Singulair 4

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Singulair 4 (Singulair Mini 4 mg)
4 mg, chewable tablets
Montelukastum
Singulair 4 and Singulair Mini 4 mg are different trade names for the same medicine.
Please read the entire leaflet carefully before giving this medicine to your child, as it
contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If your child experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What Singulair 4 is
Singulair 4 is a leukotriene receptor antagonist, which 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 Singulair 4 should be used
Your doctor has recommended Singulair 4 for the treatment of asthma in your child to prevent asthma symptoms during the day and at night.

• Singulair 4 is used in patients aged 2 to 5 years whose asthma is not adequately controlled with currently used medications and who require additional therapy.
• Singulair 4 may also be used instead of inhaled corticosteroids in patients aged 2 to 5 years who have not recently received oral corticosteroids for asthma treatment and who are unable to use inhaled corticosteroids.
• Singulair 4 also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Singulair 4 based on your child's symptoms and the severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various triggers;
• Airway hyperresponsiveness, in which the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion;
• Swelling (inflammation) of the mucous lining of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before giving Singulair 4 to a child

You should inform the child's doctor about any medical conditions or allergies the child currently has or has had in the past.

When not to give Singulair 4 to a child

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

Warnings and precautions

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

• If the child's asthma symptoms worsen or the child has difficulty breathing, contact the doctor immediately.
• Singulair 4 tablets for oral use are not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always keep a rescue inhaler available for immediate use in case of an asthma attack.
• It is important that the child takes all asthma medications prescribed by the doctor. Singulair 4 should not be used instead of other asthma medications prescribed for the child.
• Remember that if a child taking asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms and/or rash, you should contact the doctor.
• Do not give acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) to the child if they worsen the child's asthma symptoms.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, consult a doctor.

Children and adolescents

Do not use this medicine in children under 2 years of age.

Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Singulair 4 and other medicines

Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken, or might be given, including medicines available without a prescription.

Some medicines may affect the action of Singulair 4, or Singulair 4 may affect the action of other medicines the child is taking.

Before starting Singulair 4, inform the doctor if the child is taking any of the following medicines:

• phenobarbital (used in the treatment of epilepsy)
• phenytoin (used in the treatment of epilepsy)
• rifampicin (used in the treatment of tuberculosis and certain other infections).

Singulair 4 with food and drink

Do not take Singulair 4 chewable tablets 4 mg during a meal. The medicine should be taken at least 1 hour before 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.

Singulair 4 is not expected to affect the ability to drive or operate machinery. Nevertheless, individual responses to the medicine may vary.

Some adverse effects (such as dizziness and drowsiness) reported during treatment with Singulair 4 may affect the ability to drive and operate machinery.

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, equivalent to 0.674 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful to children with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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 children with liver or kidney disease, consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

3. How to use Singulair 4

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

• This medicine should be given to the child under the supervision of an adult. For children who have difficulty taking chewable tablets, granules are available.
• The child should be given only one Singulair 4 chewable tablet once daily, as directed by the doctor.
• The medicine should be taken even when the child does not have asthma symptoms, and also during an acute asthma attack.

Use in children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet once daily in the evening.
Ensure that the child taking Singulair 4 is not also taking other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet should be chewed before it is swallowed.
Singulair 4 4 mg chewable tablets should not be taken during meals; the medicine should be taken at least one hour before or two hours after a meal.

Accidental overdose of Singulair 4
Contact the child's doctor immediately.
In most cases of overdose, no adverse effects have been observed.
In cases of overdose in children and adults, the most commonly observed symptoms have been: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Singulair 4
Singulair 4 should be taken as directed by the doctor. However, if the child misses a dose, resume the regular dosing schedule—one chewable tablet once daily.
Do not give a double dose to make up for a missed dose.

Stopping Singulair 4 treatment
Singulair 4 is effective in treating the child's asthma only when taken regularly.
It is important to continue giving Singulair 4 to the child for as long as directed by the doctor. This will help keep the child's asthma under control.
If you have any further questions about the use of this medicine in the child, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical trials using Singulair 4 chewable and orally disintegrating tablets, 4 mg, the most frequently reported adverse reactions (which may occur in fewer than 1 in 10 people) considered to be related to the use of Singulair 4 were:

• abdominal pain
• excessive thirst.

Additionally, in clinical trials using Singulair 10 mg coated tablets and 5 mg chewable and orally disintegrating tablets, the following were reported:

• headache.

These symptoms were usually mild in severity and occurred more frequently in patients taking Singulair than in patients taking placebo (a tablet containing no active ingredient).

Severe adverse reactions
Contact a doctor immediately if the child experiences any of the following adverse reactions, which may be serious and may require immediate medical attention.
Not common: may occur in fewer 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures.

Rare: may occur in fewer than 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations.

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

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

Other adverse reactions reported after marketing of the medicine
Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections.

Common: may occur in fewer than 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels.

Not common: may occur in fewer than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, motor restlessness
• dizziness, drowsiness, tingling or numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria (hives)
• muscle or joint pain, muscle cramps
• nocturnal enuresis (bedwetting) in children
• weakness and (or) fatigue, malaise, oedema (swelling).

Rare: may occur in fewer than 1 in 1,000 people

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements.

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

• tender, red subcutaneous nodules most commonly appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of adverse reactions
If the child experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Singulair 4

• Keep this medicine out of the 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 refers to the last day of the stated month.
• Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Singulair 4 contains

• The active substance 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), iron oxide red (E 172), sodium croscarmellose, cherry flavour containing benzyl alcohol (E 1519), aspartame (E 951), and magnesium stearate.

What Singulair 4 looks like and contents of the pack
Singulair 4 mg chewable tablets are pink, oval, biconvex tablets with the inscription "SINGULAIR" on one side and "MSD 711" on the other side.
Blister packs containing 14 or 28 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in the Czech Republic, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

Manufacturer:
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 14/190/01-C
Parallel import authorisation number: 158/23

This medicinal product is authorised for marketing 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