PACKAGE LEAFLET: INFORMATION FOR THE USER

MONTELUKAST DOC Generici 10 mg film-coated tablets

Generic Medicine
Please read this leaflet carefully before you start taking this medicine, as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or
pharmacist. See section 4.
Contents of this leaflet:

What MONTELUKAST DOC Generici 10 mg film-coated tablets are and what they are used for
What you need to know before taking MONTELUKAST DOC Generici 10 mg film-coated tablets
How to take MONTELUKAST DOC Generici 10 mg film-coated tablets
Possible side effects
How to store MONTELUKAST DOC Generici 10 mg film-coated tablets
Contents of the pack and other information

1. What MONTELUKAST DOC Generici 10 mg film-coated tablets is and what it is used for

MONTELUKAST DOC Generici is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and also trigger allergy symptoms. By blocking leukotrienes, MONTELUKAST DOC Generici improves asthma symptoms, helps control asthma, and also improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed MONTELUKAST DOC Generici 10 mg film-coated tablets for the treatment of asthma, to prevent asthma symptoms both during the day and at night.

MONTELUKAST DOC Generici 10 mg film-coated tablets are used for the treatment of patients whose asthma is not adequately controlled with their current medications and who require additional therapy.
MONTELUKAST DOC Generici 10 mg film-coated tablets also prevent exercise-induced narrowing of the airways.
MONTELUKAST DOC Generici 10 mg film-coated tablets may also be used for symptomatic treatment of allergic rhinitis in asthmatic patients for whom treatment with this medicine is indicated for asthma.

Your doctor will determine how to use MONTELUKAST DOC Generici based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma includes:

Difficulty breathing due to narrowing of the airways. This narrowing worsens and improves in response to various triggers.
Airway sensitivity to many irritants, such as cigarette smoke, pollen, cold air, or physical exercise.
Swelling (inflammation) of the airways.

Asthma symptoms include: coughing, shortness of breath, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollens from trees, grass, and weeds. Symptoms of seasonal allergies typically include: stuffy, runny, itchy nose; sneezing; watery, puffy, red, itchy eyes.

What you need to know before taking MONTELUKAST DOC Generici 10 mg film-coated tablets
Inform your doctor about any illness or allergy you currently have or have had in the past.

Do not take MONTELUKAST DOC Generici
if you are allergic to montelukast, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If your asthma or breathing worsens, contact your doctor immediately.
MONTELUKAST DOC Generici oral tablets must not be used to treat acute asthma attacks. If an asthma attack occurs, follow your doctor’s instructions. Always carry your rescue inhaled medications for asthma attacks.
It is important that you or your child take all asthma medications prescribed by your doctor.
MONTELUKAST DOC Generici must not be used instead of other asthma medications prescribed by your doctor.
Every patient being treated with asthma medications should be aware that if they experience a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash, they should consult their doctor.
Patients should be aware that various neuropsychiatric events (e.g., changes in behavior and mood) have been reported in adults, adolescents, and children treated with MONTELUKAST DOC Generici (see section 4). If you or your child develop such symptoms while taking MONTELUKAST DOC Generici, you must consult your doctor.
You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.
If your doctor has told you that you are intolerant to certain sugars, contact them before taking this medicine.
Children and adolescents
MONTELUKAST DOC Generici 10 mg film-coated tablets are not indicated for children and adolescents under 15 years of age.
For children aged 2 to 5 years, MONTELUKAST DOC 4 mg chewable tablets (4 mg) are available.
For children aged 6 to 14 years, MONTELUKAST DOC 5 mg chewable tablets (5 mg) are available.
Other medicines and MONTELUKAST DOC Generici
Some medicines may interfere with the action of MONTELUKAST DOC Generici, or MONTELUKAST DOC Generici may interfere with the action of other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before starting MONTELUKAST DOC Generici, tell your doctor if you are taking any of the following medicines:
phenobarbital (used to treat epilepsy)
phenytoin (used to treat epilepsy)
rifampicin (used to treat tuberculosis and certain other infections)
gemfibrozil (used to treat high levels of fats – lipids – in the blood).
MONTELUKAST DOC Generici with food and drink
MONTELUKAST DOC Generici 10 mg film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
Use during pregnancy
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.
Use during breastfeeding
It is not known whether montelukast passes into human milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast.
Driving and using machines
No effects on the ability to drive or use machines are expected. However, individual responses to medicines may vary. Some adverse reactions (such as dizziness and drowsiness), which have been reported very rarely with montelukast, may affect the ability to drive and use machinery.
MONTELUKAST DOC Generici 10 mg film-coated tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
MONTELUKAST DOC Generici 10 mg film-coated tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.
MONTELUKAST DOC Generici 10 mg film-coated tablets contain soybean oil.
If you are allergic to peanuts or soy, you must not take this medicine.

3. How to take MONTELUKAST DOC Generici 10 mg film-coated tablets

You should take only one tablet of MONTELUKAST DOC Generici 10 mg film-coated tablets
per day as prescribed by your doctor.
Take the tablet even if you have no symptoms or during an acute asthma attack.
Always take MONTELUKAST DOC Generici 10 mg film-coated tablets exactly as directed
by your doctor. If you have any doubts, consult your doctor or pharmacist.
For oral use.
For adults from 15 years of age and older:
One 10 mg tablet of MONTELUKAST DOC Generici to be taken once daily in the evening. MONTELUKAST
DOC Generici 10 mg film-coated tablets may be taken with or without food.
If you are taking MONTELUKAST DOC Generici 10 mg film-coated tablets, make sure you do not
take other medicines containing the same active substance, montelukast.
If you take more MONTELUKAST DOC Generici than you should
Contact your doctor immediately.
In most reports of overdose, no adverse effects were observed. The most commonly reported
symptoms with overdose in adults and children include abdominal pain,
drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take MONTELUKAST DOC Generici
Try to take MONTELUKAST DOC Generici as prescribed. However, if you miss a dose,
resume your regular schedule of one tablet per day.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking MONTELUKAST DOC Generici
Treatment with MONTELUKAST DOC Generici 10 mg film-coated tablets will be effective
against asthma only if you continue taking it. It is important that you continue taking MONTELUKAST DOC
Generici for the entire duration prescribed by your doctor. This will help control your asthma. If you have any
further questions about the use of MONTELUKAST DOC Generici, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In clinical studies with montelukast 10 mg film-coated tablets, the side effects considered related to the use of the drug most commonly reported (occurring in at least 1 in 100 patients and in less than 1 in 10 pediatric patients treated) were:
Abdominal pain
Headache
These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active drug).

Additionally, the following side effects have been reported during post-marketing use of the medicine:

Very common (affects more than 1 in 10 people)

Upper respiratory tract infection

Common (affects up to 1 in 10 people)

Diarrhoea, nausea, vomiting
Rash
Fever

Uncommon (affects up to 1 in 100 people)

Allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
Changes in behaviour and mood (altered dream content, including nightmares, restless sleep, sleepwalking, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, depression)
Dizziness, drowsiness, tingling/numbness, seizures
Nosebleeds
Bruising, itching, urticaria
Dry mouth, digestive disturbances
Joint or muscle pain, muscle cramps
Weakness/tiredness, malaise, swelling

Rare (affects up to 1 in 1,000 people)

Increased tendency to bleed
Tremor
Palpitations

Very rare (affects up to 1 in 10,000 people)

Hepatitis (inflammation of the liver)
Painful red swellings under the skin, usually on the front of the legs (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning
Hallucinations, disorientation, suicidal thoughts and actions, stuttering

During treatment of asthmatic patients with montelukast, a combination of symptoms has been reported very rarely, including an influenza-like illness, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). You must inform your doctor immediately if you experience one or more of these symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MONTELUKAST DOC Generici 10 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The first two digits indicate the month; the last two digits indicate the year. The expiry date refers to the last day of that month.
Store the medicine in the original packaging to protect it from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MONTELUKAST DOC Generici 10 mg film-coated tablets contain
The active substance is montelukast.
Each film-coated tablet of MONTELUKAST DOC Generici 10 mg contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
The other components are:
Tablet core: Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Magnesium stearate.
Tablet coating: Polyvinyl alcohol, Titanium dioxide, Talc, Iron oxide red, Iron oxide black, Iron oxide yellow, Lecithin, Xanthan gum.

Description of the appearance of MONTELUKAST DOC Generici 10 mg film-coated tablets and pack contents
The film-coated tablets of MONTELUKAST DOC Generici 10 mg are beige-colored, round, biconvex tablets.
Blister packs containing: 7, 28, 30, 56, 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

Manufacturers:
Pharmathen S.A., 6 Dervenakion str., Pallini Attiki, 15351 Greece
Mylan bvba/sprl, Terhulpsesteenweg 6A, B-1560 Hoeilaart, Belgium