Montelukast Bluefish

Leaflet attached to the packaging: information for the user

Montelukast Bluefish, 4 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 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. Package contents 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 constrict and become inflamed. By blocking the action of leukotrienes, Montelukast Bluefish relieves the symptoms of asthma 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 children aged 2 to 5 years who have not achieved adequate asthma control with their current treatment and require additional treatment.
Montelukast Bluefish may also be used instead of inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma treatment and are unable to use inhaled corticosteroids.
Montelukast Bluefish also helps prevent exercise-induced bronchospasm in children aged 2 years and older.
The doctor will determine how to take Montelukast Bluefish based on the child's symptoms and the severity of their asthma.

What is asthma?

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

• breathing difficulties caused by airway constriction. This airway constriction 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.
• inflammation (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 your child has now or has had in the past.

When not to give Montelukast Bluefish to your child:

if your child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Montelukast Bluefish, discuss it with your doctor, pharmacist, or nurse:
If your child's asthma worsens or they experience breathing difficulties, they should see a doctor immediately.
Montelukast Bluefish oral medicine is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow the doctor's instructions. Always keep a rescue inhaler with you in case of an asthma attack in your child.
It is essential that your child takes all asthma medications prescribed by their doctor.
Do not use Montelukast Bluefish instead of other asthma medicationsprescribed by your child's doctor.
Remember that if your child is taking asthma medications and 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.
Your child should not take acetylsalicylic acid(aspirin) or other anti-inflammatory drugs(also known as non-steroidal anti-inflammatory drugs or 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 treated with montelukast (see section 4). If your child experiences such symptoms while taking

montelukast, they should consult their doctor.

Children and adolescents

Do not give this medicine to children under 2 years of age.

For children and adolescents under 18 years of age, other pharmaceutical forms of this medicine are available, suitable for their age group.

Montelukast Bluefish and other medicines

Tell your doctor or pharmacist about all medicines your child is taking now or has taken recently, as well as any medicines that may be given to your child, 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 used in your child.
Before starting to take Montelukast Bluefish, tell your doctor if your child 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, drink, and alcohol

Montelukast Bluefish, 4 mg, chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Pregnancy, breastfeeding, and fertility

This section of the leaflet does not apply to Montelukast Bluefish, 4 mg, chewable tablets, as it is intended for use in children aged 2 to 5 years. However, the following information applies to the active substance, montelukast.
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking Montelukast Bluefish.
Breastfeeding
It is not known whether Montelukast Bluefish passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Bluefish.

Driving and using machines

This section of the leaflet does not apply to Montelukast Bluefish, 4 mg, chewable tablets, as it is intended for use in children aged 2 to 5 years. However, the following information applies to the active substance, montelukast.
Montelukast Bluefish is not expected to affect the ability to drive and 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 and use machines in some patients.

Montelukast Bluefish contains aspartame (E 951) and sodium

This medicine contains 1.6 mg of aspartame in each 4 mg chewable tablet, which corresponds to 0.674 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 4 mg chewable tablet, which means the medicine is considered "sodium-free".

3. How to take Montelukast Bluefish

This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
This medicine should be given to your child under adult supervision.
Your child should take only one Montelukast Bluefish, 4 mg, chewable tablet per day, as directed by their doctor.
The medicine should be taken even when your child does not have asthma symptoms, and also when they experience an acute asthma attack.
The medicine should be taken orally.

Children aged 2 to 5 years

The recommended dose is one 4 mg chewable tablet per day, in the evening.
If your 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.
The tablet should be chewed before swallowing.
Montelukast Bluefish, 4 mg, chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.
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, 4 mg, chewable tablets are not recommended for use in children under 2 years of age.

Taking a higher dose of Montelukast Bluefish than recommended

Contact your child's doctor immediately for advice.
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 directed by your doctor. However, if your child misses a dose, they should return to their usual dosing schedule - one tablet per day.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Montelukast Bluefish

Montelukast Bluefish can only treat your child's asthma if taken regularly.
It is essential to continue taking Montelukast Bluefish as directed by your doctor. This will help control your child's 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, 4 mg, chewable tablets, the most common side effects (may occur in less than 1 in 10 people) considered related to montelukast were:
abdominal pain,
increased thirst.
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

Contact your doctor immediatelyif your child experiences 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
• tremors
• palpitations

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

• a set of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of respiratory 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 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 and numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle spasms
• 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 muscle movements

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

• tender, red lumps under the skin, most commonly 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 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.
Store in the original package to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Montelukast Bluefish contains

The active substance of the medicine is montelukast. Each tablet contains 4 mg of montelukast in the form of montelukast sodium.
The medicine also contains:
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 what the package contains

Montelukast Bluefish, 4 mg, chewable tablets are pink, oval, and biconvex, with "MOK 4" embossed on one side and "PHD471" on the other.
The medicine is packaged in OPA/Aluminum/PVC/Aluminum blisters, placed in cardboard boxes.
Package sizes: 14, 20, 28, 30, 50, 98, and 100 chewable tablets.
Not all package 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