Montelukast Bluefish

Leaflet attached to the packaging: information for the user

Montelukast Bluefish, 10 mg, coated tablets

montelukast

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Montelukast Bluefish is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause the airways in the lungs to narrow and swell, as well as cause allergy symptoms. By blocking the action of leukotrienes, Montelukast Bluefish relieves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
The doctor has prescribed Montelukast Bluefish to treat asthma and prevent asthma symptoms during the day and night.
Montelukast Bluefish is used to treat adults and adolescents aged 15 and over who have not achieved adequate control of asthma with their current treatment and require additional treatment.
Montelukast Bluefish also helps prevent narrowing of the airways caused by physical exertion.
In patients with bronchial asthma, for whom Montelukast Bluefish is used to treat asthma, it may also relieve symptoms of seasonal allergic rhinitis.
The doctor will determine how to take Montelukast Bluefish based on the patient's symptoms and the severity of asthma.

What is asthma?

Asthma is a chronic disease.
In asthma, there are:

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

Asthma symptoms include: coughing, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grasses, and weeds.
Seasonal allergy symptoms may include: stuffy nose, runny nose, itching of the nose, sneezing, tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Montelukast Bluefish

Please tell your doctor about all your current or past health problems and allergies.

When not to take Montelukast Bluefish

if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Montelukast Bluefish, discuss it with your doctor, pharmacist, or nurse:
If your asthma worsens or you have difficulty breathing, seek medical attention immediately.
Montelukast Bluefish is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow the doctor's instructions. Always carry a rescue inhaler with you.
It is essential to take all asthma medications prescribed by your doctor.
Do not take Montelukast Bluefish instead of other asthma medications prescribed by your doctor.
If you are taking asthma medications and experience a cluster of symptoms such as flu-like symptoms, tingling or numbness in your hands or feet, worsening of respiratory symptoms, and/or rash, contact your doctor.
Do not take aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma.

Psychiatric events (such as changes in behavior and mood, depression, and suicidal thoughts) have been reported in patients of all ages taking montelukast (see section 4). If you experience such symptoms while taking montelukast, consult your doctor.

Children and adolescents

Do not give this medicine to children under 15 years of age.
For children aged 2 to 5 years, Montelukast Bluefish, 4 mg, chewable tablets are available.
For children aged 6 to 14 years, Montelukast Bluefish, 5 mg, chewable tablets are available.

Montelukast Bluefish and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, 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 taking 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 some other infections),
• gemfibrozil (a medicine used to treat high blood lipid levels).

Taking Montelukast Bluefish with food and drink

Montelukast Bluefish, 10 mg, coated tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Montelukast Bluefish.
Pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast Bluefish. The doctor will assess whether it is possible to take Montelukast Bluefish during this period.
Breastfeeding
It is not known whether Montelukast Bluefish passes into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Montelukast Bluefish.

Driving and using machines

Montelukast Bluefish is not expected to affect the ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during treatment with Montelukast Bluefish may affect the ability to drive or use machines in some patients.

Montelukast Bluefish contains lactose monohydrate and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per 10 mg coated tablet, which means it is essentially sodium-free.

3. How to take Montelukast Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Take only one tablet of Montelukast Bluefish once daily, as directed by your doctor.
Take the medicine even when you do not have asthma symptoms, and also when you have an acute asthma attack.
Take the medicine orally.

Adults and adolescents aged 15 and over:

Take one 10 mg tablet once daily, in the evening.
If you are taking Montelukast Bluefish, make sure you are not taking any other medicine containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Bluefish, 10 mg, can be taken with or without food.

What to do if you take more Montelukast Bluefish than you should

Contact your doctor for advice.
In most cases of overdose, no adverse effects have been reported. The most common symptoms of overdose reported in adults and children are:
abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

What to do if you forget to take Montelukast Bluefish

Try to take Montelukast Bluefish as directed by your doctor. If you miss a dose, go back to your normal dosing schedule - one tablet once daily.
Do not take a double dose to make up for a missed dose.

What to do if you stop taking Montelukast Bluefish

Montelukast Bluefish can only treat your asthma if you take it regularly.
It is essential to continue taking Montelukast Bluefish for as long as your doctor recommends.
This will help control your asthma.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast Bluefish can cause side effects, although not everybody gets them.
In clinical studies with montelukast, 10 mg, coated tablets, the most common side effects (occurring in at least 1 in 100, but less than 1 in 10 treated patients), which were considered to be related to montelukast, were:
abdominal pain,
headache.
These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking placebo (a tablet that does not contain any medicine).

Severe side effects

Contact your doctor immediatelyif you experience any of the following side effects, which may be severe and 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 breathing or swallowing
• changes in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

Rare: may occur in less than 1 in 1000 people

• increased tendency to bleed
• tremor
• palpitations

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

• a cluster 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 behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis

Other side effects reported after marketing

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

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

Uncommon: may occur in less than 1 in 100 people

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• bedwetting in children
• weakness and/or fatigue, malaise, swelling

Rare: may occur in less than 1 in 1000 people

• changes in behavior and mood: attention disorders, memory disorders, uncontrolled movements

Very rare: may occur in less than 1 in 10,000 people
painful, red lumps under the skin, most often on the shins (erythema nodosum)
changes in behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Bluefish

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 as montelukast sodium.
The other ingredients are:
microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
low-substituted hydroxypropyl cellulose (E 463) and magnesium stearate.
Coating: 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, coated tablets are beige, square, and biconvex, with "MOK 10" engraved on one side and "PHD471" on the other.
The medicine is packaged in blisters, which are placed in cardboard boxes.
Pack sizes: 14, 20, 28, 30, 50, 98, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Poland:
Montelukast Bluefish
Date of last revision of the leaflet: October 2024