Label: information for the user

Singulair 10mg film-coated tablets

montelukast

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What Singulair is and for what it is used

2.What you need to know before starting to take Singulair

3.How to take Singulair

4.Possible adverse effects

5.Storage of Singulair

6.Contents of the package and additional information

What is Singulair

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

How Singulair works

Leukotrienes produce narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Singulair improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When to use Singulair

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

• Singulair is used to treat adults and adolescents aged 15 years and older who are not adequately controlled with their medication and need additional treatment.
• Singulair also helps prevent airway constriction caused by exercise.
• In patients with asthma for whom Singulair is indicated, Singulair may also provide symptomatic relief of seasonal allergic rhinitis.

The dosage of Singulair 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.
• Overreactive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner lining 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, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

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

Do not take Singulair

• if you are allergic to montelukast or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeSingulair.

• If your asthma or breathing worsens, inform your doctor immediately.
• Singulair 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 available.
• It is essential that you or your child use all medications for asthma prescribed by your doctor. Singulair 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, numbness or tingling 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.

Several neuropsychiatric events (e.g., changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section4). If you develop these symptoms while taking montelukast, contact your doctor.

Children and adolescents

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

For pediatric patients under 18years of age, other presentations of this medication are available based on age range.

Other medications and Singulair

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

Before taking Singulair, inform your doctor if you are taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)
• gemfibrozil (used for high plasma lipid levels treatment)

Taking Singulair with food and beverages

Singulair 10mg film-coated tablets 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 Singulair during this period.

Breastfeeding

The safety of Singulair in breastfeeding women is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Singulair.

Driving and operating machinery

Singulair 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) reported with Singulair may affect the patient's ability to drive or operate machinery.

Singulair 10mg film-coated tablets contain lactose and sodium

This medication contains lactose..If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23mg of sodium (1mmol) 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 Singulair 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 Singulair, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take Singulair 10 mg with or without food.

If you take more Singulair 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 adults and children who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Singulair:

Try to take Singulair 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 Singulair:

Singulair can only treat your asthma if you continue to take it. It is essential that you continue taking Singulair for the time your doctor prescribes. It will help control your asthma.

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

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

In clinical trials conducted with Singulair 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

These side effects were generally mild and occurred more frequently in patients treated with Singulair than with placebo (a pill that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, which may be severe and may require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

Rare (may affect up to 1 in 1,000 people):

• increased risk of bleeding
• tremors
• 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 respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood changes: 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 side effects reported during the marketing of the drug

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

• upper respiratory tract infection

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting
• skin rash
• fever
• enzymes elevated in the liver

Not common (may affect up to 1 in 100 people):

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
• dizziness, drowsiness, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruises, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, discomfort, swelling

Rare (may affect up to 1 in 1,000 people):

• behavior and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)
• behavior and mood changes: obsessive-compulsive symptoms, stuttering

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 blister pack 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Singulair

• The active ingredient is montelukast. Each tablet contains montelukast sodium corresponding to 10mg of montelukast.
• The other components are:

Microcrystalline cellulose, lactose monohydrate (89.3mg), sodium croscarmellose, hypromellose (E‑463) and magnesium stearate.

Coating: hypromellose, hypromellose (E‑463), titanium dioxide (E‑171), iron oxide red and yellow (E‑172) and carnauba wax.

Appearance of the product and contents of the package

Singulair 10mg tablets are beige, with a rounded square shape, coated with a film, with SINGULAIR engraved on one side and MSD 117 on the other.

Blister packs in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140 and 200 tablets.

Blister packs (single dose) in packages of: 49x1, 50x1 and 56x1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer

Organon Heist bv

Industriepark30

2220Heist‑op‑den‑Berg

Belgium

or

MerckSharp&Dohme, B.V.

Waarderweg39

2031BN Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Areawith the following names:

Austria, Belgium, Denmark, Finland, France, Greece, Spain, Sweden, Germany, Ireland, Italy, Luxembourg, Netherlands, Portugal

Singulair

Last review date of this leaflet:04/2023.

More detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/