Lacosamide Adroiq 10 mg/ml solution for infusion
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Lacosamida Adroiq is and what it is used for
- 2. What you need to know before starting to use Lacosamida Adroiq
- 3. How to use Lacosamida Adroiq
- 4. Possible adverse effects
- 5. Storage of Lacosamide Adroiq
- 6. Contents of the container and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Lacosamida Adroiq 10mg/ml for infusion
lacosamida
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Lacosamida Adroiq is and what it is used for
- What you need to know before using Lacosamida Adroiq
- How to use Lacosamida Adroiq
- Possible side effects
- How to store Lacosamida Adroiq
- Contents of the pack and other information
1. What Lacosamida Adroiq is and what it is used for
What Lacosamida Adroiq is
Lacosamida Adroiq contains lacosamide, which belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy.
- You have been prescribed this medicine to reduce the number of seizures you experience.
What Lacosamida Adroiq is used for
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Lacosamida Adroiq is used:
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alone or in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age for the treatment of a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;
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in combination with other antiepileptic drugs in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (major seizures with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).
2. What you need to know before starting to use Lacosamida Adroiq
Do not use Lacosamida Adroiq
- if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
- if you have a heart rhythm problem called second- or third-degree AV block.
Do not use Lacosamida Adroiq if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before starting to use Lacosamida Adroiq if:
- you have suicidal or self-harming thoughts. A small number of people being treated with antiepileptic medicines such as lacosamide have had suicidal or self-harming thoughts. If at any time you have such thoughts, contact your doctor immediately.
- you have a heart condition affecting your heartbeat and often have a particularly slow, fast, or irregular pulse (such as AV block, atrial fibrillation, or atrial flutter).
- you have severe heart disease such as heart failure or have had a myocardial infarction.
- you feel dizzy or fall frequently. Lacosamida Adroiq may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before using Lacosamida Adroiq.
If you are taking Lacosamida Adroiq, consult your doctor if you experience a new type of seizure or worsening of existing seizures.
If you are taking Lacosamida Adroiq and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), contact your doctor immediately (see section 4).
Children
Lacosamida Adroiq is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, or for children under 4 years of age with generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children of these age groups.
Other medicines and Lacosamida Adroiq
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as Lacosamida Adroiq may also affect the heart:
- medicines used to treat heart problems.
- medicines that may increase the "PR interval" on a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin.
- medicines used to treat certain types of arrhythmia or heart failure.
If any of the situations mentioned above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Lacosamida Adroiq.
Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of Lacosamida Adroiq in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
- medicines for the treatment of HIV, such as ritonavir.
- medicines used to treat bacterial infections, such as clarithromycin or rifampicin.
- a herbal remedy used for the treatment of anxiety and mild depression called St. John's wort.
If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before using Lacosamida Adroiq.
Lacosamida Adroiq and alcohol
As a safety precaution, do not take Lacosamida Adroiq with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Lacosamida Adroiq is not recommended during pregnancy, as the effects of Lacosamida Adroiq on pregnancy and the fetus are not known.
Breastfeeding is not recommended while taking Lacosamida Adroiq, because lacosamide passes into breast milk.
Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not to take Lacosamida Adroiq.
Do not stop treatment without first talking to your doctor, as this could increase seizures. Worsening of your condition may also harm the fetus.
Driving and using machines
Avoid driving, cycling, or operating any tools or machinery until you know how this medicine affects you. Indeed, Lacosamida Adroiq may cause dizziness or blurred vision.
Lacosamida Adroiq contains sodium
This medicine contains 59.8 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.
3. How to use Lacosamida Adroiq
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use of Lacosamida Adroiq
- Treatment with Lacosamida Adroiq may be initiated
- via intravenous infusion (sometimes referred to as "IV infusion"), where the medicine is administered intravenously by a doctor or nurse. It is administered over 15 to 60 minutes.
- Your doctor will decide for how many days you should receive infusions.
- Administration of two daily infusions of lacosamide has been studied for up to five days. For long-term treatment, lacosamide tablets and oral solution are available.
When switching from infusion to oral medication (or vice versa), the total daily dose and frequency of administration will remain similar.
- Take lacosamida twice daily (approximately 12 hours apart)
- Try to take it at approximately the same time each day.
What dose to use
Below are the normally recommended doses of Lacosamida Adroiq for different age and weight groups. 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 taking Lacosamida Adroiq as monotherapy:
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The usual starting dose of Lacosamida Adroiq is 50 mg twice daily.
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Treatment with Lacosamida Adroiq may also begin with a dose of 100 mg of Lacosamida Adroiq twice daily.
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Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When using Lacosamida Adroiq with other antiepileptic medicines:
- The usual starting dose of Lacosamida Adroiq is 50 mg twice daily.
- Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 200 mg twice daily.
- If you weigh 50 kg or more, your doctor may start Lacosamida Adroiq treatment with a single "loading dose" of 200 mg. You would then begin taking the regular maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that Lacosamida Adroiq is not recommended for children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Lacosamida Adroiq is not recommended for children under 4 years of age.
When using Lacosamida Adroiq as monotherapy:
- Your doctor will determine the dose of Lacosamida Adroiq based on your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may increase your daily doses by 1 mg (0.1 ml) per kilogram of body weight. This will continue until a maintenance dose is reached.
- Dosage tables below include the maximum recommended doses. Your doctor will determine the correct dose tailored to your individual needs.
For twice-daily use in children from two years of age with a body weight between 10 and 40 kg
Weight | Week 1 Starting 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 Maximum recommended dose: 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 | 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 |
For twice-daily use in children aged two years and older with a body weight between 40 and 50 kg:
Weight | Week 1 Starting 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 dose: 0.5 ml/kg |
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 |
When using Lacosamida Adroiq with other antiepileptic medicines
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Your doctor will determine the dose of Lacosamida Adroiq based on your body weight.
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For children and adolescents weighing between 10 kg and less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
-
Your doctor may increase your dose by 1 mg (0.1 ml) per kg of body weight twice daily each week. This will continue until a maintenance dose is reached.
-
The dosing tables below include the maximum recommended dose. Your doctor will determine the correct dose tailored to your individual needs.
For twice-daily use in children from two years of age with a body weight between 10 and 20 kg
Weight | Week 1 Starting 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 Recommended maximum dose: 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 | 9 ml |
For twice-daily use in children aged two years and older with a body weight between 20 and 30 kg:
Weight | Week 1 Starting 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 dose: 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 | 10 ml | 12.5 ml |
For twice-daily use in children from two years of age with a body weight between 30 and 50 kg:
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 Maximum recommended dose: 0.4 ml/kg |
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 Lacosamida Adroiq
If your doctor decides to discontinue your treatment with Lacosamida Adroiq, they will give you instructions on how to gradually reduce the dose. This is intended to prevent the recurrence or worsening of epilepsy.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Nervous system effects such as dizziness may be greater after a single "loading" dose.
Tell your doctor or pharmacist if you experience any of the following effects:
Very common: may affect more than 1 in 10 patients
- Headache;
- Feeling dizzy or sick (nausea);
- Double vision (diplopia).
Common: may affect up to 1 in 10 patients
- Brief jerking movements of a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems with balance, tremor, tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of dizziness (vertigo), feeling of drunkenness;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhoea;
- Reduced sensation, difficulty articulating words, attention disturbance;
- Ringing in the ears such as buzzing, ringing, or hissing (tinnitus);
- Irritability, trouble sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, rash.
Uncommon: may affect up to 1 in 100 patients
- Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
- Allergic reaction to the medicine, hives;
- Blood tests may show abnormalities in liver function tests, liver damage;
- Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
- Feeling angry or agitated;
- Abnormal thoughts or loss of sense of reality;
- Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
- Fainting;
- Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from available data
- Abnormally fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
- Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cells (eosinophilia);
- 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 skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizures.
Additional adverse effects when administered as intravenous infusion
Local adverse effects may occur.
Common: may affect 1 in 10 people
- Pain, discomfort, or irritation at the injection site.
Uncommon: may affect 1 in 100 people
- Redness at the injection site.
Additional adverse effects in children
Additional adverse effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioural changes, not acting as they normally do (abnormal behaviour), and lack of energy (lethargy). Drowsiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lacosamide Adroiq
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after CAD/EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Each vial of Lacosamide Adroiq solution for infusion is for single use only. Any unused solution must be discarded.
Only use a clear solution that is free from particles and discoloration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the container and other information
Composition of Lacosamida Adroiq
- The active substance is lacosamide.
1 ml of Lacosamida Adroiq, solution for infusion, contains 10 mg of lacosamide.
One vial of Lacosamida Adroiq, solution for infusion, contains 20 ml, equivalent to 200 mg of lacosamide.
- The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
- See Section 2 “This medicinal product contains 59.8 mg of sodium” (main component of table/cooking salt) per vial.
Appearance of Lacosamida Adroiq and contents of the pack
Lacosamida Adroiq, solution for infusion, is a clear, colourless solution.
Lacosamida Adroiq, solution for infusion, is available in packs containing 1 or 5 vials.
Each vial contains 20 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Extrovis EU Ltd.
Pátriárka utca 14.
2000 Szentendre
Hungary
Manufacturer responsible for batch release
Pharma Pack Hungary Kft.
Vasút u. 13.
2040 Budaörs
Hungary
For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Extrovis EU Ltd. Tel/Tel: +41 41 740 1120 | Lithuania Extrovis EU Ltd. Tel: +41 41 740 1120 |
Extrovis EU Ltd. Tel.: +41 41 740 1120 | Luxembourg/Luxembourg Extrovis EU Ltd. Tel/Tel: +41 41 740 1120 |
Czech Republic Extrovis EU Ltd. Tel: +41 41 740 1120 | Hungary Extrovis EU Ltd. Tel.: +41 41 740 1120 |
Denmark Mashal Healthcare A/S Tlf: +45 71 86 37 68 | Malta Extrovis EU Ltd. Tel: +41 41 740 1120 |
Germany Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010 | Netherlands Extrovis EU Ltd. Tel: +41 41 740 1120 |
Estonia Extrovis EU Ltd. Tel: +41 41 740 1120 | Norway Mashal Healthcare A/S Tlf: +45 71 86 37 68 |
Greece Extrovis EU Ltd. Tel: +41 41 740 1120 | Austria Zentiva, k.s. Tel: +43 720 778 877 |
Spain Zentiva, k.s. Tel: +34 931 815 250 | Poland Extrovis EU Ltd. Tel.: +41 41 740 1120 |
France Zentiva France Tel: +33 (0) 800 089 219 | Portugal Extrovis EU Ltd. Tel: +41 41 740 1120 |
Croatia Extrovis EU Ltd. Tel: +41 41 740 1120 | Ireland Extrovis EU Ltd. Tel: +41 41 740 1120 |
Romania Extrovis EU Ltd. Tel: +41 41 740 1120 | Slovenia Extrovis EU Ltd. Tel: +41 41 740 1120 |
Iceland Extrovis EU Ltd. Tel: +41 41 740 1120 | Slovakia Extrovis EU Ltd. Tel: +41 41 740 1120 |
Italy Zentiva Italia S.r.l. Tel: +39-02-38598801 | Finland/Sweden Mashal Healthcare A/S Tel/Tel: +45 71 86 37 68 |
Cyprus Extrovis EU Ltd. Tel: +41 41 740 1120 | Sweden Mashal Healthcare A/S Tel: +45 71 86 37 68 |
Latvia Extrovis EU Ltd. Tel: +41 41 740 1120 | United Kingdom (Northern Ireland) Extrovis EU Ltd. Tel: +41 41 740 1120 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
This information is intended only for healthcare professionals:
Each vial of Lacosamida Adroiq solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamida Adroiq solution for infusion can be administered without further dilution, or it may 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 standpoint, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature of 2 to 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25 °C and at 2–8 °C for preparations mixed with these diluents and stored in glass or polyvinyl chloride (PVC) bags.