Montelukast Bluefish

Leaflet accompanying the packaging: information for the user

Montelukast Bluefish, 5 mg, chewable tablets

montelukast

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific child. 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 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. By blocking the action of leukotrienes, Montelukast Bluefish relieves asthma symptoms and helps control asthma.
The doctor has prescribed Montelukast Bluefish to treat asthma and prevent asthma symptoms during the day and night.
Montelukast Bluefish is used to treat patients who have not achieved adequate control of asthma with their current treatment and require additional treatment.
Montelukast Bluefish may also be used instead of inhaled corticosteroids in children aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and who are unable to use inhaled corticosteroids.
Montelukast Bluefish also helps prevent narrowing of the airways caused by physical exertion.
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.
• airway hypersensitivity, which reacts 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.

2. Important information before taking Montelukast Bluefish

Tell your doctor about all health problems and allergies that the patient or their child has now or has had in the past.

When not to take Montelukast Bluefish

if the patient or their child is 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 the patient's or their child's asthma worsens or they experience breathing difficulties, they should see a doctor 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 that the patient takes all asthma medications prescribed by their doctor.
Montelukast Bluefish should not be used instead of other asthma medications prescribed by the doctor.
Remember that if the patient taking asthma medications experiences a set of symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of lung symptoms, and/or rash, they should contact their doctor.
The patient should not take aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen their asthma.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages taking montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, they should consult their doctor.

If the patient experiences such symptoms while taking montelukast, they should consult their doctor.

Children and adolescents

Do not give this medicine to children under 6 years of age.
For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Montelukast Bluefish and other medicines

Tell your doctor or pharmacist about all medicines the patient or their child is taking or has recently taken, as well as any medicines they plan to take, including those available 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, tell your doctor if the patient is 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 fat levels).

Taking Montelukast Bluefish with food and drink

Montelukast Bluefish, 5 mg, chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist 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 the patient is breastfeeding or plans to breastfeed, they should consult their 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 aspartame (E951) and sodium

This medicine contains 2 mg of aspartame in each 5 mg chewable tablet, which corresponds to 0.842 mg of phenylalanine per dose. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
Montelukast Bluefish contains less than 1 mmol (23 mg) of sodium per 5 mg chewable tablet, which means the medicine is considered "sodium-free".

3. How to take Montelukast Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.
Take only one tablet of Montelukast Bluefish once a day, as prescribed by your doctor.
Take the medicine even when the patient does not have asthma symptoms, as well as when they experience an acute asthma attack.
Take the medicine orally.

Children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet once daily, in the evening.
If the patient or their child is taking Montelukast Bluefish, ensure they do not take any other medicine containing the same active substance - montelukast.
This medicine is intended for oral use.
Chew the tablet before swallowing.
Montelukast Bluefish, 5 mg, chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Taking a higher dose of Montelukast Bluefish than recommended

Seek medical advice immediately.
In most cases of overdose, no side 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.

Missing a dose of Montelukast Bluefish

Try to take Montelukast Bluefish as prescribed by your doctor. However, if the patient or their child misses a dose, they should return to their usual dosing schedule - one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Montelukast Bluefish

Montelukast Bluefish can only treat asthma in the patient or their child if taken regularly.
It is essential to continue taking Montelukast Bluefish for as long as the doctor recommends.
This will help control asthma in the patient or their child.
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, 5 mg, chewable 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.
Additionally, in clinical studies with montelukast, 10 mg, film-coated tablets, and montelukast, 5 mg, chewable tablets, the following side effect was reported:

• headache.

These symptoms were usually mild and occurred more frequently in patients taking montelukast than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Seek medical help immediatelyif the patient or their child experiences any of the following side effects, which may be severe and require immediate medical attention.
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 breathing or swallowing
• changes in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

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 set of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of lung symptoms, and/or rash (Churg-Strauss syndrome) (see section 2)
• decreased 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 the medicine was marketed

Very common: may affect more than 1 in 10 people

• upper respiratory tract infections

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling and 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 affect up to 1 in 1,000 people

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

Very rare: may affect up to 1 in 10,000 people

• tender, 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 not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Montelukast Bluefish

Keep the 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 "EXP". The expiry date refers to the last day of the month.
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 5 mg of montelukast in the form of montelukast sodium.
The other ingredients are:
Mannitol (E 421), microcrystalline cellulose, low-substituted hydroxypropylcellulose, iron oxide red (E 172), sodium croscarmellose, cherry flavor (containing glycerol triacetate - E 1518, sodium octenyl succinate - E 1450), aspartame (E 951), and magnesium stearate.

What Montelukast Bluefish looks like and contents of the pack

Montelukast Bluefish, 5 mg, chewable tablets are pink, round, and biconvex, with "MOK 5" engraved on one side and "PHD471" on the other.
The medicine is packaged in OPA/Aluminum/PVC/Aluminum blisters, placed in cardboard boxes.
Pack sizes: 14, 20, 28, 30, 50, 98, and 100 chewable 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