Montelukast bluefish

Package leaflet: Information for the user

Montelukast Bluefish, 10 mg, film-coated tablets
montelukastum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents :

1. What Montelukast Bluefish is and what it is used for
2. Important information before taking Montelukast Bluefish
3. How to take Montelukast Bluefish
4. Possible side effects
5. How to store Montelukast Bluefish
6. Contents of the pack and other information

1. What Montelukast Bluefish is and what it is used for

Montelukast Bluefish is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of the airways in the lungs, as well as trigger allergy symptoms. By blocking the action of leukotrienes, Montelukast Bluefish relieves asthma symptoms, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast Bluefish for the treatment of asthma and for the prevention of asthma symptoms during the day and night.
Montelukast Bluefish is used in the treatment of adults and adolescents aged 15 years and older in whom adequate asthma control has not been achieved with previous therapy and additional treatment is required.
Montelukast Bluefish also helps prevent airway narrowing caused by physical exercise.
In patients with bronchial asthma who are being treated with Montelukast Bluefish for asthma, it may also simultaneously relieve symptoms of seasonal allergic rhinitis.
Your doctor will determine how to take Montelukast Bluefish depending on your symptoms and the severity of your asthma.

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Increased sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grasses, and weeds.
Symptoms of seasonal allergies may include: stuffy nose, runny nose, itchy nose, sneezing, watery eyes, swelling, redness, and itchy eyes.

2. Important information before using Montelukast Bluefish

Tell your doctor about any health problems and allergies you currently have or have had in the past.

When Montelukast Bluefish must not be used

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, pharmacist or nurse before starting to take Montelukast Bluefish:

If your asthma or breathing problems worsen, contact your doctor immediately.

The oral medicine Montelukast Bluefish is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions provided by your doctor. Always have your rescue inhaler medicine available for immediate use during an asthma attack.

It is important that you continue to take all asthma medicines prescribed by your doctor. Do not use Montelukast Bluefish instead of other asthma medicines prescribed for you by your doctor.

Patients taking asthma medicines should be aware that if they develop a group of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of lung symptoms and/or rash, they should contact their doctor.

Do not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, consult your doctor.

Children and adolescents

Do not use this medicine in children under 15 years of age.

Montelukast Bluefish 4 mg chewable tablets are available for children aged 2 to 5 years.

Montelukast Bluefish 5 mg chewable tablets are available for children aged 6 to 14 years.

Montelukast Bluefish with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the action of Montelukast Bluefish, and Montelukast Bluefish may affect the action of other medicines.

Before starting Montelukast Bluefish, inform your doctor if you are taking any of the following medicines:

• phenobarbital (a medicine used to treat epilepsy),
• phenytoin (a medicine used to treat epilepsy),
• rifampicin (a medicine used to treat tuberculosis and certain other infections),
• gemfibrozil (a medicine used to treat high blood lipid levels).

Taking Montelukast Bluefish with food and drink

Montelukast Bluefish 10 mg film-coated tablets may be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking Montelukast Bluefish.

Pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before using Montelukast Bluefish. Your doctor will decide whether you can take Montelukast Bluefish during this time.

Breastfeeding

It is not known whether Montelukast Bluefish passes into breast milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before using Montelukast Bluefish.

Driving and using machines

Montelukast Bluefish is not expected to affect your ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with Montelukast Bluefish may affect the ability to drive or operate machinery in some patients.

Montelukast Bluefish contains lactose monohydrate and sodium

If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg film-coated tablet; essentially, this medicine is considered "sodium-free".

3. How to take Montelukast Bluefish

This medicine should always be taken exactly as your doctor has told you. If you are not sure,
ask your doctor or pharmacist.
Take only one tablet of Montelukast Bluefish once daily, as directed by your doctor.
You should continue taking this medicine even when you do not have asthma symptoms, and also
during an acute asthma attack.
This medicine is for oral use.
Adults and adolescents aged 15 years and older:
Take one 10 mg tablet once daily in the evening.
If you are taking Montelukast Bluefish, make sure you are not also taking any other medicine
containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Bluefish 10 mg tablets may be taken with or without food.
Taking more Montelukast Bluefish than recommended
Contact your doctor immediately for advice.
In most cases of overdose, no adverse effects have been reported. The most commonly reported
symptoms of overdose in adults and children include: abdominal pain, drowsiness, increased thirst,
headache, vomiting, and hyperactivity.
If you forget to take Montelukast Bluefish
Try to take Montelukast Bluefish as directed by your doctor. However, if you miss a dose, simply
return to your regular dosing schedule—one tablet once daily.
Do not take a double dose to make up for a missed dose.
Stopping Montelukast Bluefish
Montelukast Bluefish will only control your asthma if taken regularly.
It is important to continue taking Montelukast Bluefish for as long as your doctor has instructed.
This will help control your asthma.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In clinical trials with montelukast 10 mg film-coated tablets, the most frequently reported adverse reactions (occurring in at least 1 in 100 but less than 1 in 10 treated patients), considered to be related to montelukast intake, were:
abdominal pain,
headache.
These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking placebo (tablets containing no active ingredient).

Serious adverse reactions
Contact a doctor immediately if any of the following adverse reactions occur, as they may be serious and the patient may require immediate medical attention.
Uncommon: may occur in less than 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 behaviour or hostile thoughts, depression
• seizures

Rare: may occur in less than 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may occur in less than 1 in 10,000 people

• a group of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and attempts
• swelling (inflammation) of the lungs
• severe skin reactions (e.g. erythema multiforme), which may occur without prior warning symptoms
• hepatitis (inflammation of the liver)

Other adverse reactions reported after marketing of the medicine
Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections

Common: may occur in less than 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels

Uncommon: may occur in less than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling restless, motor restlessness
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• nocturnal enuresis in children
• weakness and (or) fatigue, malaise, oedema

Rare: may occur in less than 1 in 1,000 people

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements

Very rare: may occur in less than 1 in 10,000 people
tender, red nodules under the skin, most commonly appearing on the shins (erythema nodosum)
changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Montelukast Bluefish

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton under "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Montelukast Bluefish contains
The active substance is montelukast. Each tablet contains 10 mg of montelukast in the form of
montelukast sodium.
The other ingredients are:
Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
low-substituted hydroxypropyl cellulose (E 463), and magnesium stearate.
Film-coating ingredients: black iron oxide (E 172), hypromellose, red iron oxide (E 172),
polyethylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 6000.
What Montelukast Bluefish looks like and contents of the pack
Montelukast Bluefish 10 mg film-coated tablets are beige, square-shaped, biconvex tablets,
with the imprint “MOK 10” on one side and “PHD471” on the other.
The medicine is packed in blisters, placed in cardboard cartons.
Pack sizes: 14, 20, 28, 30, 50, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Manufacturer:
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Montelukast Bluefish