Singulair 4

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Singulair 4(Singulair Mini 4 mg)

4 mg, chewable tablets

Montelukast
Singulair 4 and Singulair Mini 4 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before giving this medicine to a child, as it contains important information.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the child experiences any side effects, including any side effects not listed in this leaflet, you should tell the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Singulair 4 and what is it used for

What is Singulair 4

Singulair 4 is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.

How Singulair 4 works

Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Singulair 4 relieves asthma symptoms and helps control asthma.

When to use Singulair 4

The doctor has prescribed Singulair 4 for the treatment of asthma in a child to prevent asthma symptoms from occurring during the day and at night.

• Singulair 4 is used to treat patients aged 2 to 5 years who have not achieved adequate asthma control with their current medications and require additional medication.
• Singulair 4 may also be used instead of inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Singulair 4 also helps prevent exercise-induced bronchospasm in patients aged 2 years and older.

The doctor will determine how to use Singulair 4 based on the child's symptoms and the severity of their 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;
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, pollen, cold air, or physical exertion;
• inflammation (inflammation) of the lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of pressure in the chest.

2. Important information before giving Singulair 4 to a child

You should inform the doctor about any current or past illnesses and allergies in the child.

When not to give Singulair 4 to a child

• if the child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to give Singulair 4 to a child, you should discuss this with a doctor or pharmacist.

• If the child's asthma symptoms worsen or if they have difficulty breathing, you should immediately consult a doctor.
• Orally administered Singulair 4 is not intended for the treatment of acute asthma attacks. If such an attack occurs, you should follow the doctor's instructions. You should always have a rescue inhaler with you in case of an asthma attack in the child.
• It is essential that the child takes all asthma medications prescribed by the doctor. Singulair 4 should not be used instead of other asthma medications prescribed by the doctor.
• You should remember that if the child taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and (or) rash, you should consult a doctor.
• The child should not be given acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or 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 the patient experiences such symptoms while taking montelukast, they should consult a doctor.

During treatment with montelukast, you should consult a doctor if such symptoms occur.

Children and adolescents

This medicine should not be used in children under 2 years of age.
For children and adolescents under 18 years of age, other forms of this medicine are available, tailored to the patient's age.

Singulair 4 and other medicines

You should 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 4 or Singulair 4 may affect the action of other medicines taken by the child.
Before starting to give Singulair 4, you should inform the doctor if the 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).

Singulair 4 with food and drink

Singulair 4 chewable tablets 4 mg should not be taken with food; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

This section does not apply to Singulair 4 chewable tablets 4 mg, as this medicine is intended for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Singulair 4 chewable tablets 4 mg, as this medicine is intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance - montelukast.
You should not expect Singulair 4 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), which have been reported during treatment with Singulair 4, may affect the ability to drive and use machines.

Singulair 4 chewable tablets 4 mg contain aspartame, sodium, and benzyl alcohol

The medicine contains 1.2 mg of aspartame in each 4 mg chewable tablet, which corresponds to 0.674 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful to a child with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
The medicine contains up to 0.36 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
In the case of children with liver or kidney disease, you should consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to use Singulair 4

This medicine should always be used as directed by a doctor or pharmacist. If you have any doubts, you should consult the child's doctor or pharmacist.

• This medicine should be given to the child under adult supervision. For children who have problems taking the chewable tablet, a granule formulation is available.
• The child should be given only one Singulair 4 chewable tablet per day, as directed by the doctor.
• The medicine should be given even if the child does not have asthma symptoms, as well as in the event of an acute asthma attack.

Use in children aged 2 to 5 years

The recommended dose is one 4 mg chewable tablet per day, in the evening.
You should ensure that the child taking Singulair 4 does not take other medicines that contain the same active substance, montelukast.
This medicine is intended for oral use.
The tablet should be chewed before swallowing.
Singulair 4 chewable tablets 4 mg should not be taken with food; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Overdose of Singulair 4

You should immediately consult a doctor.
In most cases of overdose, no side effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Singulair 4

Singulair 4 should be given as directed by the doctor. However, if the child misses a dose, you should return to the usual dosing schedule - one chewable tablet per day.
You should not take a double dose to make up for a missed dose.

Stopping Singulair 4 treatment

Singulair 4 is effective in treating asthma in a child only if it is used regularly.
It is essential to continue using Singulair 4 in the child as long as the doctor has prescribed. This will help keep the child's asthma under control.
If you have any further doubts about using this medicine in the child, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During clinical trials with Singulair 4 chewable tablets 4 mg, the most commonly reported side effects (which may occur in less than 1 in 10 people) that were considered to be related to Singulair 4 were:

• abdominal pain
• excessive thirst. Additionally, in clinical trials with Singulair 10 mg film-coated tablets and 5 mg chewable tablets, the following were reported:
• headache. These symptoms were usually mild and occurred more frequently in patients taking Singulair than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

You should immediately consult a doctorif the child experiences any of the following side effects, which may be severe and 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 or hostile behavior, depression
• seizures.

Rare: may occur in less than 1 in 1000 people

• increased tendency to bleeding
• 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 of 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
• hepatitis.

Other side effects reported after the medicine was placed on the market

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 or numbness
• nasal bleeding
• 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 commonly on the shins (erythema nodosum)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering.

Reporting side effects

If the child experiences any side effects, including any side effects not listed in this leaflet, you should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Singulair 4

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The first two digits indicate the month, the last four digits indicate the year. The expiry date indicates the last day of the specified month.
• Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Singulair 4 contains

• The active substance of the medicine is montelukast. Each chewable tablet contains 4 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, hydroxypropylcellulose (E 463), red iron oxide (E 172), sodium croscarmellose, cherry flavor containing benzyl alcohol (E 1519), aspartame (E 951), and magnesium stearate.

What Singulair 4 looks like and what the pack contains

Singulair 4 chewable tablets 4 mg are pink, oval, biconvex tablets with the inscription SINGULAIR on one side and the inscription MSD 711 on the other side.
Blisters in packs of 14 or 28 tablets in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands

Manufacturer:

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:14/190/01-C

Parallel import authorization number: 158/23

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, Spain, Sweden
Singulair

Date of leaflet approval: 09.08.2023

[Information about the trademark]