Singulair 4

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult 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 adverse reactions, including any adverse reactions 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 the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and who require additional therapy.
• Singulair 4 may also be used instead of inhaled glucocorticosteroids in patients aged 2 to 5 years who have not recently received oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• 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 depending 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 factors.
• 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 membrane lining 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 and 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 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 oral medicine is not intended for the treatment of acute asthma attacks. If an asthma 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 medicines prescribed for the child by the doctor.
• Remember that if the 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 the child acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if these worsen the child's asthma symptoms.

Neuropsychiatric events (for example, 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 in a patient during treatment with 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 currently or recently given to the child, as well as any medicines that may be given in the future, 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 treatment with Singulair 4, inform the doctor if the child is taking any of the following medicines:

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

Singulair 4 with food and drink

Do not take Singulair 4 chewable tablets 4 mg 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 operating machinery

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 or operate machinery.

Singulair 4 chewable tablets 4 mg contain aspartame (E 951), sodium, and benzyl alcohol (E 1519)

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. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper 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, contact a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Singulair 4

This medicine should always be taken exactly as directed by the child's doctor or pharmacist. If in doubt,
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, a granule formulation is 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 has no 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 for oral use.
The tablet should be chewed before swallowing.
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.

Taking more Singulair 4 than recommended
Contact the 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 were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

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

Stopping Singulair 4
Singulair 4 is effective in treating asthma in children 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 there are any further doubts about using this medicine in the child, consult the doctor or pharmacist.

4. Possible adverse reactions

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

• abdominal pain
• excessive thirst

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

• headache

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

Serious adverse reactions
You should contact a doctor immediately if your child experiences any of the following adverse reactions, which may be serious and your child 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in less than 1 in 1000 people

• increased tendency to bleed
• tremor
• palpitations

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

• a group 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 suicide 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 less than 1 in 10 people

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

Uncommon: may occur in less than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, psychomotor agitation
• dizziness, somnolence, paraesthesia and numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• nocturnal enuresis in children
• weakness and (or) fatigue, malaise, oedema

Rare: may occur in less than 1 in 1000 people

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

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

• tender, red nodules under the skin, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse reactions
If your child experiences any adverse reactions, including any not listed in this leaflet, tell your 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will 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-shaped, biconvex tablets with the imprint "SINGULAIR" on one side and "MSD 711" on the other side.
Blister packs containing 14 or 28 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in the Czech Republic, the country of export:
14/190/01-C
Parallel import licence number: 271/25
This medicinal product is authorised 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, The Netherlands, Norway, Poland, Portugal, Romania,
Slovenia, Spain, Sweden
Singulair