MONTELUKAST QUALIGEN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Qualigen10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Montelukast Qualigen and what is it used for
2. What you need to know before you take Montelukast Qualigen
3. How to take Montelukast Qualigen
4. Possible side effects
5. Storage of Montelukast Qualigen
6. Contents of the pack and other information

1. What is Montelukast Qualigen and what is it used for

What is montelukast

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How montelukast works

Leukotrienes cause the airways in the lungs to narrow and swell, and can also cause allergy symptoms. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or allergic rhinitis).

When to use montelukast

Your doctor has prescribed montelukast to treat asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat adults and adolescents 15 years of age and older who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent narrowing of the airways caused by exercise.
• In patients with asthma who are indicated for asthma, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use montelukast.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various diseases.
• airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: coughing, wheezing, and congestion in the chest.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or allergic rhinitis) are an allergic reaction often caused by airborne pollen from trees, grass, and weeds. The symptoms of seasonal allergies typically include: congested nose, runny nose; sneezing; itchy, watery, swollen, red, and stinging eyes.

2. What you need to know before you take Montelukast Qualigen

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Qualigen

• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take montelukast 10 mg.

• If your asthma or breathing gets worse, tell your doctor immediately.
• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not replace other asthma medications that your doctor has prescribed for you.
• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• This medicine contains soybean oil. Do not use this medicine if you are allergic to peanuts or soybeans.

Children and adolescents

Do not give this medicine to children under 15 years of age.

For pediatric patients under 18 years of age, other presentations of this medicine are available based on the age range.

Other medicines and Montelukast Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work.

Before taking montelukast, tell your doctor if you are taking the following medicines:

• 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 Montelukast Qualigen with food and drinks

Montelukast 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will assess whether you can take this medicine during this period.

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking montelukast.

Driving and using machines

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Qualigen contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Montelukast Qualigen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should only take one tablet of montelukast once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or when you have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily in the evening.

If you are taking this medicine, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medicine is taken orally.

You can take montelukast 10 mg with or without food.

If you take more Montelukast Qualigen than you should

Seek help from your doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Montelukast Qualigen

Try to take montelukast as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once a day.

Do not take a double dose to make up for missed doses.

If you stop taking Montelukast Qualigen

Montelukast may only treat your asthma if you continue to take it. It is important that you continue to take montelukast for the time your doctor prescribes it. It will help control your asthma.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects:

Consult your doctor immediatelyif you observe any of the following side effects, which may be serious and may require urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

• allergic reactions including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• behavior and mood-related changes; excitement including aggressive or hostile behavior, depression
• seizures

Rare (may affect up to 1 in 1,000 people):

• increased risk of bleeding
• tremor
• palpitations

Very rare (may affect up to 1 in 10,000 people):

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2).
• low platelet count
• behavior and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions.
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

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
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• behavior and mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

Rare (may affect up to 1 in 1,000 people):

• behavior and mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• red, painful lumps under the skin that most frequently appear on the shins (erythema nodosum)
• behavior and mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Qualigen

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

• Store in the original packaging to protect from light and moisture.

• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Qualigen

• The active ingredient is montelukast. Each 10 mg tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are:

Lactose monohydrate, microcrystalline cellulose (E 460i), hydroxypropylcellulose (E 463), sodium croscarmellose (E 468), and magnesium stearate (E 470b).

Coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soybean lecithin (E 322), xanthan gum (E 415), and yellow and red iron oxide (E 172).

Appearance of the product and contents of the pack

Montelukast Qualigen 10 mg: orange, round, biconvex, film-coated tablets with the inscription "10" on one side.

It is presented in packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí, Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí, Barcelona

Spain

Date of last revision of this leaflet:April 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/