Montelukast aurovitas

Package leaflet: Information for the user

Montelukast Aurovitas, 10 mg, film-coated tablets
Montelukastum
Read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you personally. Do not pass it on to others.
• It may harm other people, even if their symptoms are the same as yours.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Montelukast Aurovitas is and what it is used for
2. What you need to know before taking Montelukast Aurovitas
3. How to take Montelukast Aurovitas
4. Possible side effects
5. How to store Montelukast Aurovitas
6. Contents of the pack and other information

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

What is Montelukast Aurovitas
Montelukast Aurovitas is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.
How Montelukast Aurovitas works
Leukotrienes cause narrowing and swelling of the airways and allergy symptoms. By blocking the action of leukotrienes, Montelukast Aurovitas relieves asthma symptoms, helps control them, and also alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Montelukast Aurovitas should be used
Your doctor has prescribed Montelukast Aurovitas for the treatment of asthma and prevention of its symptoms occurring during the day and at night.
Montelukast Aurovitas is used in the treatment of children and adolescents aged 15 years and older in whom adequate asthma control has not been achieved with previously used medications and additional therapy is required.
Montelukast Aurovitas also helps prevent exercise-induced narrowing of the airways.
In patients with asthma for whom Montelukast Aurovitas is indicated due to asthma, it may also relieve symptoms of seasonal allergic rhinitis.
Your doctor will determine how Montelukast Aurovitas should be used based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Difficulty breathing caused by narrowing of the airways. This narrowing increases or decreases in response to various triggers.
• Airway hyperreactivity, causing them to react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous membrane lining the airways.
  Asthma symptoms include coughing, wheezing, and chest tightness.
  What is seasonal allergy?
  Seasonal allergy (also known as hay fever or seasonal allergic rhinitis) is an allergic reaction, often triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergy may include nasal congestion, runny nose, itchy nose, sneezing, watery eyes, swelling, redness, and itchy eyes.

2. Important information before taking Montelukast Aurovitas

Inform your doctor about any medical conditions or allergies currently present or experienced in the past.

When not to take Montelukast Aurovitas: if the patient is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting Montelukast Aurovitas, discuss this with your doctor or pharmacist:

• Immediately inform your doctor if asthma worsens or if breathing difficulties occur.
• Montelukast Aurovitas for oral use is not intended for the treatment of acute asthma attacks. If an asthma attack occurs, follow your doctor's instructions. Always have a reliever inhaler available for immediate use during an asthma attack.
• It is important that the patient continues to take all anti-asthma medications prescribed by the doctor. Montelukast Aurovitas must not be used as a substitute for other anti-asthma medications prescribed by the doctor.
• Consult your doctor if, while taking asthma medications, the patient develops symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening of respiratory symptoms and/or rash.
• Do not take acetylsalicylic acid or anti-inflammatory medicines (so-called non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen asthma symptoms.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If
such symptoms occur during treatment with montelukast, consult your doctor.

Use in children and adolescents

Do not give this medicine to children under 15 years of age.

Different formulations of this medicine are available for paediatric patients under 18 years of age, depending on age.

Other medicines and Montelukast Aurovitas

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Some medicines may affect the action of Montelukast Aurovitas, or Montelukast Aurovitas may affect the action of other medicines.

Before starting Montelukast Aurovitas, inform your doctor if the patient is taking any of the following medicines:

• phenobarbital (used in the treatment of epilepsy),
• phenytoin (used in the treatment of epilepsy),
• rifampicin (used in the treatment of tuberculosis and certain other infections),
• gemfibrozil (used in the treatment of high plasma lipid levels).

Montelukast Aurovitas with food and drink

Montelukast Aurovitas 10 mg may be taken during or independent of meals.

Pregnancy and breastfeeding

If pregnant, breastfeeding, suspecting pregnancy, or planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will decide whether Montelukast Aurovitas can be used during pregnancy.

Breastfeeding

It is not known whether Montelukast Aurovitas passes into human milk. If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using Montelukast Aurovitas.

Driving and using machines

Montelukast Aurovitas 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 with Montelukast Aurovitas may affect the ability to drive or operate machinery in some individuals.

Montelukast Aurovitas contains lactose

Montelukast Aurovitas 10 mg film-coated tablets contain lactose. If the patient has an intolerance to certain sugars, consult a doctor before taking this medicine.

Montelukast Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; i.e. the medicine is considered "sodium-free".

3. How to take Montelukast Aurovitas

This medicine should always be taken as described in the patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

• Take only one Montelukast Aurovitas tablet once daily, as prescribed by your doctor.
• This medicine should be taken even when you have no symptoms or during an acute asthma attack.

Use in children and adolescents aged 15 years and older
The recommended dose is one 10 mg tablet once daily, taken in the evening.
If you are taking Montelukast Aurovitas, ensure that you are not taking any other medicines containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Aurovitas 10 mg tablets may be taken with or without food.

Taking more Montelukast Aurovitas than recommended
Seek medical advice immediately.
In most cases of overdose, no adverse effects were observed. The most commonly reported adverse effects after overdose in adults and children were: abdominal pain, drowsiness, increased thirst, headache, vomiting, and increased motor activity.

If you forget to take Montelukast Aurovitas
Try to take Montelukast Aurovitas as directed. If you miss a dose, return to your regular dosing schedule of one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Montelukast Aurovitas
Montelukast Aurovitas is effective in treating asthma only when taken regularly. It is important to continue taking Montelukast Aurovitas for as long as your doctor has instructed. This will help control your asthma.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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 at a dose of 10 mg in the form of coated tablets,
the most frequently reported adverse reactions, probably related to montelukast use,
were (may occur in not more than 1 in 100, but less than 1 in 10 people):

• abdominal pain,
• headache.

These symptoms were usually mild in severity and occurred more frequently in patients treated with montelukast
than in patients receiving placebo (a tablet without active ingredient).

Serious adverse reactions
Seek immediate medical advice if any of the following adverse reactions occur, as they may be serious and may require immediate medical attention.

Uncommon: may occur in not more 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 hostile attitude, depression
• seizures

Rare: may occur in not more than 1 in 1,000 people

• increased tendency to bleeding
• tremor
• palpitations

Very rare: may occur in not more than 1 in 10,000 people

• a group of symptoms such as flu-like symptoms, sensation of pricking and tingling or numbness of 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 suicide 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 not more than 1 in 10 people

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

Uncommon: may occur in not more than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, sensation of pricking and tingling or numbness
• nosebleeds
• dryness of the 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 not more than 1 in 1,000 people

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

Very rare: may occur in not more 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 your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 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 provide more information on the safety of the medicine.

5. How to store Montelukast Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original container to protect from light and moisture.
Use within 30 days after first opening the HDPE bottle.
Medicines should not be disposed of via wastewater 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 Aurovitas contains

• The active substance is montelukast. One film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• Other ingredients are:
  Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose, hydroxypropylcellulose (E463), magnesium stearate (E572).

Coating composition: Hydroxypropylcellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171), yellow iron oxide (E172), carnauba wax (E903), red iron oxide (E172).

What Montelukast Aurovitas looks like and contents of the pack
Film-coated tablets
Square, beige, film-coated tablets with rounded edges, imprinted with the symbol "X" on one side and "54" on the other.
Packaged in Polymide/Aluminum/PVC/Aluminum blisters in a cardboard box.
Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 tablets.
HDPE bottles with PP closure and desiccant contained in a cardboard box:
Pack size: 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
France: Montelukast Arrow Lab 10 mg, comprimé pelliculé
Germany: Montelukast Aurobindo 10 mg Filmtabletten
Ireland: MONTELUKAST 10 mg Film-Coated Tablets
Italy: Montelukast Aurobindo 10mg compresse rivestite con film
Malta: Montelukast Aurobindo 10mg film-coated tablets
Netherlands: Montelukast Aurobindo 10 mg, filmomhulde tabletten
Poland: Montelukast Aurovitas
Spain: Montelukast Aurovitas 10 mg comprimidos recubiertos con película EFG