LEUKAST 4 mg Жевательные Таблетки
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Инструкция по применению LEUKAST
Содержание инструкции
LEUKAST 10 mg film-coated tablets
Montelukast
“Equivalent medicine”
Read this leaflet carefully before taking this medicine as 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.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- 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 LEUKAST is and what it is used for
- 2. What you need to know before you take LEUKAST
- 3. How to take LEUKAST
- 4. Possible side effects
- 5. How to store LEUKAST
- 6. Contents of the pack and other information
1. What is LEUKAST and what is it for
What is LEUKAST
LEUKAST is a leukotriene receptor antagonist that blocks substances called
Leukotrienes.
How LEUKAST works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also cause
allergic symptoms. By blocking leukotrienes, LEUKAST improves asthma symptoms and helps to
control it and improves the symptoms of seasonal allergies (also known as hay fever and
seasonal allergic rhinitis).
When should LEUKAST be used
Your doctor has prescribed LEUKAST for the treatment of asthma, to prevent asthma symptoms
both during the day and during the night.
- LEUKAST is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their medications and who need additional therapy.
- LEUKAST also prevents the narrowing of the airways induced by exercise.
- In asthmatic patients where LEUKAST is indicated for asthma, LEUKAST may provide relief from symptoms of seasonal allergic rhinitis. Your doctor will determine how to use LEUKAST depending on your symptoms and the severity of your asthma. What is asthma?Asthma is a long-term illness. Asthma includes:
- difficulty breathing due to narrowing of the airways. The narrowing of the airways gets worse and better in response to various conditions.
- airways that react to many irritating stimuli, such as cigarette smoke, pollen, cold air or exercise.
- swelling (inflammation) of the airways.
Asthma symptoms include: cough, shortness of breath and a feeling of tightness in the chest.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by pollen in the air that comes from trees, grass and seeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose, sneezing, red, swollen, itchy, and watery eyes.
2. What you need to know before taking LEUKAST
Tell your doctor about any existing or past medical conditions and any
allergies.
Do not take LEUKAST
- if you are allergic (hypersensitive) to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking LEUKAST.
- If your asthma or breathing gets worse, contact your doctor immediately.
- LEUKAST for oral use should not be used to treat acute asthma attacks. If attacks occur, follow your doctor's instructions. Always keep your emergency inhaler medication with you for asthma attacks.
- It is important that you take all asthma medications prescribed by your doctor. LEUKAST should not be used instead of other asthma medications that your doctor has prescribed for you.
- Patients taking asthma medications should be aware that if they experience a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin redness, they should consult a doctor.
- You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also called non-steroidal anti-inflammatory drugs or NSAIDs) if your asthma worsens.
Patients should be aware that various neuropsychiatric events (e.g., changes in
behaviour and mood) have been reported in adults, adolescents and children treated with
LEUKAST (see section 4). If you develop these symptoms during treatment with LEUKAST,
you should consult your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
Different formulations of this medicine are available for pediatric patients under
15 years of age based on the age group.
Othermedicines and LEUKAST
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those that you obtain without a prescription.
Some medicines can interfere with the effect of LEUKAST, or LEUKAST can
interfere with the effect of other medicines.
Tell your doctor if you are taking the following medicines before starting to take LEUKAST:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
- gemfibrozil (used to lower the level of fats - lipids - in the blood, for example triglycerides).
LEUKAST with food and drink
LEUKAST 10 mg film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking LEUKAST.
Pregnancy
Your doctor will decide if you can take LEUKAST under these circumstances.
Breastfeeding
It is not known whether LEUKAST can be excreted in human milk. If you are breastfeeding or intend to breastfeed, consult
your doctor before taking LEUKAST.
Driving and using machines
No effects of LEUKAST on the ability to drive and operate machinery are expected.
Individual responses to medicines can however vary.
Some undesirable effects (such as dizziness and drowsiness) that have been reported very rarely
with LEUKAST may affect the ability to drive and operate machinery.
LEUKAST 10 mg film-coated tablets contains lactose and sodium.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, i.e.
essentially ‘sodium-free’.
3. How to take LEUKAST
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
- Take only one LEUKAST tablet a day as prescribed by your doctor.
- The tablet must be taken even if you do not have symptoms or have an acute asthma attack.
For adults and adolescents 15 years and older:
The recommended dose is one 10 mg tablet to be taken every evening.
If you are taking LEUKAST, make sure you are not taking other medicines that contain the
same active ingredient, montelukast.
This medicine is for oral use.
You can take LEUKAST 10 mg with or without food.
If you take more LEUKAST than you should
Consult your doctor immediately.
In the majority of overdosage reports, no adverse effects have been reported. The
symptoms most frequently reported with overdosage in adults and children
include abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.
If you forget to take LEUKAST
Try to take LEUKAST as it has been prescribed. If however you forget to take a
tablet, continue to take the medicine according to the usual dosage. Do not take a double
dose to make up for the missed tablet.
If you stop taking LEUKAST
Treatment with LEUKAST may only be effective against asthma if you continue to take it.
It is important to continue taking LEUKAST for as long as your doctor has prescribed it.
It will help you control your asthma.
If you have any doubts 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 everyone will experience them.
In clinical studies with LEUKAST 10 mg film-coated tablets, the side effects considered
related to LEUKAST reported most commonly (may affect up to 1 in 10 people) were:
- abdominal pain
- headache
These side effects were normally mild and occurred more frequently
in patients treated with LEUKAST compared to those treated with placebo (a tablet that does not
contain medicinal substance).
Serious side effects
Tell your doctor immediatelyif you notice any of the following side effects, which
may be serious and require urgent medical treatment.
Uncommon: may affect up to 1 in 100 people
- allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
- changes in behaviour and mood: agitation including aggressive or hostile behaviour, depression
- convulsions
Rare: may affect up to 1 in 1,000 people
- increased tendency to bleed
- tremor
- palpitations
Very rare: may affect up to 1 in 10,000 people
- a complex of symptoms such as a flu-like illness, tingling or numbness in the arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome) (see section 2)
- low platelet count in the blood
- changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- inflammation of the lungs
- severe skin reactions (erythema multiforme) which can occur without warning
- liver inflammation (hepatitis)
Other side effects during post-marketing use of the medicine
Very common: may affect more than 1 in 10 people
- upper respiratory tract infection
Common: may affect up to 1 in 10 people
- diarrhoea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: may affect up to 1 in 100 people
- changes in behaviour and mood: altered dreams, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, drowsiness, tingling/numbness
- nosebleeds
- dry mouth, digestive disorders
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- involuntary loss of urine during sleep by children
- weakness/feeling unwell, malaise, swelling
Rare: may affect up to 1 in 1,000 people
- changes in behaviour and mood: impaired attention, memory impairment, uncontrolled muscle movements
Very rare: may affect up to 1 in 10,000 people
- painful, red swellings of the subcutaneous tissue, most commonly located on the front of the legs (erythema nodosum)
- changes in behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through
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 LEUKAST
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 blister pack after the word ‘Scad.’
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from light and moisture.
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. Contents of the pack and other information
What LEUKAST contains
- The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
- The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. Tablet coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of LEUKAST and contents of the pack
Pack of 28 tablets: 4 blisters of 7 tablets each.
Marketing Authorisation Holder
Konpharma S.r.l. - Via Pietro della Valle 1 - 00193 Rome
Manufacturer
Adamed Pharma S.A.ul.Marszałka J. Piłsudskiego 595-200 Pabianice, Poland
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- Страна регистрации
- Форма выпускаChewable tablet, 4 MG
- Код АТХR03DC03
- 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 LEUKASTФорма выпуска: Chewable tablet, 4 MGДействующее вещество: монтелукастПроизводитель: LANOVA FARMACEUTICI S.R.L.Отпускается по рецептуФорма выпуска: Chewable tablet, 4 MGДействующее вещество: монтелукастПроизводитель: A.G.I.P.S. FARMACEUTICI SRLОтпускается по рецептуФорма выпуска: Chewable tablet, 4 MGДействующее вещество: монтелукастПроизводитель: PIAM FARMACEUTICI S.P.A.Отпускается по рецепту
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Аналог LEUKAST в Украина
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LEUKAST требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество LEUKAST — монтелукаст. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
LEUKAST производится компанией KONPHARMA S.R.L.. 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 LEUKAST 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 LEUKAST в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (монтелукаст) включают ALEAST, BROKAST, ELUNKAST. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
