take Lacosamide Accord 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 or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
It is recommended not to use Lacosamide Accord during pregnancy, as the effects of
Lacosamide Accord on the fetus are unknown. It is recommended not to breastfeed while taking
Lacosamide Accord, as Lacosamide Accord passes into breast milk.
. Consult your doctor immediately if you are pregnant or planning a pregnancy. They will help you
decide whether to use Lacosamide Accord 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 Accord can cause dizziness or
blurred vision.

Lacosamide Accord contains sodium
This medicine contains 2.6 mmol (or 60 mg) of sodium (the main component of table salt)
per vial. This amount is equivalent to 3% of the maximum recommended daily intake of sodium
for an adult. This should be taken into consideration if you are following a diet with a controlled sodium
regime.

3. How to use Lacosamide Accord

Always use this medicine exactly as your doctor or pharmacist has told you. Consult your
doctor or pharmacist if you are not sure.

Using Lacosamide Accord

• Lacosamide Accord can be started:
• by taking the medicine by mouth or
• with administration as an intravenous infusion (sometimes called an “IV infusion”) where 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 Accord 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 Accord twice every day - once in the morning and once in the evening.
• Try to use it at about the same time each day.

How much to use
Below are listed the normal recommended doses of Lacosamide Accord for the different age
groups and weights. 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 Accord alone
The starting dose of Lacosamide Accord is usually 50 mg twice a day.
The doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord 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 Accord with other antiepileptic medicines
The starting dose of Lacosamide Accord 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 Accord 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: note that Lacosamide Accord is not recommended in children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Accord is not recommended in children under 4 years of age.

Use of Lacosamide Accord alone

• The doctor will decide the dose of Lacosamide Accord based on your body weight.
• The usual starting 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.

For reference purposes only. The doctor will calculate the dose suitable for you.

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

When you use Lacosamide Accord with other antiepileptic medicines

• The doctor will decide the dose of Lacosamide Accord based on your body weight.
• For children and adolescents with a body weight between 10 kg and less than 50 kg, the usual starting 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. For informational purposes only. The doctor will calculate the right dose for you:

To be used twice a dayfor children from 2 years of age and weighing between 10 Kg and
less than 20 kg

To be used twice a dayfor children from 2 years of age with a body weight between
20 kg and less than 30 kg:

In children from 4 years of age with a body weight between 30 and 50 kg:

• Usually the starting 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. The recommended maximum
dose is 4 mg (0.4 mL), for each kg of body weight, twice a day. Below are
reported the dosage tables, including the recommended dose
Use of Lacosamide Accord with other antiepileptic medicines - Children and adolescents with weight
body between 30 kg and 50 kg -For informational purposes only. The doctor will calculate
the dose suitable for you:

To be used twice a dayfor children and adolescents with a body weight between 30 kg and
less than 50 kg:

If you stop taking Lacosamide AccordIf the doctor decides to stop therapy
with Lacosamide Accord, the dose must be gradually reduced. This is to prevent

the recurrence or worsening of epilepsy.
If you have any doubts about using 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.

Talk to 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 cuts;
• 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, buzzing 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 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 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);
• Seizure.

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

Common: may affect up to 1 in 10 people

• Pain, 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
(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 detailed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Lacosamide Accord

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 the vial after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Each vial of Lacosamide Accord solution for infusion must be used only once.
Any remaining unused solution must 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 Accord contains

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

Description of Lacosamide Accord and package contents

• Lacosamide Accord 10 mg/mL solution for infusion is a clear and colorless solution, free from particulate matter. Lacosamide Accord 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 Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6 Planta,
08039, Barcelona
Spain

Manufacturer
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50,
95-200 Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain

Further information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:
Each vial of Lacosamide Accord solution for infusion must be used only once
(single use). Any unused solution must be discarded (see section 3).
Lacosamide Accord solution for infusion can be administered without further dilution,
or it may be diluted with the following solution: 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 should 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 in 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.