Montelukast bluefish pharma

Package leaflet: Information for the user

Montelukast Bluefish Pharma, 10 mg, film-coated tablets
Montelukastum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of the leaflet

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 Montelukast Bluefish Pharma is
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 and also trigger allergy 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 Montelukast Bluefish Pharma should be used
Your doctor has prescribed Montelukast Bluefish Pharma for the treatment of asthma and prevention of daytime and nighttime asthma symptoms.
­ Montelukast Bluefish Pharma is used in the treatment of adults and adolescents aged 15 years and older who have not achieved adequate asthma control with their current treatment and require additional therapy.
­ Montelukast Bluefish Pharma also helps prevent exercise-induced narrowing of the airways.
­ In patients with asthma who are treated with Montelukast Bluefish Pharma, it may simultaneously relieve symptoms of seasonal allergic rhinitis.
Your doctor will determine how to use Montelukast Bluefish Pharma based on your symptoms and the severity of your 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.
­ Hyperreactivity 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.
Asthma symptoms include cough, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions commonly triggered by airborne pollen from trees, grasses, and weeds. Symptoms of seasonal allergies may include nasal congestion, runny nose, itchy nose, sneezing, watery eyes, eye swelling, redness, and itching of the eyes.

2. Important information before using Montelukast Bluefish Pharma

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

When not to use Montelukast Bluefish Pharma

• if you 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 or pharmacist before taking Montelukast Bluefish Pharma.

• If your asthma symptoms worsen or you have difficulty breathing, contact your doctor immediately.
• The oral medicine Montelukast Bluefish Pharma is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always keep your reliever inhaler medicine with you for use during an asthma attack.
• It is important that you continue to take all asthma medicines prescribed by your doctor. Do not use Montelukast Bluefish Pharma instead of other asthma medicines prescribed for you by your doctor.
• If you are taking asthma medicines and experience a combination of symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms and/or rash, contact your doctor.
• Do not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma symptoms.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, 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 formulations appropriate for the respective age group.

Montelukast Bluefish Pharma and other medicines Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, and 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.

Tell your doctor if you are taking any of the following medicines before starting Montelukast Bluefish Pharma:

• 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 levels of fats in the blood).

Montelukast Bluefish Pharma with food and drink Montelukast Bluefish Pharma 10 mg film-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, consult your doctor or pharmacist before using this medicine.

Pregnancy
Your doctor will decide whether you can take Montelukast Bluefish Pharma during pregnancy.

Breastfeeding
It is not known whether Montelukast Bluefish Pharma passes into human milk. If you are breastfeeding or intend to breastfeed, consult your 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) reported during treatment with Montelukast Bluefish Pharma may affect the ability to drive or operate machinery in some patients.

Montelukast Bluefish Pharma contains lactose monohydrate and sodium
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is considered "sodium-free".

3. How to use Montelukast Bluefish Pharma

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

Adults and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet once daily, taken in the evening.
If the patient is taking Montelukast Bluefish Pharma, ensure that they are not also taking any other
medicine containing the same active substance, montelukast.
This medicine should be taken orally.
Montelukast Bluefish Pharma 10 mg may be taken with or without food.

Taking more Montelukast Bluefish Pharma than recommended
Seek immediate medical advice from your doctor.
In most cases of overdose, no adverse effects have been reported.
The most commonly reported overdose symptoms in adults and children include: abdominal pain,
drowsiness, increased thirst, headache, vomiting, and hyperactivity.

If you miss a dose of Montelukast Bluefish Pharma
Take Montelukast Bluefish Pharma exactly as directed by your doctor. However, if a dose is missed,
simply 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 Pharma
Montelukast Bluefish Pharma is effective in treating the patient's asthma only when taken regularly.
It is important to continue taking Montelukast Bluefish Pharma for as long as your doctor has advised.
This will help control the patient's asthma symptoms.
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, the most commonly reported adverse reactions (which may occur in fewer than 1 in 10 people) considered to be related to montelukast treatment were:
­ abdominal pain,
­ 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).

Severe adverse reactions
You should contact your doctor immediately if you experience one or more of the following adverse reactions, which may be serious and for which immediate treatment may be required.

Uncommon: may occur in fewer 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 hostility, depression,
­ seizures.

Rare: may occur in fewer than 1 in 1,000 people
­ increased tendency to bleed,
­ tremor,
­ palpitations.

Very rare: may occur in fewer than 1 in 10,000 people
­ a group of symptoms such as: flu-like symptoms, tingling or numbness in hands or feet, worsening respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2),
­ reduced platelet count,
­ changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and suicide attempts,
­ swelling (inflammation) of the lungs,
­ severe skin reactions (erythema multiforme), which may occur without prior warning symptoms,
­ hepatitis (liver inflammation).

Other adverse reactions reported after the medicine was marketed

Very common: may occur in more than 1 in 10 people
­ upper respiratory tract infection.

Common: may occur in fewer than 1 in 10 people
­ diarrhoea, nausea, vomiting,
­ rash,
­ fever,
­ elevated liver enzyme levels.

Uncommon: may occur in fewer 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 (or) numbness,
­ nosebleeds,
­ dryness in the mouth, indigestion,
­ bruising, itching, urticaria (hives),
­ muscle or joint pain, muscle cramps,
­ nocturnal enuresis in children,
­ weakness or fatigue, malaise, oedema (swelling).

Rare: may occur in fewer than 1 in 1,000 people
­ changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle spasms.

Very rare: may occur in fewer 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, inform your doctor, pharmacist, or nurse. 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 181C
02-222 Warsaw
Phone: +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 provide more information on the safety of this 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 carton after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should 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 10 mg of montelukast as montelukast sodium.
• The other ingredients are: Tablet core: lactose monohydrate, mannitol (E 421), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate. Tablet coating: hypromellose 2910, titanium dioxide (E 171), hydroxypropylcellulose, carnauba wax, iron oxide yellow (E 172), iron oxide red (E 172).

What Montelukast Bluefish Pharma looks like and contents of the pack
Film-coated tablets.
Beige, square-shaped film-coated tablets with rounded edges (measuring 7.9 x 7.9 mm),
imprinted with the symbol “I” on one side and “114” on the other.
The medicine is packed in aluminium/aluminium foil blisters containing 28 tablets.
Marketing Authorisation Holder and Manufacturer/Importer
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 10 mg Film-coated Tablets
Poland Montelukast Bluefish Pharma
Portugal Montelucaste Bluefish