Lacosamide Hikma
Italy
Table of Contents
- Package leaflet: Information for the patient
- Lacosamide Hikma 10 mg/ml solution for infusion
- 1. What is Lacosamide Hikma and what is it used for
- 2. What you should know before using Lacosamide Hikma
- 3. How to use Lacosamide Hikma
- 4. Possible side effects
- 5. How to store Lacosamide Hikma
- 6. Contents of the pack and other information
- The following information is intended for healthcare professionals only:
Package leaflet: Information for the patient
Lacosamide Hikma 10 mg/ml solution for infusion
lacosamide
Equivalent medicine
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, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Lacosamide Hikma is and what it is used for
- What you need to know before using Lacosamide Hikma
- How to use Lacosamide Hikma
- Possible side effects
- How to store Lacosamide Hikma
- Contents of the pack and other information
1. What is Lacosamide Hikma and what is it used for
What is Lacosamide Hikma
Lacosamide Hikma 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 Hikma is used for
- It is used:
- as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age onwards, to treat a specific type of epilepsy characterised by partial-onset seizures with or without secondary generalisation. In this form of epilepsy, seizures initially affect only one side of the brain, but 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 onwards, 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 should know before using Lacosamide Hikma
Do not use Lacosamide Hikma
- 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 Hikma if you fall into either of the above categories. If you are unsure, speak with your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Hikma if:
- you have had thoughts of harming yourself or of suicide. A small number of people treated with antiepileptic medicines such as lacosamide have experienced thoughts of self-harm or suicide. If you have any such thoughts at any time, inform your doctor immediately.
- you have a heart condition affecting your heartbeat and often have a heartbeat that is particularly slow, fast, or irregular (e.g. AV block, atrial fibrillation, or atrial flutter).
- you have a severe heart condition, such as heart failure or have had a heart attack.
- you often feel dizzy or have falls. Lacosamide Hikma may cause dizziness – this may increase the risk of injury or accidental falls. This means you should be cautious until you become accustomed to the effects of this medicine. If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before using this medicine. If you are taking Lacosamide Hikma, talk to your doctor if you experience seizures of a different type or if your existing seizures worsen. If you are taking Lacosamide Hikma and develop symptoms of an abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, or fainting), consult your doctor immediately (see section 4). Children Lacosamide Hikma 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 or safe in children in these age groups.
Other medicines and Lacosamide Hikma
Tell 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, because Lacosamide Hikma may also affect your heart:
- medicines used to treat heart problems;
- 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 you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before using this medicine. 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 Hikma in your body:
- antifungal medicines called fluconazole, itraconazole, or ketoconazole;
- an HIV medicine called ritonavir;
- antibiotics called clarithromycin or rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John’s wort (Hypericum perforatum). If you fall into any of the above categories (or are unsure), consult your doctor or pharmacist before using this medicine.
Lacosamide Hikma and alcohol
As a precautionary safety measure, do not take Lacosamide Hikma with alcohol.
Pregnancy, breastfeeding, and fertility
Women of childbearing potential should discuss the use of contraception with their doctor.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
The use of Lacosamide Hikma during pregnancy is not recommended, as the effects of lacosamide on pregnancy and the fetus are unknown.
Breastfeeding is not recommended during treatment with Lacosamide Hikma, as lacosamide passes into breast milk.
Seek immediate advice from your doctor if you become pregnant or are planning a pregnancy. Your doctor will help you decide whether or not to use Lacosamide Hikma.
Do not stop treatment without first discussing it with 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 Hikma may cause dizziness or blurred vision.
Lacosamide Hikma contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt) in each vial. This amount corresponds to 3% of the maximum daily recommended intake of sodium for an adult.
3. How to use Lacosamide Hikma
Always use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Using Lacosamide Hikma
- Lacosamide Hikma may be initiated:
- by taking the medicine orally, or
- by intravenous infusion (sometimes referred to as "IV infusion"), where the medicine is administered into a vein by a doctor or nurse over a period of 15 to 60 minutes.
- Intravenous infusion is usually used for a short period when you are unable to take the medicine by mouth.
- 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 intravenous infusion to oral administration (or vice versa), the total daily amount and dosing frequency remain the same.
- Use Lacosamide Hikma twice daily (approximately 12 hours apart).
- Try to take it at approximately the same times each day. Dosage Below are the usual recommended doses of Lacosamide Hikma 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 Hikma as monotherapy
The usual starting dose of Lacosamide Hikma is 50 mg twice daily.
Treatment may also be initiated with 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 the maintenance dose, ranging from 100 mg to 300 mg twice daily.
When using Lacosamide Hikma with other antiepileptic medicines
The usual starting dose of Lacosamide Hikma is 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 Hikma 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 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 Hikma as monotherapy
Your doctor will determine the dose of Lacosamide Hikma 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 the maintenance dose.
The dosing tables below include the maximum recommended doses. Your doctor will determine the appropriate dose for you.
For reference only. Your doctor will calculate the dose suitable 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: | 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 |
| 0.1 ml/kg | 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 40 kg to 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 Hikma with other antiepileptic medicines
Your doctor will decide the dose of Lacosamide Hikma based on your body weight.
For children and adolescents weighing between 10 kg and less than 50 kg, the usual starting dose is 1 mg
(0.1 ml) per kilogram (kg) of body weight, twice daily.
Your doctor may then increase your dose weekly by 1 mg (0.1 ml) per kilogram (kg) of body weight, twice
daily, until a maintenance dose is reached.
The dosing tables below are provided for your information only. Your doctor will determine the appropriate
dose for you.
To be used twice daily in 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 | 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 a 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 Hikma
If your doctor decides to discontinue treatment with Lacosamide Hikma, the dose should be gradually reduced.
This is done to prevent the recurrence or worsening of epilepsy.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nervous system side effects, such as dizziness, may be more frequent after a single "loading" dose.
Contact your doctor or pharmacist if you experience any of the following symptoms:
Very common: may affect more than 1 in 10 people
- Headache;
- Feeling dizzy or unwell (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, tendency to fall and 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;
- Feeling unwell (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;
- 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 heart's electrical activity (conduction disorder);
- Exaggerated sense of well-being, seeing and/or hearing things that are not there;
- Allergic reaction following medicine intake, hives (urticaria);
- Blood tests may show abnormal liver function, liver damage;
- Thoughts of self-harm or suicide, suicide attempt – inform your doctor immediately;
- Feeling of anger or agitation;
- Unusual 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 suffering from more infections than usual. Blood tests may show a severe reduction in the number of cells of a specific class 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 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.
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
Other side effects observed in children include fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, acting unlike oneself (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 inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Lacosamide Hikma
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.
Do not store above 25°C.
Each vial of Lacosamide Hikma solution for infusion is for single use only. Any unused portion of the solution must be discarded.
The solution should only be used if it is clear, particle-free, and shows no change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Lacosamide Hikma contains
- The active substance is lacosamide. 1 ml of Lacosamide Hikma solution for infusion contains 10 mg of lacosamide. 1 vial contains 20 ml of Lacosamide Hikma solution for infusion, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injections.
Description of the appearance of Lacosamide Hikma and contents of the pack
Lacosamide Hikma 10 mg/ml solution for infusion is a clear, colourless solution.
Lacosamide Hikma solution for infusion is available in packs of 1 vial.
Each vial contains 20 ml.
Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A and 8B
Fervença
2705-906 Terrugem SNT
Portugal
This medicinal product is authorised in EEA Member States under the following names:
Italy: Lacosamide Hikma
Portugal: Lacosamida Hikma
Austria: Lacosamid Hikma
Belgium: Lacosamide Hikma
France: Lacosamide Hikma
Netherlands: Lacosamide Hikma
Germany: Lacosamid Hikma
Spain: Lacosamida Hikma
This leaflet was last revised on: {MM/YYYY}.
The following information is intended for healthcare professionals only:
Each vial of Lacosamide Hikma solution for infusion is for single use only.
Any unused solution should be discarded (see section 3).
Lacosamide Hikma solution for infusion may be administered without further dilution or 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 up to a temperature of 25°C
for the product mixed with these diluents and stored in glass containers or PVC bags.