Montelukast Bluefish Pharma

Leaflet accompanying the packaging: information for the user

Montelukast Bluefish Pharma, 10 mg, coated tablets

Montelukast

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 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 packaging 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 the airways in the lungs to narrow and become inflamed, and also cause allergy symptoms. By blocking the action of leukotrienes, Montelukast Bluefish Pharma relieves asthma symptoms, helps control asthma, and relieves 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 and prevent asthma symptoms during the day and night.
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Montelukast Bluefish Pharma is used to treat adults and adolescents aged 15 and over who have not achieved adequate control of asthma with their current treatment and require additional treatment.
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Montelukast Bluefish Pharma also helps prevent narrowing of the airways caused by physical exertion.
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In patients with bronchial asthma, for whom Montelukast Bluefish Pharma is used to treat asthma, it may also relieve symptoms of seasonal allergic rhinitis.
The doctor will determine how to use Montelukast Bluefish Pharma based on the patient's symptoms and the severity of their asthma.

What is asthma?

Asthma is a chronic disease.
In asthma, there are:
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Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various factors.
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Sensitivity of the airways, which react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
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Inflammation (inflammation) 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 reaction caused by airborne pollen from trees, grasses, and weeds. Seasonal allergy symptoms may include: stuffy nose, runny nose, itchy nose, sneezing, tearing, swelling, redness, and itchy eyes.

2. Important information before taking Montelukast Bluefish Pharma

Please tell your doctor about all your current or past health problems and allergies.

When not to use Montelukast Bluefish Pharma

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Warnings and precautions

Before starting treatment with Montelukast Bluefish Pharma, you should discuss it with your doctor or pharmacist.
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Montelukast Bluefish Pharma is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, you should follow the instructions given by your doctor. You should always carry a rescue inhaler with you.
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It is essential that you take all your asthma medicines as prescribed by your doctor.
Montelukast Bluefish Pharma should not be used instead of other asthma medicines prescribed by your doctor.
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You should not take aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma symptoms.

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 you experience such symptoms while taking montelukast, you should consult your doctor.

If you experience such symptoms while taking montelukast, you should consult your doctor.

Children and adolescents

This medicine should not be given to children under 15 years of age.
For children and adolescents under 18 years of age, this medicine is available in other forms suitable for their age group.

Montelukast Bluefish Pharma and other medicines

Please tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Montelukast Bluefish Pharma, and Montelukast Bluefish Pharma may affect the action of other medicines.
Before starting treatment with Montelukast Bluefish Pharma, you should inform your doctor if you are taking any of the following medicines:
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phenobarbital (a medicine used to treat epilepsy),
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phenytoin (a medicine used to treat epilepsy),
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rifampicin (a medicine used to treat tuberculosis and some other infections),
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gemfibrozil (a medicine used to treat high levels of fats in the blood).

Montelukast Bluefish Pharma with food and drink

Montelukast Bluefish Pharma, 10 mg, coated tablets, can be taken with or without food .

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will assess whether you can take Montelukast Bluefish Pharma during this period .
Breastfeeding
It is not known whether Montelukast Bluefish Pharma passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Bluefish Pharma.

Driving and using machines

Montelukast Bluefish Pharma is not expected to affect your 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 reported during treatment with Montelukast Bluefish Pharma, may affect your ability to drive or use machines in some patients.

Montelukast Bluefish Pharma contains lactose monohydrate and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Montelukast Bluefish Pharma

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
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You should take only one tablet of Montelukast Bluefish Pharma once a day, as prescribed by your doctor.
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You should take the medicine even if you do not have asthma symptoms, as well as if you experience an acute asthma attack.

Adults and adolescents aged 15 and over

The recommended dose is one 10 mg tablet once daily, in the evening.
If you are taking Montelukast Bluefish Pharma, you should make sure that you are not taking any other medicine containing the same active substance, montelukast.
The medicine should be taken orally.
Montelukast Bluefish Pharma, 10 mg, can be taken with or without food.

Taking a higher dose of Montelukast Bluefish Pharma than recommended

You should contact your 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 Pharma

You should take Montelukast Bluefish Pharma as prescribed by your doctor. However, if you forget to take a dose, you should return to your usual dosing schedule - one tablet once daily.
You should 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 you only if you take it regularly.
It is essential that you continue to take Montelukast Bluefish Pharma for as long as your doctor recommends. This will help control your asthma symptoms.
If you have any further doubts about taking this medicine, you should consult your 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, the most common side effects (which may occur in less than 1 in 10 people) considered to be related to montelukast were:
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abdominal pain,
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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

You should contact your doctor immediatelyif you experience one or more of the following side effects, which may be severe and require immediate treatment.
Uncommon: may occur in less than 1 in 100 people
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allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing,
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changes in behavior and mood: agitation, including aggressive behavior or hostility, depression,
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seizures.
Rare: may occur in less than 1 in 1,000 people
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increased tendency to bleed,
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tremors,
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palpitations.
Very rare: may occur in less than 1 in 10,000 people
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a set of symptoms, such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of respiratory symptoms, and (or) rash (Churg-Strauss syndrome) (see section 2),
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low platelet count,
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changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts,
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inflammation (inflammation) of the lungs,
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severe skin reactions (erythema multiforme), which may occur without prior symptoms,
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inflammation of the liver.

Other side effects reported after the medicine was marketed

Very common: may occur in more than 1 in 10 people
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upper respiratory tract infection.
Common: may occur in less than 1 in 10 people
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diarrhea, nausea, vomiting,
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rash,
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fever,
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elevated liver enzyme levels.
Uncommon: may occur in less than 1 in 100 people
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changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness,
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dizziness, drowsiness, tingling, and (or) numbness,
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nosebleeds,
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dry mouth, indigestion,
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bruising, itching, hives,
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muscle or joint pain, muscle spasms,
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bedwetting in children,
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weakness or fatigue, malaise, swelling.
Rare: may occur in less than 1 in 1,000 people
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changes in behavior and mood: attention disorders, memory disorders, uncontrolled muscle spasms.
Very rare: may occur in less than 1 in 10,000 people
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tender, red, subcutaneous nodules, most commonly occurring on the shins (erythema nodosum),
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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, you should tell your doctor, pharmacist, or nurse. 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 181C
02-222 Warsaw
Phone: + 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

The medicine should be stored 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 month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Montelukast Bluefish Pharma contains

• The active substance of the medicine is montelukast. Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: Tablet core: lactose monohydrate, mannitol (E 421), sodium croscarmellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), hydroxypropyl cellulose, carnauba wax, yellow iron oxide (E 172), red iron oxide (E 172).

What Montelukast Bluefish Pharma looks like and what the pack contains

Coated tablets.
Beige, square, coated tablets with rounded edges (measuring 7.9 x 7.9 mm) with the symbol "I" embossed on one side and "114" on the other.
The medicine is packaged in aluminum/aluminum blisters of 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 10 mg Film-coated Tablets
Poland
Montelukast Bluefish Pharma
Portugal
Montelucaste Bluefish
Date of last revision of the leaflet:May 2025