MONTELUKAST ALMUS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Almus 10 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, pharmacist, or nurse.
• 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 Almus and what is it used for
2. What you need to know before you take Montelukast Almus
3. How to take Montelukast Almus
4. Possible side effects
5. Storage of Montelukast Almus
6. Contents of the pack and other information

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

What is Montelukast Almus

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

How Montelukast Almus works

Leukotrienes cause the airways 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 Almus

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

• Montelukast is used for the treatment of 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 exercise-induced narrowing of the airways.
• In patients with asthma who are indicated for montelukast, 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.
• inflammation (swelling) of the inner layer of the airways.

The symptoms of asthma include: Cough, wheezing, and chest congestion.

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: stuffy nose, runny nose; sneezing; itchy, watery, swollen, red, and scratchy eyes.

2. What you need to know before you start taking Montelukast Almus

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

Do not take Montelukast Almus

• 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 Almus.

• 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 use all asthma medications prescribed by your doctor. Montelukast 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 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.

Children and adolescents

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

Taking Montelukast Almus with other medicines

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

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

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

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 lipid levels in plasma)

Taking Montelukast Almus with food and drinks

Montelukast Almus 10 mg 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 montelukast 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 Almus.

Driving and using machines

Montelukast Almus 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 very rarely with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Almus 10 mg film-coated tablets contain lactose.

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

Montelukast Almus 10 mg film-coated tablets contain sodium

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

3. How to take Montelukast Almus

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You should only take one Montelukast Almus tablet 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 Montelukast, make sure you do not take any other medicine that contains the same active ingredient, montelukast.

This medicine is taken orally.

You can take Montelukast Almus 10 mg with or without food.

If you take more Montelukast Almus than you should

Seek immediate medical attention.

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 ingested.

If you forget to take Montelukast Almus

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 Almus

Montelukast can only treat your asthma if you continue to take it.

It is important that you continue to take montelukast for as long as your doctor prescribes it. 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, 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 (occurring in at least 1 in 100 patients and 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 than with placebo (a tablet that does not contain medicine).

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 up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

Frequency not known: cannot be estimated from the available data.

In addition, since the medicine is marketed, the following side effects have been reported:

• upper respiratory infection (Very common)
• increased risk of bleeding (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon); tremor, attention disturbance, memory disturbance (Rare); hallucinations, disorientation, suicidal thoughts and actions and stuttering (Very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon),swelling (inflammation) of the lungs (Very rare)
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• skin rash (Common); bruising, itching, urticaria (Uncommon); red, painful bumps under the skin that most often appear on the shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, malaise, swelling (Uncommon)

In patients with asthma treated with montelukast, very rare cases of 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) have been reported. You should immediately inform your doctor if you have one or more of these symptoms (see section 2).

Reporting of side effects

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

5. Storage of Montelukast Almus

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 carton 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 package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy for proper disposal. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Almus

• The active substance is montelukast. Each tablet contains montelukast sodium, which corresponds to 10 mg of montelukast.

• The other ingredients are:

Core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose (E463), and magnesium stearate.

Coating: hypromellose, hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Montelukast Almus 10 mg film-coated tablets are round, pink, convex, and film-coated.

Montelukast Almus 10 mg film-coated tablets are available in blisters of 14, 28, and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira

2710-089 Sintra, Portugal

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares, Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of last revision of this leaflet: March 2024

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