Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

MONTELUKAST VIKETO 4MG CHEWABLE TABLETS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

WHAT MONTELUKAST VIKETO IS AND WHAT IT IS USED FOR

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




MONTELUKAST VIKETO 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 VIKETO 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 VIKETO also helps prevent the narrowing of airways triggered by
exercise for patients 2 years of age and older.

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


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

Take special care with MONTELUKAST VIKETO






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

phenobarbital (used for treatment of epilepsy)

phenytoin (used for treatment of epilepsy)

rifampicin (used to treat tuberculosis and some other infections)
Taking MONTELUKAST VIKETO with food and drink
MONTELUKAST VIKETO 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 VIKETO 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 VIKETO. Your doctor will assess whether you can take
MONTELUKAST VIKETO during this time.
Use in breast-feeding
It is not known if MONTELUKAST VIKETO appears in breast milk. You should consult your
doctor before taking MONTELUKAST VIKETO if you are breast-feeding or intent to breastfeed.
Driving and using machines
This subsection is not applicable for the MONTELUKAST VIKETO 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 VIKETO 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 VIKETO
may affect some patients´ ability to drive or operate machinery.
Important information about some of the ingredients of MONTELUKAST VIKETO
MONTELUKAST VIKETO 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 VIKETO






This medicine is to be given to a child under adult supervision.
Your child should take only one tablet of MONTELUKAST VIKETO 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 VIKETO 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 VIKETO 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 VIKETO, 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 VIKETO 5 mg chewable tablets are available.
The MONTELUKAST VIKETO 4 mg chewable tablets is not recommended below 2 years of
age.

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

abdominal pain

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





Keep out of the reach and sight of children.
Do not use MONTELUKAST VIKETO 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 VIKETO 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 VIKETO 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 VIKETO 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

Montelukast Viketo 4 mg таблетка за дъвчене

Czech Republic
Greece
Hungary
Poland
Romania
Slovak Republic
United Kingdom

Montelukast Viketo 4 mg žvýkací tableta
Mokast 4 mg Μασώμενα δισκίo
Montelukast Viketo 4 mg Rágótabletta
Airuno 4 mg Tabletka do rozgryzania i żucia
Montelukast Viketo 4 mg Comprimate masticabile
Montelukast Viketo 4 mg žuvacie tablety
Montelukast Viketo 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.

Hide