Lacosamide Tarbis Farma 10 mg/ml solution for infusion EFG
Spain
Table of Contents
- Package leaflet: Information for the patient
- Introduction
- 1. What Lacosamida Tarbis Farma is and what it is used for
- 2. What you need to know before starting to take Lacosamida Tarbis Farma
- 3. How to take/use Lacosamida Tarbis Farma
- 4. Possible adverse effects
- 5. Storage of Lacosamida Tarbis Farma
- 6. Contents of the pack and other information
Package leaflet: Information for the patient
Introduction
Package leaflet: information for the patient
Lacosamida Tarbis Farma 10 mg/ml solution for infusion EFG
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 any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Lacosamida Tarbis Farma is and what it is used for
- What you need to know before using Lacosamida Tarbis Farma
- How to use Lacosamida Tarbis Farma
- Possible adverse effects
- How to store Lacosamida Tarbis Farma
- Contents of the pack and other information
1. What Lacosamida Tarbis Farma is and what it is used for
What Lacosamida Tarbis Farma is
Lacosamida Tarbis Farma 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 Tarbis Farma is used for
- Lacosamide is used:
- as monotherapy and in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age, to treat 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;
- in combination with other antiepileptic drugs in adults, adolescents, and children from 4 years of age, 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 Lacosamida Tarbis Farma
Do not use Lacosamida Tarbis Farma
- 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 certain type of heart rhythm problem called second- or third-degree AV block.
Do not use lacosamide if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medicine.
Warnings and precautions
Talk to your doctor before starting to use lacosamide if:
- you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If you experience such thoughts at any time, 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 often feel dizzy or fall frequently. Lacosamide 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 starting to use lacosamide.
If you are taking lacosamide, consult your doctor if you experience a new type of seizure or a worsening of existing seizures.
If you are taking lacosamide and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), consult your doctor immediately (see section 4).
Children
Lacosamide 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 its efficacy and safety in children of these age groups have not yet been established.
Other medicines and Lacosamida Tarbis Farma
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamide 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 antiepileptic or pain medicines called carbamazepine, lamotrigine, and 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 starting to use lacosamide.
Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of lacosamide in your body:
- antifungal medicines such as fluconazole, itraconazole, and ketoconazole;
- an HIV medicine such as ritonavir;
- antibiotics such as clarithromycin and rifampicin;
- a herbal remedy used to treat mild anxiety and depression called St. John’s wort (Hypericum perforatum).
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use lacosamide.
Use of Lacosamida Tarbis Farma with alcohol
As a safety precaution, do not take lacosamide with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Lacosamide is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are not known.
Breastfeeding is not recommended while taking lacosamide, because lacosamide passes into breast milk.
Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. Your doctor will help you decide whether or not you should take lacosamide.
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
Do not drive, ride a bicycle, or operate machinery until you know how this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.
Lacosamida Tarbis Farma contains sodium
This medicine contains 59.8 mg of sodium (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 take/use Lacosamida Tarbis Farma
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use of Lacosamida Tarbis Farma
- Treatment with lacosamide may be started:
- by taking the medicine orally, or
- administered as an intravenous infusion (sometimes referred to as IV infusion), during which the doctor or nurse administers the medicine into a vein. The administration lasts from 15 to 60 minutes.
- The IV infusion is usually used for a short period of time, when the medicine cannot be taken orally.
- Your doctor will decide for how many days infusions will be administered. Experience exists with administering lacosamide infusions twice daily for up to 5 days. For longer-term treatment, lacosamide tablets and oral solution are available.
When switching from infusion to oral intake or vice versa, the total daily amount you take and the frequency will remain the same.
- Take lacosamide twice daily (with an interval of approximately 12 hours).
- Try to take it at approximately the same time each day.
What dose to use
The following are the normally recommended doses of lacosamide 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 using lacosamide alone:
- The usual starting dose is 50 mg twice daily.
- Treatment with lacosamide may also start with a dose of 100 mg lacosamide twice daily.
- 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 lacosamide with other antiepileptic medicines:
The usual starting dose 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 decide to start lacosamide treatment with a single "loading" dose of 200 mg. You will then begin taking your ongoing 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 determine the lacosamide dose 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 twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until reaching the maintenance dose.
- Dosage tables with the recommended maximum doses are shown below.
- These doses are for informational purposes only. Your doctor will calculate the correct dose for you.
To be used twice daily, for children aged 2 years and older who weigh from 10 kg to less than 40 kg
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 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 used twice daily, for adolescents and children weighing 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 Recommended maximum 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 medicines
- Your doctor will determine the lacosamide dose according to your body weight.
- For children and adolescents weighing from 10 kg to less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may increase the dose taken twice daily by 1 mg (0.1 ml) per kg of body weight each week until the maintenance dose is reached.
- The dosing tables below show the maximum recommended dose.
- These doses are for informational purposes only. Your doctor will calculate the correct dose for you.
To be used twice daily, for children from 2 years of age weighing from 10 kg to 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 | 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 used twice daily, for adolescents and children weighing 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 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 |
To be used twice daily, for adolescents and children weighing 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 discontinue treatment with Lacosamida Tarbis Farma
If your doctor decides to discontinue your treatment with lacosamide, your dose will be gradually reduced step by step. This is to prevent epilepsy from recurring or worsening.
If you have any further questions about the use of this product, 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 of a muscle or group of muscles (myoclonic seizures);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, agitation (tremor), tingling (paraesthesia), or muscle spasms, falling easily and bruising;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid uncontrolled eye movements (nystagmus), blurred vision;
- Feeling dizzy (vertigo), sensation of drunkenness;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
- Reduced sensitivity, difficulty articulating words, attention disorder;
- Ringing in the ears such as buzzing or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, tiredness 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 taking the medicine, hives;
- Blood tests may show abnormalities in liver function, liver damage;
- Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
- Feeling angry or agitated;
- Abnormal thoughts and/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 levels of liver enzymes and of a type of white blood cells (eosinophilia);
- Widespread rash with blisters and skin peeling, 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.
Other adverse effects of intravenous administration
Local adverse 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 adverse effects in children
Additional adverse effects observed in children were 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 adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lacosamida Tarbis Farma
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 vial. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Each vial of Lacosamida Tarbis Farma solution for infusion is for single use only. Any unused solution must be discarded.
Only clear solutions that are free from particles and show no change in colour should be used.
Medicines must not be disposed of via wastewater or household waste. Return empty containers and any medicines no longer required to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lacosamida Tarbis Farma
The active substance is lacosamide.
1 ml of Lacosamida Tarbis Farma solution for infusion contains 10 mg of lacosamide.
1 vial contains 20 ml of solution for infusion, equivalent to 200 mg of lacosamide.
The other components are:
sodium chloride, hydrochloric acid 0.85% v/v and water for injections.
Appearance of the product and contents of the pack
Lacosamida Tarbis Farma 10 mg/ml solution for infusion is a clear, colourless solution.
Lacosamida Tarbis Farma solution for infusion is available in packs containing 1 vial and 5 vials.
Each vial contains 20 ml.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Tarbis Farma S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain
Manufacturer
Amarox Pharma B.V.
Rouboslaan 32
Voorschoten, 2252TR
The Netherlands
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Lacosamid Amarox 10 mg/ml Infusionslösung
Spain: Lacosamida Tarbis Farma 10 mg/ml solución para perfusión EFG
Netherlands: Lacosamide Amarox 10 mg/ml, oplossing voor infusie
Date of the most recent revision of this leaflet: October 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
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This information is intended only for medical or healthcare professionals:
Each vial of Lacosamida Tarbis Farma solution for infusion is for single use only. Any unused solution must be discarded (see section 3).
Lacosamida Tarbis Farma solution for infusion may 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 lactated Ringer's solution.
From a microbiological standpoint, the product 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 must not exceed 24 hours at a temperature of 2 to 8 °C, unless dilution has taken place under validated controlled and aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25 °C for drug products mixed with these diluents and stored in glass or PVC bags.