Pluralais 10 mg hard capsules EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Pluralais 10 mg hard capsules EFG
montelukast
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 or pharmacist.
- 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 could 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
- What Pluralais is and what it is used for
- What you need to know before taking Pluralais
- How to take Pluralais
- Possible side effects
- How to store Pluralais
- Contents of the pack and other information
1. What Pluralais is and what it is used for
What Pluralais is
Pluralais is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Pluralais works
Leukotrienes cause narrowing and swelling of the airways in the lungs and can also trigger allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Pluralais should be used
Your doctor has prescribed montelukast to treat asthma and to prevent asthma symptoms during the day and night.
- montelukast 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 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: 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 starting to take 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 to montelukast or to 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, inform your doctor immediately.
-
Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor. Always keep your inhaled rescue medication for asthma attacks on hand.
-
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 in arms or legs, worsening of lung symptoms, and/or skin rash, they must consult their doctor.
-
You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.
Patients should be aware that several neuropsychiatric events have been reported with [this medicinal product (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 this medicine, you should consult your doctor or your child's 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 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 montelukast works, or montelukast may affect how other medicines work.
Before taking montelukast, 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 plasma lipid levels)
Taking Pluralais with food and drink
Montelukast 10 mg hard capsules may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may 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 montelukast during this period.
Breastfeeding
It is unknown whether montelukast is excreted in breast milk. If you are breastfeeding or plan to breastfeed, you should 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 adverse reactions (such as dizziness and somnolence) reported with montelukast may affect a patient's ability to drive or operate machinery.
Pluralais contains lactose and sodium
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per hard capsule; hence, it is essentially “sodium-free”.
3. How to take Pluralais
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
- You should take only one montelukast capsule once daily, as prescribed by your doctor.
- It should be taken even when you do not have symptoms or during an acute asthma attack.
For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg capsule taken once daily in the evening.
If you are taking montelukast, make sure you do not take any other product containing the same active substance, montelukast.
This medicine is taken orally.
You may take this medicine with or without food.
If you take more Pluralais 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 medicine and the amount ingested.
If you forget to take Pluralais
Try to take montelukast as prescribed. However, if you miss a dose, simply resume your regular schedule of one capsule once daily.
Do not take a double dose to make up for missed doses.
If you stop taking Pluralais
Montelukast can only treat your asthma if you continue taking it. It is important that you continue taking montelukast for the length of time prescribed by your doctor. It will help control your asthma.
If you have any further questions about the use of this medicine, 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 (may affect up to 1 in 10 people) 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 pill containing no 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 in behaviour and mood: excitability 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 of arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning
- inflammation of the liver (hepatitis)
Other adverse effects reported during post-marketing use of the medicine
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
- rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes in 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
- bed-wetting (in children)
- weakness/fatigue, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements
Very rare (may affect up to 1 in 10,000 people):
- painful red lumps under the skin, which most frequently appear on the shins (erythema nodosum)
- changes in 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 expiry date is the last day of the month indicated.
Store in the original packaging to protect from light. Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps 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 components (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).
Nature of the product and pack size
Pluralais 10 mg is a hard capsule size №2 with a white body and red cap. The capsule size is 18 mm.
Blister pack made of a complex film of polyamide/aluminum/PVC and another thermosealed aluminum layer. Each package contains 28 hard capsules.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es