Montelukast bluefish pharma

Package leaflet: Information for the user

Montelukast Bluefish Pharma, 4 mg, chewable tablets
Montelukastum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are identical.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Montelukast Bluefish Pharma is and what it is 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 package and other information

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

What is Montelukast Bluefish Pharma
Montelukast Bluefish Pharma is a leukotriene receptor antagonist that blocks substances known as leukotrienes.
How Montelukast Bluefish Pharma works
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 Pharma relieves asthma symptoms, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When to use Montelukast Bluefish Pharma
Your doctor has prescribed Montelukast Bluefish Pharma for the treatment of asthma in your child and for preventing daytime and nighttime asthma symptoms.
Montelukast Bluefish Pharma is used in the treatment of children aged 2 to 5 years (4 mg dose) in whom adequate asthma control has not been achieved with previous treatment and additional therapy is required.
Montelukast Bluefish Pharma may also be used as an alternative to inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
Montelukast Bluefish Pharma also helps prevent exercise-induced narrowing of the airways in children aged 2 years and older.
Your doctor will determine how to use Montelukast Bluefish Pharma based on your child's symptoms and the severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing fluctuates in response to various triggers.
• Airway hyperresponsiveness, in which the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous membrane lining 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 commonly triggered by airborne allergens such as tree, grass, and weed pollens. Seasonal allergy symptoms typically include nasal congestion, runny nose, nasal itching, sneezing, watery eyes, swollen eyelids, redness, and itchy eyes.

2. Important information before using Montelukast Bluefish Pharma

Tell the doctor about any medical conditions and allergies your child currently has or has had in the past.

When not to give Montelukast Bluefish Pharma to your child:

Do not give this medicine if your child is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Montelukast Bluefish Pharma:

• If your child's asthma symptoms worsen or if breathing difficulties occur, contact a doctor immediately.
• Montelukast Bluefish Pharma 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 medicine available for your child in case of an asthma attack.
• It is important that your child takes all asthma medicines prescribed by the doctor.
• Montelukast Bluefish Pharma should not be used instead of other asthma medicines prescribed for your child by the doctor.
• If your child experiences a combination of symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash while taking asthma medicines, contact the doctor immediately.
• Your child should not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (also known as NSAIDs), if these worsen asthma symptoms.

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

Children and adolescents

Do not use this medicine in children under 2 years of age.

Other pharmaceutical forms of this medicine, appropriate for children and adolescents under 18 years of age, are available.

Montelukast Bluefish Pharma and other medicines

Tell your doctor or pharmacist about all medicines your child is currently taking or has recently taken, including medicines obtained without a prescription, and 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 by your child.

Before starting Montelukast Bluefish Pharma, inform the 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 certain other infections).

Montelukast Bluefish Pharma with food and drink

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

Pregnancy and breastfeeding

This section of the leaflet does not apply to Montelukast Bluefish Pharma 4 mg chewable tablets, as this medicine is intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.

Pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before using Montelukast Bluefish Pharma. The doctor will assess whether it is safe to take Montelukast Bluefish Pharma during pregnancy.

Breastfeeding

It is not known whether Montelukast Bluefish Pharma passes into breast milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using Montelukast Bluefish Pharma.

Driving and using machines

This section of the leaflet does not apply to Montelukast Bluefish Pharma 4 mg chewable tablets, as this medicine is intended for use in children aged 2 to 5 years. However, the following information refers to the active substance, montelukast.

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

Montelukast Bluefish Pharma contains aspartame and sodium

This medicine contains 1.2 mg of aspartame (4 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 improper excretion.

Montelukast Bluefish Pharma contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Montelukast Bluefish Pharma

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
This medicine should be given to a child under the supervision of an adult.
Give the child only one tablet of Montelukast Bluefish Pharma once daily, as directed by the doctor.
This medicine should be taken even when the child does not have asthma symptoms, as well as during an acute asthma attack.
This medicine is to be taken orally.
Children aged 2 to 5 years
One 4 mg chewable tablet once daily, taken in the evening.
If the child is taking Montelukast Bluefish Pharma 4 mg chewable tablets, ensure that the child is not taking any other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet must be chewed before swallowing.
Montelukast Bluefish Pharma 4 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.
Montelukast Bluefish Pharma 4 mg chewable tablets are not recommended for use in children under 2 years of age.
Taking more Montelukast Bluefish Pharma than recommended
Contact the child's 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 a dose of Montelukast Bluefish Pharma is missed
Continue using Montelukast Bluefish Pharma as directed by the doctor. If the child forgets to take a dose, return to the regular dosing schedule—one tablet once daily.
Do not take a double dose to make up for a missed dose.
Stopping Montelukast Bluefish Pharma
Montelukast Bluefish Pharma is effective in treating the child's asthma only when taken regularly.
It is important to continue using Montelukast Bluefish Pharma for as long as your doctor has instructed. This will help control the child's asthma symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical trials using montelukast 4 mg chewable tablets,
the most commonly reported adverse reactions (which may occur in less than 1 in 10 people),
considered to be related to the use of montelukast chewable tablets, were:
abdominal pain
increased thirst
Additionally, in clinical trials using montelukast 5 mg chewable tablets, the following adverse reaction was reported:
headache
These symptoms were usually mild and occurred more frequently in patients taking montelukast than
in patients taking placebo (a tablet containing no active medicine).

Serious adverse reactions
If any of the following serious adverse reactions occur, seek medical advice immediately,
as urgent medical treatment may be required.
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 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 group 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 behaviour and mood: hallucinations, disorientation, suicidal thoughts and behaviour
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis (inflammation of the liver)

Adverse reactions 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

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

Uncommon: may occur in less than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, psychomotor agitation
• dizziness, drowsiness, tingling and (or) numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• nocturnal enuresis in children
• feeling tired, malaise, oedema

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

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

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

• tender, red nodules under the skin, most commonly 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 adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 expiry date stated on the blister pack and carton after "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Montelukast Bluefish Pharma contains
The active substance is montelukast. Each tablet contains sodium montelukast equivalent to 4 mg of montelukast.
The other ingredients are: mannitol, sodium croscarmellose, hydroxypropylcellulose, ferric oxide red (E 172), microcrystalline cellulose, aspartame (E 951), cherry flavour, and magnesium stearate.

What Montelukast Bluefish Pharma looks like and contents of the pack
Chewable tablet.
Light pink, mottled, oval, biconvex chewable tablets, embossed with the mark “I” on one side and “112” on the other.
The medicine is available in aluminium/aluminium blisters, in cardboard boxes containing 28 tablets.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Ireland Montelukast Bluefish 4 mg Chewable Tablets
Poland Montelukast Bluefish Pharma
Portugal Montelucaste Bluefish