LACOSAMIDE 10 mg /Ml Infusion Solution
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Інструкція із застосування LAKOSAMIDE IKMA
Зміст інструкції
Lacosamide Hikma 10 mg/ml solution for infusion
lacosamide
Generic medicine
Read this leaflet carefully before you start to use 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What Lacosamide Hikma is and what it is used for
- 2. What you need to know before you use 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
1. What is Lacosamide Hikma and what is it used for
What is Lacosamide Hikma
Lacosamide Hikma contains lacosamide. It belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.
- This medicine has been given to you to reduce the number of seizures (epileptic fits) you experience. What is Lacosamide Hikma used for
- It is used: either alone or in combination with other antiepileptic medicines in adults, adolescents and children 2 years of age and over to treat a specific type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this form of epilepsy, the seizures initially involve only one side of your brain. However, they may then spread to larger areas on both sides of the brain; or in combination with other antiepileptic medicines in adults, adolescents and children 4 years of age and over to treat primary generalized tonic-clonic seizures (complex epileptic fits, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).
2. What you need to know before you use 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 not sure if you are allergic, consult your doctor.
- if you have a particular type of heart rhythm problem called AV block of second or third degree. Do not use Lacosamide Hikma if this applies to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor before using Lacosamide Hikma if:
- you have thought about harming yourself or committing suicide. A small number of people treated with anti-epileptic medicines like lacosamide have had thoughts of self-harm or suicide. If you should have any of these thoughts at any time, tell your doctor immediately.
- you have a heart problem that affects your heartbeat and often have a heartbeat that is particularly slow, fast or irregular (e.g. AV block, atrial fibrillation and flutter)
- you have a serious heart condition, such as heart failure or have had a heart attack.
- you often feel dizzy or fall. Lacosamide Hikma can cause dizziness - this can increase the risk of injury or accidental falls. This means you should be careful until you get used to the effects of this medicine. If you fall into any of the above cases (or are not sure), talk to your doctor or pharmacist before using this medicine. If you are taking Lacosamide Hikma, talk to your doctor if you have a seizure that is different from usual or if your existing seizures get worse. If you are taking Lacosamide Hikma and experience symptoms of an abnormal heartbeat (such as a slow, fast or irregular heartbeat, palpitations, shortness of breath, feeling dizzy, fainting), consult your doctor immediately (see section 4). ChildrenLacosamide Hikma is not recommended for children under 2 years of age with epilepsy characterized by the occurrence of 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 if it works and if it is safe for children in this age group.
Other medicines and Lacosamide Hikma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that
affect the heart, because Lacosamide Hikma can also affect your heart:
- medicines to treat heart problems;
- medicines that can prolong the “P-R interval” in a heart scan (ECG or electrocardiogram) such as medicines for epilepsy or pain, called carbamazepine, lamotrigine or pregabalin;
- medicines used to treat some forms of irregular heartbeat or heart failure. If you fall into any of the above cases (or are not sure) talk to your doctor or pharmacist before using this medicine. Also tell your doctor or pharmacist if you are taking any of the following medicines, because they can increase or decrease the effect of Lacosamide Hikma on your body:
- medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
- a medicine for HIV called ritonavir;
- medicines for bacterial infections called clarithromycin or rifampicin;
- an herbal medicine used to treat mild anxiety and depression called St John's wort ( Hypericum perforatum). If you fall into any of the above cases (or are not sure), talk to your doctor or pharmacist before using this medicine.
Lacosamide Hikma with alcohol
As a safety precaution, do not take Lacosamide Hikma with alcohol.
Pregnancy, breastfeeding and fertility.
Women of childbearing potential should discuss the use of contraceptives with their doctor.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
The use of Lacosamide Hikma is not recommended during pregnancy, as the effects of lacosamide
on pregnancy and the fetus are not known.
Breastfeeding is not recommended during treatment with Lacosamide Hikma, as
lacosamide passes into breast milk.
Ask your doctor immediately if you become pregnant or are planning a pregnancy. They will
help you decide whether to use Lacosamide Hikma or not.
Do not stop treatment without discussing it first with your doctor, as this can cause
an increase in seizures (fits). A worsening of your illness can also be harmful to
your baby.
Driving and using machines
Do not drive vehicles, ride a bicycle, use tools or machinery until you have checked how
this medicine affects you. This is because Lacosamide Hikma can 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 is equivalent to 3% of the recommended maximum daily intake of sodium
for an adult.
3. How to use Lacosamide Hikma
Always use this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
Using Lacosamide Hikma
- Lacosamide Hikma can be started:
- by taking the medicine by mouth or
- with administration as an intravenous infusion (sometimes called an “IV infusion”) in which the medicine is given to you in a vein by a doctor or nurse over a period of between 15 and 60 minutes.
- The intravenous infusion is usually used for a short period when you cannot take the medicine by mouth.
- The doctor will decide for how many days you will receive infusions. There is data on two daily infusions of lacosamide for up to 5 days. For treatments for longer periods, lacosamide tablets and syrup are available. When you switch from the infusion to taking the medicine by mouth (or vice versa), the total amount you take each day and the frequency of doses remain the same.
- Use Lacosamide Hikma twice every day (approximately 12 hours apart).
- Try to use it at about the same time each day. How much to useBelow are listed the normal recommended doses of Lacosamide Hikma for different age groups and weights. The doctor may prescribe a different dose if you suffer from kidney or liver problems.
Adolescents and children weighing 50 kg or more and adults
When you use Lacosamide Hikma alone
The initial dose of Lacosamide Hikma is usually 50 mg twice a day.
Treatment may also start with an initial dose of 100 mg of lacosamide twice a day.
The doctor may increase your daily dose by 50 mg twice a day each week, up to
reaching the maintenance dose, between 100 mg and 300 mg twice a day.
When you use Lacosamide Hikma with other antiepileptic medicines
The initial dose of Lacosamide Hikma is usually 50 mg twice a day.
The doctor may increase your daily dose by 50 mg twice a day each week, up to
reaching a maintenance dose between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, the doctor may decide to start treatment with Lacosamide Hikma with a
single “loading” dose of 200 mg. 12 hours later, you would then start your maintenance dose.
Children and adolescents weighing less than 50 kg
In the treatment of partial seizures:please note that lacosamide is not recommended for
children under 2 years of age.
In the treatment of primary generalized tonic-clonic seizures:please note that lacosamide is not
recommended for children under 4 years of age.
When you use Lacosamide Hikma alone
The doctor will decide the dose of Lacosamide Hikma based on your body weight.
Usually the initial dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
The doctor may then increase your daily dose by 1 mg (0.1 ml) for each kg of body weight twice a week, up to reaching a maintenance dose.
The dosage tables that include the maximum recommended dose are reported below. Your
doctor will decide the right dose for you.
For reference only. The doctor will calculate the dose suitable for you.
To be used twice a dayfor children starting from 2 years of age weighing between 10
kg and less than 40 kg
| Weight | g 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 |
To be used twice a dayfor children and adolescents weighing between 40 kg and less than 50 kg:
When you use Lacosamide Hikma with other antiepileptic medicines
The 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 initial dose is 1 mg
(0.1 ml), for each kilogram (kg) of body weight, twice a day.
The doctor may then increase your dose by 1 mg (0.1 ml) for each kilogram (kg) of
body weight twice a week, up to reaching a maintenance dose.
The dosage tables that include the maximum recommended dose are provided below. This is only
for your information. Your doctor will decide the right dose for you.
To be used twice a dayin children starting from 2 years of age with body weight between 10 kg and less
than 20 kg:
To be used twice a dayfor children and adolescents with body weight between 20 kg and
less than 30 kg:
| 0.1 ml/kg | o c 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 | a 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 | m 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 | r 21 ml |
| Weight | Week 1 Initial Dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | F Week 4 0.4 ml/kg | Week 5 Maximum recommended: 0.5 ml/kg |
| 40 kg | 4 ml | 8 ml | 12 ml | l 16 ml | 20 ml |
| 45 kg | 4.5 ml | 9 ml | 13.5 ml | 18 ml | 22.5 ml |
| Weight | g Week 1 Dose Initial: 0.1 ml/kg | I Week a 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: 0.6 ml/kg |
| 10 kg | 1 ml | 2 ml | 3 ml | 4 ml | 5 ml | 6 ml |
| 15 kg | 1.5 ml | i 3 ml | 4.5 ml | 6 ml | 7.5 ml | 9 ml |
| Weight | g Week 1 Dose Initial: 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: 0.5 ml/kg |
| A 20 kg | 2 ml | 4 ml | 6 ml | 8 ml | 10 ml |
To be used twice a dayfor children and adolescents with body weight between 30 kg and
less than 50 kg:
If you stop taking Lacosamide Hikma
If the doctor decides to stop therapy with Lacosamide Hikma, the dose must 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.
Side effects affecting the nervous system, such as dizziness, may be more frequent after
a single “loading” dose.
Talk to 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 (paresthesia) or muscle spasms, falling and bruising easily;
- Memory problems, difficulty thinking or finding the right words, confusion;
- Rapid and uncontrollable eye movements (nystagmus), blurred vision;
- Feeling of “spinning” (vertigo), drunkenness;
- Feeling sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
- Reduced sense of touch or sensitivity, difficulty articulating words, attention disorder;
- Noises in the ear such as ringing, trilling or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, irritation.
| 25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml | o 12.5 ml |
| Weight | Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | m Week 4 Maximum recommended dose: 0.4 ml/kg |
| 30 kg | 3 ml | 6 ml | 9 ml | r 12 ml |
| 35 kg | 3.5 ml | 7 ml | 10.5 ml | a 14 ml |
| 40 kg | 4 ml | 8 ml | 12 ml | 16 ml |
| 45 kg | 4.5 ml | 9 ml | 13.5 ml | F 18 ml |
Uncommon: may affect up to 1 in 100 people
- Decreased heart rate, palpitations, irregular heartbeat or other changes in the heart's electrical activity (conduction disturbance);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not there;
- Allergic reaction after taking the medicine, hives;
- Blood tests may show abnormal liver function, liver damage;
- Thoughts of self-harm or suicide, attempt to commit suicide, 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 available data
- Fast heartbeat (ventricular tachycardia);
- 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 that may include high fever and other flu-like symptoms, a rash on the face, widespread rash, swollen glands (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cells (eosinophilia);
- A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
- Convulsions.
Other side effects when administered as an intravenous infusion
Local side effects may occur.
Common: may affect up to 1 in 10 people
- Pain or 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 in children have been fever (pyrexia), runny nose (nasopharyngitis), sore throat
(pharyngitis), eating less than usual (decreased appetite), changes in behavior, not
acting like themselves (abnormal behavior) and lack of energy (lethargy). Feeling
sleepy is a very common side effect in children and may affect more than 1 in 10 children.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://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 Hikma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and vial after
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Each vial of Lacosamide Hikma infusion solution must be used only once
(single use). Any unused solution must be discarded.
The solution must only be used if it is clear, free from particles and without any colour changes.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.
6. Package contents and other information
What Lacosamide Hikma contains
- The active ingredient 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 ingredients 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 and colorless solution.
Lacosamide Hikma solution for infusion is available in packs of 1 vial
Each vial contains 20 ml.
Marketing authorization holder and manufacturer
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
This medicinal product is authorised in the Member States of the EEA 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
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The following information is intended for healthcare professionals only:
Each vial of Lacosamide Hikma solution for infusion must be used only once
(single use). Any unused solution must be discarded (see section 3).
Lacosamide Hikma solution for infusion can be administered without further dilution, or
it can 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 point of view, the product must be used immediately. If not used
immediately, the storage times during use and the conditions prior to use are
the responsibility of the user and should not exceed 24 hours at 2 to 8°C, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Chemical and physical stability during use 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.
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- Країна реєстрації
- Лікарська формаInfusion solution, 10 MG/ML
- Код АТХN03AX18
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до LAKOSAMIDE IKMAЛікарська форма: Film-coated tablet, 50 MGДіюча речовина: ЛакосамидВиробник: ACCORD HEALTHCARE, S.L.U.Потрібен рецептЛікарська форма: Infusion solution, 10 mg / mlДіюча речовина: ЛакосамидВиробник: EXTROVIS EU LTDПотрібен рецептЛікарська форма: Film-coated tablet, 50 MGДіюча речовина: ЛакосамидВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецепт
Аналоги LAKOSAMIDE IKMA в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LAKOSAMIDE IKMA у Іспанія
Аналог LAKOSAMIDE IKMA у Польща
Аналог LAKOSAMIDE IKMA у Україна
Лікарі онлайн щодо LAKOSAMIDE IKMA
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Заповніть форму за 2 хвилини
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Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LAKOSAMIDE IKMA потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у LAKOSAMIDE IKMA — Лакосамид. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
LAKOSAMIDE IKMA виробляється компанією HIKMA FARMACEUTICA (PORTUGAL) S.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування LAKOSAMIDE IKMA з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати LAKOSAMIDE IKMA у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Лакосамид) включають LAKOSAMIDE AKKORD, LAKOSAMIDE ADROIQ, LAKOSAMIDE AUROBINDO. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
