Prospect: information for the user

Singulair 4mg chewable tablets

montelukast

Read this prospect carefully before giving this medicine to your child,because it contains important information..

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

1.What Singulair is and for what it is used

2.What you need to know before your child takes 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 constriction 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 your child's asthma and prevent asthma symptoms during the day and night.

• Singulair is used to treat patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Singulair is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age 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 in patients 2 years of age and older.

The dosage of Singulair will depend on your child's symptoms and the severity of their asthma, as determined by your doctor.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to constriction of the airways. This constriction 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.
• Swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Singulair to your child

• if he or she is allergic to montelukast or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your child's doctor or pharmacist before givingSingulairto your child.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Singulair oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your child's doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.
• It is essential that your child uses all medications for asthma prescribed by your child's doctor. Singulair should not be used in place of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening respiratory symptoms, and/or skin rash, consult your child's doctor.
• Your child should not take acetylsalicylic acid (aspirin) or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your child's asthma worse.

Neuropsychiatric events have been reported in patients of all ages treated with montelukast (see section4). If you develop these symptoms while taking montelukast, contact your child's doctor.

Children and adolescents

Do not give this medication to children under 2years 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 child's doctor or pharmacist if your child is taking, has recently taken, 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 your child is using.

Before taking Singulair, inform your child's doctor if your child is 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 4mg chewable tablets should not be taken with meals; it should be taken at least 1hour before or 2hours after meals.

Pregnancy and breastfeeding

This subsection is not applicable to Singulair 4mg chewable tablets, as its use is indicated in children between 2 and 5years of age.

Driving and operating machinery

This subsection is not applicable to Singulair 4mg chewable tablets, as its use is indicated in children between 2 and 5years of age, however, the following information is important for the active ingredient, montelukast.

Singulair is not expected to affect your child's 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 4mg chewable tablets contain aspartame, sodium, and benzyl alcohol

This medication contains 1.2mg of aspartame in eachchewable tablet of 4mgequivalent to 0.674mg of phenylalanine. Aspartame contains a source of phenylalanine that may be detrimental in cases of 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; this is, essentially “sodium-free”.

This medication contains up to 0.36mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.

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

Follow exactly the administration instructions of this medication indicated by your child's doctor or pharmacist. In case of doubt, consult the doctor or pharmacist again.

• This medication should be administered to children under the supervision of an adult. For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one Singulair chewable tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one chewable tablet of 4 mg daily at night.

If your child is taking Singulair, make sure they do not take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

Singulair 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If your child takes more Singulair than they should:

Seek help from your child's 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 were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicological 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 give Singulair to your child:

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

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment with Singulair:

Singulair can only treat your child's asthma if they continue taking it.

It is essential that your child continues to take Singulair for the time prescribed by their doctor. It will help control your child's asthma.

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

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

In clinical trials conducted with Singulair 4mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to1 in 10people), were:

• abdominal pain
• thirst

Additionally, the following side effects were reported in clinical trials with Singulair 10mg film-coated tablets and 5mg chewable 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 effectsin your child, which may be severe andyour childmay require urgent medical treatment.

Uncommon (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
• inflammation of the liver (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
• high liver enzymes

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

• behavior and mood changes:sleep disturbances, including nightmares, sleep problems, somnambulism, 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 your child experiences 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 Medicinal Products 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 packagingafter 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 medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Singulair

• The active ingredient is montelukast. Each chewable tablet contains montelukast sodium corresponding to 4mg 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 4mg chewable tablets are pink, oval, biconvex, with SINGULAIR engraved on one side and MSD711 on the other.

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Health, 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‑op‑den‑Berg

Belgium

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

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden

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/