Lacosamide TilloMed
Italy
Table of Contents
- Package leaflet: Information for the user
- Lacosamide Tillomed 10 mg/mL solution for infusion
- 1. What Lacosamide Tillomed is and what it is used for
- 2. What you need to know before using Lacosamide Tillomed
- 3. How to use Lacosamide Tillomed
- 4. Possible side effects
- 5. How to store Lacosamide Tillomed
- 6. Package contents and other information
- The following information is intended for healthcare professionals only:
Package leaflet: Information for the user
Lacosamide Tillomed 10 mg/mL solution for infusion
Equivalent medicine
Please read this leaflet carefully before using 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 Tillomed is and what it is used for
- What you need to know before using Lacosamide Tillomed
- How to use Lacosamide Tillomed
- Possible side effects
- How to store Lacosamide Tillomed
- Contents of the pack and other information
1. What Lacosamide Tillomed is and what it is used for
What Lacosamide Tillomed is
Lacosamide Tillomed 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 Tillomed is used for
Lacosamide Tillomed is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a specific type of epilepsy characterized by partial-onset seizures with or without secondary generalization. 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 for the treatment of primary generalized tonic-clonic seizures (complex epileptic seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).
2. What you need to know before using Lacosamide Tillomed
Do not use Lacosamide Tillomed
- 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 Tillomed if you fall into any of the above categories. If you are unsure, speak to your
doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Tillomed if:
- you have had thoughts of harming or killing yourself. 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 heart rhythm and often experience a particularly slow, fast, or irregular heartbeat (e.g. AV block, atrial fibrillation, or atrial flutter).
- you have a severe heart condition, such as heart failure or a history of heart attack.
- you frequently feel dizzy or have falls. Lacosamide may cause dizziness – this may increase the risk of accidental injury or falls. Therefore, you should exercise caution until you are accustomed to the effects of this medicine.
If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before
using Lacosamide Tillomed.
If you are using Lacosamide Tillomed, contact your doctor if you experience seizures of a different
type or if your existing seizures worsen.
If you are using Lacosamide Tillomed 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 Tillomed is not recommended for children under 2 years of age with 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 Tillomed
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 may also affect your heart:
- medicines used to treat heart diseases;
- medicines that may prolong the "PR interval" on a heart scan (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of irregular heartbeat or heart failure.
If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before
using Lacosamide Tillomed.
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 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. If you fall into any of the above categories (or are unsure), speak to your doctor or pharmacist before using Lacosamide Tillomed.
Lacosamide Tillomed and alcohol
As a precautionary safety measure, do not take lacosamide with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptive measures with their doctor.
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
It is recommended not to use Lacosamide Tillomed during pregnancy, as the effects of lacosamide on
the unborn baby are unknown.
It is recommended not to breastfeed while taking Lacosamide Tillomed, as lacosamide passes into
breast milk.
Contact your doctor immediately if you are pregnant or planning a pregnancy. Your doctor will help
you decide whether or not to use Lacosamide Tillomed.
Do not stop treatment without first consulting your doctor, as this could 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 may cause dizziness or blurred vision.
Lacosamide Tillomed contains sodium
This medicine contains 60 mg of sodium (a main component of table salt) per vial.
This amount is equivalent to 3.2% of the maximum daily recommended sodium intake for an adult.
3. How to use Lacosamide Tillomed
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Using Lacosamide Tillomed
- Lacosamide Tillomed may be initiated:
- by taking the medicine orally (other formulations), or
- by intravenous infusion (sometimes referred to as "IV infusion"), during which the medicine is administered into a vein by a doctor or nurse. It is administered 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 how many days you will receive infusions. Data are available for two daily infusions of lacosamide for up to 5 days. For longer treatment periods, other formulations of lacosamide are available.
When switching from infusion to oral administration (or vice versa), the total daily amount you take and the frequency of doses remain the same.
- Take Lacosamide Tillomed 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 Tillomed 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 Tillomed as monotherapy
- The usual starting dose of Lacosamide Tillomed is 50 mg twice daily.
- Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Tillomed twice daily.
- Your doctor may increase your dose by 50 mg twice daily each week, until reaching the maintenance dose, ranging from 100 mg to 300 mg twice daily.
When using Lacosamide Tillomed with other antiepileptic medicines
- The usual starting dose of Lacosamide Tillomed is 50 mg twice daily.
- Your doctor may increase your daily dose by 50 mg twice daily each week, up to a maintenance dose ranging from 100 mg to 200 mg twice daily.
- If you weigh 50 kg or more, your doctor may decide to start treatment with Lacosamide Tillomed using a single "loading dose" of 200 mg. Twelve 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 is not recommended in children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that lacosamide is not recommended in children under 4 years of age.
When using Lacosamide Tillomed as monotherapy
- Your doctor will determine the dose of Lacosamide Tillomed 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 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 dosage tables below are provided, including the maximum recommended dose. For reference 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 Tillomed with other antiepileptic medicines
- Your doctor will determine the dose of Lacosamide Tillomed based on your body weight.
- The usual starting dose is 1 mg (0.1 mL) per kilogram (kg) of body weight, taken twice daily.
- Your doctor may then increase your dose by 1 mg (0.1 mL) per kg of body weight each week, given in two divided doses, until a maintenance dose is reached.
- Dosage tables, including the maximum recommended dose, are provided below. 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 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 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 Tillomed
If your doctor decides to discontinue treatment with Lacosamide Tillomed, 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.
If you experience any of the following symptoms, speak to your doctor or pharmacist:
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 seizures)
- Difficulty coordinating movements or walking
- Problems with balance, tremors, tingling (paraesthesia), muscle spasms, increased tendency to fall or bruise easily
- 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 sensation or sensitivity, difficulty articulating words, attention disturbance
- Ringing noises in the ears such as buzzing, ringing, or whistling (tinnitus)
- Irritability, difficulty sleeping, depression
- Drowsiness, fatigue, or weakness (asthenia)
- Itching, skin rash
Uncommon (may affect up to 1 in 100 people)
- Reduced heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of your heart (cardiac conduction disorder)
- Exaggerated feeling of well-being, seeing and/or hearing things that are not present
- Allergic reaction after taking the medicine, hives (urticaria)
- Blood tests may show abnormal liver function, liver damage
- Suicidal thoughts or self-harming 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)
Not known (frequency cannot be estimated from the available data)
- Rapid heartbeat (ventricular tachyarrhythmia)
- Sore throat, high fever, and increased number of infections compared to usual. Blood tests may show a severe decrease in the number of cells 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 skin rash with blisters and peeling of the skin, 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
Other 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
Other 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, 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, please tell 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 Tillomed
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and
on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Each bottle of Lacosamide Tillomed must be used only once. Any unused solution remaining
must be discarded.
The solution should only be used if it is clear, with no change in colour and free from foreign particles.
Do not dispose of any medicine 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 Tillomed contains
- The active substance is lacosamide. 1 mL of Lacosamide Tillomed contains 10 mg of lacosamide. One vial contains 20 mL of Lacosamide Tillomed, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injections.
Description of the appearance of Lacosamide Tillomed and contents of the pack
Lacosamide Tillomed is a clear, colourless solution, packaged in a transparent glass vial with a chlorobutyl rubber stopper, sealed with an aluminium seal and a blue plastic flip-off cap.
Lacosamide Tillomed is available in packs containing 1 vial or 5 vials. Each vial contains 20 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Tower A
20143 Milan (MI), Italy
Manufacturer
Tillomed Malta Ltd.
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN3000,
Malta
The following information is intended for healthcare professionals only:
Each vial of Lacosamide Tillomed infusion solution must be used only once (single use). Any unused solution must be discarded (see section 3).
Lacosamide Tillomed 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 in-use 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 dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for the product mixed with these diluents and stored in glass containers or PVC bags.