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MONTELUKAST CINTRADOL 5MG CHEWABLE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST CINTRADOL 5 mg chewable tablets
Montelukast

Read all of this leaflet carefully before your child starts taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for your child. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

1.

What MONTELUKAST CINTRADOL is and what it is used for
Before MONTELUKAST CINTRADOL is taken
How to take MONTELUKAST CINTRADOL
Possible side effects
How to store MONTELUKAST CINTRADOL
Further information

WHAT MONTELUKAST CINTRADOL IS AND WHAT IT IS USED FOR

MONTELUKAST CINTRADOL is a leukotriene receptor antagonist that blocks substances
called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By
blocking leukotrienes, MONTELUKAST CINTRADOL improves asthma symptoms and helps
control asthma.
Your doctor has prescribed MONTELUKAST CINTRADOL to treat your child’s asthma,
preventing asthma symptoms during the day and night.




MONTELUKAST CINTRADOL is used for the treatment of 6 to 14 year old patients who
are not adequately controlled on their medication and need additional therapy.
MONTELUKAST CINTRADOL 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.
MONTELUKAST CINTRADOL also helps prevent the narrowing of airways triggered by
exercise for patients 6 years of age and older.

Your doctor will determine how MONTELUKAST CINTRADOL 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) of the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest tightness.
2. BEFORE MONTELUKAST CINTRADOL IS TAKEN
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give MONTELUKAST CINTRADOL to your child if he/she


is allergic (hypersensitive) to montelukast or any of the other ingredients of
MONTELUKAST CINTRADOL (see 6. FURTHER INFORMATION).

Take special care with MONTELUKAST CINTRADOL






If your child’s asthma or breathing gets worse, tell your doctor immediately.
Oral MONTELUKAST CINTRADOL 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.
MONTELUKAST CINTRADOL should not be used instead of other asthma medications
your doctor has prescribed for your child.
If your child is on anti-asthma medicines, be aware that if he/she develops 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.

Taking other medicines
Some medicines may affect how MONTELUKAST CINTRADOL works, or MONTELUKAST
CINTRADOL may affect how your child’s other medicines work.
Please tell your doctor or pharmacist if your child is taking or has recently taken other
medicines, including those obtained without a prescription.
Tell your doctor if your child is taking the following medicines before starting
MONTELUKAST CINTRADOL:

phenobarbital (used for treatment of epilepsy)

phenytoin (used for treatment of epilepsy)

rifampicin (used to treat tuberculosis and some other infections)
Taking MONTELUKAST CINTRADOL with food and drink
MONTELUKAST CINTRADOL 5 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 MONTELUKAST CINTRADOL 5 mg chewable
tablets since they are intended for use in children 6 to 14 years of age, however the following
information is relevant to the active ingredient, montelukast.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before
taking MONTELUKAST CINTRADOL. Your doctor will assess whether you can take
MONTELUKAST CINTRADOL during this time.
Use in breast-feeding
It is not known if MONTELUKAST CINTRADOL appears in breast milk. You should consult
your doctor before taking MONTELUKAST CINTRADOL if you are breast-feeding or intent to
breast-feed.
Driving and using machines
This subsection is not applicable for the MONTELUKAST CINTRADOL 5 mg chewable
tablets since they are intended for use in children 6 to 14 years of age, however the following
information is relevant to the active ingredient, montelukast.
MONTELUKAST CINTRADOL 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 MONTELUKAST
CINTRADOL may affect some patients´ ability to drive or operate machinery.
Important information about some of the ingredients of MONTELUKAST CINTRADOL
MONTELUKAST CINTRADOL chewable tablets contains aspartame, a source of
phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism)
you should take into account that each 5-mg chewable tablet contains 1.68 mg of phenylalanine.

3. HOW TO TAKE MONTELUKAST CINTRADOL






This medicine is to be given to a child under adult supervision.
Your child should take only one tablet of MONTELUKAST CINTRADOL 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.
Always have your child take MONTELUKAST CINTRADOL as your doctor has told you.
You should check with your child’s doctor or pharmacist if you are not sure.
To be taken by mouth.

For children 6 to 14 years of age:
One 5 mg chewable tablet daily to be taken in the evening. MONTELUKAST CINTRADOL 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 your child is taking MONTELUKAST CINTRADOL, be sure that he/she does not take any
other medicines that contain the same active ingredient, montelukast.
For children 2 to 5 years old, MONTELUKAST CINTRADOL 4 mg chewable tablets are
available.

If your child takes more MONTELUKAST CINTRADOL 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 MONTELUKAST CINTRADOL to your child
Try to take MONTELUKAST CINTRADOL as prescribed. However, if your child misses a
dose, just resume the usual schedule of one tablet once daily.
Do not give a double dose to make up for a forgotten dose.
If your child stops taking MONTELUKAST CINTRADOL
MONTELUKAST CINTRADOL can treat your child’s asthma only if he/she continues taking
it.
It is important for your child to continue taking MONTELUKAST CINTRADOL 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 product, ask your child’s doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, MONTELUKAST CINTRADOL can cause side effects, although not
everybody gets them.
In clinical studies with MONTELUKAST CINTRADOL 5 mg chewable tablets, the most
commonly reported side effects (occurring in alt least 1 of 100 patients and less than 1 of 10
paediatric patients treated) thought to be related to MONTELUKAST CINTRADOL was:

headache
Additionally, the following side effect was reported in clinical studies with MONTELUKAST
CINTRADOL 10 mg film-coated tablets:

abdominal pain
These were usually mild and occurred at a greater frequency in patients treated with
MONTELUKAST CINTRADOL than placebo (a pill containing no medication).
Additionally, while the medicine has been on the market, the following have been reported:

increased bleeding tendency

allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing behaviour and mood related changes [dream
abnormalities, including nightmares, hallucinations, irritability, feeling anxious,
restlessness, agitation including aggressive behaviour, tremor, depression, trouble sleeping,
suicidal thoughts and actions (in very rare cases)]

dizziness, drowsiness, pins and needles/numbness, seizure

palpitations

nosebleed

diarrhoea, dry mouth, indigestion, nausea, vomiting

hepatitis





bruising, itching, hives, tender red lumps under the skin most commonly on your shins
(erythema nodosum),
joint or muscle pain, muscle cramps
tiredness, feeling unwell, swelling, fever

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.
Ask your doctor or pharmacist for more information about side effects. If any of the side effects
gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’s
doctor or pharmacist.

5. HOW TO STORE MONTELUKAST CINTRADOL






Keep out of the reach and sight of children.
Do not use MONTELUKAST CINTRADOL after the expiry date which is stated on the
carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original blister and keep the blister in the outer carton in order to protect from
light and moisture.
Do not use MONTELUKAST CINTRADOL if you notice visible signs of deterioration.
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.

6. FURTHER INFORMATION
What MONTELUKAST CINTRADOL contains:



The active substance is montelukast. Each tablet contains montelukast sodium which
corresponds to 5 mg of montelukast.
The other ingredients are: mannitol (E-421), microcrystalline cellulose,
hydroxypropylcellulose, croscarmellose sodium, red iron oxide (E-172), strawberry flavour
(with propylene glycol), aspartame (E-951) and magnesium stearate.

What MONTELUKAST CINTRADOL looks like and content of the pack
The 5 mg chewable tablets are pink, round, biconvex with “5” debossed on one side.
It is supplied in pack sizes containing 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 and
200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Invent Farma, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona - Spain
This medicinal product is authorised in the Member States of the EEA under the following
names:
Czech Republic

Montelukast Cintradol 5 mg žvýkací tableta

Hungary
Poland
Slovak Republic
United Kingdom

Montelukast Cintradol 5 mg Rágótabletta
Lamoten 5 mg Tabletka do rozgryzania i żucia
Montelukast Cintradol 5 mg žuvacie tablety
Montelukast Cintradol 5 mg Chewable tablet

This leaflet was last approved in
10/2010

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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