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MONTELUKAST INVENT FARMA 10MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST INVENT FARMA 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 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

1. 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 and seasonal allergy (also known as hay fever or seasonal
allergic rhinitis).
Your doctor has prescribed MONTELUKAST INVENT FARMA to treat your asthma,
preventing asthma symptoms during the day and night.




MONTELUKAST INVENT FARMA 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 INVENT FARMA also helps prevent the narrowing of airways
triggered by exercise.
In patients with asthma where MONTELUKAST INVENT FARMA is indicated for
asthma, it can also provide symptom relief for seasonal allergic rhinitis.

Your doctor will determine how MONTELUKAST INVENT FARMA 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 INVENT FARMA
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take MONTELUKAST INVENT FARMA


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

Take special care with MONTELUKAST INVENT FARMA






If your 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. 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 INVENT FARMA 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 INVENT FARMA works, or
MONTELUKAST INVENT FARMA 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
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 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 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
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 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 INVENT FARMA
For adults aged 15 years and older:





You should take only one tablet of MONTELUKAST INVENT FARMA 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 INVENT FARMA 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 INVENT FARMA, 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 INVENT FARMA 4 mg chewable tablets are
available.
For children 6 to 14 years old, MONTELUKAST INVENT FARMA 5 mg chewable tablets are
available.

If you take more MONTELUKAST INVENT FARMA 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 INVENT FARMA
Try to take MONTELUKAST INVENT FARMA 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 INVENT FARMA
MONTELUKAST INVENT FARMA can treat your asthma only if you continue taking it.
It is important for you to continue taking MONTELUKAST INVENT FARMA 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 INVENT FARMA can cause side effects, although not
everybody gets them.
In clinical studies with MONTELUKAST INVENT FARMA 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 INVENT FARMA
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 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 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 INVENT FARMA 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:
Bulgaria
Czech Republic
Germany
Greece
Hungary
Iceland
Poland
Romania
Slovak Republic
United Kingdom

Montelukast Invent Farma 10 mg Филмирана таблетка
Montelukast Invent Farma 10 mg Potahovaná tableta
Montelukast Invent Farma 10 mg Filmtabletten
For adolescents and adults from 15 years
Brolyt 10 mg Επικαλυμμένο με λεπτό υμένιο δισκίο
Montelukast Invent Farma 10 mg Filmtabletta
Montelukast Qualigen 10 mg Filmuhúðuð tafla
Montelukast Invent Farma 10 mg Tabletka powlekana
Montelukast Invent Farma 10 mg Comprimate filmate
Montelukast Invent Farma 10 mg filmom obalené tablety
Montelukast Invent Farma 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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