Montelukast Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast Mylan Generics 10 mg film-coated tablets

montelukast
Generic medicine
Please read 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, because 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 Montelukast Mylan Generics is and what it is used for
2. What you need to know before taking Montelukast Mylan Generics
3. How to take Montelukast Mylan Generics
4. Possible side effects
5. How to store Montelukast Mylan Generics
6. Contents of the pack and other information

1. What Montelukast Mylan Generics is and what it is used for

Montelukast Mylan Generics contains montelukast, which is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast Mylan Generics improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergic rhinitis (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast Mylan Generics to treat your asthma and to prevent both daytime and nighttime asthma symptoms.

• Montelukast Mylan Generics 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.
• Montelukast Mylan Generics also helps prevent narrowing of the airways caused by physical exercise.
• In asthmatic patients for whom Montelukast Mylan Generics is indicated for asthma, it may additionally provide symptomatic relief of seasonal allergic rhinitis.

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Your doctor will determine how Montelukast Mylan Generics should be used based on your symptoms and the severity of your asthma.
Montelukast Mylan Generics 10 mg tablets should only be administered to adults and adolescents 15 years of age and older.
What is asthma?
Asthma is a long-term condition.
Asthma involves:

• difficulty breathing due to narrowing of the airways. This 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 lining tissue of the airways.

Asthma symptoms include: coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne plant pollens and grasses.
Typical symptoms of seasonal allergies include: blocked or runny, itchy nose; sneezing; and watery, swollen, red, itchy eyes.

2. What you need to know before taking Montelukast Mylan Generics

Inform your doctor about any medical conditions or allergies you currently have or have had in the past.

Do not take Montelukast Mylan Generics:

• if you are allergic (hypersensitive) 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 Mylan Generics.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Mylan Generics is not intended to treat acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always keep your rescue medication for asthma attacks with you.
• Consult your doctor if you need more inhaled rescue medication than usual to treat your acute asthma attacks.
• It is important that you continue taking all asthma medications prescribed by your doctor. Montelukast Mylan Generics must not replace other asthma medications prescribed by your doctor.
• If you are being treated with asthma medications, you should be aware that if you develop a combination of symptoms such as flu-like illness, tingling, numbness in arms or legs, worsening of pulmonary symptoms and/or skin rash, you should consult your 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 (for example, changes in behaviour and mood, depression and suicidal thoughts) have been reported in patients of all age groups treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you must consult your doctor.

Children and adolescents
Do not administer this medicine to children under 15 years of age.
Different formulations of this medicine are available for pediatric patients under 18 years of age, based on age group.

Other medicines and Montelukast Mylan Generics
Some medicines may affect how Montelukast Mylan Generics works, or Montelukast Mylan Generics may affect how other medicines work.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Before starting Montelukast Mylan Generics, inform your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and similar infections)
• gemfibrozil (used to treat high levels of lipids in the blood)

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Montelukast Mylan Generics. Your doctor will assess whether you can take Montelukast Mylan Generics during pregnancy.
Breastfeeding
It is not known whether Montelukast Mylan Generics is present in breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Mylan Generics.

Driving and using machines
Montelukast Mylan Generics is not expected to affect the ability to drive or operate machinery. However, individual responses to medicines may vary. Some adverse effects (such as dizziness and somnolence), which have been reported with Montelukast Mylan Generics, may affect the ability of some patients to drive or use machinery.

Montelukast Mylan Generics contains the colour Sunset Yellow and sodium.
The colour Sunset Yellow (E110) may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Montelukast Mylan Generics

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

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

Adults (including the elderly) and adolescents aged 15 years and older:
The recommended dose is:

• One 10 mg tablet taken once daily in the evening.

Use in children and adolescents
Montelukast Mylan Generics is not suitable for children and adolescents under 15 years of age.
If you are taking Montelukast Mylan Generics, make sure you do not take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
You may take Montelukast Mylan Generics with or without food.

If you take more Montelukast Mylan Generics than you should
Contact your doctor immediately.
In most overdose reports, no adverse effects have been reported. The most commonly reported symptoms in cases of overdose include: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast Mylan Generics
Try to take Montelukast Mylan Generics as prescribed. However, if you have missed a dose, resume your usual regimen of one tablet daily.
Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast Mylan Generics
Montelukast Mylan Generics can only control your asthma if you continue taking it.
It is important to keep taking Montelukast Mylan Generics for the entire duration prescribed by your doctor. This will help you manage your asthma.
If you have any questions about the use of 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 conducted with Montelukast Mylan Generics, the most commonly reported side effects (occurring in up to 1 in 10 people), considered likely to be related to Montelukast Mylan Generics, were:

• abdominal pain
• headache

These effects were generally mild and occurred more frequently in patients treated with Montelukast Mylan Generics than in those receiving placebo (a pill containing no active ingredient).

Serious side effects
Contact your doctor immediately if you experience any of the following side effects, which may be serious and for which urgent medical attention may be required.

Uncommon (may affect up to 1 in 100 people)

• allergic reactions including swelling of the face, lips, tongue or throat, which may cause difficulty 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)

• combination 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 rashes (erythema multiforme) that may occur without warning
• hepatitis (inflammation of the liver)

Other side effects reported during post-marketing experience of the drug:

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
• skin rash
• fever
• increased liver enzymes

Uncommon (may affect up to 1 in 100 people)

• changes in behaviour and mood: abnormal dreams, including nightmares, sleep disorders, sleepwalking, irritability, anxiety, restlessness
• dizziness, drowsiness, tingling, numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• involuntary urination (often at night) in children
• fatigue, malaise, swelling

Rare (may affect up to 1 in 1,000 people)

• changes in behaviour and mood: attention disorders, memory impairment, uncontrollable muscle movements (tics)

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

• painful red lumps under the skin, usually appearing on the shins (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 Montelukast Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton, and the blister after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Montelukast Mylan Generics contains

• The active substance is montelukast.
• Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other components are:

Tablet core: microcrystalline cellulose, mannitol, sodium croscarmellose,
magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silicon dioxide.
Film coating: polydextrose, titanium dioxide (E171), hypromellose, triacetin,
indigo carmine aluminium lake (E132), macrogol, sunset yellow aluminium lake
(E110) (see section 2 “Montelukast Mylan Generics contains sunset yellow (E110)”).

What Montelukast Mylan Generics looks like and contents of the pack
Blue, film-coated, round, biconvex tablets with bevelled edges, imprinted with “MO” above “10” on one side and “M” on the other.
Montelukast Mylan Generics 10 mg tablets are available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets, or in perforated unit dose blisters of 28x1 tablets, or in bottles with silica gel desiccant containing 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20 – 20124 Milan, Italy

Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1, Hungary
Mylan B.V.,
Krijgsman 20, Amstelveen,
1186DM,
The Netherlands
Logiters, Logística Portugal, S.A.
Estrada dos Arneiros, 4,
Azambuja, 2050-306, Portugal

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Czech Republic: Montelukast Viatris
Denmark: Montelukast Viatris
Finland: Montelukast Mylan
France: MONTELUKAST Viatris 10 mg, comprimé pelliculé
Germany: Montelukast dura 10mg Filmtabletten
Ireland: Montelukast Viatris 10mg film coated tablets
Italy: Montelukast Mylan Generics
Portugal: Montelucaste Mylan
Slovakia: Montelukast Viatris 10mg
Spain: Montelukast Viatris 10 mg comprimidos recubiertos con película EFG
Sweden: Montelukast Viatris
The Netherlands: Montelukast Viatris 10mg, filmomhulde tabletten
United Kingdom (Northern Ireland): Montelukast 10mg film-coated tablets