Prospect: information for the user

Singulair 4mg granulated

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 takesSingulair

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 your child's asthma and prevent asthma symptoms during the day and night.

• Singulair is used to treat patients between 6 months 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 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 child's doctor about any allergy or medical condition your child has now or has had.

Do not give Singulair to your child

• if they are 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 you. 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 their 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, numbness or tingling in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take aspirin or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make their asthma worse.

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 6months 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 epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)

Taking Singulair with food and drinks

Singulair granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This subsection does not apply to Singulair 4mg granules, as its use is indicated in children aged 6months to 5years.

Driving and operating machinery

This subsection does not apply to Singulair 4mg granules, as its use is indicated in children aged 6months to 5years, however, the following information is important for the active ingredient, montelukast.

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 contains sodium

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

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 must be administered to children under the supervision of an adult.
• Your child must take Singulair every night. It should be taken even when your child does not have symptoms or when having an acute asthma attack.

For children from 6 months to 5 years of age:

The recommended dose is one packet of Singulair 4 mg granulated orally every night.

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

How should I give Singulair granulated to my child?

This medication is taken orally.

• Do not open the packet until the time of use.
• Singulair granulated can be administered:
• • Directly in the mouth;
  • Or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce, ice cream, carrots, and rice).

• Mix the entire content of Singulair granulated in a spoonful of cold or room temperature soft food, being careful to observe that the full dose is mixed with the food.
• Make sure to administer the entire spoonful to the child immediately (within 15 minutes).

IMPORTANT: Never keep leftovers of the food/granulated mixture for later use.

• Singulair granulated is not intended to dissolve in liquids. However, your child can take liquids after swallowing Singulair granulated.
• Singulair granulated can be taken regardless of meal times.

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 in adults and children were abdominal pain, drowsiness, thirst, 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, limit yourself to resuming the usual regimen of one packet per day.

Do not give a double dose to compensate for the 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 taking Singulair for the time their doctor prescribes. It will help control your child's asthma.

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

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

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

• diarrhea
• hyperactivity
• asthma
• skin with itching or scaly skin
• skin rash

In addition, the following side effects were reported in clinical trials with Singulair 10mg film-coated tablets and Singulair 5mg or 4mg 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.

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

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 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 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.
• Do not store at a temperature above 25°C. 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 sachet of granules contains montelukast sodium equivalent to 4mg of montelukast.
• The other components are: Mannitol (E‑421), hypromellose (E‑463) and magnesium stearate.

Appearance of the product and contents of the packaging

Singulair 4mg granules are a white granule.

Packages of 7, 20, 28 and 30sachets.

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

Phone: 915911279

Responsible manufacturer

Merck Sharp & Dohme, B.V.

Waarderweg 39

2031 BN, Haarlem

Netherlands

Vianex,S.A.FactoryA

12Km.National Road

Metamorphossi Attiki

Lamia, Athens GR‑14451

Greece

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, Slovakia, Spain, Sweden

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/