Singulair Mini

Leaflet accompanying the packaging: information for the user

Singulair Mini, 4 mg, granules

Montelukast

Read the leaflet carefully before giving this medicine to a child, as it contains important information.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Singulair Mini and what is it used for
• 2. Important information before giving Singulair Mini to a child
• 3. How to use Singulair Mini
• 4. Possible side effects
• 5. How to store Singulair Mini
• 6. Contents of the pack and other information

1. What is Singulair Mini and what is it used for

What is Singulair Mini

Singulair Mini is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.

How Singulair Mini works

Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Singulair Mini relieves asthma symptoms and helps control asthma.

When to use Singulair Mini

The doctor has prescribed Singulair Mini for the treatment of asthma in a child to prevent asthma symptoms from occurring during the day and at night.

• Singulair Mini is used in the treatment of patients from 6 months to 5 years of age who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Singulair Mini may also be used instead of inhaled corticosteroids in patients from 2 to 5 years of age who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Singulair Mini also helps prevent narrowing of the airways caused by physical exertion in patients 2 years of age and older.

The doctor will determine how to use Singulair Mini based on the child's symptoms and the severity of the asthma.

What is asthma?

Asthma is a chronic disease.

In asthma, there are:

• breathing difficulties caused by narrowing of the airways, which worsens and improves in response to various factors.
• sensitivity of the airways, which react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and a feeling of tightness in the chest.

2. Important information before giving Singulair Mini to a child

Tell the doctor about any current or past illnesses and allergies in the child.

When not to give Singulair Mini to a child

Warnings and precautions

Discuss this with the doctor or pharmacist before giving Singulair Mini to a child.

• If the child's asthma symptoms worsen or if there are difficulties breathing, seek medical attention immediately.
• Singulair Mini taken orally is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always have a rescue inhaler with you in case of an asthma attack in a child.
• It is essential that the child takes all asthma medications prescribed by the doctor. Do not use Singulair Mini instead of other asthma medications prescribed by the doctor.
• Remember that if a child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and/or rash, seek medical attention.
• Do not give the child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen the child's asthma symptoms.

Various 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 such symptoms occur in a patient while taking montelukast, consult a doctor.

If the patient experiences such symptoms while taking montelukast, consult a doctor.

Children and adolescents

Do not use this medicine in children under 6 months of age.

For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Singulair Mini and other medicines

Tell the doctor or pharmacist about all medicines given to the child currently or recently, as well as any medicines that may be given to the child, including those available without a prescription.

Some medicines may affect the action of Singulair Mini, or Singulair Mini may affect the action of other medicines taken by the child.

Before starting Singulair Mini, tell the doctor if the child is taking:

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

Singulair Mini with food and drink

Singulair Mini granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This section does not apply to Singulair Mini granules 4 mg, as this medicine is intended for use in children from 6 months to 5 years of age.

Driving and using machines

This section does not apply to Singulair Mini 4 mg granules, as this medicine is intended for use in children from 6 months to 5 years of age. However, the following information is relevant to the active substance, montelukast.

Do not expect Singulair Mini to affect the ability to drive and use machines. However, individual reactions to the medicine may vary.

Some side effects (such as dizziness and drowsiness) reported during the use of Singulair Mini may affect the ability to drive and use machines.

Singulair Mini contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is essentially 'sodium-free'.

3. How to use Singulair Mini

This medicine should always be used in a child according to the doctor's or pharmacist's instructions. If in doubt, consult the child's doctor or pharmacist.

• This medicine should be given to the child under adult supervision. Singulair Mini should be given to the child once daily in the evening.
• The medicine should be given even when the child does not have asthma symptoms, as well as in the event of an acute asthma attack.

Use in children from 6 months to 5 years of age:

The recommended dose is one 4 mg Singulair Mini granule sachet taken orally once daily in the evening.

Ensure that the child taking Singulair Mini does not take any other medicines containing the same active substance, montelukast.

How to give Singulair Mini granules to a child:

This medicine is intended for oral use.

• Open the sachet immediately before use.
• Singulair Mini granules can be given:
• directly by mouth;
• OR after mixing with a spoonful of soft food (such as apple sauce, ice cream, or carrot and rice), cold or at room temperature.
• Mix the entire contents of the Singulair Mini granule sachet with a spoonful of soft food, cold or at room temperature, ensuring that the entire dose is mixed with the food. After mixing the granules with food, give the dose to the child immediately (within 15 minutes). IMPORTANT: do not store the granules mixed with food for later use.
• Singulair Mini granules are not intended to be dissolved in a liquid. However, the granules can be followed by a liquid.
• Singulair Mini granules can be taken regardless of meal times.

Accidental ingestion of a larger dose of Singulair Mini

Contact the doctor immediately.

In most cases of overdose, no side effects have been observed.

In cases of overdose in children and adults, the following symptoms have been most commonly observed: stomach pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Singulair Mini

Singulair Mini should be given according to the doctor's instructions. However, if the child misses a dose, return to the usual dosing schedule - one sachet once daily.

Do not take a double dose to make up for a missed dose.

Stopping Singulair Mini treatment

Singulair Mini is effective in treating asthma in a child only if it is used regularly.

It is essential to continue using Singulair Mini in a child as long as the doctor has prescribed. This will help keep the child's asthma under control.

If you have any further questions about using this medicine in a child, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, Singulair Mini can cause side effects, although not everybody gets them.

During clinical trials with Singulair Mini 4 mg granules, the most commonly reported side effects (which may occur in less than 1 in 10 people) considered to be related to Singulair Mini were:

• diarrhea
• hyperactivity
• asthma
• skin peeling and itching
• rash

In addition, in clinical trials with Singulair 10 mg film-coated tablets and 5 mg or 4 mg chewable tablets, the following have been reported:

• stomach pain
• headache
• excessive thirst

These symptoms usually have a mild intensity and occur more frequently in patients taking Singulair than in those taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Contact a doctor immediatelyif the child experiences any of the following severe side effects, which may require immediate medical attention.

Uncommon: may occur in less than 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing
• changes in behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

Rare: may occur in less than 1 in 1000 people

• increased tendency to bleed
• tremors
• palpitations

Very rare: may occur in less than 1 in 10,000 people

• a syndrome of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2)
• decreased platelet count
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• inflammation of the liver

Other side effects reported after the medicine was marketed

Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections

Common: may occur in less than 1 in 10 people

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels

Uncommon: may occur in less than 1 in 100 people

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling and numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• muscle or joint pain, muscle cramps
• bedwetting in children
• weakness and/or fatigue, malaise, swelling

Rare: may occur in less than 1 in 1000 people

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

Very rare: may occur in less than 1 in 10,000 people

• tender, red lumps under the skin, most often on the shins (erythema nodosum)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting side effects

If your child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Singulair Mini

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the sachet after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month stated.
• Do not store above 25°C. Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Singulair Mini contains

• The active substance is montelukast. Each sachet of granules contains 4 mg of montelukast as montelukast sodium.
• The other ingredients are: mannitol (E 421), hydroxypropylcellulose (E 463), and magnesium stearate.

What Singulair Mini looks like and contents of the pack

Singulair Mini 4 mg granules are white granules.

The pack contains 7, 20, 28, or 30 sachets.

In Poland, the following pack sizes are authorized: 7, 28, 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.

ul. Marszałkowska 126/134

00-008 Warsaw

Tel.: +48 22 105 50 01

e-mail: [email protected]

Manufacturer

Merck Sharp & Dohme B.V.

PO Box 581, Waarderweg 39

2031 BN Haarlem

Netherlands

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 the leaflet: 04/2023