Singulair 4

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Singulair 4 (Singulair Mini 4 mg)
4 mg, chewable tablets
Montelukastum
Singulair 4 and Singulair Mini 4 mg are different brand 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If your child experiences any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Singulair 4 is and what it is used for
2. What you need to know 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 daytime and nighttime asthma symptoms.

• 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 taken 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 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, meaning the airways 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 chest tightness.

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2. Important information before giving Singulair 4 to a child

You should inform the child's doctor about any medical conditions and allergies currently present or experienced in the past by 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 the doctor or pharmacist.

• If the child's asthma symptoms worsen or if the child experiences difficulty breathing, contact the doctor immediately.
• Singulair 4 taken orally is not intended for the treatment of acute asthma attacks. If such an attack occurs, follow the doctor's instructions. Always keep a reliever 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 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.

Various neuropsychiatric events (for example, changes in behaviour and mood, depression and suicidal thoughts) 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.

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 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 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
Singulair 4, 4 mg chewable tablets, should not be taken during meals; the medicine should be taken at least one hour before a meal or two 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 reactions (such as dizziness and drowsiness) reported during treatment with Singulair 4 may affect the ability to drive and operate machinery.

Singulair 4 4 mg chewable tablets 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. 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 body and cause adverse effects (so-called metabolic acidosis).

3. How to take Singulair 4

This medicine should always be taken as directed by the child's doctor or pharmacist. If in doubt,
consult the child's doctor or pharmacist.

• This medicine should be administered to the child under the supervision of an adult. For children who have difficulty taking the chewable tablet, granules are available.
• The child should be given only one Singulair 4 chewable tablet per day, as directed by the doctor.
• This 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 for oral use.
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The tablet must 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 a meal or two hours after a meal.

Taking more Singulair 4 than recommended
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 include 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 misses 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 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 there are 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 tablets 4 mg, the most commonly reported adverse reactions (may occur in less than 1 in 10 people), considered related to treatment with Singulair 4, were:

• abdominal pain
• excessive thirst

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

• headache

These symptoms were usually mild in intensity and occurred more frequently in patients receiving Singulair 4 than in patients receiving placebo (a tablet containing no active ingredient).

Serious adverse reactions
Contact a doctor immediately if your child experiences any of the following adverse reactions, which may be serious and require urgent 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 1,000 people

• increased tendency to bleed
• tremor
• palpitations

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

• a syndrome involving 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 (e.g. 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 hyperactivity
• dizziness, drowsiness, tingling 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 1,000 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, inform your doctor, pharmacist, or nurse.
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 4921301, Fax: +48 22 4921309, 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.

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• Do not use this medicine after the expiry date stated on the packaging. 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 no longer in use. This will help protect the environment.

6. Contents of the packaging 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 imprint "SINGULAIR" on one side and "MSD 711" on the other side.
Blister packs in cartons containing: 14 or 28 tablets.
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
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in the Czech Republic, country of export: 14/190/01-C
Parallel Import Licence Number: 101/24
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, Netherlands, Norway, Poland, Portugal, Romania,
Slovenia, Spain, Sweden
Singulair
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