Montelukast Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast MABO 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because

it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people,

even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are

adverse effects not listed in this leaflet.

Leaflet contents:

1. What Montelukast MABO 10 mg is and what it is used for
2. What you need to know before taking Montelukast MABO 10 mg
3. How to take Montelukast MABO 10 mg
4. Possible adverse effects
5. How to store Montelukast MABO 10 mg
6. Contents of the pack and other information

1. What Montelukast MABO 10 mg is and what it is used for

Montelukast MABO is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast MABO improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

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

??Montelukast MABO is used for the treatment of patients who are not adequately controlled with their current medication and require additional therapy.

? Montelukast MABO also helps prevent airway narrowing caused by exercise.

??In those asthmatic patients for whom Montelukast MABO is indicated for asthma, Montelukast MABO 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 MABO.

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 triggers.

??Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

??Swelling (inflammation) of the inner lining of the airways.

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 response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. WHAT YOU NEED TO KNOW BEFORE STARTING TO TAKE Montelukast MABO 10 mg

Do not take Montelukast MABO if

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast MABO oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor. Always have your rescue inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast MABO should not replace other asthma medications prescribed by your doctor.
• 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (NSAIDs) if they cause your asthma to worsen.

Use in children

For children aged 2 to 5 years, Montelukast MABO 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast MABO 5 mg chewable tablets are available.

Taking Montelukast MABO with other medicines

Some medicines may affect the way Montelukast MABO works, or Montelukast MABO may affect the way other medicines you are taking work.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Before taking Montelukast MABO, inform your doctor if you are taking the following medicines:

??phenobarbital (used for the treatment of epilepsy)

??phenytoin (used for the treatment of epilepsy)

??rifampicin (used for the treatment of tuberculosis and some other infections)

Taking Montelukast MABO with food and drink

Montelukast MABO 10 mg may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy

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

Use during breastfeeding

It is not known whether Montelukast MABO passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast MABO.

Driving and using machines

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

Montelukast MABO 10 mg contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to TAKE Montelukast MABO 10 mg

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

Use in adults and adolescents aged 15 years and older

One 10 mg tablet should be taken daily at night. Montelukast MABO 10 mg may be taken with or without food.

If you are taking Montelukast MABO, make sure you do not take any other medicine containing the same active substance, montelukast.

• You should take only one Montelukast MABO tablet once daily, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.
• Always take Montelukast MABO exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
• It must be taken by mouth.

If you take more Montelukast MABO than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast MABO

Try to take Montelukast MABO as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet daily.

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

If you stop taking Montelukast MABO

Montelukast MABO will only treat your asthma if you continue taking it. It is important that you continue taking Montelukast MABO for the length of time prescribed by your doctor. It will help control your asthma.

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

4. Possible side effects

Like all medicines, Montelukast MABO may cause side effects, although not everybody gets them.

In clinical trials conducted with Montelukast MABO 10 mg film-coated tablets, the side effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in 100 patients and in less than 1 in 10 patients treated), were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with Montelukast MABO than in those treated with placebo (a tablet containing no active ingredient).

The frequency of possible side effects listed below is defined using the following convention:

• Very common: may affect more than 1 in 10 people
• Common: may affect between 1 and 10 in 100 people
• Uncommon: may affect between 1 and 10 in 1,000 people
• Rare: may affect between 1 and 10 in 10,000 people
• Very rare: may affect less than 1 in 10,000 people

Additionally, since the medicine has been marketed, the following side effects have been reported:

??upper respiratory tract infection (Very common)

??increased tendency to bleeding (Rare)

??allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon)

??changes related to behaviour and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness, excitement including aggressive behaviour or hostility, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts and actions (Very rare)]

??dizziness, somnolence, tingling/numbness, seizures (Uncommon)

??palpitations (Rare)

??nosebleeds (Uncommon)

??diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)

??hepatitis (inflammation of the liver) (Very rare)

??bruising, itching, urticaria (Uncommon); painful red lumps under the skin which usually appear on the shins (erythema nodosum) (Very rare)

??joint or muscle pain, muscle cramps (Uncommon)

??fever (Common); fatigue, malaise, swelling (Uncommon)

??stuttering (Very rare)

In asthmatic patients treated with Montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You should contact your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects.

If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.

5. Storage of Montelukast MABO 10 mg

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. PACK CONTENT AND ADDITIONAL INFORMATION

Composition of Montelukast MABO

• The active substance is Montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other components are: Core: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose (E-463), sodium croscarmellose, magnesium stearate. Coating: Opadry orange 03B23378 (hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172), and polyethylene glycol).

Appearance of the product and pack contents

Montelukast MABO 10 mg film-coated tablets are beige-colored, square-shaped, biconvex tablets, marked with "MOK 10" on one side and "PHD 741" on the other.

The packs contain 28 film-coated tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Meditrial Internationals Ltd.

Iztok Distr.

119A Tsarigradsko shose blvd.

1784 Sofia

Bulgaria

Date of the most recent revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/