LACOSAMIDE 10 mg /Ml Roztwór Do Infuzji
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Treść ulotki
Lacosamide Adroiq 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 Adroiq is and what it is used for
- 2. What you need to know before you use Lacosamide Adroiq
- 3. How to use Lacosamide Adroiq
- 4. Possible side effects
- 5. How to store Lacosamide Adroiq
- 6. Contents of the pack and other information
1. What is Lacosamide Adroiq and what is it used for
What is Lacosamide Adroiq
Lacosamide Adroiq 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 is Lacosamide Adroiq used for
- Lacosamide Adroiq 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 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 thought to have a genetic cause).
2. What you need to know before using Lacosamide Adroiq
Do not use Lacosamide Adroiq
- 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 Adroiq if any of the above apply to you. If you are not sure, ask your doctor or
pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Adroiq if:
- you have thought about harming yourself or committing suicide. A small number of people treated with antiepileptic drugs
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 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 Adroiq 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 any of the above apply to you (or you are not sure), ask your doctor or pharmacist before using Lacosamide Adroiq. If you are taking Lacosamide Adroiq, talk to your doctor if you have a different type of seizure or your existing seizures get worse. If you are taking Lacosamide Adroiq and experience symptoms of an abnormal heartbeat (such as a slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy or fainting), see your doctor immediately (see section 4).
Children
Lacosamide Adroiq 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 Adroiq
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 Adroiq 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 types of irregular heartbeat or heart failure. If any of the above apply to you (or you are not sure) ask your doctor or pharmacist before using Lacosamide Adroiq.
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 Adroiq on your body:
- medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
- a medicine for HIV such as ritonavir;
- medicines for bacterial infections such as clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St John's Wort. If any of the above apply to you (or you are not sure), ask your doctor or pharmacist before using Lacosamide Adroiq.
Lacosamide Adroiq with alcohol
As a safety precaution, do not use Lacosamide Adroiq 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 using this medicine.
It is recommended not to use Lacosamide Adroiq during pregnancy, as the effects of
Lacosamide Adroiq on the fetus are unknown.
It is recommended not to breastfeed while taking Lacosamide Adroiq, as Lacosamide
Adroiq 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 Adroiq or not.
Do not stop treatment without consulting your doctor first, as this may cause an
increase in seizures. 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 Adroiq can cause dizziness or
blurred vision.
Lacosamide Adroiq contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt) in each
vial, which is equal to 3% of the recommended maximum daily intake of sodium for an adult.
3. How to use Lacosamide Adroiq
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable
for children: ask your doctor or pharmacist.
Using Lacosamide Adroiq
- Lacosamide Adroiq can be administered:
- with an intravenous infusion in which the medicine is administered into a vein by a doctor or a nurse. The medicine is administered over 15-60 minutes. The doctor will decide for how many days to perform the infusions.
- Experience has been gained with lacosamide infusions twice a day for a maximum of 5 days. For longer-term treatment lacosamide is available in tablets and syrup. When switching from infusion to oral administration of the drug (or vice versa), the total amount to be taken each day and the frequency remain unchanged.
- Use lacosamide twice every day (approximately 12 hours apart).
- Try to use it at about the same time each day.
How much to use
Below are listed the normal recommended doses of Lacosamide Adroiq for different age
groups and weights. Your doctor may prescribe a different dose if you suffer from kidney or liver problems.
Adolescents and children weighing 50 kg or more and adults
When using Lacosamide Adroiq alone
- The initial dose of Lacosamide Adroiq is usually 50 mg twice a day.
- Treatment with Lacosamide Adroiq may also start with a dose of 100 mg of Lacosamide Adroiq 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 using Lacosamide Adroiq with other antiepileptic medicines
- The initial dose of Lacosamide Adroiq is usually 50 mg twice a day.
- Your doctor may increase the 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.
day.
- If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Adroiq 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 Adroiq is not recommended in children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Adroiq is not recommended in children under 4 years of age.
When using Lacosamide Adroiq alone
- The doctor will decide the dose of Lacosamide Adroiq based on body weight.
- The usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
- The doctor may then increase the dose twice a day by 1 mg (0.1 ml) per kg of body weight each week, up to the maintenance dose.
- Below are dosage tables including the recommended maximum dose, for informational purposes only. The doctor will establish the right dose for the patient.
To be used twice a day for children starting from 2 years of age with a weight between 10 and
less than 40 kg
To be used twice a day for children and adolescents with a weight between 40 and less than 50 kg:
When using Lacosamide Adroiq with other antiepileptic drugs
- The doctor will decide the dose of Lacosamide Adroiq based on body weight.
- For children and adolescents weighing between 10 and less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
- The doctor may then increase the dose twice a day by 1 mg (0.1 ml) per kg of body weight each week, up to the maintenance dose.
- Below are dosage tables including the recommended maximum dose, for informational purposes only. The doctor will establish the right dose for the patient.
To be used twice a day for children starting from 2 years of age with a weight between 10 and
less than 20 kg
| Weight | Week 1 Initial dose 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg a | d Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 Maximum recommended dose: 0.6 ml/kg |
| 10 kg | 1 ml | 2 ml | n 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 | a 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 | i 9 ml | 12 ml | 15 ml | 18 ml |
| 35 kg | 3.5 ml | l 7 ml | 10.5 ml | 14 ml | 17.5 ml | 21 ml |
| Weight | t I Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 Maximum recommended: 0.5 ml/kg |
| 40 kg | a 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 |
To be used twice a day for children and adolescents with a weight between 20 and less than 30 kg:
To be used twice a day for children and adolescents with a weight between 30 and less than 50 kg:
If you stop using Lacosamide Adroiq
If your doctor decides to stop the therapy with Lacosamide Adroiq, they will gradually reduce the dose
to avoid a relapse or worsening of epilepsy.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects affecting the nervous system, such as dizziness, may be more frequent
after a single “loading” dose.
See your doctor or pharmacist if you experience any of the following symptoms:
Very common:may affect more than 1 in 10 people
- Headache;
- Feeling dizzy or nauseous;
- Double vision (diplopia).
Common:may affect up to 1 in 10 people
- Brief spasms in a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, tremors, tingling (paresthesia) or muscle spasms, 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
| Weight | Week 1 Initial dose 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 Dose or maximum recommended: 0.6 ml/kg |
| 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 | c 9 ml |
| Weight | Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | m Week 4 0.4 ml/kg r | Week 5 Maximum dose recommended: 0.5 ml/kg |
| 20 kg | 2 ml | 4 ml | 6 ml | 8 ml | 10 ml |
| 25 kg | 2.5 ml | 5 ml | 7.5 ml | a 10 ml | 12.5 ml |
| Weight | Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 l 0.3 ml/kg | Week 4 Maximum dose recommended: 0.4 ml/kg |
| 30 kg | 3 ml | 6 ml | e 9 ml | 12 ml |
| 35 kg | 3.5 ml | 7 ml | 10.5 ml | 14 ml |
| 40 kg | 4 ml | 8 ml | d 12 ml | 16 ml |
| 45 kg | 4.5 ml | 9 ml | 13.5 ml | 18 ml |
in the intestine, diarrhea;
- Decreased sense of touch or sensation, difficulty articulating words, attention disorder;
- Noises in the ear such as ringing, whistling or buzzing;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, rash.
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 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 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 of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing peeling skin in more than 30% of the body surface (toxic epidermal necrolysis);
- Convulsions.
Other side effects when administered as an intravenous infusion
There may be side effects at the injection site.
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 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). Sleepiness is a very common side effect in children and may affect more than 1 child in
- 10.
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 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 Adroiq
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 on the vial
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Each vial of Lacosamide Adroiq solution for infusion must be used only once
(single-use). The unused solution must be discarded.
Only a clear solution, free from particles and discolouration, should be used.
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. Contents of the pack and other information
What Lacosamide Adroiq contains
- The active substance is lacosamide. 1 ml of Lacosamide Adroiq solution for infusion contains 10 mg of lacosamide. 1 vial contains 20 ml of Lacosamide Adroiq solution for infusion, equivalent to 200 mg of lacosamide.
- The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
- See section 2: This medicine contains 59.8 mg of sodium (the main component of table salt) in each vial.
Description of the appearance of Lacosamide Adroiq and contents of the pack
- Lacosamide Adroiq solution for infusion is a clear and colourless solution.
Lacosamide Adroiq solution for infusion is available in packs of 1 or 5 vials. Each
vial contains 20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Extrovis EU Ltd.
Pátriárka utca 14.
2000 Szentendre
Hungary
Manufacturer
Pharma Pack Hungary Kft.
Vasút u. 13.
2040 Budaörs
Hungary
Pharma Pack Hungary Kft.
Building B, Raktarvarosi Ut 9,
Torokbalint,
2045 Hungary
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Extrovis EU Ltd.
Tél/Tel: +41 41 740 1120
[email protected]
Lietuva
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
България
Extrovis EU Ltd.
Teл.: +41 41 740 1120
[email protected]
Luxembourg/Luxemburg
Extrovis EU Ltd.
Tél/Tel: +41 41 740 1120
[email protected]
Česká republika
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Magyarország
Extrovis EU Ltd.
Tel.: +41 41 740 1120
[email protected]
Malta
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]
Danmark
Mashal Healthcare A/S
Tlf: +45 71 86 37 68
[email protected]
Nederland
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Eesti
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Norge
Mashal Healthcare A/S
Tlf: +45 71 86 37 68
[email protected]
Ελλάδα
Extrovis EU Ltd.
Τηλ: +41 41 740 1120
[email protected]
Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]
España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
[email protected]
Polska
Extrovis EU Ltd.
Tel.: +41 41 740 1120
[email protected]
France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]
Portugal
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Hrvatska
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Ireland
Extrovis EU Ltd.
Tel: +41 41 740 1120
România
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Slovenija
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected] [email protected]
Ísland
Extrovis EU Ltd.
Sími: +41 41 740 1120
[email protected]
Slovenská republika
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]
Suomi/Finland
Mashal Healthcare A/S
Puh/Tel: +45 71 86 37 68
[email protected]
Κύπρος
Extrovis EU Ltd.
Τηλ: +41 41 740 1120
[email protected]
Sverige
Mashal Healthcare A/S
Tel: +45 71 86 37 68
[email protected]
Latvija
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
United Kingdom (Northern Ireland)
Extrovis EU Ltd.
Tel: +41 41 740 1120
[email protected]
Other sources of 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 Adroiq solution for infusion must be used only once
(single use). Any unused solution must be discarded (see section 3).
Lacosamide Adroiq solution for infusion can be administered without further dilution,
or it can be diluted with the following solutions: sodium chloride 9 mg/mL (0.9 %),
glucose 50 mg/mL (5 %), or Ringer's lactate solution.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times during use and the conditions prior to use are
the responsibility of the user and should not exceed 24 hours between 2 and 8 °C, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical stability during use has been demonstrated for 24 hours at temperatures up to 25 °C and at
2-8 °C for the product mixed with these diluents and stored in glass containers or polyvinyl chloride (PVC) bags.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 10 mg / ml
- Kod ATCN03AX18
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LAKOSAMIDE ADROIQPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: lacosamideProducent: ACCORD HEALTHCARE, S.L.U.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: lacosamideProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 50 MGSubstancja czynna: lacosamideProducent: DOC GENERICI SRLWymaga recepty
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LAKOSAMIDE ADROIQ wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LAKOSAMIDE ADROIQ jest lacosamide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LAKOSAMIDE ADROIQ jest produkowany przez EXTROVIS EU LTD. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie LAKOSAMIDE ADROIQ jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić LAKOSAMIDE ADROIQ w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (lacosamide) to m.in. LAKOSAMIDE AKKORD, LAKOSAMIDE AUROBINDO, LAKOSAMIDE DOK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
