Trelema 10 mg/ml Infusionsvätska, lösning

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

16-11-2020

Produktens egenskaper Produktens egenskaper (SPC)

08-03-2021

Aktiva substanser:
lakosamid
Tillgänglig från:
G.L. Pharma GmbH,
ATC-kod:
N03AX18
INN (International namn):
lacosamide
Dos:
10 mg/ml
Läkemedelsform:
Infusionsvätska, lösning
Sammansättning:
lakosamid 10 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Injektionsflaska, 10 ml; Injektionsflaska, 5 x 10 ml; Ampull, 20 ml; Ampull, 5 x 20 ml
Bemyndigande status:
Godkänd
Godkännandenummer:
55380
Tillstånd datum:
2018-06-20

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

24-03-2021

Produktens egenskaper Produktens egenskaper - engelska

16-11-2020

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

20-06-2018

Läs hela dokumentet

Package leaflet: Information for the patient

Trelema 10 mg/ml solution for infusion

lacosamide

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What [Lacosamide] is and what it is used for

What you need to know before you use [Lacosamide]

How to use [Lacosamide]

Possible side effects

How to store [Lacosamide]

Contents of the pack and other information

1.

What [Lacosamide] is and what it is used for

What [Lacosamide] is

[Lacosamide] contains lacosamide. This belongs to a group of medicines called ‘antiepileptic

medicines’. These medicines are used to treat epilepsy.

You have been given this medicine to lower the number of fits (seizures) you have.

What [Lacosamide] is used for

[Lacosamide] is used in adults, adolescents and children aged 4 years and older.

It is used to treat a certain type of epilepsy called ‘partial-onset seizure with or without

secondary generalisation’.

In this type of epilepsy, fits first affect only one side of your brain. However, these may then

spread to larger areas on both sides of your brain.

[Lacosamide] may be used on its own or with other antiepileptic medicines.

2.

What you need to know before you use [Lacosamide]

Do not use [Lacosamide]

if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in

section 6). If you are not sure whether you are allergic, please discuss with your doctor.

if you have a certain type of heart beat problem called second or third degree AV block.

Do not use [Lacosamide] 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] if

you have thoughts of harming or killing yourself. A small number of people being treated

with antiepileptic medicinal products such as lacosamide have had thoughts of harming or

killing themselves. If you have any of these thoughts at any time, tell your doctor straight

away.

you have a heart problem that affects the beat of your heart and you often have a particularly

slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).

you have severe heart disease such as heart failure or have had a heart attack.

you are often dizzy or fall over. [Lacosamide] may make you dizzy – this could increase the

risk of accidental injury or a fall. This means that you should take care until you are 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].

If you are using [Lacosamide] and you are experiencing symptoms of abnormal heartbeat (such

as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded,

fainting), seek medical advice immediately (see section 4).

Children under 4 years

[Lacosamide] is not recommended for children aged under 4 years. This is because we do not

yet know whether it will work and whether it is safe for children in this age group.

Other medicines and [Lacosamide]

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 your heart. This is because [Lacosamide] can also affect your heart:

medicines to treat heart problems

medicines

which

increase

‘PR

interval’

scan

heart

(ECG

electrocardiogram)

such

medicines

epilepsy

pain

called

carbamazepine,

lamotrigine or pregabalin

medicines used to treat certain types of irregular heart beat or heart failure

Also tell your doctor or pharmacist if you are taking any of the following medicines. This is

because they may increase or decrease the effect of [Lacosamide] 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

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].

[Lacosamide] with alcohol

As a safety precaution do not use [Lacosamide] with alcohol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before using this medicine.

It is not recommended to use [Lacosamide] if you are pregnant

or breast-feeding, as the effects

of [Lacosamide] on pregnancy and the unborn baby or the new-born child are not known. Also,

it is not known whether [Lacosamide] passes into breast milk. Seek advice immediately from

your doctor if you get pregnant or are planning to become pregnant. They will help you decide

if you should use [Lacosamide] or not.

Do not stop treatment without talking to your doctor first as this could increase your fits

(seizures). A worsening of your disease can also harm your baby.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know how this medicine affects you.

This is because [Lacosamide] may make you feel dizzy or cause blurred vision.

This medicine contains 30 mg sodium (main component of cooking/table salt) in each vial or

60 mg sodium in each ampoule. This is equivalent to 1.5% or 3% of the WHO recommended

maximum daily intake of 2 g sodium for an adult.

3.

How to use [Lacosamide]

Always use this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Using [Lacosamide]

[Lacosamide] can be started by:

taking the medicine by mouth or

by being given as an intravenous infusion (sometimes called an ‘i.v. infusion’) where

the medicine is given into your vein by a doctor or nurse. It is given over 15 to 60

minutes.

The i.v. infusion is usually used for a short time when you cannot take the medicine by

mouth.

Your doctor will decide for how many days you will have infusions. There is experience with

twice daily infusions of [Lacosamide] for up to 5 days. For longer term treatment

[Lacosamide] tablets and syrup are available.

When you change from the infusion to taking the medicine by mouth (or the other way around)

the total amount you take each day and how often you take it stays the same.

Use [Lacosamide] twice each 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

Listed below are the normal recommended doses of [Lacosamide] for different age groups and

weights. Your doctor may prescribe a different dose if you have problems with your kidneys or

with your liver.

Adults, adolescents and children weighing 50 kg or more

When you use [Lacosamide] on its own

The usual starting dose of [Lacosamide] is 50 mg twice a day.

The treatment with [Lacosamide] may also start with a dose of 100 mg of [Lacosamide] twice

a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be until you

reach a maintenance dose between 100 mg and 300 mg twice a day.

When you use [Lacosamide] with other antiepileptic medicines

The usual starting dose of [Lacosamide] is 50 mg twice a day.

Your doctor may increase your twice daily dose every week by 50 mg. This will be 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 [Lacosamide] treatment with a

single ‘loading’ dose of 200 mg. You would then start your ongoing maintenance dose 12 hours

later.

Children and adolescents weighing less than 50 kg

When you use [Lacosamide] on its own

Your doctor will decide the dose of [Lacosamide] based on your body weight.

Weight

0.1 ml/kg

Starting

dose

0.2 ml/kg

0.3 ml/kg

0.4 ml/kg

0.5 ml/kg

0.6 ml/kg

Maximum

recommended

dose

10 kg

1 ml

2 ml

3 ml

4 ml

5 ml

6 ml

15 kg

1.5 ml

3 ml

4.5 ml

6 ml

7.5 ml

9 ml

20 kg

2 ml

4 ml

6 ml

8 ml

10 ml

12 ml

25 kg

2.5 ml

5 ml

7.5 ml

10 ml

12.5 ml

15 ml

30 kg

3 ml

6 ml

9 ml

12 ml

15 ml

18 ml

35 kg

3.5 ml

7 ml

10.5 ml

14 ml

17.5 ml

21 ml

Weight

0.1 ml/kg

Starting dose

0.2 ml/kg

0.3 ml/kg

0.4 ml/kg

0.5 ml/kg

Maximum

recommended

dose

40 kg

4 ml

8 ml

12 ml

16 ml

20 ml

45 kg

4.5 ml

9 ml

13.5 ml

18 ml

22.5 ml

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg

of your body weight. This will be until you reach a maintenance dose. The maximum

recommended dose is 6 mg (0.6 ml) for each kg of body weight, twice a day, for children

weighing under 40 kg. The maximum maintenance dose is 5 mg (0.5 ml) for each kg of body

weight, twice a day, for children weighing from 40 kg to under 50 kg. Dosing charts are provided

below:

Using [Lacosamide] on its own – This is for information only. Your doctor will work out the right

dose for you.

To be used twice daily for children from 4 years of age weighing less than 40 kg:

To be used twice daily for children and adolescents from 4 years of age weighing 40 kg to under

50 kg:

When you use [Lacosamide] with other antiepileptic medicines

Your doctor will decide the dose of [Lacosamide] based on your body weight.

In children from 4 years of age with a body weight of under 20 kg:

he usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg

of body weight. This will be until you reach a maintenance dose. The maximum recommended

Weight

0.1 ml/kg

Starting

dose

0.2 ml/kg

0.3 ml/kg

0.4 ml/kg

0.5 ml/kg

0.6 ml/kg

Maximum

recommended

dose

10 kg

1 ml

2 ml

3 ml

4 ml

5 ml

6 ml

15 kg

1.5 ml

3 ml

4.5 ml

6 ml

7.5 ml

9 ml

Weight

0.1 ml/kg

Starting dose

0.2 ml/kg

0.3 ml/kg

0.4 ml/kg

0.5 ml/kg

Maximum

recommended

dose

20 kg

2 ml

4 ml

6 ml

8 ml

10 ml

25 kg

2.5 ml

5 ml

7.5 ml

10 ml

12.5 ml

dose is 6 mg (0.6 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Using [Lacosamide] with other antiepileptic medicines - Children above 4 years of age

weighing less than 20 kg - This is for information only. Your doctor will work out the right dose

for you.

To be used twice daily for children from 4 years of age weighing less than 20 kg:

In children from 4 years of age with a body weight of 20 to under 30 kg:

The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg

of body weight. This will be until you reach a maintenance dose. The maximum recommended

dose is 5 mg (0.5 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Using [Lacosamide] with other antiepileptic medicines - Children and adolescents with a

body weight of 20 kg to under 30 kg - This is for information only. Your doctor will work out

the right dose for you:

To be used twice daily for children and adolescents from 4 years of age weighing 20 kg to under

30 kg:

In children from 4 years of age with a body weight of 30 to under 50 kg:

he usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.

Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg

of body weight. This will be until you reach a maintenance dose. The maximum recommended

dose is 4 mg (0.4 ml), for each kg of body weight, twice a day. A dosing chart is provided below.

Using [Lacosamide] with other antiepileptic medicines - Children and adolescents with a

body weight of 30 kg to under 50 kg - This is for information only. Your doctor will work out

the right dose for you:

To be used twice daily for children and adolescents from 4 years of age weighing 30 kg to under

50 kg:

Weight

0.1 ml/kg

Starting dose

0.2 ml/kg

0.3 ml/kg

0.4 ml/kg

Maximum

recommended dose

30 kg

3 ml

6 ml

9 ml

12 ml

35 kg

3.5 ml

7 ml

10.5 ml

14 ml

40 kg

4 ml

8 ml

12 ml

16 ml

45 kg

4.5 ml

9 ml

13.5 ml

18 ml

If you stop using [Lacosamide]

If your doctor decides to stop your treatment with [Lacosamide], they will decrease the dose

step by step. This is to prevent your epilepsy from coming back again or becoming worse.

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.

Nervous system side effects such as dizziness may be higher after a loading dose.

Talk to your doctor or pharmacist if you get any of the following:

Very common (may affect more than 1 in 10 people)

Headache

Feeling dizzy or sick (nausea)

Double vision (diplopia)

Common (may affect up to 1 in 10 people)

Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle

spasms, falling easily and getting bruises

Trouble with your memory, thinking or finding words, confusion

Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision

A spinning sensation (vertigo), feeling drunk

Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or

bowel, diarrhoea

Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention

Noise in the ear such as buzzing, ringing or whistling

Irritability, trouble sleeping depression

Sleepiness, tiredness or weakness (asthenia)

Itching, rash

Uncommon (may affect up to 1 in 100 people)

Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your

heart (conduction disorder)

Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there

Allergic reaction to medicine intake, hives

Blood tests may show abnormal liver function, liver injury

Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away

Feeling angry or agitated

Abnormal thinking or losing of touch with reality

Serious allergic reaction which causes swelling of the face, throat, hand, feet, ankles, or

lower legs

Fainting

Difficulties in coordinating your movements or walking

Not known (frequency cannot be estimated from the available data)

A sore throat, high temperature and getting more infections than usual. Blood tests may

show a severe decrease in a specific class of white blood cells (agranulocytosis).

A serious skin reaction which may include a high temperature and other flu-like symptoms,

a rash on the face, extended rash, swollen glands (enlarged lymph nodes). Blood tests may

show increased levels of liver enzymes and a type of white blood cell (eosinophilia).

A widespread rash with blisters and peeling skin, particularly 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

Abnormal rapid heartbeat (ventricular tachyarrhythmia

Additional side effects when given as an intravenous infusion

There may be local side effects.

Common (may affect up to 1 in 10 people)

Injection site pain or discomfort or irritation

Uncommon (may affect up to 1 in 100 people)

Injection site redness

Additional side effects in children

Common (may affect up to 1 in 10 children)

Runny nose (nasopharyngitis)

Fever (pyrexia)

Sore throat (pharyngitis)

Eating less than usual

Uncommon (may affect up to 1 in 100 children)

Feeling sleepy or lacking in energy

Not known (frequency cannot be estimated from the available data)

Changes in behaviour, not acting like themselves

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 via the national reporting

system. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store [Lacosamide]

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 and vial/ampoule

after EXP. The expiry date refers to the last day of that month.

Do not freeze.

Each vial/ampoule of [Lacosamide] solution for infusion must be used only once (single use).

Any unused solution should be discarded.

Only clear solution free from particles and discoloration should be used.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What [Lacosamide] contains

The active substance is lacosamide.

1 ml [Lacosamide] solution for infusion contains 10 mg lacosamide.

1 vial contains 10 ml [Lacosamide] solution for infusion equivalent to 100 mg lacosamide.

ampoule

contains

20 ml

[Lacosamide]

solution

infusion

equivalent

200 mg

lacosamide.

The other ingredients are:

sodium chloride, hydrochloric acid (for pH adjustment), sodium

hydroxide (for pH adjustment), water for injection.

What [Lacosamide] looks like and contents of the pack

[Lacosamide] 10 mg/ml solution for infusion is a clear, colourless solution.

[Lacosamide] solution for infusion is available in packages of 1 vial/ampoule and 5 vials/

ampoules. Each vial contains 10 ml. Each ampoule contains 20 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach

This leaflet was last revised in 15 January 2021.

The following information is intended for medical or healthcare professionals only.

This medicinal product is for single use only, any unused solution should be discarded.

[Lacosamide] solution for infusion was found to be physically compatible and chemically stable

when mixed with the following diluents for at least 48 hours and stored in glass bottles or PVC

bags at temperatures up to 25°C.

Diluents:

Sodium chloride 9 mg/mL (0.9%) solution for injection

Glucose 50 mg/mL (5%) solution for injection

Ringer’s solution for injection

Sodium chloride and Dextrose solution for injection (Sodium chloride 0.18% w/v and

Dextrose 4% w/v)

Lactated Ringer’s solution for injection

Product with particulate matter or discolouration should not be used.

After dilution:

Chemical and physical in-use stability has been demonstrated for 48 hours at temperatures up

to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags.

From a microbiological point of view, the product should be used immediately. If not used

immediately, in-use storage times and conditions prior to use are the responsibility of the user

and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled

and validated aseptic conditions.

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