LEVETIRACETAM 100 mg /Ml Оральный Раствор
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Инструкция по применению LEVETIRAKETAM AKKORD EALTKARE
Содержание инструкции
Levetiracetam Accord Healthcare 100 mg/ml oral solution
Generic medicine
Read this leaflet carefully before you or your child start 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Levetiracetam Accord Healthcare is and what it is used for
- 2. What you need to know before you take Levetiracetam Accord Healthcare
- 3. How to take Levetiracetam Accord Healthcare
- 4. Possible side effects
- 5. How to store Levetiracetam Accord Healthcare
- 6. Contents of the pack and other information
1. What is Levetiracetam Accord Healthcare and what is it used for
Levetiracetam Accord Healthcare is an antiepileptic medicine (a medicine used to treat seizures).
Levetiracetam Accord Healthcare is used:
- alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the epileptic form in which the initial attack affects only one part of the brain but may subsequently extend to larger areas of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
- as an addition to other antiepileptic medicines to treat: partial-onset seizures, with or without generalization, in adults, adolescents, children and infants starting from 1 month of age
- myoclonic seizures (brief shock-like spasms of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).
2. What you need to know before taking Levetiracetam Accord Healthcare
Do not take Levetiracetam Accord Healthcare
- If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Levetiracetam Accord Healthcare.
- If you have kidney problems, follow your doctor's instructions. The doctor may decide whether the dose needs to be adjusted.
- If you notice a slowing of growth or unexpected onset of puberty in a child, contact your doctor.
- A limited number of people treated with antiepileptic drugs like Levetiracetam Accord Healthcare have experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal ideas, contact your doctor.
- If you have a family or medical history of irregular heartbeat (visible on an electrocardiogram), or if you have a condition and/or are taking treatment that makes you prone to heart rhythm irregularities or electrolyte imbalances.
Tell your doctor or pharmacist if any of the following side effects worsen or last for more than a few
days:
- Abnormal thoughts, feeling irritable or more aggressive than usual, or if you or your family and friends notice the appearance of significant changes in mood or behavior.
- Worsening of epilepsy
- Seizures may rarely worsen or occur more frequently, especially during the first month of treatment or after increasing the dose.
- In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills, you may notice that seizures remain present or worsen during treatment.
- If any of these new symptoms occur while taking Levetiracetam Accord, consult your doctor as soon as possible.
Children and adolescents
Levetiracetam Accord Healthcare alone (monotherapy) is not indicated in children and adolescents under
16 years of age.
Other medicines and Levetiracetam Accord Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take macrogol (a medicine used as a laxative) for one hour before and for one hour after taking levetiracetam because it may cause a loss of its effect.
Levetiracetam Accord Healthcare with food, drinks and alcohol
You can take Levetiracetam Accord Healthcare with or without food. As a precautionary measure
do not take it with alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Levetiracetam Accord Healthcare can be used during pregnancy only if, after careful
assessment, this is considered necessary by the doctor. Do not stop your treatment
without discussing this with your doctor. A risk of birth defects for the fetus cannot be
completely excluded.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Accord Healthcare may reduce your ability to drive vehicles or use tools or
machinery as Levetiracetam Accord Healthcare can cause drowsiness. This is more likely
at the beginning of treatment or after an increase in dose. Do not drive or use machinery until
you have checked that your ability to perform these activities is not affected.
Levetiracetam Accord Healthcare oral solution contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol.
Levetiracetam Accord Healthcare oral solution contains methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) which may cause allergic reactions (including delayed reactions).
Levetiracetam Accord Healthcare oral solution also contains maltitol (E965). If your doctor has
diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
3. How to take Levetiracetam Accord Healthcare
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Levetiracetam Accord Healthcare must be taken twice a day, once in the morning and once in
the evening, approximately at the same time each day.
Take the oral solution following your doctor's instructions.
Monotherapy (starting from 16 years of age)
- Adultsand adolescents (starting from 16 years of age):Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years of age and older. Recommended dose: Levetiracetam Accord Healthcare is taken twice a day in two equally divided doses, each between 5 ml (500 mg) and 15 ml (1.500 mg). When you start taking Levetiracetam Accord Healthcare for the first time, your doctor will prescribe a lower dosefor 2 weeks before administering the lowest recommended daily dose.
Add-on therapy
- Dose for adults and adolescents (from 12 to 17 years):Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years of age and older.
Recommended dose: Levetiracetam Accord Healthcare is taken twice a day in two equally
divided doses, each between 5 ml (500 mg) and 15 ml (1.500 mg).
The doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Accord Healthcare
according to age, weight and dose.
For children from 6 months to 4 years: measure the appropriate dosage using the 3 ml
syringe included in the package.
For children over 4 years: measure the appropriate dosage using the 10 ml
syringe included in the package.
Recommended dose: Levetiracetam Accord Healthcare is taken twice a day in two equally
divided doses, each between 0.1 ml (10 mg) and 0.3 ml (300 mg) per kg of body
weight of the child (see the following table for dose examples).
Dose for children aged 6 months and over:
| n Weight | Initial dose: 0.1 ml/kg twice a day | m Maximum dose: 0.3 ml/kg twice a day |
| e 6 kg | 0.6 ml twice a day | 1.8 ml twice a day |
| 8 kg | 0.8 ml twice a day | 2.4 ml twice a day |
| g 10 kg | 1 ml twice a day | 3 ml twice a day |
| 15 kg | 1.5 ml twice a day | 4.5 ml twice a day |
| 20 kg | 2 ml twice a day | 6 ml twice a day |
| A 25 kg | 2.5 ml twice a day | 7.5 ml twice a day |
| From 50 kg and over | 5 ml twice a day | 15 ml twice a day |
- Dose for infants (from 1 month to less than 6 months):For infants from 1 month to less than 6 months:measure the appropriate dosage using the 1 mlsyringe included in the package. Recommended dose: Levetiracetam Accord Healthcare is taken twice a day in two equally divided doses, each between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of body weight of the infant (see the following table for dose examples).
Dose for infants (from 1 month to less than 6 months):
Method of administration:
After measuring the correct dose with an appropriate syringe, Levetiracetam Accord Healthcare
oral solution can be diluted in a glass of water or in the baby bottle. Levetiracetam Accord
Healthcare can be taken with or without food. After oral administration, you may perceive
the bitter taste of levetiracetam.
Instructions for use
- Opening the bottle: press on the cap and rotate counterclockwise (figure 1)
| Weight | Initial dose: 0.07 ml/kg twice a day | m Maximum dose: 0.21 ml/kg twice a day |
| 4 kg | 0.3 ml twice a day | 0.85 ml twice a day |
| 5 kg | 0.35 ml twice a day | r 1.05 ml twice a day |
| 6 kg | 0.45 ml twice a day | 1.25 ml twice a day |
| 7 kg | 0.5 ml twice a day | a 1.5 ml twice a day |
- Separate the adapter from the syringe (figure 2). Insert the adapter into the neck of the bottle (figure 3). Make sure it is firmly attached.
- Take the syringe and position it on the opening of the adapter (figure 4). Turn the bottle upside down (figure 5).
- Fill the syringe with a small amount of solution, pulling the plunger down (figure 5A), then push the plunger up to remove any bubbles (figure 5B). Pull the plunger down to the graduation mark corresponding to the amount in milliliters (ml) prescribed by the doctor (figure 5C).
- Turn the bottle into the correct position (figure 6A). Remove the syringe from the adapter (figure 6B).
- Empty the contents of the syringe into a glass of water or baby bottle by pressing the syringe plunger (figure 7).
- Drink all the contents of the glass or bottle
- Close the bottle with the plastic screw cap
- Wash the syringe using only water (figure 8).
Duration of treatment:
- Levetiracetam Accord Healthcare is used as a chronic treatment. The treatment with Levetiracetam Accord Healthcare must last as long as prescribed by your doctor.
- Do not stop treatment without your doctor's advice as this could increase the number of seizures.
If you take more Levetiracetam Accord Healthcare than you should:
Possible side effects of an overdose of Levetiracetam Accord Healthcare are drowsiness,
agitation, aggression, decreased attention, respiratory inhibition and coma.
Contact your doctor if you have taken more Levetiracetam Accord Healthcare than you should. The
doctor will establish the best possible treatment for the overdose.
If you forget to take Levetiracetam Accord Healthcare:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed dose.
If you stop taking Levetiracetam Accord Healthcare:
If treatment is discontinued, Levetiracetam Accord Healthcare must be discontinued
gradually to avoid an increase in seizures. If your doctor decides to stop the
treatment with Levetiracetam Accord Healthcare, he will give you instructions regarding the gradual
suspension of Levetiracetam Accord Healthcare.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention or go to the nearest emergency room if you experience:
- weakness, feeling dizzy or lightheaded, or difficulty breathing, as these may be signs of a serious allergic reaction (anaphylactic)
- swelling of the face, lips, tongue and throat (angioedema)
- flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
- symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion and swelling of legs, ankles or feet, as these may be a sign of sudden decrease in kidney function
- a rash that may appear with blisters that look like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme)
- a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome)
- a more severe form of rash that causes skin peeling in more than 30% of the body surface area ( toxic epidermal necrolysis)
- signs of severe mental changes or if someone around you notices signs of confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.
The most frequently reported side effects are: nasopharyngitis, drowsiness, headache,
fatigue and dizziness. At the beginning of treatment or when the dose is increased, side effects
such as drowsiness, fatigue and dizziness may be more common.
These effects should, in any case, decrease over time.
Very common: may affect more than 1 in 10 people
- nasopharyngitis;
- drowsiness, headache.
Common: may affect up to 1 in 10 people
- anorexia (loss of appetite);
- depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
- convulsion, balance disorder, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
- vertigo (sensation of spinning);
- cough;
- abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
- rash;
- asthenia/fatigue (feeling weak).
Uncommon: may affect up to 1 in 100 people
- decreased number of platelets in the blood, decreased number of white blood cells in the blood;
- weight loss, weight gain;
- attempted suicide and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation;
- amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), impaired attention (loss of concentration);
- diplopia (double vision), blurred vision;
- elevated/abnormal values in liver function tests;
- hair loss, eczema, itching;
- muscle weakness, myalgia (muscle pain);
- trauma.
Rare: may affect up to 1 in 1,000 people
- infection;
- decreased number of all types of blood cells;
- serious allergic reactions (DRESS, anaphylactic reaction [serious and important allergic reaction], angioedema [swelling of face, lips, tongue and throat]);
- decreased concentration of sodium in the blood;
- suicide, personality disorders (behavioral problems), altered thinking (slowness of thought, inability to concentrate);
- seizures may worsen or occur more frequently;
- delirium
- encephalopathy (see the sub-paragraph “seek immediate medical attention” for a detailed description of the symptoms);
- seizures may worsen or occur more frequently;
- uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
- altered heart rate (electrocardiogram);
- pancreatitis;
- liver failure, hepatitis;
- sudden decrease in kidney function;
- a rash that may form blisters and appear as small targets (dark central spot surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form that causes skin peeling in more than 30% of the body surface area ( toxic epidermal necrolysis).
- rhabdomyolysis (breakdown of muscle tissue) and increased blood creatine phosphokinase associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
- limping gait or difficulty walking.
- combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
Very rare: may affect up to 1 in 10,000.
- repetitive unwanted thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).
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 Italian Medicines Agency Website: 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 Levetiracetam Accord Healthcare
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 bottle after
“Exp.”.
The expiry date refers to the last day of that month.
Do not use for 4 months after first opening the bottle.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in 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 the medicine containsLevetiracetam Accord Healthcare oral solution:
The active ingredient is levetiracetam.
- Each ml contains 100 mg of levetiracetam.
- The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), liquid maltitol (E965), acesulfame potassium (E950), grape flavour containing flavouring agents and propylene glycol, purified water.
Description of the appearance of Levetiracetam Accord Healthcareoral solutionand package contents
Levetiracetam Accord Healthcare oral solution is a clear, colourless liquid with a grape flavour. pH
from 5.0 to 7.0.
The 300 ml bottle of Levetiracetam Accord Healthcare oral solution (for children from 4 years of age,
adolescents and adults) is packaged in a cardboard box containing a 10 ml oral syringe
(graduated every 0.25 ml) and an adapter for the syringe.
The 150 ml bottle of Levetiracetam Accord Healthcare oral solution (for infants and young children
from 6 months to less than 4 years of age) is packaged in a cardboard box containing a 3 ml oral syringe
(graduated every 0.1 ml) and an adapter for the syringe.
The 150 ml bottle of Levetiracetam Accord Healthcare oral solution (for infants from 1 month to less
than 6 months of age) is packaged in a cardboard box containing a 1 ml oral syringe (graduated
every 0.05 ml) and an adapter for the syringe.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
| Country | i Medicine name |
| Portugal | Levetiracetam Accord 100 mg/ml oral solution |
| Austria | z Levetiracetam Accord 100 mg/ml solution for ingestion |
| France | Levetiracetam Accord 100 mg/ml drinkable solution |
| Italy | n Levetiracetam Accord Healthcare |
| Netherlands | Levetiracetam Accord 100 mg/ml drink |
| Sweden | e Levetiracetam Accord 100 mg/ml oral solution |
| g United Kingdom | Levetiracetam Accord 100 mg/ml oral solution |
| Germany | Levetiracetam Accord 100 mg/ml solution for ingestion |
| Germany | Levetiracetam Accord 100 mg/ml solution for ingestion |
| A Denmark | Levetiracetam Accord Healthcare |
| Malta | Levetiracetam Accord 100 mg/ml oral solution |
| Poland | Levetiracetam Accord, 100 mg/ml, oral solution |
| Romania | Levetiracetam Accord 100 mg/ml oral solution |
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- Страна регистрации
- Форма выпускаOral solution, 100MG/ML
- Код АТХN03AX14
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги LEVETIRAKETAM AKKORD EALTKAREФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: ЛеветирацетамПроизводитель: NEURAXPHARM ITALY S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: ЛеветирацетамПроизводитель: PIAM FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Film-coated tablet, 500 MGДействующее вещество: ЛеветирацетамОтпускается по рецепту
Аналоги LEVETIRAKETAM AKKORD EALTKARE в других странах
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Аналог LEVETIRAKETAM AKKORD EALTKARE в Испания
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Часто задаваемые вопросы
LEVETIRAKETAM AKKORD EALTKARE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество LEVETIRAKETAM AKKORD EALTKARE — Леветирацетам. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
LEVETIRAKETAM AKKORD EALTKARE производится компанией ACCORD HEALTHCARE, S.L.U.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения LEVETIRAKETAM AKKORD EALTKARE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить LEVETIRAKETAM AKKORD EALTKARE в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (Леветирацетам) включают EPITIRAM, GRIFOXINA, ITALEPT. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
