Monast

Package leaflet: Information for the user

Monast 10 mg film-coated tablets

montelukast
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Monast is and what it is used for

What Monast is
Monast is a leukotriene receptor antagonist that blocks substances known as leukotrienes.

How Monast works
Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergic symptoms. By blocking leukotrienes, Monast improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever and seasonal allergic rhinitis).

When Monast should be used
Your doctor has prescribed Monast for the treatment of asthma, to prevent asthma symptoms both during the day and at night.

• Monast is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medications and who require additional therapy.
• Monast also prevents exercise-induced narrowing of the airways.
• In asthmatic patients for whom Monast is indicated for asthma, Monast may provide relief from symptoms of seasonal allergic rhinitis. Your doctor will determine how to use Monast based on your symptoms and the severity of your asthma.

What is asthma?
Asthma is a long-term condition.
Asthma includes:

• Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• Airway hypersensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the airways. Asthma symptoms include coughing, shortness of breath, and chest tightness.

What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollens from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: nasal congestion, runny nose, nasal itching; sneezing; red, swollen, itchy eyes, and tearing.

2. What you need to know before taking Monast

Inform your doctor of any medical conditions you currently have or have had in the past, and of any allergies.
Do not take Monast

• 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 Monast

• If your asthma or breathing worsens, contact your doctor immediately.
• Monast for oral use must not be used to treat acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep your emergency inhaled asthma medication with you.
• It is important that you, or your child, take all asthma medications prescribed by your doctor. Monast must not be used instead of other asthma medications prescribed for you by your doctor.
• Patients taking anti-asthma medications should be aware that if they experience a combination of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or skin redness, they must consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms during treatment with montelukast, you must consult your doctor.
Children and adolescents
Do not give this medicine to children under 15 years of age.
For children aged 2 to 5 years, other medicines are available in the form of chewable tablets and granules containing 4 mg of montelukast.
For children aged 6 to 14 years, other medicines are available in the form of chewable tablets containing 5 mg of montelukast.
Other medicines and Monast
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may interfere with the way Monast works, or Monast may interfere with the way other medicines work.
Tell your doctor if you are taking the following medicines before starting Monast:

• 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).

Monast with food and drinks
Monast 10 mg film-coated tablet can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking Monast.
Pregnancy
Your doctor will decide whether you can take Monast under these circumstances.
Breastfeeding
It is not known whether Monast passes into human milk. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Monast.
Driving and using machines
No effects of Monast on the ability to drive or operate machinery are expected. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and drowsiness) reported with Monast may affect the ability to drive or operate machinery.
Monast 10 mg film-coated tablets contain aspartame.
This medicine contains 1.5 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.

3. How to take Monast

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• You should take only one Monast tablet daily as prescribed by your doctor.
• Take the tablet even if you have no symptoms or are experiencing an acute asthma attack.

For adults and adolescents from 15 years of age and older:
The recommended dose is one 10 mg tablet taken once daily in the evening.
If you are taking Monast, make sure not to take other products containing the same active ingredient, montelukast.
This medicine is for oral use.
You may take Monast 10 mg with food or on an empty stomach.

If you take more Monast than you should
Contact your doctor immediately.
In most cases of overdose, no adverse effects have been reported. The most frequently reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Monast
Try to take Monast as prescribed. However, if you forget to take a tablet, continue taking the medicine as normally scheduled.
Do not take a double dose to make up for the forgotten tablet.

If you stop treatment with Monast
Treatment with Monast is effective against asthma only if you continue taking it. It is important to keep taking Monast for the entire duration prescribed by your doctor. This will help you control your asthma.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

In clinical studies with montelukast 10 mg film-coated tablets, the most commonly reported side effects considered related to montelukast (which may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active ingredient).

Serious side effects
Speak to your doctor immediately if you notice 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 (convulsion)

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 illness, tingling or numbness in 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) that 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, drowsiness, 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, usually located on the front of the legs (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects
If you experience any side effect, including those 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 Monast

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister after the word EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.
• Store Monast in the original packaging to protect the medicine from light and moisture.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Monast contains

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are: Mannitol (E421), Croscarmellose sodium, Aspartame (E951), Banana flavouring, Microcrystalline cellulose, Hypromellose (E463), Magnesium stearate. Coating (Opadry Yellow 20A33251): Hypromellose 3cP, Hydroxypropylcellulose (E463), Talc, Titanium dioxide (E171), Yellow iron oxide and Red iron oxide (E172), Purified water.

Description of the appearance of Monast and contents of the pack
Monast tablets are film-coated, beige-coloured, round, biconvex tablets.
Blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Genetic S.p.A. Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. – Contrada Canfora, 84084 – Fisciano (SA)