Pluralais 10 mg film-coated tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
PLURALAIS 10 mg film-coated tablets EFG
(Montelukast)
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents:
- What PLURALAIS is and what it is used for
- What you need to know before taking PLURALAIS
- How to take PLURALAIS
- Possible adverse effects
- How to store PLURALAIS
- Contents of the pack and other information
1. What PLURALAIS is and what it is used for
PLURALAIS is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in your lungs and can also cause allergy symptoms. By blocking leukotrienes, PLURALAIS 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 PLURALAIS to treat your asthma and to prevent asthma symptoms during the day and night.
- PLURALAIS is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medication and who need additional treatment.
- PLURALAIS also helps prevent airway narrowing caused by exercise.
- In those asthma patients for whom PLURALAIS is indicated for asthma, PLURALAIS 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 PLURALAIS.
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.
Symptoms of asthma 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 taking PLURALAIS
Inform your doctor of any allergies or medical conditions you currently have or have had in the past.
Do not take PLURALAIS if you
- are allergic (hypersensitive) to montelukast or to any of the other components of PLURALAIS (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take PLURALAIS
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If your asthma or breathing worsens, inform your doctor immediately.
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PLURALAIS oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always keep your inhaled rescue medication for asthma attacks on hand.
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It is important that you or your child use all asthma medications prescribed by your doctor. PLURALAIS should not replace other asthma medications prescribed by your doctor.
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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.
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You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
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Patients should be aware that various neuropsychiatric events have been reported with montelukast (e.g., behavioral and mood-related changes) in adults, adolescents, and children (see section 4). If you or your child develops these symptoms while taking montelukast, you must consult your doctor or your child's doctor.
Various neuropsychiatric events (for example, behaviour- and mood-related changes, depression, and suicide) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you should contact your doctor. |
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 depending on the age range.
Other medicines and PLURALAIS
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Some medicines may affect how PLURALAIS works, or PLURALAIS may affect how other medicines you are taking work.
Before taking PLURALAIS, 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 certain other infections)
- gemfibrozil (used for the treatment of elevated lipid levels in plasma)
Taking PLURALAIS with food and drinks
PLURALAIS 10 mg may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will assess whether you can take PLURALAIS during this period.
Breastfeeding
It is unknown whether PLURALAIS passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking PLURALAIS.
Driving and using machines
PLURALAIS 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 somnolence), which have been reported very rarely with PLURALAIS, may affect the patient's ability to drive or operate machinery.
PLURALAIS contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.
3. How to take PLURALAIS
Follow exactly the administration instructions for Pluralais given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
- You should take only one tablet of PLURALAIS once daily, as prescribed by your doctor.
- You should take it 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 PLURALAIS, make sure you do not take any other product containing the same active substance, montelukast.
This medicine is taken orally.
You may take PLURALAIS with or without food.
If you take more PLURALAIS than you should
If you have taken more Pluralais than you should, consult your doctor or pharmacist immediately.
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.
Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20 immediately, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take PLURALAIS
Try to take PLURALAIS as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet once daily.
Do not take a double dose to make up for missed doses.
If you stop taking PLURALAIS
PLURALAIS can treat your asthma only if you continue taking it. It is important that you continue taking PLURALAIS for as long as your doctor prescribes 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, PLURALAIS may cause adverse effects, although not everyone experiences them.
In clinical trials with PLURALAIS 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (in more than 1 in 10 people) were:
- abdominal pain
- headache
These adverse effects were generally mild and occurred more frequently in patients treated with PLURALAIS or with placebo (a pill that does not contain any active medicine).
Serious adverse effects
Contact your doctor immediately if you experience any of the following adverse 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 breathing or swallowing
- changes related to behaviour and mood: excitement including aggressive behaviour or hostility, 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):
- 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) (see section 2)
- low platelet count
- changes related to behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- serious skin reactions (erythema multiforme) which may occur without warning
- inflammation of the liver (hepatitis)
Other adverse effects reported during the medicine's marketing
Very common (may affect more than 1 in 10 people):
- upper respiratory tract infection
Common (may affect up to 1 in 10 people):
- diarrhoea, nausea, vomiting
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes related to behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, somnolence, tingling/numbness
- nosebleeds
- dry mouth, indigestion
- bruising, itching, urticaria
- joint or muscle pain, muscle cramps
- bedwetting (in children)
- weakness/fatigue, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes related to behaviour and mood: attention disturbance, memory disturbance, uncontrolled muscle movements
Very rare (may affect up to 1 in 10,000 people):
- painful red lumps under the skin, which more frequently appear on the shins (erythema nodosum)
- changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering
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 PLURALAIS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister 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 specified month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of PLURALAIS
- The active substance is montelukast. Each tablet contains 10 mg of montelukast.
- The other components are: Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate. Coating: Opadry White.
Appearance of the medicinal product and contents of the pack
Pluralais 10 mg are film-coated, round, white tablets.
They are presented in packs containing 28 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
or
Laboratorios Alter S.A.
C/ Zeus, 6
Polígono Industrial R2
28880 Meco (Madrid)
Spain
Date of the most recent revision of this leaflet: March 2025
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) http://www.aemps.gob.es