Lacosamida fresenius kabi 10 mg/ml solucion para perfusion efg
Introduction
Patient Information:information for the Patient
Lacosamide Fresenius Kabi 10 mg/ml Infusion Solution EFG
Read this Patient Information 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
1. What is Lacosamida Fresenius Kabi and what is it used for
What is Lacosamida
This medicine contains lacosamida, which belongs to a group of medicines called
“anti-epileptic medicines”. These medicines are used to treat epilepsy.
•You have been prescribed this medicine to reduce the number of seizures you experience.
What is lacosamida used for
Lacosamida Fresenius Kabi is used:
- alone and in combination with other anti-epileptic medicines in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy characterized by the occurrence of 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;
- in combination with other anti-epileptic medicines in adults, adolescents, and children aged 4 years and older to treat 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 take Lacosamide Fresenius Kabi
Do not use Lacosamida Fresenius Kabi
•if you are allergic to lacosamida or any of the other ingredients in this medicine
(listed in section 6). If you are unsure if you are allergic, consult your doctor.
•if you have a certain type of heart rhythm problem called second- or third-degree AV block.
Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Consult your doctor before starting to use this medicine if:
•you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamida have had thoughts of self-harm or suicide. If
you have these thoughts at any time, contact your doctor immediately.
•you have a heart problem that affects your heartbeat and your pulse is often
especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
•you have a serious heart condition such as heart failure or have had a heart attack.
•you often get dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are
used to the effects of this medicine.
If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.
If you are taking this medicine, consult your doctor if you experience a new type of seizure or worsening of existing seizures.
If you are taking this medicine and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting, consult your doctor immediately (see section 4).
Children
Lacosamida is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years with primary generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.
Other medicines and Lacosamida Fresenius Kabi
Inform your doctor or pharmacist if you are using or have used recently or may have to take any other medicine.
Particularly, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamida may also affect the heart:
•medicines to treat heart problems.
•medicines that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin.
•medicines used to treat certain types of arrhythmia or heart failure.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking this medicine.
Inform your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of lacosamida in your body:
•antifungal medicines called fluconazole, itraconazole, or ketoconazole.
•a medicine for HIV called ritonavir.
•antibacterial medicines called clarithromycin or rifampicin.
•a medicinal herb used to treat mild anxiety and depression called St. John's Wort.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamida.
Use of Lacosamida Fresenius Kabi with alcohol
As a precaution, do not use this medicine with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptives 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 is not recommended if you are pregnant or breastfeeding, as its effects on pregnancy and the fetus or newborn are unknown.
Additionally, it is not known if lacosamida passes into breast milk.
Ask your doctor immediately if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.
Do not stop treatment without talking to your doctor, as this could increase seizures (crises). A worsening of your condition may also harm the fetus.
Driving and operating machinery
You should not drive, cycle, or use machines until you know if this medicine affects you. The reason is that lacosamida may cause dizziness or blurred vision.
Lacosamida Fresenius Kabi contains sodium
This medicine contains 59.8 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult.
3. How to take/use Lacosamida Fresenius Kabi
Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Usage ofLacosamidaFreseniusKabi
- The treatment with this medication can start:
- by taking the medication orally or
- administered as an intravenous infusion (also known as IV infusion) where your doctor or nurse will administer the medication through a vein. The infusion lasts from 15 to 60 minutes.
- The IV infusion is usually used for a short period of time when the medication cannot be taken orally.
- Your doctor will decide for how many days you will receive infusions. There is experience with the administration of lacosamide infusions twice a day for up to 5 days. For longer-term treatment, lacosamide tablets and syrup are available.
When changing from infusion to oral administration or vice versa, the total amount you will take per day and the frequency of administration will remain the same.
- Use lacosamide twice a day (with an interval of approximately 12 hours).
- Try to use it at roughly the same time every day.
How much to take
The following are the usual recommended doses of lacosamide for different age groups and weights. 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 using lacosamide alone:
The usual starting dose is 50 mg twice a day.
Treatment with lacosamide can also start with a dose of 100 mg of lacosamide twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.
When taking lacosamide with other antiepileptic medications::
The usual starting dose is 50 mg twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, 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 start treatment with a single "loading" dose of 200 mg. Then you would start taking the continuous maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- In the treatment of partial onset seizures:note that lacosamide is not recommended for children under 2 years of age.
-In the treatment of primary generalized tonic-clonic seizures:note that lacosamide is not recommended for children under 4 years of age.
When using lacosamide alone
- Your doctor will decide the dose of lacosamide based on your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), twice a day.
- Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
- The following are the dosage tables with the maximum recommended dose. These doses are merely informative. Your doctor will calculate the correct dose for you.
To be taken twice a day,for children aged 2 years or olderweighing 10 kg to less than 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 |
To be taken twice a day,for adolescents and childrenweighing 40 kg to less than 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 lacosamide with other antiepileptic medications
- Your doctor will decide the dose of lacosamide based on your body weight.
- For children and adolescents weighing 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
- Your doctor may increase the dose you take twice a day each week by 1 mg (0.1 ml) per kg of body weight, until you reach the maintenance dose.
- The following are the dosage tables with the maximum recommended dose. These doses are merely informative. Your doctor will calculate the correct dose for you.
To be taken twice a dayfor children aged 2 years or olderweighing 10 kg to less than 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 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 |
To be taken twice a day,for adolescents and childrenweighing 20 kg to less than 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 Maximum recommended dose: 0.5 ml/kg |
20 kg | 2 ml | 4 ml | 6 ml | 8 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml |
To be taken twice a day,for adolescents and childrenweighing 30 kg to less than 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 taking Lacosamida Fresenius Kabi
If your doctor decides to stop your treatment with this medication, they will gradually reduce your dose. This is to prevent seizures from recurring or worsening.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, lacosamide may cause side effects, although not everyone will experience them. Nervous system side effects, such as dizziness, may be more pronounced after a single "loading dose".
Inform your doctor or pharmacist if you experience any of the following side effects:
Very common: may affect more than 1 in 10 patients
•Headache;
•Feeling dizzy or nauseous;
•Diplopia (double vision).
Common: may affect up to 1 in 10 patients
•Myoclonic seizures (brief muscle or muscle group spasms);
•Difficulty coordinating movements or walking;
•Problems maintaining balance, agitation (tremor), paresthesia (tingling), or muscle spasms, easy falling, and bruising;
•Memory problems, difficulty thinking or finding words, confusion;
•Nystagmus (rapid, uncontrolled eye movements), blurred vision;
•Sensation of dizziness (vertigo), feeling intoxicated;
•Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
•Decreased sensitivity, difficulty articulating words, attention alteration;
•Ringing in the ears (tinnitus) like buzzing or hissing;
•Irritability, difficulty 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 heart electrical activity (conduction disorder);
•Exaggerated sense of well-being, seeing and/or hearing things that are not real;
•Allergic reaction to the medication, hives;
•Blood tests may show abnormalities in liver function tests, liver damage;
•Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;
•Feeling angry or agitated;
•Abnormal thoughts or loss of sense of reality;
•Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;
•Loss of consciousness.
•Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from available data
•Abnormally fast heart rate (ventricular tachyarrhythmia);
•Sore throat, elevated temperature, and increased frequency of infections; Blood tests may show severe decrease in a specific type of white blood cell (agranulocytosis);
•Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, facial rash, generalized rash with lymph node inflammation (enlarged lymph nodes); Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
•Generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis):
•Seizures.
Other side effects of intravenous administration
Local reactions may occur.
Common: may affect up to 1 in 10 patients
•Pain or discomfort at the injection site or irritation.
Uncommon: may affect up to 1 in 100 patients
•Redness at the injection site.
Other side effects in children
Additional side effects observed in children were fever (pyrexia), nasal congestion (nasopharyngitis), sore throat (pharyngitis), decreased appetite, changes in behavior, not acting normally (abnormal behavior), and lethargy. Drowsiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.Reporting side effects can help provide more information about the safety of this medication..
5. Conservation of Lacosamida Fresenius Kabi
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and on the vial after CAD. The expiration date is the last day of the month indicated.
Do not store at a temperature above 25 °C.
Each vial of Lacosamida Fresenius Kabi infusion solution must be used only once (single use). Unused solution must be discarded.
Only transparent solutions, free of particles, and without color change should be used.
Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Lacosamida Fresenius Kabi Composition
- The active ingredient is lacosamide.
1 ml of infusion solution contains 10 mg of lacosamide.
1 vial contains 20 ml of infusion solution, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid 0.86%, water for injectable preparations.
Product appearance and packaging contents
Lacosamida Fresenius Kabi 10 mg/ml infusion solution EFG is a transparent and colorless solution.
Lacosamida Fresenius Kabi infusion solution is available in 1, 5, and 10 vial packs. Each vial contains 20 ml of infusion solution.
Only some package sizes may be marketed.
Marketing Authorization Holder
Fresenius Kabi España S.A.U.
Torre Mapfre-Vila Olímpica
C/ Marina 16-18
08005-Barcelona
Spain
Responsible for manufacturing
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
or
Labesfal – Laboratórios Almiro, S.A.
Zona Industrial do Lagedo,
Santiago de Besteiros, 3465-157,
Portugal
Last review date of this leaflet: January 2024
Other sources of information
The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)This information is intended only for doctors or healthcare professionals:
Each vial of Lacosamida Fresenius Kabi infusion solution should be used only once (single use). Unused solution should be discarded (see section 3).
Lacosamida Fresenius Kabi infusion solution can be administered without additional dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or Ringer lactate solution.
Chemical and physical stability has been demonstrated for 7 days at temperatures up to 25 °C for medications mixed with these diluents and stored in glass or bags (PVC or No-PVC).
From a microbiological point of view, the medication should be used immediately. If not used immediately, storage times in use and previous conditions are the responsibility of the user and should not exceed 24 hours at a temperature of between 2 to 8 °C, unless the dilution has taken place in validated and controlled conditions.
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