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MONTELUKAST CINTRADOL 10MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST CINTRADOLCINTRADOL 10 mg film-coated tablets
Montelukast

Read all of this leaflet carefully before you start 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 you. 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.

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

1. WHAT MONTELUKAST CINTRADOLCINTRADOL IS AND WHAT IT IS USED
FOR
MONTELUKAST CINTRADOLCINTRADOL is a leukotriene receptor antagonist that blocks
substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the
lungs. By blocking leukotrienes, MONTELUKAST CINTRADOLCINTRADOL improves
asthma symptoms and helps control asthma and seasonal allergy (also known as hay fever or
seasonal allergic rhinitis).
Your doctor has prescribed MONTELUKAST CINTRADOLCINTRADOL to treat your
asthma, preventing asthma symptoms during the day and night.





MONTELUKAST CINTRADOLCINTRADOL is used for the treatment of 15 years of age
and older patients who are not adequately controlled on their medication and need
additional therapy.
MONTELUKAST CINTRADOLCINTRADOL also helps prevent the narrowing of
airways triggered by exercise.
In patients with asthma where MONTELUKAST CINTRADOLCINTRADOL is indicated
for asthma, it can also provide symptom relief for seasonal allergic rhinitis.

Your doctor will determine how MONTELUKAST CINTRADOL should be used depending on
the symptoms and severity of your 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.
What are seasonal allergies?
Seasonal allergies (also called hay fever or seasonal allergic rhinitis) are an allergic reaction
often caused by air borne pollen from the trees, grass and weeds. The symptoms of seasonal
allergies can typically include: blocked nose, catarrh, itchy nose, sneezing; watery, swollen, red
and itchy eyes.

2. BEFORE YOU TAKE MONTELUKAST CINTRADOL
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take MONTELUKAST CINTRADOL


if you are allergic (hypersensitive) to montelukast, peanut or soya or any of the other
ingredients of MONTELUKAST CINTRADOL (see 6. FURTHER INFORMATION).

Take special care with MONTELUKAST CINTRADOL









If your 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. Always have your inhaled
rescue medicine for asthma attacks with you.
It is important that you take all asthma medications prescribed by your doctor.
MONTELUKAST CINTRADOL should not be used instead of other asthma medications
your doctor has prescribed to you.
If you are on anti-asthma medicines, 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 should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also
known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make yours asthma
worse.

Taking other medicines
Some medicines may affect how MONTELUKAST CINTRADOL works, or MONTELUKAST
CINTRADOL may affect how your other medicines work.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines,
including those obtained without a prescription.
Tell your doctor if you are 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 10 mg film-coated tablets may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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
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 contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.

3. HOW TO TAKE MONTELUKAST CINTRADOL
For adults aged 15 years and older:





You should take only one tablet of MONTELUKAST CINTRADOL once a day as
prescribed by your doctor. It is independent from food intake.
It should be taken even when you have no symptoms or if you have an acute asthma attack.
Always take MONTELUKAST CINTRADOL as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole, without chewing them, with a glass of liquid, preferably water.

If you are taking MONTELUKAST CINTRADOL, be sure that you do 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.
For children 6 to 14 years old, MONTELUKAST CINTRADOL 5 mg chewable tablets are
available.

If you take more MONTELUKAST CINTRADOL 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 MONTELUKAST CINTRADOL
Try to take MONTELUKAST CINTRADOL as prescribed. However, if you miss a dose, just
resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you stop taking MONTELUKAST CINTRADOL
MONTELUKAST CINTRADOL can treat your asthma only if you continue taking it.
It is important for you to continue taking MONTELUKAST CINTRADOL for as long as your
doctor prescribes. It will help control your asthma.
If you have any further questions on the use of this product, ask your 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 10 mg film-coated 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 were:

abdominal pain

headache
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 [drean 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 you get 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 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 10 mg of montelukast.
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose,
croscarmellose sodium, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin (soya), xanthan gum,
and red and yellow iron oxide (E 172).

What MONTELUKAST CINTRADOL looks like and content of the pack
The 10 mg film-coated tablets are pale orange, round, biconvexwith “10” 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
Manufacturer
Laboratorios Lesvi, 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
Hungary
Poland
Slovak Republic
United Kingdom

Montelukast Cintradol 10 mg Potahovaná tableta
Montelukast Cintradol 10 mg Filmtabletta
Lamoten 10 mg Tabletka powlekana
Montelukast Cintradol 10 mg filmom obalené tablety
Montelukast Cintradol 10 mg Film-coated tablet

This leaflet was last approved in October 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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