Trelema 150 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

01-10-2019

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:
150 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
lakosamid 150 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 40 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 112 tabletter; Blister, 120 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
55378
Tillstånd datum:
2018-06-20

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Package leaflet: Information for the patient

Trelema 50 mg film-coated tablets

Trelema 100 mg film-coated tablets

Trelema 150 mg film-coated tablets

Trelema 200 mg film-coated tablets

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.

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.

Swallow the [Lacosamide] tablet with a glass of water.

You may take [Lacosamide] with or without food.

The tablet can be divided into equal doses.

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

When you take [Lacosamide] on its own

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

Your doctor may also prescribe a starting 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 take [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 below 50 kg

The dose depends on their body weight. They usually start treatment with the syrup and only

change to tablets if they are able to take tablets and get the correct dose with the different

tablet strengths. The doctor will prescribe the formulation that is best suited to them.

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 tablet 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 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 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.

Each tablet of [Lacosamide] 50 mg contains 50 mg lacosamide.

Each tablet of [Lacosamide] 100 mg contains 100 mg lacosamide.

Each tablet of [Lacosamide] 150 mg contains 150 mg lacosamide.

Each tablet of [Lacosamide] 200 mg contains 200 mg lacosamide.

The other ingredients are:

Tablet

core:

microcrystalline

cellulose,

hydroxypropylcellulose

substituted,

hydroxylpropylcellulose, crospovidone, colloidal anhydrous silica, magnesium stearate

Film-coat: poly(vinyl alcohol), macrogol, titanium dioxide (E 171), talc, colourants*

* The colourants are:

50 mg tablet:

iron

oxide

172),

black

iron

oxide

172),

indigo

carmine

aluminium lake (E 132)

100 mg tablet:

yellow iron oxide (E 172)

150 mg tablet:

yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide

(E 172)

200 mg tablet:

indigo carmine aluminium lake (E 132)

What [Lacosamide] looks like and contents of the pack

[Lacosamide] 50 mg are pink, oval film-coated tablets with a break-score on both sides.

tablet can be divided into equal doses.

[Lacosamide] 100 mg are yellow, oval film-coated tablets with a break-score on both sides.

The tablet can be divided into equal doses.

[Lacosamide] 150 mg are brown, oval film-coated tablets with a break-score on both sides.

The tablet can be divided into equal doses.

[Lacosamide] 200 mg are blue, oval film-coated tablets with a break-score on both sides. The

tablet can be divided into equal doses.

[Lacosamide] is available in packs of 10, 14, 20, 28, 30, 40, 56, 60, 84, 90, 100, 112, and 120

film-coated tablets. The packs are available with PVC/Al blister or PVC/PVdC/Al blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

G.L. Pharma GmbH, 8502 Lannach

Manufacturer

G.L. Pharma GmbH, 8502 Lannach

Delorbis Pharmaceuticals Ltd., 2643 Ergates, Lefkosia

This leaflet was last revised in November 2020.

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