Trelema 10 mg/ml Sirap

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

25-06-2018

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:
Sirap
Sammansättning:
metylparahydroxibensoat Hjälpämne; glycerol 85% Hjälpämne; lakosamid 10 mg Aktiv substans; sorbitol Hjälpämne
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Flaska, 100 ml (med doskopp och doseringsspruta); Flaska, 200 ml (med doskopp och doseringsspruta); Flaska, 300 ml (med doskopp och doseringsspruta); Flaska, 500 ml (med doskopp och doseringsspruta)
Bemyndigande status:
Godkänd
Godkännandenummer:
55381
Tillstånd datum:
2018-06-20

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

16-11-2020

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 syrup

lacosamide

Read all of this leaflet carefully before you start taking 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.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

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 take [Lacosamide]

How to take [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 take [Lacosamide]

Do not take [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 take [Lacosamide] 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] 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

taking [Lacosamide].

If you are taking [Lacosamide] and you are experiencing symptoms of abnormal heartbeat

(such

slow,

rapid

irregular

heartbeat,

palpitations,

shortness

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

taking [Lacosamide].

[Lacosamide] with alcohol

As a safety precaution do not take [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 taking this medicine.

It is not recommended to take [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 take [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.

[Lacosamide] syrup contains

one ingredient called methyl hydroxybenzoate (E 218) which may cause allergic reactions

(possibly delayed).

sorbitol (E 420). Sorbitol is a source of fructose. If your doctor has told you that you (or

your child) have an intolerance to some sugars or if you have been diagnosed with

hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot

break down fructose, talk to your doctor before you (or your child) take or receive this

medicine.

1.35 mg sodium (main component of cooking/table salt) in each ml, which is 81 mg

sodium per 60 ml (the maximum recommended daily dose). This is equivalent to 4% of

the recommended maximum daily dietary intake of sodium for an adult.

3.

How to take [Lacosamide]

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

pharmacist if you are not sure.

Taking [Lacosamide]

Take [Lacosamide] twice each day - once in the morning and once in the evening.

Try to take it at about the same time each day.

You may take [Lacosamide] with or without food.

You will usually start by taking a low dose each day and your doctor will slowly increase this

over a number of weeks. When you reach the dose that works for you, this is called the

‘maintenance dose’, you then take the same amount each day. [Lacosamide] is used as a long

term treatment. You should continue to take [Lacosamide] until your doctor tells you to stop.

How much to take

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

Use the measuring cup provided in the carton box.

When you take [Lacosamide] on its own

The usual starting dose of [Lacosamide] is 50 mg (5 ml) twice a day.

Your doctor may also prescribe a starting dose of 100 mg (10 ml) of [Lacosamide] twice a

day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until

you reach a maintenance dose between 100 mg (10 ml) and 300 mg (30 ml) twice a day.

When you take [Lacosamide] with other antiepileptic medicines

The usual starting dose of [Lacosamide] is 50 mg (5 ml) twice a day.

Your doctor may increase your twice daily dose every week by 50 mg (5 ml). This will be until

you reach a maintenance dose between 100 mg (10 ml) and 200 mg (20 ml) 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 (20 ml). You would then start your ongoing maintenance

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

dose 12 hours later.

Children and adolescents weighing less than 50 kg

Use the oral syringe provided in the carton box.

When you take [Lacosamide] on its own

Your doctor will decide the dose of [Lacosamide] 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.

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 recommended 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:

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

right dose for you.

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

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

50 kg:

When you take [Lacosamide] with other antiepileptic medicines

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

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

body

weight.

This

will

until

reach

maintenance

dose.

maximum

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

is provided below.

Taking [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 taken 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

body

weight.

This

will

until

reach

maintenance

dose.

maximum

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

is provided below.

Taking [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 taken 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

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

body

weight.

This

will

until

reach

maintenance

dose.

maximum

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

is provided below.

Taking [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 taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under

50 kg:

Instructions for use: measuring cup

Adults, adolescents and children weighing 50 kg or more

Use the measuring cup provided in this pack.

Shake the bottle well before use.

Fill the measuring cup to the graduation mark(s) corresponding to your prescribed dose.

Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg (for example

2 graduation marks correspond to 100 mg).

Swallow the dose of syrup and then

drink some water.

Instructions for use: oral syringe

Your doctor will show you how to use the oral syringe, before you use it for the first time. If you

have any questions, please go back to your doctor or pharmacist.

Children and adolescents weighing less than 50 kg

Use the oral syringe and the adaptor provided in this pack.

Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).

Follow these steps the first time you take [Lacosamide]:

Take off the adaptor from the oral syringe (figure 2).

Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You

do not need to remove the adaptor after use.

Follow these steps each time you take [Lacosamide]:

Put the oral syringe into the adaptor opening (figure 4).

Turn the bottle upside down (figure 5).

Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.

Pull the piston down to fill the oral syringe with a small amount of solution (figure 6).

Push the piston up to get rid of any bubbles (figure 7).

Pull the piston down to the millilitre (ml) dose marker prescribed by your doctor

(figure 8).

Turn the bottle the right way up (figure 9).

Take the oral syringe out of the adaptor (figure 10).

There are two ways in which you can choose to drink the medicine:

Empty the contents of the oral syringe into a little water by pushing the piston to the

bottom of the oral syringe (figure 11) – you will then need to drink all of the water (add

just enough to make it easy to drink) or

Drink the solution directly from the oral syringe without water (figure 12) – drink the

whole content of the oral syringe.

Close the bottle with the plastic screw cap (you do not need to remove the adaptor).

Wash the oral syringe with water only (figure 13).

You may take [Lacosamide] with or without food.

If you take more [Lacosamide] than you should

If you have taken more [Lacosamide] than you should, contact your doctor immediately. Do

not try to drive.

You may experience:

Dizziness

Feeling sick (nausea) or being sick (vomiting)

Fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a

fall in blood pressure with rapid heartbeat and sweating.

If you forget to take [Lacosamide]

If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon

as you remember.

If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the

missed syrup anymore. Instead take [Lacosamide] at the next time that you would

normally take it.

Do not take a double dose to make up for a forgotten dose.

If you stop taking [Lacosamide]

Do not stop taking [Lacosamide] without talking to your doctor, as your epilepsy may

come back again or become worse.

If your doctor decides to stop your treatment with [Lacosamide], he/she will instruct you

about how you should decrease the dose step by step.

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).

serious

skin

reaction

which

include

high

temperature

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 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 bottle after

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

Once you have opened the syrup bottle, you must not use it longer than a maximum of

2 months.

This medicine does not require any special storage conditions.

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] syrup contains 10 mg lacosamide.

The other ingredients are:

Glycerol, methyl hydroxybenzoate (E 218), carmellose sodium, sorbitol liquid (E 420),

Macrogol, sodium chloride, citric acid monohydrate, sodium citrate, sucralose, strawberry

flavor (contains propylene glycol), maltol, purified water.

What [Lacosamide] looks like and contents of the pack

[Lacosamide] 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid with

the smell and taste of strawberries.

[Lacosamide] is available in bottles of 100, 200, 300 or 500 ml.

Not all pack sizes may be marketed.

A measuring cup with graduation marks (5 ml corresponding to 50 mg lacosamide) is provided

with the syrup,

suitable for adults, adolescents and children weighing 50 kg and above.

An oral syringe is suitable for children and adolescents below 50 kg. It is designed for a

maximum single dispensed dosage volume of 12.5 ml. 10 ml of the oral syringe corresponds

to 100 mg of lacosamide. As from the 1 ml graduation mark, each graduation corresponds to

0.25 ml which is 2.5 mg of lacosamide.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was last revised in November 2020.

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