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MONTELUKAST INVENT FARMA 4MG CHEWABLE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST INVENT FARMA 4 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 INVENT FARMA is and what it is used for
Before MONTELUKAST INVENT FARMA is taken
How to take MONTELUKAST INVENT FARMA
Possible side effects
How to store MONTELUKAST INVENT FARMA
Further information

WHAT MONTELUKAST INVENT FARMA IS AND WHAT IT IS USED FOR

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





MONTELUKAST INVENT FARMA is used for the treatment of 2 to 5 year old patients
who are not adequately controlled on their medication and need additional therapy.
MONTELUKAST INVENT FARMA 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.
MONTELUKAST INVENT FARMA also helps prevent the narrowing of airways
triggered by exercise for patients 2 years of age and older.

Your doctor will determine how MONTELUKAST INVENT FARMA 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 INVENT FARMA IS TAKEN
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give MONTELUKAST INVENT FARMA to your child if he/she


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

Take special care with MONTELUKAST INVENT FARMA






If your child’s asthma or breathing gets worse, tell your doctor immediately.
Oral MONTELUKAST INVENT FARMA 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 INVENT FARMA 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 INVENT FARMA works, or
MONTELUKAST INVENT FARMA 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 INVENT FARMA:

phenobarbital (used for treatment of epilepsy)

phenytoin (used for treatment of epilepsy)

rifampicin (used to treat tuberculosis and some other infections)
Taking MONTELUKAST INVENT FARMA with food and drink
MONTELUKAST INVENT FARMA 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 MONTELUKAST INVENT FARMA 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.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before
taking MONTELUKAST INVENT FARMA. Your doctor will assess whether you can take
MONTELUKAST INVENT FARMA during this time.
Use in breast-feeding
It is not known if MONTELUKAST INVENT FARMA appears in breast milk. You should
consult your doctor before taking MONTELUKAST INVENT FARMA if you are breastfeeding or intent to breast-feed.
Driving and using machines
This subsection is not applicable for the MONTELUKAST INVENT FARMA 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.
MONTELUKAST INVENT FARMA 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
INVENT FARMA may affect some patients´ ability to drive or operate machinery.
Important information about some of the ingredients of MONTELUKAST INVENT
FARMA
MONTELUKAST INVENT FARMA 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 4-mg chewable tablet contains 1.35 mg of phenylalanine.

3. HOW TO TAKE MONTELUKAST INVENT FARMA






This medicine is to be given to a child under adult supervision.
Your child should take only one tablet of MONTELUKAST INVENT FARMA 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 INVENT FARMA 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 2 to 5 years of age:
One 4 mg chewable tablet daily to be taken in the evening. MONTELUKAST INVENT
FARMA 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 is taking MONTELUKAST INVENT FARMA, be sure that he/she does not take
any other medicines that contain the same active ingredient, montelukast.
For children 6 to 14 years old, MONTELUKAST INVENT FARMA 5 mg chewable tablets are
available. The MONTELUKAST INVENT FARMA 4 mg chewable tablets is not

recommended below 2 years of age.
If your child takes more MONTELUKAST INVENT FARMA 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 INVENT FARMA to your child
Try to take MONTELUKAST INVENT FARMA 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 INVENT FARMA
MONTELUKAST INVENT FARMA can treat your child’s asthma only if he/she continues
taking it.
It is important for your child to continue taking MONTELUKAST INVENT FARMA 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 INVENT FARMA can cause side effects, although not
everybody gets them.
In clinical studies with MONTELUKAST INVENT FARMA 4 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 INVENT FARMA were:

abdominal pain

thirst
Additionally, the following side effect was reported in clinical studies with MONTELUKAST
INVENT FARMA 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 INVENT FARMA 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 INVENT FARMA





Keep out of the reach and sight of children.
Do not use MONTELUKAST INVENT FARMA 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 INVENT FARMA 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 INVENT FARMA contains:



The active substance is montelukast. Each tablet contains montelukast sodium which
corresponds to 4 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 INVENT FARMA looks like and content of the pack
The 4 mg chewable tablets are pink, oval, biconvex with “4” debossed on one side.
It is supplied in pack sizes containing 7, 10, 14, 20, 28, 30, 49, 50, 56, 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:
Bulgaria
Czech Republic
Germany
Greece
Hungary
Iceland
Poland
Romania
Slovak Republic
United Kingdom

Montelukast Invent Farma 4 mg таблетка за дъвчене
Montelukast Invent Farma 4 mg žvýkací tableta
Montelukast Invent Farma 4 mg Kautabletten
For children from 2 to 5 years
Brolyt 4 mg Μασώμενα δισκίo
Montelukast Invent Farma 4 mg Rágótabletta
Montelukast Qualigen 4 mg Tuggutafla
Montelukast Invent Farma 4 mg Tabletka do rozgryzania i żucia
Montelukast Invent Farma 4 mg Comprimate masticabile
Montelukast Invent Farma 4 mg žuvacie tablety
Montelukast Invent Farma 4 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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