Montelukast Aurobindo

Package leaflet: Information for the user

Montelukast Aurobindo 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Montelukast Aurobindo is
Montelukast Aurobindo is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Aurobindo works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergy symptoms.
By blocking leukotrienes, Montelukast Aurobindo improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When to use Montelukast Aurobindo
Your doctor has prescribed Montelukast Aurobindo to treat your asthma, preventing asthma symptoms during both day and night.

• Montelukast Aurobindo is used to treat adult patients and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Montelukast Aurobindo also helps prevent exercise-induced narrowing of the airways.
• In asthmatic patients for whom Montelukast Aurobindo is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how Montelukast Aurobindo should be used based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma includes:

• Breathing difficulties caused by narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airway lining.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or allergic rhinitis) are allergic reactions often triggered by airborne pollen from trees, grasses, and weeds. Symptoms of seasonal allergies typically include: stuffy nose, runny nose, itchy nose, sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Aurobindo

Inform your doctor of any health problems or allergies you currently have or have had in the past.
Do not take Montelukast Aurobindo

• 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 Aurobindo.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Aurobindo for oral use is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor. You must always have your emergency inhaled medicine for asthma attacks with you.
• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast Aurobindo must not be substituted for other asthma medications prescribed by your doctor.
• Every patient treated with anti-asthma medications should be aware that if a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash develops, medical advice must be sought.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Patients should be aware that various neuropsychiatric events (for example, changes in behaviour and mood) have been reported in adults, adolescents and children treated with Montelukast Aurobindo (see section 4). If you or your child develops these symptoms during treatment with Montelukast Aurobindo, you must consult your child's doctor.
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 group.
Other medicines and Montelukast Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect how Montelukast Aurobindo works, or Montelukast Aurobindo may affect the action of other medicines.
Inform your doctor if you are taking the following medicines before starting Montelukast Aurobindo:

• Phenobarbital (used to treat epilepsy)
• Phenytoin (used to treat epilepsy)
• Rifampicin (used to treat tuberculosis and certain other infections)
• Gemfibrozil (used to treat high levels of lipids in the blood)

Montelukast Aurobindo with food and drink
Montelukast Aurobindo may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will assess whether you can take Montelukast Aurobindo during this period.
Breastfeeding
It is not known whether Montelukast Aurobindo passes into breast milk. If you are breastfeeding or intend to breastfeed, you must consult your doctor before taking Montelukast Aurobindo.
Driving and using machines
Montelukast Aurobindo should not affect the ability to drive or use machines.
However, individual responses to medicines may vary. Some side effects (such as dizziness and drowsiness) reported with Montelukast Aurobindo may affect some patients' ability to drive or use machines.
Montelukast Aurobindo 10 mg film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Montelukast Aurobindo

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• You should take only one tablet of Montelukast Aurobindo once daily as prescribed by your doctor.
• It should be taken even when you have no symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet taken daily in the evening.
If you are taking Montelukast Aurobindo, make sure you are not also taking any other product containing the same active substance, montelukast.
This medicine is for oral use.
Montelukast Aurobindo 10 mg may be taken with or without food.

If you take more Montelukast Aurobindo than you should
Contact your doctor immediately for advice.
No significant adverse effects have been reported in most cases of overdose. The most frequently reported symptoms in cases of overdose in adults and children have been abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast Aurobindo
Try to take Montelukast Aurobindo as prescribed. However, if you miss a dose, simply take one tablet the next day at your usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast Aurobindo
Montelukast Aurobindo will only control your asthma if you continue taking it.
It is important to keep taking Montelukast Aurobindo for as long as prescribed by your doctor.
It will help you control your asthma.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, the side effects considered related to Montelukast Aurobindo most commonly reported (may affect up to 1 in 10 people) were:

• Abdominal pain.
• Headache. These were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active drug).

Serious side effects
Speak to your doctor immediately if you experience any of the following side effects, which may be serious and for which you may need urgent medical treatment.
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.
• Seizure.

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 combination of symptoms such as flu-like illness, tingling or numbness in the arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2).
• Low platelet count in the blood.
• Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions.
• Swelling (inflammation) of the lungs.
• Severe skin reactions (erythema multiforme) which may occur without warning.
• Inflammation of the liver (hepatitis).

Other side effects during post-marketing use 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.
• Elevated liver enzymes.

Uncommon: may affect up to 1 in 100 people

• Changes in behaviour and mood: dream abnormalities, including nightmares, insomnia, sleepwalking, irritability, feeling anxious, restlessness.
• Dizziness, somnolence, tingling/numbness.
• Nosebleed.
• Dry mouth, digestive disturbances.
• Bruising, itching, urticaria.
• Joint or muscle pain, muscle cramps.
• Involuntary loss of urine during sleep in children.
• Weakness/tiredness, malaise, swelling.

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

• Changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements.

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

• Painful red swellings under the skin, most commonly on the front of the legs (erythema nodosum).
• Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast Aurobindo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label or bottle after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
After first opening the HDPE bottle, use within 30 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Montelukast Aurobindo contains

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are: Tablet core: Microcrystalline cellulose (E460), monohydrate lactose, croscarmellose sodium, hydroxypropyl cellulose (E463), magnesium stearate (E572). Coating: Hydroxypropyl cellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171), yellow iron oxide (E172), carnauba wax (E903), red iron oxide (E172).

Description of the appearance of Montelukast Aurobindo and contents of the pack
Film-coated tablets.
Beige, square-shaped, rounded film-coated tablets, marked with ‘X’ on one side and ‘54’ on the other side.
Blister packs made of polyamide/aluminum/PVC-aluminum foil.
Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 tablets.
HDPE bottles with polypropylene caps containing silica gel as desiccant:
Pack sizes: 30 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 - Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD - United Kingdom

This medicinal product is authorized 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
Malta Montelukast Aurobindo 10 mg film-coated tablets
Netherlands Montelukast Aurobindo 10 mg, filmomhulde tabletten
Poland Montelukast Aurovitas
Portugal Montelucaste Aurovitas
Romania Montelukast Aurobindo 10 mg comprimate filmate
Spain Montelukast Aurovitas 10 mg comprimidos recubiertos con película EFG
United Kingdom Montelukast 10 mg film-coated tablets