Prospecto: information for the user

Singulair 5mg chewable tablets

montelukast

Read this prospect carefully before you or your child start taking this medicine, because it contains important information for you or your child.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you or your child, and should not be given to other people even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

1.What is Singulair and what it is used for

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. By blocking leukotrienes, Singulair improves asthma symptoms and helps control asthma.

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 pediatric patients aged 6 to 14 years who are not adequately controlled with their medication and require additional treatment.
• Singulair is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma treatment and have demonstrated an inability to use inhaled corticosteroids.
• Singulair also helps prevent airway constriction caused by exercise.

The use of Singulair will depend on your symptoms and the severity of your asthma or your child's 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.
• Sensitive 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.

Inform your doctor of any allergy or medical condition you or your child may have now or have had.

Do not take Singulair

• if you or your child 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 you or your child start takingSingulair.

• If your asthma or breathing or your child's 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 your doctor has given you or your child. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Singulair should not be used in place of 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 in arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your asthma worse.

Neuropsychiatric events have been reported (e.g., changes in behavior and mood, depression, and suicidal tendencies) 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 6years of age.

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

Other medications andSingulair

Inform your doctor or pharmacist if you or your child 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 or your child are taking the following medications:

• 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)

Taking Singulair with food and beverages

Singulair 5mg chewable tablets should not be taken with meals; it should be taken at least 1hour before or 2hours after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become 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 5mg chewable tablets contain aspartame, sodium, and benzyl alcohol

This medication contains 1.5mg of aspartame in each 5mg chewable tablet, equivalent to 0.842mg of phenylalanine. Aspartame contains a source of phenylalanine that may be harmful if you or your child have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

This medication contains up to 0.45mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you or your child have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

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

• You or your child should only take one Singulair chewable tablet once a day, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or when having an acute asthma attack.

For children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet daily at night.

If you or your child are taking Singulair, make sure neither you nor your child take any other product containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

Singulair 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child 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 overdose cases in adults and children wereabdominal pain,drowsiness,thirst,headache,vomiting,andhyperactivity.

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 or forgot to give Singulair to your child:

Try to take Singulair as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one chewable tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you or your child interrupt treatment with Singulair:

Singulair can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue taking Singulair for the time your doctor prescribes. It will help control your asthma or your child's 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 5mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to1 in 10people), were:

• headache

Additionally, the following side effects were reported in clinical trials with Singulair 10mg film-coated tablets:

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

Severe side effects

Consult your doctor immediatelyif you observe any of the following side effects, which may be severe andyou or your childmay require urgent medical treatment.

Rare (may affect up to 1 in 100people):

• 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 1,000people):

• increased risk of bleeding
• tremors
• palpitations

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

• 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 section2)
• low platelet count
• behavior and mood changes: hallucinations,disorientation,suicidal thoughts and actions
• lung inflammation
• severe skin reactions (erythema multiforme) that may occur without warning
• liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

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

• upper respiratory tract infection

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

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

Rare (may affect up to 1 in 100people):

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

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

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

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

• red, painful lumps 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 or your child 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 containers and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Singulair Composition

• The active ingredient is montelukast. Each chewable tablet contains montelukast sodium corresponding to 5mg of montelukast.
• The other components are:

Manitol (E‑421), microcrystalline cellulose, hypromellose (E‑463), red iron oxide (E‑172), sodium croscarmellose, cherry flavor containing benzyl alcohol (E‑1519), aspartame (E‑951), and magnesium stearate.

Appearance of the product and contents of the package

Singulair 5mg chewable tablets are pink, round, biconvex, with SINGULAIR engraved on one side and MSD 275 on the other.

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

Blister packs (single dose) in packages of: 49x1, 50x1, and 56x1tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible manufacturer

MerckSharp&Dohme, B.V.

Waarderweg39

2031BN Haarlem

Netherlands

or

Organon Heist bv

Industriepark30

2220Heist‑on‑the‑Berg

Belgium

This medicine is authorized in the member states of the European Economic Area with 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.

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