Montelukast bluefish

Package leaflet: Information for the user

Montelukast Bluefish, 4 mg, chewable tablets
montelukastum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific child. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you notice any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Montelukast Bluefish is and what it is used for
2. What you need to know 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 to treat asthma and to prevent asthma symptoms during the day and night.
Montelukast Bluefish is used to treat children aged 2 to 5 years whose asthma is not adequately controlled with their current treatment and who require additional therapy.
Montelukast Bluefish 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 who are unable to use inhaled corticosteroids.
Montelukast Bluefish 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 depending on the child's symptoms and 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 of the airways worsens and improves in response to various triggers.
• Increased sensitivity of the airways, which 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 the doctor about any health problems and allergies your child currently has or has had in the past.

When not to give Montelukast Bluefish 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, pharmacist, or nurse before starting treatment with Montelukast Bluefish:

• If your child's asthma worsens or if breathing difficulties occur, contact a doctor immediately.
• The oral medicine Montelukast Bluefish is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions provided by your doctor. Always keep a reliever inhaler available for your child to use during an asthma attack.
• It is important that your child continues to take all asthma medications prescribed by the doctor.
• Montelukast Bluefish must not be used instead of other asthma medicines prescribed for your child by the doctor.
• Remember that if your child, while taking asthma medicines, develops a group of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of lung symptoms and/or rash, you should contact the doctor.
• Your child should not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (also known as NSAIDs), if these worsen their asthma.
• Various neuropsychiatric events (for example, changes in behavior and mood, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in a patient during treatment with montelukast, consult a doctor.

Children and adolescents

• Do not use this medicine in children under 2 years of age.
• Other dosage forms of this medicine appropriate for children and adolescents under 18 years of age are available.

Montelukast Bluefish and other medicines

Tell the doctor or pharmacist about all medicines currently or recently given to your child, as well as any medicines that may be given in the future, including those available without a prescription.

Some medicines may affect the action of Montelukast Bluefish, and Montelukast Bluefish may affect the action of other medicines used by your child.

Before starting treatment with Montelukast Bluefish, 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),
• gemfibrozil (a medicine used to treat high blood lipid levels).

Taking Montelukast Bluefish with food, drink, and alcohol

Montelukast Bluefish 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.

Pregnancy, breastfeeding, and fertility

This section of the leaflet does not apply to Montelukast Bluefish 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

If a patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using Montelukast Bluefish.

Breastfeeding

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

Driving and operating machinery

This section of the leaflet does not apply to Montelukast Bluefish 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 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) reported during treatment with Montelukast Bluefish may affect the ability to drive or operate machinery in some patients.

Montelukast Bluefish contains aspartame (E 951) and sodium

This medicine contains 1.6 mg of aspartame in each 4 mg chewable tablet, equivalent to 0.674 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 4 mg chewable tablet, meaning the medicine is considered "sodium-free".

3. How to use Montelukast Bluefish

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
This medicine should be given to a child under the supervision of an adult.
Only one Montelukast Bluefish chewable tablet should be given to the child once daily, as directed by the doctor.
This medicine should be taken even when the child has no asthma symptoms, and also during an acute asthma attack.
This medicine is for oral use.
Children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet once daily in the evening.
If the child is taking Montelukast Bluefish, ensure that they are not also taking any other medicine containing the same active substance – montelukast.
This medicine is intended for oral use.
The tablet must be chewed before swallowing.
Montelukast Bluefish 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 4 mg chewable tablets are available for children aged 2 to 5 years.
Montelukast Bluefish 5 mg chewable tablets are available for children aged 6 to 14 years.
Montelukast Bluefish 4 mg chewable tablets are not recommended for use in children under 2 years of age.
Taking more Montelukast Bluefish 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.
Missing a dose of Montelukast Bluefish
Try to use Montelukast Bluefish exactly as prescribed 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 Montelukast Bluefish
Montelukast Bluefish will only control asthma in the child if taken regularly.
It is important to continue giving Montelukast Bluefish to the child for as long as the doctor has recommended. This will help control the child's asthma.
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 (may occur in less than 1 in
10 people), considered to be related to montelukast intake, were:
abdominal pain,
increased thirst.
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 medicine).
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 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 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 1000 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 of 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 attempts
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• hepatitis (inflammation of the liver)

Other adverse reactions reported after marketing of the medicine
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, restlessness
• dizziness, drowsiness, tingling 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 1000 people

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

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

• tender, red nodules under the skin, 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 adverse reactions not listed
in this leaflet, tell a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions
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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the
safety of using the medicine.

5. How to store Montelukast Bluefish

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Montelukast Bluefish contains
The active substance is montelukast. Each tablet contains 4 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 4 mg are pink, oval-shaped, biconvex tablets, embossed with "MOK 4" on one side and "PHD471" on the other.
The medicine is packed in blisters made of OPA/Aluminium/PVC/Aluminium, 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 member states of the European Economic Area under the following names:
Poland: Montelukast Bluefish