Package Insert: Information for the User

Montelukast Almus 10 mgfilm-coated tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before taking Montelukast Almus

3. How to take Montelukast Almus

4. Possible side effects

5. Storage of Montelukast Almus

6. Contents of the pack and additional information

What is Montelukast Almus

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

How Montelukast Almus works

Leukotrienes produce narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal 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 airway constriction caused by exercise.
• In patients with asthma for whom montelukast is indicated, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

The dosage of Montelukast will depend on your symptoms and the severity of your asthma, as determined by your doctor.

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 conditions.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

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. Typical symptoms of seasonal allergies may include: Stuffy nose, runny nose, sneezing; itchy nose; watery, swollen, red, and itchy eyes.

Inform your doctor of any allergy or medical condition you have now or have had.

Do not take Montelukast Almus

-if you are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Montelukast Almus.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast oral is not indicated for treating 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 essential 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

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

Taking Montelukast Almus with other medications

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

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications you are using.

Before taking Montelukast Almus, inform your doctor if you are taking the following

medications:

• 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)
• gemfibrozil (used for the treatment of elevated lipid levels in plasma)

Taking Montelukast Almus with food and beverages

Montelukast Almus 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

Breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Almus.

Driving and operating machinery

Montelukast Almus is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary.

Certain adverse effects (such as dizziness and somnolence) that have been reported 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 certain sugars, consult with them before taking this medication.

Montelukast Almus 10 mg film-coated tablets contain sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You should only take one Montelukast Almus tablet once a day, as prescribed by your doctor.
• You should take it 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 at night.

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

This medication is taken orally.

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

If you take more Montelukast Almus than you should:

Seek help from your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast Almus:

Try to take Montelukast as prescribed. However, if you forget a dose, simply resume the usual regimen of one tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast Almus:

Montelukast can only treat your asthma if you continue taking it.

It is essential that you continue taking montelukast for the time your doctor prescribes. It will help control your asthma.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (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 a medicine).

The frequency of possible side effects, indicated 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 available data.

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

• upper respiratory tract infection(Very common)
• increased risk of bleeding(Rare)
• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, depression(Uncommon); tremor, altered attention, altered memory(Rare); hallucinations, disorientation, suicidal thoughts and actions, and stuttering(Very rare)]
• dizziness, somnolence, paresthesia, convulsions (Uncommon)
• palpitations (Rare)
• nasal bleeding(Uncommon),inflammation of the lungs(Very rare)
• diarrhea, nausea, vomiting(Common); dry mouth, indigestion(Uncommon)
• hepatitis (inflammation of the liver)(Very rare)
• skin rash(Common); hematomas, pruritus, urticaria(Uncommon); red painful bumps under the skin that more frequently appear on the acne (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning(Very rare)
• musculoskeletal pain or muscle cramps(Uncommon)
• fever(Common); weakness/fatigue, malaise, swelling(Uncommon)

In patients with asthma treated with montelukast, rare cases of a combination of symptoms such as flu-like illness, paresthesia or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported.You must immediately inform your doctor if you have one or more of these symptoms (see section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash.Deposit the packaging and the

medications you do not need at your local SIGREdrop-off point at your usual pharmacy.Ask your pharmacist how to dispose of the packaging and the medications you do not need. This will help protect the environment.

Composition of Montelukast Almus

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

- The other components are:

Core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,

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 content of the container

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

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing

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

Last review date of this leaflet: March 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/