Montelukast bluefish pharma

Patient Information Leaflet

Montelukast Bluefish Pharma, 5 mg, chewable tablets
Montelukastum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of 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 pack 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 called leukotrienes.
How Montelukast Bluefish Pharma works
Leukotrienes cause narrowing and swelling of the airways in the lungs, as well as allergic 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 asthma symptoms during the day and night.
Montelukast Bluefish Pharma is used in the treatment of children aged 6 to 14 years (5 mg dose) in whom adequate asthma control has not been achieved with previous treatment and who require additional therapy.
Montelukast Bluefish Pharma may also be used as an alternative to 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 Pharma also helps prevent exercise-induced narrowing of the airways.
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 of the airways varies in intensity in response to various triggers.
• Airway sensitivity, where 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.

Symptoms of asthma 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 triggered by airborne pollen from trees, grasses, and weeds. Symptoms of seasonal allergies typically include nasal congestion, runny nose, itchy nose, sneezing, watery eyes, swollen eyelids, redness, and itchy eyes.

2. Important information before using Montelukast Bluefish Pharma

Tell the doctor about any health problems and allergies the child currently has or has had in the past.

When not to give Montelukast Bluefish Pharma to the child:

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

Warnings and precautions

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

• If the child's asthma symptoms worsen or if breathing difficulties occur, contact the doctor immediately.
• The oral medicine Montelukast Bluefish Pharma is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow the doctor's instructions. Always keep a reliever inhaler available for the child in case of an asthma attack.
• It is important that the child takes all asthma medicines prescribed by the doctor. Do not use Montelukast Bluefish Pharma instead of other asthma medicines prescribed for the child.
• If the child taking asthma medicines develops a group of symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash, contact the doctor.
• The child should not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) if these worsen asthma symptoms.

Neuropsychiatric events (for example, behavioral and mood changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur during treatment with montelukast, consult the doctor.

Children and adolescents

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

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

Montelukast Bluefish Pharma with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

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

Before starting treatment with 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 certain other infections).

Montelukast Bluefish Pharma with food and drink

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

Pregnancy and breastfeeding

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 use Montelukast Bluefish Pharma during pregnancy.

Breastfeeding

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

Driving and using machines

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 reactions (such as dizziness and drowsiness), although very rare with Montelukast Bluefish Pharma, may affect the ability to drive or operate machinery in some patients.

Montelukast Bluefish Pharma contains aspartame and sodium

This medicine contains 1.5 mg of aspartame (5 mg dose) per tablet. Aspartame is a source of phenylalanine. It may be harmful for 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, meaning the medicine is considered "sodium-free".

3. How to use Montelukast Bluefish Pharma

This medicine should always be used as directed by the doctor. If in doubt, consult the
doctor or pharmacist.
This medicine should be administered 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.
The medicine should be taken even when the child has no asthma symptoms, and also during an acute asthma attack.
This medicine should be taken by mouth.
Children aged 6 to 14 years
One 5 mg chewable tablet once daily, taken in the evening.
If the child is taking Montelukast Bluefish Pharma 5 mg chewable tablets, 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 it is swallowed.
Montelukast Bluefish Pharma 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.
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 asthma in children only when taken regularly.
It is important to continue giving Montelukast Bluefish Pharma to the child for as long as the doctor has recommended. This will help control the child’s asthma symptoms.
If you have any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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 ingredient).

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 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 warning 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, feelings of anxiety, psychomotor hyperactivity
• dizziness, drowsiness, tingling and (or) numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• nocturnal enuresis in children
• feeling of fatigue, malaise, swelling

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 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 provide more information on the safety of the medicine.

5. How to store Montelukast Bluefish Pharma

Keep this 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.
No special storage conditions apply for this medicine.
Medicines must 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 pack and other information

What Montelukast Bluefish Pharma contains
The active substance is montelukast. Each tablet contains montelukast sodium equivalent to
5 mg of montelukast.
The other ingredients are: mannitol, sodium croscarmellose, hydroxypropylcellulose, iron(III) 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 "I" on one side and "113" on the other side.
The medicine is available in aluminium/aluminium blisters, in cardboard boxes containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
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 medicinal product is authorised in the European Economic Area countries under the following names:
Ireland Montelukast Bluefish 5 mg Chewable Tablets
Poland Montelukast Bluefish Pharma
Portugal Montelucaste Bluefish