Montelukast aurovitas

Package leaflet: Information for the user

Montelukast Aurovitas, 5 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 Montelukast Aurovitas is
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 Montelukast Aurovitas should be used
Your doctor has prescribed Montelukast Aurovitas for the treatment of asthma in your child to prevent daytime and nighttime asthma symptoms.

• Montelukast Aurovitas is used in the treatment of children and adolescents aged 6 to 14 years whose current treatment is unsatisfactory and who require additional medication.
• Montelukast Aurovitas may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 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.

Your doctor will determine how to use Montelukast Aurovitas 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. Airways may narrow or widen in response to various triggers.
• Airway hyperresponsiveness reacting to various factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the lining of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before taking Montelukast Aurovitas

Inform your doctor about any medical conditions or allergies you currently have or have had in the
past.
When not to take Montelukast Aurovitas
if the adult patient or child 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.

• If asthma symptoms worsen or if breathing difficulties occur in an adult patient or child, inform your doctor immediately.
• The oral medicine Montelukast Aurovitas is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow your doctor's instructions. Always keep readily available the rescue inhaled medicine prescribed for immediate use in the adult patient or child.
• It is important that the adult patient or child takes all asthma medications prescribed by the doctor. Montelukast Aurovitas must not be used as a substitute for other asthma medications prescribed by the doctor.
• Remember to consult your doctor if a patient taking asthma medications experiences symptoms such as flu-like illness, tingling or numbness in the limbs, worsening shortness of breath and/or rash.
• An adult patient or child 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).

Neuropsychiatric events (for example, 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 during treatment
with montelukast, consult your doctor.
Use in children
Do not use this medicine in children under 6 years of age.
For children and adolescents under 18 years of age, other formulations of this medicine are available, appropriate for the patient's age.
Other medicines and Montelukast Aurovitas
Tell your doctor or pharmacist about all medicines currently or recently taken by the adult patient or child, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may affect the action of Montelukast Aurovitas or Montelukast Aurovitas may affect the action of other medicines.
Before starting treatment with Montelukast Aurovitas, inform your doctor if the adult patient or 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 5 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.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking Montelukast Aurovitas.
Pregnancy
Your doctor will assess whether you may take Montelukast Aurovitas during this period.
Breastfeeding
It is not known whether Montelukast Aurovitas passes into human breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking 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 during treatment with Montelukast Aurovitas may affect the ability to drive or operate machinery.
Montelukast Aurovitas contains aspartame, which is a source of phenylalanine. If the child taking this medicine has phenylketonuria (a rare, inherited metabolic disorder), please note that each 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg of phenylalanine per 5 mg chewable tablet).
Montelukast Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Montelukast Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.

• The adult patient or child should take one tablet of Montelukast Aurovitas once daily, as directed by the doctor.
• This medicine should be taken even when the adult patient or child does not have asthma symptoms, and also during an acute asthma attack.

Children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet taken once daily in the evening.
If the adult patient or child is taking Montelukast Aurovitas, ensure that the adult patient or child is not
taking any other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet should be chewed before swallowing.
Montelukast Aurovitas 5 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.

Taking more Montelukast Aurovitas than prescribed
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been observed. In cases of overdose in children and adults, the most commonly observed symptoms were abdominal pain, drowsiness, thirst, headache, vomiting, and increased motor activity.

If you forget to take Montelukast Aurovitas
Try to take Montelukast Aurovitas as directed by your doctor. However, if a dose is missed, resume the usual regimen of one tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping Montelukast Aurovitas
Montelukast Aurovitas is effective in treating asthma in adults and children only when taken regularly.
It is important to continue taking the medicine in the adult patient or child for as long as directed by the doctor. This will help keep asthma symptoms under control.
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 studies using montelukast at a dose of 5 mg in the form of chewable tablets, the most frequently reported adverse reaction (which may affect up to 1 in 10 people), considered related to the use of Montelukast Aurovitas, was:

• headache.

Additionally, the following adverse reactions were observed in clinical studies with montelukast 10 mg coated tablets:

• abdominal pain.

These symptoms were usually mild in intensity and occurred more frequently in patients treated with montelukast than in patients receiving placebo (a tablet without active ingredient).
Serious adverse reactions
You should contact your doctor immediately if any of the following adverse reactions occur, as they may be serious and the patient may require immediate medical assistance.
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 or hostile behaviour, 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, 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 behaviour
• 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 authorization
Very common: may affect more than 1 in 10 people

• upper respiratory tract infections

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 of uneasiness, motor restlessness
• dizziness, drowsiness, sensation of pricking and tingling or 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 affect up to 1 in 1,000 people

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

Very rare: may affect up to 1 in 10,000 people

• tender, red nodules under the skin, most commonly occurring 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 not listed in this leaflet, inform your 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 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 authorization holder.
Reporting adverse reactions helps to 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 pack following: Expiry
date. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store 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. These measures 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 5 mg of montelukast.
• Other ingredients are: Mannitol (E 421), microcrystalline cellulose (PH-101), hydroxypropylcellulose 2% (6 to 10 mPa·s), 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, mottled, round, biconvex, uncoated tablets, embossed with the code 'X' on one side and '53' 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 Warszawa
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 Member States of the European Economic Area under the following names:
France MONTELUKAST ARROW LAB 5 mg, comprimé à croquer
Germany Montelukast Aurobindo 5 mg Kautabletten
Ireland MONTELUKAST Paediatric 5 mg Chewable Tablets
Italy Montelukast Aurobindo Pharma Italia 5 mg Compressa masticabile
Malta Montelukast Aurobindo 5 mg Chewable Tablets
Netherlands Montelukast Aurobindo 5 mg, kauwtabletten
Poland Montelukast Aurovitas
Spain Montelukast Aurovitas 5 mg comprimidos masticables EFG