What Yocair™ is
Yocair™ is a leukotriene receptor antagonist that blocks substances called
leukotrienes.
How Yocair™ works
Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking
leukotrienes, Yocair™ improves asthma symptoms and helps control asthma.
When Yocair™ should be used
Your doctor has prescribed Yocair™ to treat asthma, preventing your asthma
symptoms during the day and night.
• Yocair™ is used for the treatment of paediatric patients 6 to 14 years of age who
are not adequately controlled on their medication and need additional therapy.
• Yocair™ may also be used as an alternative treatment to inhaled corticosteroids for
6 to 14 year old patients who have not recently taken oral corticosteroids for their
asthma and have shown that they are unable to use inhaled corticosteroids.
• Yocair™ also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Yocair™ should be used depending on the
symptoms and severity of your or your child's asthma.
What is asthma?
Asthma is a long-term disease. Asthma includes:
• difficulty breathing because of narrowed airways. This narrowing of airways
worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air,
or exercise.
• swelling (inflammation) in the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest tightness.

Tell your doctor about any medical problems or allergies you or your child has now
or has had.
Do not take Yocair™
• if you or your child is allergic to montelukast or any of the other ingredients of this
medicine (listed in section 6).
Take special care with Yocair™
Talk to your doctor or pharmacist before you or your child take Yocair™.
• If you or your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral Yocair™ is not meant to treat acute asthma attacks. If an attack occurs, follow
the instructions your doctor has given you or your child. Always have your inhaled
rescue medicine for asthma attacks with you.
• It is important that you or your child take all asthma medications prescribed by your
doctor.
Yocair™ should not be used instead of other asthma medications your doctor has
prescribed for you or your child.
• Any patient on anti-asthma medicines should be aware that if you develop a
combination of symptoms such as flu-like illness, pins and needles or numbness of
arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult
your doctor.
• You or your child should not take acetyl-salicylic acid (aspirin) or
anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or
NSAIDs) if they make your asthma worse.
Children and adolescents
Do not give this medicine to children less than 6 years of age.
There are different form(s) of this medicine available for paediatric patients under
18 years of age based on age range.
Other medicines and Yocair™
Tell your doctor or pharmacist if you or your child is taking or has recently taken
other medicines, including those obtained without a prescription.
Some medicines may affect how Yocair™ works, or Yocair™ may affect how other
medicines work.
Tell your doctor if you or your child is taking the following medicines before starting
Yocair™:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Yocair™ with food and drink
Yocair™ 5 mg chewable tablets should not be taken immediately with food; it should
be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking Yocair™.
Pregnancy
Your doctor will assess whether you can take Yocair™ during this time.
Breast-feeding
It is not known if Yocair™ appears in breast milk. You should consult your doctor
before taking Yocair™ if you are breast-feeding or intend to breast-feed.
Driving and using machines
Yocair™ is not expected to affect your ability to drive a car or operate machinery.
However, individual responses to medication may vary. Certain side effects (such as
dizziness and drowsiness) that have been reported very rarely with Yocair™ may
affect some patients’ ability to drive or operate machinery.
Important information about some of the ingredients of Yocair™
Yocair™ chewable tablets contain aspartame, a source of phenylalanine. If you or
your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you
should take into account that each Yocair™ 5 mg chewable tablet contains
phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
• You or your child should take only one tablet of Yocair™ once a day as prescribed
by your doctor.
• It should be taken even when you or your child has no symptoms or has an acute
asthma attack.
For children 6 to 14 years of age:
The recommended dose is one Yocair™ 5 mg chewable tablet daily to be taken in the
evening.
If you or your child is taking Yocair™, be sure that you or your child does not take
any other products that contain the same active ingredient, montelukast.
This medicine is for oral use.
The tablets are to be chewed before swallowing.
Yocair™ 5 mg chewable tablets should not be taken immediately with food; it should
be taken at least 1 hour before or 2 hours after food.
If you or your child takes more Yocair™ than you should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdose reports. The most
frequently occurring symptoms reported with overdose in adults and children
included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Yocair™ or give Yocair™ to your child
Try to take Yocair™ as prescribed. However, if you or your child misses a dose, just
resume the usual schedule of one chewable tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you or your child stops taking Yocair™
Yocair™ can treat you or your child’s asthma only if you or your child continues to
take it.
It is important to continue taking Yocair™ for as long as your doctor prescribes. It
will help control you or your child’s asthma.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
In clinical studies with montelukast 5 mg chewable tablets, the most commonly
reported side effects (occurring in at least 1 of 100 patients and less than
1 of 10 paediatric patients treated) thought to be related to montelukast were:
• headache
Additionally, the following side effect was reported in clinical studies with
montelukast 10 mg film- coated tablets:
• abdominal pain
These were usually mild and occurred at a greater frequency in patients treated with
montelukast than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following
convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Additionally, while the medicine has been on the market, the following have been
reported:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat which
may cause difficulty in breathing or swallowing (Uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares,
trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation
including aggressive behaviour or hostility, depression (Uncommon); tremor,
disturbance in attention, memory impairment (Rare); hallucinations, disorientation,
suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon), swelling (inflammation) of the lungs (Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the
skin most commonly on your shins (erythema nodosum), severe skin reactions
(erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon)
In asthmatic patients treated with montelukast, very rare cases of a combination of
symptoms such as flu-like illness, pins and needles or numbness of arms and legs,
worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been
reported. You must tell your doctor right away if you get one or more of these
symptoms (See section 2).

• Keep out of the reach and sight of children.
• Do not store above 30 ºC.
• Do not use this medicine after the date shown following EXP on the blister and
carton.
• Store in the original package in order to protect from light and moisture.
• 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
to protect the environment.