SINGULAIR 4 mg GRANULES

2. What you need to know before your child takes Singulair

Tell your doctor about any allergy or medical problem 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 ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before giving Singulair to your child.

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

Several neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, they should contact their doctor.

Children and adolescents

Do not give this medicine to children under 6 months of age.

For pediatric patients under 18 years of age, other formulations of this medicine are available based on the age range.

Other medicines and Singulair

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how Singulair works, or Singulair may affect how other medicines your child is using work.

Before taking Singulair, tell your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Taking Singulair with food and drinks

Singulair granules can be taken without regard to meals.

Pregnancy and breastfeeding

This subsection is not applicable to Singulair 4 mg granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and using machines

This subsection is not applicable to Singulair 4 mg granules, as its use is indicated in children between 6 months and 5 years of age. However, the following information is important for the active substance, montelukast.

Singulair is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with Singulair may affect your child's ability to drive or operate machinery.

Singulair contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

3. How to take Singulair

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

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

For children from 6months to 5years of age:

The recommended dose is one sachet of Singulair 4 mg granules orally every night.

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

How should I give Singulair granules to my child?

This medicine is taken orally.

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

• Mix the entire contents of Singulair granules in a spoonful of soft cold or room temperature food, making sure to observe that the entire dose is mixed with the food.
• Make sure to give the entire spoonful of the food/granule mixture to the child immediately (within 15 minutes).

IMPORTANT: Never save any leftover food/granule mixture for later use.

• Singulair granules are not intended to be dissolved in liquids. However, your child can drink liquids after swallowing Singulair granules.
• Singulair granules can be taken without regard to meals.

If your child takes more Singulair than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

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

If you forget to give Singulair to your child

Try to give Singulair as prescribed. However, if your child misses a dose, just resume the usual routine of one sachet once a day.

Do not give a double dose to make up for missed doses.

If your child stops taking Singulair

Singulair may only treat your child's asthma if they continue to take it. It is important that your child continues to take Singulair for as long as their doctor prescribes it. It will help control your child's asthma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with Singulair 4 mg granules, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• diarrhea
• hyperactivity
• asthma
• itchy or scaly skin
• skin rash

Additionally, the following side effects were reported in clinical trials with Singulair 10 mg film-coated tablets and Singulair 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• thirst

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

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and your child may need urgent medical treatment.

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

• allergic reactions including swelling of the face, lips, tongue, and/or throat that can 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
• tremor
• 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 lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing 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):

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

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

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

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

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

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

Reporting of side effects:

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Singulair

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the sachet after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month that is indicated.
• Do not store above 25°C. Store in the original package to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Singulair

• The active substance is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients are: Mannitol (E-421), hypromellose (E-463), and magnesium stearate.

Appearance and packaging of the product

Singulair 4 mg granules are a white granule.

Pack sizes: 7, 20, 28, and 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme, B.V.

Waarderweg 39

2031 BN, Haarlem

Netherlands

Vianex, S.A. Factory A

12 Km. National Road

Metamorphossi Attiki

Lamia, Athens GR-14451

Greece

This medicine is authorized in the Member States of the European Economic Area under 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

Date of last revision of this leaflet:04/2023.

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