Lacosamide AdroIQ
ItalyTable of Contents
Package leaflet: Information for the patient
Lacosamide Adroiq 10 mg/ml solution for infusion
lacosamide
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, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide Adroiq is and what it is used for
- What you need to know before using Lacosamide Adroiq
- How to use Lacosamide Adroiq
- Possible side effects
- How to store Lacosamide Adroiq
- Contents of the pack and other information
1. What Lacosamide Adroiq is and what it is used for
What Lacosamide Adroiq is
Lacosamide Adroiq 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 you to reduce the number of seizures (epileptic fits) you experience.
What Lacosamide Adroiq is used for
- Lacosamide Adroiq is used:
- as monotherapy and 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 Adroiq
Do not use Lacosamide 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 particular type of heart rhythm problem called second- or third-degree AV block.
Do not use Lacosamide Adroiq if any of the above apply to you. If you are unsure, talk to your doctor or
pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Adroiq if:
-
you have had thoughts of harming yourself or of suicide. A small number of people treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or of 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 heartbeat that is particularly slow, fast, or irregular (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 often feel dizzy or fall. Lacosamide Adroiq 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 you are unsure), talk to your doctor or pharmacist before using Lacosamide Adroiq. If you are taking Lacosamide Adroiq, contact your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Adroiq and develop symptoms of an 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 Adroiq 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 Adroiq
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 Adroiq 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 you are unsure), talk to your doctor or pharmacist before using Lacosamide Adroiq.
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 Adroiq in your body:
- antifungal medicines such as fluconazole, itraconazole, or ketoconazole;
- an HIV medicine such as ritonavir;
- medicines for bacterial infections such as clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort.
If any of the above apply to you (or you are unsure), talk to your doctor or pharmacist before using Lacosamide Adroiq.
Lacosamide Adroiq and alcohol
As a precautionary safety measure, do not take Lacosamide Adroiq with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptive measures with their doctor.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of Lacosamide Adroiq during pregnancy is not recommended, as the effects of Lacosamide Adroiq on the unborn baby are unknown.
Breastfeeding is not recommended during treatment with Lacosamide Adroiq, as lacosamide passes into breast milk.
Consult your doctor immediately if you are pregnant or planning to become pregnant. Your doctor will help you decide whether or not to use Lacosamide Adroiq.
Do not stop treatment without first consulting your doctor, as this may lead to an increase in seizures (attacks). 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 Adroiq may cause dizziness or blurred vision.
Lacosamide Adroiq contains sodium
This medicine contains 59.8 mg of sodium (a main component of table salt) per vial, equivalent to 3% of the maximum recommended daily intake of sodium for an adult.
3. How to use Lacosamide Adroiq
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable
for children: please ask your doctor or pharmacist.
Using Lacosamide Adroiq
- Lacosamide Adroiq can be administered:
- via intravenous infusion, in which the medicine is given into a vein by a doctor or nurse. The medicine is administered over 15–60 minutes. Your doctor will decide how many days of infusions are needed.
- Twice-daily infusions of lacosamide have been studied for up to 5 days. For longer-term treatment, lacosamide is available in tablet and syrup forms. When switching from infusion to oral administration (or vice versa), the total daily dose and frequency remain unchanged.
- Use 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 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 using Lacosamide Adroiq as monotherapy
- The initial dose of Lacosamide Adroiq is usually 50 mg twice daily.
- Treatment with Lacosamide Adroiq may also start with a dose of 100 mg of Lacosamide Adroiq 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 300 mg twice daily.
When using Lacosamide Adroiq with other antiepileptic medicines
-
The initial dose of Lacosamide Adroiq is usually 50 mg twice daily.
-
Your doctor may increase the 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 Adroiq using a single "loading dose" of 200 mg. Twelve hours later, you would then start your regular maintenance dose.
Children and adolescents weighing less than 50 kg
- For the treatment of partial-onset seizures: note that Lacosamide Adroiq is not recommended in children below 2 years of age.
- For the treatment of primary generalized tonic-clonic seizures: note that Lacosamide Adroiq is not recommended in children below 4 years of age.
When using Lacosamide Adroiq as monotherapy
- Your doctor will determine the dose of Lacosamide Adroiq based on body weight.
- The usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may then increase the dose by 1 mg (0.1 ml) per kg of body weight twice daily each week, until the maintenance dose is reached.
- The dosage tables below are provided for informational purposes only and include the maximum recommended dose. Your doctor will determine the appropriate dose for the patient.
To be used twice daily in children from 2 years of age with body weight between 10 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 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 Adroiq with other antiepileptic drugs
- The doctor will determine the dose of Lacosamide Adroiq based on body weight.
- For children and adolescents weighing between 10 and less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- The doctor may then increase the dose 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 are provided for informational purposes only and include the recommended maximum dose. The appropriate dose for the patient will be determined by the doctor.
To be used twice daily in children from 2 years of age weighing between 10 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 weighing between 20 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 weighing between 30 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 using Lacosamide Adroiq
If your doctor decides to discontinue your treatment with Lacosamide Adroiq, they will gradually reduce the dose to avoid a recurrence or worsening of epilepsy.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 with balance, tremors, tingling (paraesthesia), muscle spasms, increased tendency to fall or bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, 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 or buzzing sounds in the ear (tinnitus);
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, skin rash.
Uncommon: may affect up to 1 in 100 people
- Slowed heart rate, palpitations, irregular heartbeat, or other changes in the electrical activity of the heart (cardiac conduction disorder);
- Exaggerated sense of well-being, seeing and/or hearing things that are not present;
- Allergic reaction following medicine intake, hives (urticaria);
- 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).
Not known: frequency cannot be estimated from the available data
- Fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high fever, and increased frequency of infections. 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 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.
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, 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Each vial of Lacosamide Adroiq infusion solution is for single use only (single-dose). Any unused solution must be discarded.
Only a clear solution, free from particles and discoloration, should be used.
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 Adroiq contains
- The active substance is lacosamide. 1 ml of Lacosamide Adroiq solution for infusion contains 10 mg of lacosamide. One vial contains 20 ml of Lacosamide Adroiq solution for infusion, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injections.
- See section 2: This medicinal product contains 59.8 mg of sodium (the main component of table salt) in each vial.
Description of the appearance of Lacosamide Adroiq and contents of the pack
- Lacosamide Adroiq solution for infusion is a clear, colourless solution.
Lacosamide Adroiq solution for infusion is available in packs of 1 or 5 vials. Each
vial contains 20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Extrovis EU Ltd.
Pátriárka utca 14.
2000 Szentendre
Hungary
Manufacturer
Pharma Pack Hungary Kft.
Vasút u. 13.
2040 Budaörs
Hungary
Pharma Pack Hungary Kft.
Building B, Raktarvarosi Ut 9,
Torokbalint,
2045 Hungary
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Extrovis EU Ltd. Extrovis EU Ltd.
Tél/Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]
България Luxembourg/Luxemburg
Extrovis EU Ltd. Extrovis EU Ltd.
Teл.: +41 41 740 1120 Tél/Tel: +41 41 740 1120
[email protected] [email protected]
Česká republika Magyarország
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel.: +41 41 740 1120
[email protected] [email protected]
Danmark Malta
Mashal Healthcare A/S Extrovis EU Ltd.
Tlf: +45 71 86 37 68 Tel: +41 41 740 1120
[email protected] [email protected]
Deutschland Nederland
Zentiva Pharma GmbH Extrovis EU Ltd.
Tel: +49 (0) 800 53 53 010 Tel: +41 41 740 1120
[email protected] [email protected]
Eesti Norge
Extrovis EU Ltd. Mashal Healthcare A/S
Tel: +41 41 740 1120 Tlf: +45 71 86 37 68
[email protected] [email protected]
Ελλάδα Österreich
Extrovis EU Ltd. Zentiva, k.s.
Τηλ: +41 41 740 1120 Tel: +43 720 778 877
[email protected] [email protected]
España Polska
Zentiva Spain S.L.U. Extrovis EU Ltd.
Tel: +34 671 365 828 Tel.: +41 41 740 1120
[email protected] [email protected]
France Portugal
Zentiva France Extrovis EU Ltd.
Tél: +33 (0) 800 089 219 Tel: +41 41 740 1120
[email protected] [email protected]
Hrvatska România
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]
Ireland Slovenija
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]
Ísland Slovenská republika
Extrovis EU Ltd. Extrovis EU Ltd.
Sími: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]
Italia Suomi/Finland
Zentiva Italia S.r.l. Mashal Healthcare A/S
Tel: +39-02-38598801 Puh/Tel: +45 71 86 37 68
[email protected] [email protected]
Κύπρος Sverige
Extrovis EU Ltd. Mashal Healthcare A/S
Τηλ: +41 41 740 1120 Tel: +45 71 86 37 68
[email protected] [email protected]
Latvija United Kingdom (Northern Ireland)
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
The following information is intended exclusively for healthcare professionals:
Each vial of Lacosamide Adroiq infusion solution is for single use only.
Any unused solution must be discarded (see section 3).
Lacosamide Adroiq infusion solution may be administered without further dilution,
or it may be diluted with one of 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 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 and at 2–8 °C for the product mixed with these diluents and stored in glass containers or polyvinyl chloride (PVC) bags.