Montelukast Bluefish Pharma

Leaflet attached to the packaging: information for the user

Montelukast Bluefish Pharma, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this 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, tell the doctor or pharmacist. See section 4.

Table of contents of the 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 alleviates symptoms of asthma, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast Bluefish Pharma

The doctor has prescribed Montelukast Bluefish Pharma to treat asthma in a child and prevent asthma symptoms during the day and night. Montelukast Bluefish Pharma is used in children aged 2 to 5 years (4 mg dose) who have not achieved adequate asthma control with their current treatment and require additional treatment. Montelukast Bluefish Pharma 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 Pharma also helps prevent bronchospasm caused by physical exertion in children aged 2 years and older. The doctor will determine how to use 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, 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 of the body, often caused by airborne pollen from trees, grasses, and weeds. Seasonal allergy symptoms usually include: feeling of nasal congestion, runny nose, and itching of the nose, sneezing, tearing, swelling of the eyelids, redness, and itching of the eyes.

2. Important information before taking Montelukast Bluefish Pharma

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

When not to give Montelukast Bluefish Pharma to a child:

If the 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 Pharma, discuss it with the doctor or pharmacist: If the child's asthma symptoms worsen or difficulty breathing occurs, seek medical attention immediately. Montelukast Bluefish Pharma 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 in case of an asthma attack. It is essential that the child takes all asthma medications prescribed by the doctor. Montelukast Bluefish Pharma should not be used instead of other asthma medications prescribed by the doctor. If the child 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, consult a doctor. The child should not take aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen asthma symptoms. Inform 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 the 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 the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient 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 the child. Before starting to take Montelukast Bluefish Pharma, inform the doctor if the 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 during meals; the medicine should be taken at least 1 hour before meals or 2 hours after meals.

Pregnancy and breastfeeding

This section of the leaflet does not apply to Montelukast Bluefish Pharma, 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. PregnancyWomen who are pregnant or planning to have a child 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. BreastfeedingIt 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

This section of the leaflet does not apply to Montelukast Bluefish Pharma, 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. It is not expected that Montelukast Bluefish Pharma will affect the ability to drive and 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 and use machines 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 its improper excretion. Montelukast Bluefish Pharma contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Montelukast Bluefish Pharma

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. The medicine should be given to the child under adult supervision. The 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 the child does not have asthma symptoms, as well as when an acute asthma attack occurs. The medicine should be taken orally.

Children aged 2 to 5 years

One 4 mg chewable tablet once daily, taken in the evening. Montelukast Bluefish Pharma, 4 mg, chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before meals or 2 hours after meals. Montelukast Bluefish Pharma, 4 mg, chewable tablets are not recommended for use in children under 2 years of age. If the child is taking Montelukast Bluefish Pharma, ensure that they do not take any other medicine containing the same active substance - montelukast.

Using a higher dose of Montelukast Bluefish Pharma than recommended

Consult the 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, include: abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

Missing a dose of Montelukast Bluefish Pharma

Take Montelukast Bluefish Pharma as directed by the doctor. However, if the 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 treatment with Montelukast Bluefish Pharma

Montelukast Bluefish Pharma is effective in treating asthma in the child only if taken regularly. It is essential to continue taking Montelukast Bluefish Pharma in the child as long as the doctor has prescribed it. This will help control asthma symptoms in the child. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials with montelukast, 4 mg, chewable tablets, the most common side effects (may occur in less than 1 in 10 people) considered to be related to montelukast were: abdominal pain, increased thirst. Additionally, in clinical trials 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

In case of any of the following severe side effects, seek medical attention immediately, as urgent medical attention may be necessary. Not very common: 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 or hostile behavior, depression
• Seizures

Rare: may occur in less than 1 in 1000 people

• Increased tendency to bleeding
• 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)
• Low platelet count
• Changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and behavior
• Inflammation (inflammation) of the lungs
• Severe skin reactions (erythema multiforme), which may occur without prior symptoms
• Hepatitis

Side effects reported after the medicine was placed on the market

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

Not very common: 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
• Nocturnal enuresis in children
• Feeling tired, unwell, swelling

Rare: may occur in less than 1 in 1000 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

• 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 any side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Bluefish Pharma

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 "Expiry Date (EXP)". The expiry 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast Bluefish Pharma contains

The active substance of the medicine is montelukast. Each tablet contains montelukast sodium, equivalent to 4 mg of montelukast. The other ingredients are: mannitol, sodium croscarmellose, hydroxypropyl cellulose, iron oxide red (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 "112" 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 4 mg Chewable Tablets Poland Montelukast Bluefish Pharma Portugal Montelucaste Bluefish Date of last revision of the leaflet: