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Montecon 10 mg. 30 tablets

Product Code: Montecon 10 mg. 30 tablets
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What Montecon 10 mg film-coated tablets are and what they are used for

Montecon contains the active substance montelukast sodium. Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the walls of the airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montecon 10 mg film-coated tablets improve asthma symptoms, help control it and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montecon 10 mg film-coated tablets for the treatment of asthma to prevent asthma symptoms during the day and at night.

Montecon 10 mg film-coated tablets are used to treat patients who are not adequately controlled by their medications and require additional therapy.
Montecon 10 mg film-coated tablets also help prevent the narrowing of the airways caused by physical exertion.
In patients suffering from asthma, Montecon 10 mg film-coated tablets may also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montecon 10 mg film-coated tablets should be used, depending on the symptoms and severity of your asthma.

Montecon 10 mg film-coated tablets are indicated for patients 15 years of age and older.

If you do not feel better or if you feel worse, you should talk to your doctor or pharmacist.

What is asthma?
Asthma is a long-term disease.

Asthma includes:

difficulty breathing due to narrowed airways. This narrowing of the airways worsens and improves in response to various conditions;
sensitive airways that react to many factors, such as cigarette smoke, pollen, cold air or exercise;
edema (inflammation) of the lining of the respiratory tract.
Asthma symptoms include: Coughing, wheezing and chest tightness.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic reaction often triggered by airborne pollens from trees, grasses, and weeds. Symptoms of seasonal allergies can usually include: stuffy nose; runny nose; itchy nose; sneezing; moist, swollen, red and itchy eyes.

2. What you need to know before you take Montecon 10 mg film-coated tablets

Tell your doctor about any medical problems or allergies you have or have had.

Do not take Montecon 10 mg film-coated tablets:

if you are allergic (hypersensitive) to montelukast or any of the other ingredients of Montecon 10 mg film-coated tablets (see section 6.)
Warnings and precautions

If your asthma or breathing gets worse, tell your doctor right away.
Oral Montecon 10 mg film-coated tablets are not intended for the treatment of acute asthmatic attacks. If an attack occurs, follow the instructions given by your doctor. You should always have a life-saving inhaler available to relieve attacks.
It is important that you or your child take all the asthma medicines prescribed by your doctor. Montecon 10 mg film-coated tablets should not be used in place of other asthma medicines prescribed by your doctor.
Any patient taking anti-asthma medication should know that if they develop a combination of symptoms such as a flu-like illness, numbness or tingling in the hands or feet, worsening of lung symptoms and/or a rash, they should consult their doctor.
You should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Children and adolescents
Montecon 10 mg film-coated tablets are not recommended for use in children and adolescents under 15 years of age.
For children from 2 to 5 years, Montecon 4 mg chewable tablets are available.
Montecon 5 mg chewable tablets are available for children and adolescents from 6 to 14 years of age.

Other medicines and Montecon 10 mg film-coated tablets
Some medicines can affect the effect of Montecon 10 mg film-coated tablets or Montecon 10 mg film-coated tablets can affect the effect of other medicines.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you are taking the following medicines before you start taking Montecon 10 mg film-coated tablets:

phenobarbital (used to treat epilepsy);
phenytoin (used to treat epilepsy);
rifampicin (used to treat tuberculosis and some other infections);
gemfibrozil (used to treat high plasma lipid levels).
Taking Montecon 10 mg film-coated tablets with food, drink and alcohol
Montecon 10 mg film-coated tablets can be taken with or without food.

Pregnancy, lactation and fertility
3. How to take Montecon 10 mg film-coated tablets

Always take Montecon 10 mg film-coated tablets exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
You should only take one tablet of Montecon 10 mg once a day as prescribed by your doctor.
The medicine should be taken even if you have no symptoms or if you have an acute asthma attack.
The tablet should be taken orally.

For adults and adolescents aged 15 and over:
It should be taken one tablet of 10 mg daily, in the evening. Montecon 10 mg film-coated tablets can be taken with or without food.

If you are taking Montecon 10 mg film-coated tablets, you should make sure that you are not taking other medicines that contain the same active ingredient montelukast.

If you have taken more than the required dose of Montecon 10 mg film-coated tablets
Contact your doctor immediately.
The majority of overdose reports do not report adverse reactions. The most common symptoms reported with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montecon 10 mg film-coated tablets
Try to take Montecon 10 mg film-coated tablets as prescribed. However, if you miss a dose, simply continue with the usual schedule of one tablet once a day.
Do not take a double dose to make up for a missed dose.

If you have stopped taking Montecon 10 mg film-coated tablets
Montecon 10 mg film-coated tablets can only treat your asthma if you continue to take them.

It is important to continue taking Montecon 10 mg film-coated tablets for as long as your doctor has prescribed. It will help you control your asthma.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In patients with asthma treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, numbness or tingling of the hands and feet, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You should tell your doctor right away if you get one or more of these symptoms.

In clinical trials with montelukast, the most commonly reported side effects (occurring in at least 1 in 100 patients and less than 1 in 10 patients) thought to be related to it were:

stomach ache;
headache.
These are usually mild and occur more frequently in patients treated with montelukast than in those receiving placebo (a tablet containing no medicine).

If any of the following happen, stop taking Montecon 10 mg film-coated tablets and contact a doctor or go to the nearest hospital as you may need urgent medical attention:

allergic reactions, including rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing;
sensitive red lumps under the skin, most often on the shins (erythema nodosum);
severe skin reactions (erythema multiforme) which may appear without warning.
In addition, since the drug has been on the market, the following have been reported:
Very common: may affect more than 1 in 10 people:

upper respiratory tract infection.
Common: may affect up to 1 in 10 people:

diarrhea, nausea, vomiting;
rash;
fever;
Uncommon: may affect up to 1 in 100 people:

behavioral and mood changes [sleep disturbances including nightmares, sleep problems, sleepwalking, irritability, feelings of anxiety, restlessness, agitation including aggressive behavior or hostility, depression];
allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing;
dizziness, drowsiness, numbness/numbness, seizures;
nosebleeds;
dry mouth, indigestion;
bleeding, itching, rash;
joint or muscle pain, muscle cramps;
weakness / fatigue, malaise, swelling.
Rare: may affect up to 1 in 1,000 people:

increased tendency to bleed;
attention disorder, memory disorders;
palpitations;
tremor, attention disorder, memory disorder.
Very rare: may affect up to 1 in 10,000 people:

hallucinations, disorientation, suicidal thoughts and actions;
hepatitis (inflammation of the liver);
painful red nodules on the skin, most often on the lower limbs (erythema nodosum), severe skin reactions (erythema multiforme), which may appear suddenly;
pulmonary eosinophilia.
5. How to store Montecon 10 mg film-coated tablets

Keep out of the reach of children.

Do not use Montecon 10 mg film-coated tablets after the expiry date which is stated on the label or carton after EXP. The expiration date corresponds to the last day of the specified month.

To be stored below 25 °C.

Store in the original package to protect from light and moisture.

Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Montecon 10 mg film-coated tablets contain

The active substance is: montelukast. Each film-coated tablet contains montelukast.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose (101), hydroxypropyl cellulose (E 463), croscarmellose sodium, magnesium stearate.
Film coating: hydroxypropyl cellulose (E 463), hypromellose 6cP (E 464), titanium dioxide (E 171), carnauba wax, yellow iron oxide (E 172), red iron oxide (E 172).
What Montecon 10 mg film-coated tablets look like and contents of the pack
Montecon 10 mg are beige, square, biconvex, film-coated tablets debossed with "X" on one side and "54" on the other side, measuring 8.1 x 8.1 mm.

Montekon 10 mg film-coated tablets are packed in Al/Al blisters, placed in a cardboard package of 30 tablets.

 

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