MONTELUKAST 10 mg Tabletki Powlekane
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Treść ulotki
Montelukast SUN 10 mg film-coated tablets
montelukast
Generic 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.
- 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 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 Montelukast SUN is and what it is used for
- 2. What you need to know before you take Montelukast SUN
- 3. How to take Montelukast SUN
- 4. Possible side effects
- 5. How to store Montelukast SUN
- 6. Contents of the pack and other information
1. What is Montelukast SUN and what is it used for
Montelukast SUN is a leukotriene receptor antagonist that blocks substances called
leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the
lungs, as well as causing allergy symptoms. Montelukast SUN blocks leukotrienes, improves
asthma symptoms, helps to keep asthma under control and improves seasonal allergy
symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast SUN for the treatment of asthma, to prevent
asthma symptoms during the day and night.
- Montelukast SUN is used for the treatment of patients aged 15 years and over whose disease is not adequately controlled with their medicines and who need additional therapy.
- Montelukast SUN also helps to prevent the narrowing of the airways caused by exercise.
- In asthmatic patients aged 15 years and over in whom Montelukast SUN is indicated for asthma, Montelukast SUN may also relieve the symptoms of seasonal allergic rhinitis.
Your doctor will decide how much Montelukast SUN you need to take based on your symptoms and the severity
of your asthma.
What is asthma?
Asthma is a long-term illness.
Asthma involves:
- Difficulty breathing due to narrowing of the airways. This narrowing of the airways improves and worsens in response to different conditions.
- Sensitivity of the airways that react to many factors, such as cigarette smoke, pollen, cold air or exercise.
- Swelling (inflammation) of the inner wall of the airways.
Asthma symptoms include: coughing, wheezing and a feeling of tightness in the chest.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis)
consist of an allergic reaction often caused by pollen carried in the air
from trees, grass or herbaceous plants. Usually, the symptoms of seasonal allergies
may include: stuffy nose, runny nose, itchy nose, sneezing, eyes that
water, swollen, red, itchy eyes.
2. What you need to know before taking Montelukast SUN
Tell your doctor if you have had or have any medical problems or allergies.
Do not take Montelukast SUN
- if you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Montelukast SUN:
- If your asthma or breathing gets worse, tell your doctor immediately.
- Montelukast SUN is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions you have received from your doctor. Always carry your inhaler medicine for asthma attacks with you.
- It is important that you or your child take all the asthma medicines prescribed by your doctor. Montelukast SUN should not be used instead of other asthma medicines that your doctor has prescribed.
- Any patient taking asthma medicines should be informed that if they develop a set of symptoms, such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms and/or rash, they should see a doctor.
- You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
- Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents and children treated with Montelukast SUN (see section 4). If
develops these symptoms during treatment with Montelukast SUN, you should consult your child's doctor.
Other medicines and Montelukast SUN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the activity of Montelukast SUN, or Montelukast SUN
can affect the activity of other medicines.
Before starting to take Montelukast SUN, tell your doctor if you are taking the
following medicines:
- phenobarbital (used to treat epilepsy).
- phenytoin (used to treat epilepsy).
- rifampicin (used to treat tuberculosis and other infections).
- gemfibrozil (used to treat high levels of lipids in the blood).
Montelukast SUN with food and drink
Montelukast SUN 10 mg can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
Pregnant women or those planning to become pregnant should consult
their doctor before taking Montelukast SUN. The doctor will assess whether they can take
Montelukast SUN during this period.
Breastfeeding
It is not known whether Montelukast SUN is excreted in breast milk. If you are breastfeeding or
intend to breastfeed, consult your doctor before taking Montelukast SUN.
Driving and using machines
No effects on your ability to drive or operate machinery are expected.
However, responses to the medicine may vary from person to person. Certain side
effects (such as dizziness and drowsiness), which have been reported with Montelukast SUN,
may affect the ability of some patients to drive or use machines.
Montelukast SUN contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to take Montelukast SUN
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 Montelukast SUN tablet once a day as prescribed by your doctor.
- You should take it even when you do not have symptoms or when you have an acute asthma attack.
For adults 15 years and older
One 10 mg tablet to be taken every day in the evening. Montelukast SUN 10 mg can be
taken with or without food.
If you are taking Montelukast SUN, be careful not to take other medicines that
contain the same active ingredient, montelukast.
This medicine is for oral use.
You can take Montelukast 10 mg with or without food
If you take more Montelukast SUN than you should
Consult your doctor immediately. In most reports of overdose, no adverse effects have been
reported. Among the symptoms most frequently reported in overdose reports in adults and
children are abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.
If you forget to take Montelukast SUN
Try to take Montelukast SUN as prescribed. However, if you forget a dose,
take one tablet once a day at your usual usual time.
Do not take a double dose to make up for a missed dose.
If you stop taking Montelukast SUN
Montelukast SUN can only work on asthma if you continue to take it.
It is important to continue taking Montelukast SUN as long as your doctor prescribes it.
It will help you keep asthma under control.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Montelukast SUN can cause side effects, although not everybody gets them.
In clinical studies with Montelukast, 10 mg film-coated tablets, the most common side effects
(which may affect 1 in 10 people), considered related to Montelukast were:
- abdominal pain
- headache
Usually, these were mild and occurred more frequently in patients
treated with Montelukast rather than with placebo (a pill that does not contain any
medicine).
Serious side effects
See your doctor immediatelyif you experience any of the following side
effects, they could be serious and may require urgent medical
treatment.
Uncommon: the following side effects may affect up to 1 in 100 people
- allergic reactions, including swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing
- changes in behaviour and mood: agitation including aggressive or hostile behaviour, depression
- convulsions
Rare: the following side effects may affect up to 1 in 1,000 people
- increased tendency to bleed
- tremor
- palpitations.
Very rare: the following side effects may affect up to 1 in 10,000 people
- combination of symptoms such as flu-like symptoms, tingling or numbness of arms and legs, worsening of lung symptoms and/or rash. (Churg-Strauss syndrome) (see section 2)
- low number of platelets in the blood
- changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- inflammation of the lungs
- severe skin reactions (erythema multiforme) that can occur without warning
- inflammation of the liver (hepatitis)
Other side effects reported after the medicine has been marketed
Very common: the following side effects may affect more than 1 in 10 people
- upper respiratory tract infection.
Common: the following side effects may affect up to 1 in 10 people
- diarrhoea, nausea, vomiting
- rash
- fever.
- increased levels of liver enzymes
Uncommon: the following side effects may affect up to 1 in 100 people
- changes in behaviour and mood: abnormal dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, drowsiness, tingling/numbness
- nosebleeds
- dry mouth, indigestion
- bruising, itching, hives
- joint or muscle pain, muscle cramps
- bedwetting in children
- weakness/fatigue, feeling unwell, swelling.
Rare: the following side effects may affect up to 1 in 1,000 people
- behaviour and mood related changes: attention disorders, memory disorders, uncontrolled muscle movements
Very rare: the following side effects may affect up to 1 in 10,000 people
- painful red nodules under the skin, most often on the shins (erythema nodosum)
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:
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 Montelukast SUN
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 package and on the blister
after Exp. The expiry date refers to the last day of that month.
Store in the original package 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 Montelukast SUN contains
- The active ingredient is montelukast. Each tablet contains montelukast sodium, equivalent to 10 mg of montelukast.
- The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. Coating: Opadry Yellow 03B 52874 (hypromellose, titanium dioxide, macrogol, yellow iron oxide, red iron oxide).
Description of the appearance of Montelukast SUN and contents of the pack
Montelukast SUN 10 mg tablets are beige to light yellow in colour, square
with rounded edges, film-coated, with “M10” imprinted on one side and smooth on the other
side.
Blisters are available in packs of 14, 28, 30, 50, 56, 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands
Legal Representative for Italy:
Sun Pharma Italia Srl - Viale Giulio Richard, 1 - 20143 Milano
Manufacturers responsible for batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Str.
400 632 – Cluj Napoca - Romania
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- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 10 MG
- Kod ATCR03DC03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki MONTELUKAST SUNPostać farmaceutyczna: Chewable tablet, 4 MGSubstancja czynna: montelukastProducent: LANOVA FARMACEUTICI S.R.L.Wymaga receptyPostać farmaceutyczna: Chewable tablet, 4 MGSubstancja czynna: montelukastProducent: A.G.I.P.S. FARMACEUTICI SRLWymaga receptyPostać farmaceutyczna: Chewable tablet, 4 MGSubstancja czynna: montelukastProducent: PIAM FARMACEUTICI S.P.A.Wymaga recepty
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MONTELUKAST SUN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MONTELUKAST SUN jest montelukast. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MONTELUKAST SUN jest produkowany przez SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie MONTELUKAST SUN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić MONTELUKAST SUN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (montelukast) to m.in. ALEAST, BROKAST, ELUNKAST. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
