Montelukast Almus 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Montelukast Almus 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, 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. See section 4.

Leaflet contents:

1. What Montelukast Almus is 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. How to store Montelukast Almus
6. Contents of the pack and other information

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

What is Montelukast Almus

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

How Montelukast Almus works

Leukotrienes cause 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 symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast Almus

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

• Montelukast is used for the treatment of adults and adolescents aged 15 years and older who are not adequately controlled with their current medication and require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom montelukast is 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 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: cough, 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: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

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

Tell your doctor about any allergies or medical conditions you currently have or have had in the past.

Do not take Montelukast Almus

• if you are allergic 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 you start taking Montelukast Almus.

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication available 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they must consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

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

Taking Montelukast Almus with other medicines

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

Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.

Before taking Montelukast Almus, 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)
• gemfibrozil (used for the treatment of elevated lipid levels in plasma)

Taking Montelukast Almus with food and drinks

Montelukast Almus 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.

Pregnancy

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

Breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should 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 adverse 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 informed you that you have an intolerance to certain sugars, consult with him 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; hence, it is essentially “sodium-free”.

3. How to take Montelukast Almus

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

• You should take only one Montelukast Almus tablet once daily, as prescribed by your doctor.
• It should be taken even when you have no symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

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

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

This medicine is for oral use.

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

If you take more Montelukast Almus than you should

Seek immediate help from your doctor.

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 medication and the amount ingested.

If you forget to take Montelukast Almus

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

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

If you stop taking Montelukast Almus

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

It is important that you continue taking montelukast for as long as your doctor has prescribed it. 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 adverse effects

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

In clinical trials with montelukast 10 mg film-coated tablets, the adverse 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 adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet that does not contain any active medicine).

The frequency of the possible adverse 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 available data.

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

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (Uncommon)
• changes in behavior and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness, excitement including aggressive behavior or hostility, depression (Uncommon); tremor, attention disturbance, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions, and stuttering (Very rare)]
• dizziness, somnolence, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon), swelling (inflammation) of the lungs (Very rare)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• skin rash (Common); bruising, itching, urticaria (Uncommon); painful red lumps under the skin, usually appearing on the shins (erythema nodosum), serious skin reactions (erythema multiforme) which may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, malaise, swelling (Uncommon)

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 must inform your doctor immediately if you experience one or more of these symptoms (see section 2).

Reporting of adverse effects

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

5. Storage of Montelukast Almus

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month shown.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Montelukast Almus

• 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, 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 contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

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 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 of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/