Montelukast Bluefish Pharma

Package Leaflet: Information for the User

Montelukast Bluefish Pharma, 5 mg, Chewable Tablets

Montelukast

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

• Keep this package 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 person. Do not give it 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

What is Montelukast Bluefish Pharma

Montelukast Bluefish Pharma is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Bluefish Pharma works

Leukotrienes cause narrowing and swelling of the airways in the lungs, as well as symptoms of allergy. By blocking the action of leukotrienes, Montelukast Bluefish Pharma relieves symptoms of asthma, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to take Montelukast Bluefish Pharma

Your doctor has prescribed Montelukast Bluefish Pharma to treat asthma in children and prevent asthma symptoms during the day and night.
Montelukast Bluefish Pharma is used to treat children aged 6 to 14 years (5 mg dose) who have not achieved adequate control of asthma with their current treatment and require additional treatment.
Montelukast Bluefish Pharma may also be used instead of inhaledcorticosteroidsin children aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
Montelukast Bluefish Pharma also helps prevent bronchospasmcaused by physical exertion.
Your doctor will determine how to take Montelukast Bluefish Pharma based on the child's symptoms and the severity of asthma.

What is asthma?

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

• Difficulty breathing due to 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.
• Inflammation (swelling) 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 an allergic response caused by airborne pollen from trees, grasses, and weeds. Seasonal allergy symptoms often include: stuffy nose, runny nose, and itchy nose, sneezing, tearful eyes, puffy eyelids, redness, and itchy eyes.

2. Important information before taking Montelukast Bluefish Pharma

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 Pharma 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 taking Montelukast Bluefish Pharma, discuss with your doctor or pharmacist:
If your child's asthma symptoms worsen or difficulty breathing occurs, seek medical attention immediately.
Montelukast Bluefish Pharma is not intended for the treatment of acuteasthma attacks. If an asthma attack occurs, follow the doctor's instructions. Always have a rescue inhaler with you for your child's asthma attacks.
It is essential that your child takes all asthma medications prescribed by the doctor.
Do not use Montelukast Bluefish Pharma instead of other asthma medicationsprescribed by the doctor for your child.
Remember that if your child is taking asthma medications and experiences a set of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of respiratory symptoms, and/or rash, contact your doctor.
Your child should not take acetylsalicylic acid(aspirin) or other anti-inflammatorymedications(also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma symptoms.
Tell the patient that in adults, adolescents, and children treated with Montelukast Bluefish Pharma, various neuropsychiatric events(such as changes in behavior and mood) have occurred (see section 4). If your child experiences such symptoms while taking Montelukast Bluefish Pharma, consult a pediatrician.

Children and adolescents

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

Montelukast Bluefish Pharma and other medicines

Tell your doctor or pharmacist about all medicines your child is taking or has recently taken, as well as any medicines your child plans to take.
Some medicines may affect the action of Montelukast Bluefish Pharma, and Montelukast Bluefish Pharma may affect the action of other medicines used in your child.
Before taking Montelukast Bluefish Pharma, 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).

Montelukast Bluefish Pharma with food and drink

Montelukast Bluefish Pharma should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding

Pregnancy
Pregnant or breastfeeding women should consult their doctor before taking Montelukast Bluefish Pharma. The doctor will assess whether it is possible to take Montelukast Bluefish Pharma during this period.
Breastfeeding
It is not known whether Montelukast Bluefish Pharma passes into breast milk. If a woman is breastfeeding or plans to breastfeed, she should consult her doctor before taking Montelukast Bluefish Pharma.

Driving and using machines

Montelukast Bluefish Pharma 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), which have been very rarely reported during treatment with Montelukast Bluefish Pharma, may affect the ability to drive or use machines in some patients.

Montelukast Bluefish Pharma contains aspartame and sodium

This medicine contains 1.5 mg of aspartame (5 mg dose) per tablet. 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 excretion.
Montelukast Bluefish Pharma contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".

3. How to take Montelukast Bluefish Pharma

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 tablet of Montelukast Bluefish Pharma once a day, as directed by the doctor.
The medicine should be taken even when your child does not have asthma symptoms, as well as when your child experiences an acute asthma attack.
The medicine should be taken orally.

Children aged 6 to 14 years

One 5 mg chewable tablet once daily, taken in the evening. Montelukast Bluefish Pharma, 5 mg, chewable tablets should notbe taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.
If your child is taking Montelukast Bluefish Pharma, ensure they do not take any other medicine containing the same active substance - montelukast.

Overdose of Montelukast Bluefish Pharma

Contact your child's doctor for 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 Pharma

Take Montelukast Bluefish Pharma as directed by your doctor. However, if your child misses a dose, return to the usual dosing schedule - one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Montelukast Bluefish Pharma treatment

Montelukast Bluefish Pharma is effective in treating asthma in your child only if taken regularly.
It is essential to continue taking Montelukast Bluefish Pharma for your child as long as the doctor recommends. This will help control asthma symptoms in your 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 Pharma 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
In addition, in clinical studies with 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

If you experience any of the following severe side effects, seek medical attention immediately, as urgent medical attention may be necessary.
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 1,000 people

• increased tendency to bleed
• tremor
• 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 in the 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 behaviors
• inflammation (infection) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis

Side effects reported after marketing authorization

Very common: may occur in more than 1 in 10 people

• upper respiratory tract infection

Common: may occur in less than 1 in 10 people

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

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/or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• feeling tired, unwell, swelling

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

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

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the blister and carton after "Expiration Date (EXP)". The expiration date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Pharma contains

The active substance is montelukast. Each tablet contains montelukast sodium, equivalent to 5 mg of montelukast.
The other ingredients are: mannitol, sodium croscarmellose, hydroxypropyl cellulose, red iron oxide (E 172), microcrystalline cellulose, aspartame (E 951), cherry flavor, and magnesium stearate.

What Montelukast Bluefish Pharma looks like and contents of the pack

Chewable tablet.
Pink, speckled, oval, biconvex chewable tablets with "I" engraved on one side and "113" on the other.
The medicine is available in aluminum/aluminum blisters, in cardboard boxes containing 28 tablets.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Manufacturer/Importer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Ireland
Montelukast Bluefish 5 mg Chewable Tablets
Poland
Montelukast Bluefish Pharma
Portugal
Montelucaste Bluefish
Date of last revision of the leaflet: