PLURALAIS 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pluralais10 mg hard capsules EFG

montelukast

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

1. What is Pluralais and what is it used for

What is Pluralais

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

How Pluralais 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 Pluralais

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 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.
• swelling (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 allergic rhinitis) are an allergic reaction often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: stuffy nose, runny nose; sneezing; itchy, watery, red, and swollen eyes.

2. What you need to know before you take Pluralais

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

Do not take Pluralais

• 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 this medicine.

• If your asthma or breathing worsens, tell 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 have your rescue inhalation 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 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 worsen your asthma.

Children and adolescents

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

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

Other medicines and Pluralais

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 Pluralais with food and drinks

Montelukast 10 mg hard capsules 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 this medicine.

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.

Pluralais 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 23 mg of sodium (1 mmol) per hard capsule; this is essentially "sodium-free".

3. How to take Pluralais

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

• You should only take one montelukast capsule 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 capsule daily in the evening.

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

This medicine is taken orally.

You can take this medicine with or without food.

If you take more Pluralais 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 ingested.

If you forget to take Pluralais

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

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

If you stop taking Pluralais

Montelukast may 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 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 with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you notice 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 which may cause difficulty in breathing or swallowing
• 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
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• liver inflammation (hepatitis)

Other side effects reported during the marketing of the medicine

Very common (may affect more than 1 in 10 people):

• upper respiratory 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):

• 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):

• 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)
• 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 they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pluralais

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 expiry date refers to the last day of the month shown.

Store in the original package to protect from light. Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, 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 Pluralais

• The active substance is montelukast. Each hard capsule contains montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients (excipients) are:

core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate.

capsule composition:gelatin, titanium dioxide (E-171), and red iron oxide (E-172).

Appearance of the product and pack contents

Pluralais 10 mg is a hard capsule, size 2, with a white body and a red cap. The capsule size is 18 mm.

Blister pack formed by a complex laminate of polyamide/aluminum/PVC and aluminum, heat-sealed. Each pack contains 28 hard capsules.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of last revision of this leaflet: February 2025

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