Montelukast bluefish

Package leaflet: Information for the user

Montelukast Bluefish, 5 mg, chewable tablets
montelukastum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific child. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Montelukast Bluefish is and what it is 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. Contents of the pack and other information

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

Montelukast Bluefish is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking the action of leukotrienes, Montelukast Bluefish relieves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast Bluefish for the treatment of asthma and prevention of asthma symptoms during the day and night.
Montelukast Bluefish is used in patients who have not achieved adequate asthma control with previous treatment and require additional therapy.
Montelukast Bluefish may also be used instead of inhaled corticosteroids in children aged 6 to 14 years who have not recently taken oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
Montelukast Bluefish also helps prevent airway narrowing caused by physical exercise.
Your doctor will determine how to use Montelukast Bluefish based on the symptoms and severity of asthma present in the patient.

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Airway sensitivity, where airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the lining of the airways.

Symptoms of asthma include coughing, wheezing, and chest tightness.

2. Important information before using Montelukast Bluefish

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

When not to use Montelukast Bluefish

Do not use Montelukast Bluefish if you or your child are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Montelukast Bluefish:

If asthma symptoms or breathing difficulties worsen, contact your doctor immediately.

Oral Montelukast Bluefish is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep a reliever inhaler available for immediate use during an asthma attack.

It is important that you continue to take all asthma medications prescribed by your doctor. Do not replace other prescribed asthma medications with Montelukast Bluefish.

Remember that if you or your child taking asthma medications develop a combination of symptoms such as: flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash, contact your doctor.

Do not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your asthma.

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

Children and adolescents

Do not use this medicine in children under 6 years of age.

Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Montelukast Bluefish and other medicines

Tell your doctor or pharmacist about any medicines you or your child are currently taking, have recently taken, or plan to take, including medicines obtained without a prescription.

Some medicines may affect the action of Montelukast Bluefish, and Montelukast Bluefish may affect the action of other medicines.

Before starting Montelukast Bluefish, inform your doctor if you are 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),
• gemfibrozil (a medicine used to treat high blood lipid levels).

Taking Montelukast Bluefish with food and drink

Montelukast Bluefish 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using Montelukast Bluefish.

Pregnancy

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

Breastfeeding

It is not known whether Montelukast Bluefish passes into human breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before using Montelukast Bluefish.

Driving and operating machinery

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

Montelukast Bluefish contains aspartame (E951) and sodium

This medicine contains 2 mg of aspartame in each 5 mg chewable tablet, equivalent to 0.842 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 impaired excretion.

Montelukast Bluefish contains less than 1 mmol (23 mg) of sodium per 5 mg chewable tablet; therefore, the medicine is considered "sodium-free".

3. How to take Montelukast Bluefish

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Take only one Montelukast Bluefish tablet per day, as directed by your doctor.
The medicine should be taken even when the patient does not have asthma symptoms, and also during an acute asthma attack.
This medicine should be taken by mouth.

Children aged 6 to 14 years
The recommended dose is one 5 mg chewable tablet once daily in the evening.
If the patient or their child is taking Montelukast Bluefish, ensure they are not taking any other medicine containing the same active substance – montelukast.
This medicine is intended for oral use.
The tablet must be chewed before it is swallowed.
Montelukast Bluefish 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Taking more Montelukast Bluefish than prescribed
Contact your 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 you forget to take Montelukast Bluefish
Try to take Montelukast Bluefish as prescribed by your doctor. However, if the patient or their child misses 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
Montelukast Bluefish can only control asthma when taken regularly.
It is important to continue taking Montelukast Bluefish for as long as your doctor has instructed.
This will help control asthma in the patient or their child.
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 everybody will experience them.
In clinical trials using montelukast 5 mg chewable tablets, the most commonly reported adverse reactions (occurring in at least 1 in 100 but less than 1 in 10 patients treated), considered related to montelukast administration, were:
abdominal pain.

Additionally, in clinical trials using montelukast 10 mg film-coated tablets and 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 ingredient).
Serious adverse reactions
Contact a doctor immediately if any of the following adverse reactions occur in a child, as they may be serious and the patient or their child may 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 behaviour and mood: agitation, including aggressive behaviour or hostile attitude, 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 syndrome of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• decreased platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and suicide attempts
• swelling (inflammation) of the lungs
• severe skin reactions (e.g. erythema multiforme), which may occur without prior symptoms
• hepatitis (inflammation of the liver)

Other adverse reactions reported after marketing authorization
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

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

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, motor restlessness
• dizziness, somnolence, paraesthesia and numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• nocturnal enuresis in children
• weakness and (or) fatigue, 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 subcutaneous nodules most commonly appearing 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 not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products at 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
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

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 the carton after
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Montelukast Bluefish contains
The active substance is montelukast. Each tablet contains 5 mg of montelukast in the form of montelukast sodium.
The other ingredients are:
Mannitol (E 421), microcrystalline cellulose, low-substituted hydroxypropylcellulose,
iron oxide red (E 172), sodium croscarmellose, cherry flavour (containing glyceryl triacetate - E 1518, sodium octenyl succinate - E 1450), aspartame (E 951) and magnesium stearate.

What Montelukast Bluefish looks like and contents of the pack
Montelukast Bluefish chewable tablets 5 mg are pink, round, biconvex tablets, embossed with "MOK 5" on one side and "PHD471" on the other.
The medicine is packed in blisters made of OPA/Aluminum/PVC/Aluminum, placed in cardboard boxes.
Pack sizes: 14, 20, 28, 30, 50, 98 and 100 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Poland: Montelukast Bluefish