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 your child’s asthma, preventing your
asthma symptoms during the day and night.
• Yocair™ is used for the treatment of paediatric patients 2 to 5 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
2 to 5 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 for
patients 2 years of age and older.
Your doctor will determine how Yocair™ should be used depending on the
symptoms and severity of 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 give Yocair™ to your child
• if he/she 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 give Yocair™ to your child.
• If 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 for your child. Always have your child’s
inhaled rescue medicine for asthma attacks with you.
• It is important that 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 your child.
• If your child on anti-asthma medicines, be aware that if he/she 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.
• 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 his/her asthma worse.
Children and adolescents
Do not give this medicine to children less than 2 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 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 your
child’s other medicines work.
Tell your doctor if 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™ 4 mg chewable tablets should not be taken immediately with food; they
should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the Yocair™ 4 mg chewable tablets since they
are intended for use in children 2 to 5 years of age.
Driving and using machines
This subsection is not applicable for the Yocair™ 4 mg chewable tablets since they
are intended for use in children 2 to 5 years of age, however the following
information is relevant to the active ingredient, montelukast.
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™ 4mg chewable tablets contain aspartame, a source of phenylalanine. If your
child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should
take into account that each Yocair™ 4 mg chewable tablet contains phenylalanine
(equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).

Always have your child take this medicine exactly as your doctor or pharmacist has
told you. Check with your child’s doctor or pharmacist if you are not sure.
• This medicine is to be given to a child under adult supervision.
• Your child should take only one tablet of Yocair™ once a day as prescribed by your
doctor.
• It should be taken even when your child has no symptoms or if he/she has an acute
asthma attack.
For children 2 to 5 years of age:
The recommended dose is one Yocair™ 4 mg chewable tablet daily to be taken in the
evening.
If your child is taking Yocair™, be sure that he/she does not take any other
medicines that contain the same active ingredient, montelukast.
This medicine is for oral use.
The tablets are to be chewed before swallowing.
Yocair™ 4 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 your child takes more Yocair™ than he/she should
Contact your child’s 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 give Yocair™ to your child
Try to give Yocair™ as prescribed. However, if your child misses a dose, just resume
the usual schedule of one chewable tablet once daily.
Do not give a double dose to make up for a forgotten dose.
If your child stops taking Yocair™
Yocair™ can treat your child’s asthma only if he/she continues to taking it.
It is important for your child to continue taking Yocair™ for as long as your doctor
prescribes. It will help control your child’s asthma.
If you have any further questions on the use of this medicine, ask your child’s doctor
or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
In clinical studies with montelukast 4 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:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with
montelukast 10 mg film- coated tablets and 5 mg chewable tablets:
• headache
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 your child gets 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.