Montelukast aurovitas

Package leaflet: Information for the user

Montelukast Aurovitas, 4 mg, chewable tablets
Montelukastum
Please read the entire 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Montelukast Aurovitas is and what it is used for
2. Important information 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, meaning it blocks the action of substances called leukotrienes.

How Montelukast Aurovitas works
Leukotrienes cause narrowing and swelling of the airways. By inhibiting the action of leukotrienes, Montelukast Aurovitas relieves asthma symptoms and helps control asthma.

When to use Montelukast Aurovitas
Your doctor has recommended Montelukast Aurovitas for the treatment of asthma in children, to prevent asthma symptoms during the day and at night.

• Montelukast Aurovitas is used in the treatment of patients aged 2 to 5 years whose current treatment results are unsatisfactory and who require additional medication.
• Montelukast Aurovitas may also be used instead of inhaled corticosteroids in children aged 2 to 5 years who have not recently taken oral corticosteroids and who are unable to use inhaled corticosteroids.
• Montelukast Aurovitas also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Montelukast Aurovitas based 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. The airways may narrow or widen in response to various triggers.
• Increased sensitivity of the airways reacting 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 a feeling of tightness in the chest.

2. Important information before taking Montelukast Aurovitas

Inform your doctor about any health problems or allergies the patient currently has or has had 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 treatment in a child, discuss it with the doctor or pharmacist.

• If asthma symptoms worsen or the child experiences shortness of breath, inform the doctor immediately.
• Oral Montelukast Aurovitas is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always keep a fast-acting inhaled asthma medicine for immediate use by the child.
• It is important to give the child all asthma medicines prescribed by the doctor. Montelukast Aurovitas must not be used as a substitute for other asthma medicines prescribed by the doctor.
• Remember that if the child taking asthma medicines develops symptoms such as flu-like illness, tingling or numbness in the limbs, worsening shortness of breath and/or rash, a doctor should be consulted immediately.
• Children whose asthma symptoms worsen after taking acetylsalicylic acid (aspirin) must not take medicines containing this substance or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs, NSAIDs).

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 in the patient while taking montelukast, consult a doctor.

Children and adolescents

Do not give this medicine to children under 2 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.

Other medicines and Montelukast Aurovitas

Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken or plans to take, including medicines obtained without a prescription.

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

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

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections).

Montelukast Aurovitas with food, drink and alcohol

Montelukast Aurovitas 4 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

This section does not apply to Montelukast Aurovitas 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast Aurovitas 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance of the medicine, montelukast.

Montelukast Aurovitas is not expected to affect the ability to drive or operate machinery. Nevertheless, individual responses to the medicine may vary. In very rare cases, adverse reactions (such as dizziness and drowsiness) have been reported during treatment with Montelukast Aurovitas, which may affect the ability to drive or operate machinery.

Montelukast Aurovitas contains aspartame, a source of phenylalanine. If the child taking the medicine has phenylketonuria (a rare inherited metabolic disorder), note that each 4 mg chewable tablet contains phenylalanine (equivalent to 0.674 mg of phenylalanine per 4 mg chewable tablet).

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

Montelukast Aurovitas should always be used in children exactly as recommended by the child's doctor or pharmacist. If in doubt, consult the child's doctor or pharmacist.

• This medicine should be given to the child under the supervision of an adult.
• The child should take one tablet of Montelukast Aurovitas 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.

Children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet taken once daily in the evening.
Ensure that the child taking Montelukast Aurovitas is not also taking other medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablets must be chewed before swallowing.
Montelukast Aurovitas 4 mg chewable tablets should not be taken during meals; the medicine should be taken at least one hour before or two hours after a meal.

If more Montelukast Aurovitas has been taken than recommended
Contact the child's doctor immediately.
In most cases, no adverse effects have been observed with overdose. In cases of overdose in adults and children, the most commonly reported symptoms have been abdominal pain, drowsiness, increased thirst, headache, vomiting, and hyperactivity.

If a dose of Montelukast Aurovitas is missed
Montelukast Aurovitas should be taken as prescribed by the doctor. If a dose is missed, return to the regular 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 in children only when taken regularly.
It is important to continue giving the medicine to the child for as long as directed by the child's doctor.
This will help keep asthma symptoms under control.
If you have any further questions about the use of this medicine in children, consult the child's doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

In clinical studies using montelukast 4 mg chewable and dispersible tablets, the most frequently reported adverse reactions (which may affect up to 1 in 10 people), considered to be related to the use of Montelukast Aurovitas, were:

• abdominal pain
• excessive thirst.

Additionally, the following adverse reaction was observed in clinical studies with montelukast in the form of 10 mg film-coated tablets and 5 mg chewable and dispersible tablets:

• headache.

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

Serious adverse reactions
Contact your doctor immediately if any of the following adverse reactions occur, as they may be serious and may require immediate medical attention.

Uncommon: may affect up to 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 affect up to 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations.

Very rare: may affect up to 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)
• decreased 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 affect more than 1 in 10 people

• upper respiratory tract infection.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, motor restlessness
• dizziness, drowsiness, 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 affect up to 1 in 1,000 people

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

Very rare: may affect up to 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 you experience any adverse reactions, including any not listed in this leaflet, tell 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 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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Montelukast Aurovitas

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry
date. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep in the original packaging to protect from light and moisture.
HDPE bottle containing 500 tablets.
Use within 12 months 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. This will help protect the environment.

6. Contents of the pack and other information

What Montelukast Aurovitas contains

• The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients are: Mannitol (E 421), microcrystalline cellulose (PH-101), hydroxypropylcellulose 2% (6 to 10 mPaS), sodium croscarmellose, iron oxide red (E 172), microcrystalline cellulose (PH-102), aspartame (E 951), artificial cherry flavour [flavouring substances, modified starch], and magnesium stearate.

What Montelukast Aurovitas looks like and contents of the pack
Chewable tablets
Pink, speckled, oval, biconvex, uncoated tablets with the imprint 'X' on one side and '52' on the other side.
Montelukast Aurovitas is available as chewable tablets packed in blisters made of PVC/Polyamide/Aluminium/PVC/Aluminium and in HDPE bottles with a PP closure containing a desiccant.
Pack sizes:
Blisters: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 chewable tablets.
HDPE bottles: 30, 90 and 500 chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
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 4 mg, comprimé à croquer
Germany Montelukast Aurobindo 4 mg Kautabletten
Italy Montelukast Aurobindo Pharma Italia 4 mg Compressa masticabile
Malta Montelukast Aurobindo 4 mg Chewable Tablets
Poland Montelukast Aurovitas
Spain Montelukast Aurovitas 4 mg comprimidos masticables EFG