Lacosamide Vivanta
Italy
Table of Contents
Package leaflet: Information for the patient
Lacosamide Vivanta 10 mg/mL solution for infusion
lacosamide
Generic medicine
Please read this leaflet carefully before taking 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 experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide Vivanta is and what it is used for
- What you need to know before using Lacosamide Vivanta
- How to use Lacosamide Vivanta
- Possible side effects
- How to store Lacosamide Vivanta
- Contents of the pack and other information
1. What Lacosamide Vivanta is and what it is used for
What Lacosamide Vivanta is
Lacosamide Vivanta contains the active substance lacosamide. It belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.
- This medicine has been prescribed to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide Vivanta is used for
- Lacosamide Vivanta is used:
- alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this type of epilepsy, seizures initially involve only one side of the brain. However, they may then spread to broader areas on both sides of the brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age to treat primary generalised tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).
2. What you need to know before using Lacosamide Vivanta
Do not use Lacosamide Vivanta
- 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 specific type of heart rhythm problem called second- or third-degree AV block.
Do not use Lacosamide Vivanta if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Vivanta if:
- you have had thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If you experience any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heartbeat and often experience a particularly slow, fast, or irregular heartbeat (e.g., AV block, atrial fibrillation, or atrial flutter)
- you have a serious heart condition, such as heart failure or have had a heart attack.
- you frequently experience dizziness or falls. Lacosamide Vivanta may cause dizziness – this may 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 if you are unsure), consult your doctor or pharmacist before using Lacosamide Vivanta. If you are taking Lacosamide Vivanta, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Vivanta and develop symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).
Children
Lacosamide Vivanta 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 whether it is effective and safe in children of these age groups.
Other medicines and Lacosamide Vivanta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart: this is because Lacosamide Vivanta may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "P-R interval" on a heart scan (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of irregular heartbeat or heart failure.
If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before using Lacosamide Vivanta.
Also inform your doctor or pharmacist if you are taking any of the following medicines—because they may increase or decrease the effect of Lacosamide Vivanta in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- an HIV medicine such as ritonavir;
- medicines used to treat bacterial infections such as clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort (Hypericum perforatum).
If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before using Lacosamide Vivanta.
Lacosamide Vivanta and alcohol
As a precautionary safety measure, do not take Lacosamide Vivanta with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraceptive measures with their doctor.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Lacosamide Vivanta is not recommended during pregnancy, as the effects of Lacosamide Vivanta on the fetus are unknown.
Breastfeeding is not recommended while taking Lacosamide Vivanta, as lacosamide passes into breast milk.
Consult your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help you decide whether or not to use Lacosamide Vivanta.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures. Worsening of your condition may also be harmful to your baby.
Driving and using machines
Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Lacosamide Vivanta may cause dizziness or blurred vision.
Lacosamide Vivanta contains sodium
This medicine contains 60 mg of sodium (a key component of table salt) per vial. This amount corresponds to 3% of the maximum daily recommended intake of sodium for an adult.
3. How to use Lacosamide Vivanta
Always use this medicine exactly as prescribed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.
Using Lacosamide Vivanta
- Lacosamide treatment may be started:
- by taking the medicine orally, or
- by intravenous infusion (sometimes referred to as “IV infusion”), administered into a vein by a doctor or nurse. The infusion is given over a period of 15 to 60 minutes.
- The IV infusion is usually used for a short period when you are unable to take the medicine orally.
- Your doctor will decide for how many days you will receive infusions. Data are available for up to two daily infusions of lacosamide for up to 5 days. For longer-term treatment, lacosamide tablets and oral solution are available.
When switching from infusion to oral administration (or vice versa), the total daily amount and dosing frequency remain the same.
- Take lacosamide twice daily, approximately 12 hours apart.
- Try to take it at approximately the same time each day.
Dosage
Below are the usual 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 Vivanta as monotherapy:
- The usual starting dose of lacosamide is 50 mg twice daily.
- Your doctor may alternatively prescribe a starting dose of 100 mg of lacosamide twice daily.
- Your doctor may increase your daily dose by 50 mg twice daily each week, until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When using Lacosamide Vivanta with other antiepileptic medicines:
- The usual starting dose of lacosamide is 50 mg twice daily.
- Your doctor may increase your dose by 50 mg twice daily each week, up to 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. Twelve hours later, your regular maintenance dose would then begin.
Children and adolescents weighing less than 50 kg
- For the treatment of partial-onset seizures: Note that Lacosamide Vivanta is not recommended in children below 2 years of age.
- For the treatment of primary generalized tonic-clonic seizures: Note that Lacosamide Vivanta is not recommended in children below 4 years of age.
When using Lacosamide Vivanta as monotherapy:
- Your doctor will determine the dose of Lacosamide Vivanta based on your body weight.
- The usual starting dose is 1 mg of lacosamide (0.1 mL) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase your daily dose by 1 mg (0.1 mL) per kg of body weight twice daily each week, until reaching a maintenance dose.
- The dosing tables below are provided for reference, including the maximum recommended dose. These are for informational purposes only. Your doctor will calculate the appropriate dose for you.
To be used twice daily in children from 2 years of age weighing between 10 kg and 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 children and adolescents weighing between 40 kg and less than
50 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 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 Vivanta with other antiepileptic medicines
- Your doctor will determine the dose of Lacosamide Vivanta based on your body weight.
- For children and adolescents with a body weight between 10 kg and less than 50 kg, the usual starting dose is 1 mg of lacosamide (0.1 mL) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase your twice-daily dose by 1 mg (0.1 mL) per kg of body weight each week, until a maintenance dose is reached.
- The dosing tables below are provided, including the recommended maximum dose. 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 with body weight between 10 kg 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 | 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 | 6 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 children and adolescents with a body weight between 20 kg and
less than 30 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 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 children and adolescents with body weight between 30 kg and
less than 50 kg:
| Weight | Week 1 Initial 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 treatment with Lacosamide Vivanta
If your doctor decides to discontinue treatment with Lacosamide Vivanta, the dose should be
gradually reduced. This is intended to prevent the recurrence 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.
Consult your doctor or pharmacist if you experience any of the following symptoms:
Very common: may affect more than 1 in 10 people
- Headache
- Dizziness or nausea;
- 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 (paraesthesia), or muscle spasms, increased tendency to fall and bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus), blurred vision;
- Sensation of spinning (vertigo), feeling of drunkenness;
- Vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines, diarrhoea;
- Reduced touch or sensitivity, difficulty articulating words, attention disturbance;
- Ringing noises in the ears such as buzzing, ringing, or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, irritation.
Uncommon: may affect up to 1 in 100 people
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present;
- Allergic reaction following medicine intake, hives;
- Blood tests may show abnormal liver function, liver damage;
- Self-harming thoughts or suicidal thoughts, suicide attempt – 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).
Frequency not known: frequency cannot be estimated from the available data
- Increased heart rate (ventricular tachyarrhythmia);
- Sore throat, high fever, and experiencing more infections than usual. Blood tests may show a severe decrease in the number of a specific type of white blood cells (agranulocytosis);
- Severe skin reaction which may include high fever and other flu-like symptoms, facial rash, widespread rash, swollen glands (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, particularly 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);
- Seizure.
Additional side effects when administered as intravenous infusion
Local side effects may occur.
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.
Additional side effects in children
Additional side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (reduced appetite), changes in behaviour, behaviour different from normal (abnormal behaviour), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Lacosamide Vivanta
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
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Each vial of Lacosamide Vivanta solution for infusion is for single use only. Any unused solution must be discarded.
The solution should only be used if it is clear, with no colour alteration and free from foreign particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Lacosamide Vivanta contains
- The active substance is lacosamide. 1 mL of infusion solution contains 10 mg of lacosamide. One vial contains 20 mL of infusion solution, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid 0.36% (for pH adjustment), water for injections.
Description of the appearance of Lacosamide Vivanta and contents of the pack
- Lacosamide Vivanta 10 mg/mL is a clear, colourless infusion solution. Lacosamide Vivanta infusion solution is available in packs containing 1 vial and 5 vials. Each vial contains 20 mL.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Vivanta Generics s.r.o.
Třtinová 260/1, Čakovice
196 00 - Prague 9
Czech Republic
Manufacturer
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park,
Paola, PLA3000,
Malta
MSN Labs Europe Limited,
KW20A Corradino Park,
Paola, PLA3000,
Malta
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Lacosamid Vivanta 10 mg/ml Infusionslösung
Spain Lacosamida Vivanta 10 mg/ml solución para perfusión EFG
Netherlands Lacosamide Vivanta 10 mg/ml oplossing voor infusie
France Lacosamide Vivanta 10 mg/ml solution pour perfusion
Italy Lacosamide Vivanta
Norway Lacoasmide Vivanta
Denmark Lacosamide “Vivanta”
Finland Lacosamide Vivanta 10 mg/ml infuusioneste,liuos
Sweden Lacosamide Vivanta 10 mg/ml infusionsvätska, lösning
The following information is intended exclusively for healthcare professionals:
Each vial of Lacosamide Vivanta infusion solution is for single use only.
Any unused solution must be discarded (see section 3).
Lacosamide Vivanta infusion solution may be administered without further dilution,
or 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 product should be used immediately. If not used immediately,
the storage times and 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 in-use stability has been demonstrated for 24 hours at temperatures up to 25°C
for the product mixed with these diluents and stored in PVC bags.