Singulair 4

Package Leaflet: Information for the User

Singulair 4, 4 mg, Chewable Tablets

Montelukast

Read the package 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 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 not listed in this leaflet, 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 take 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 the airways to narrow and swell. 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 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 control of asthma with their current medications and require additional treatment.
• 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 narrowing of the airways caused by physical exertion in patients aged 2 years and older.

The doctor will determine how to take 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. This narrowing 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.
• swelling (inflammation) of the lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of chest tightness.

2. Important information before giving Singulair 4 to a child

Tell the doctor about any current or past illnesses or 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

Discuss with the doctor or pharmacist before giving Singulair 4 to a child.

• If the child's asthma symptoms worsen or have difficulty breathing, seek medical attention immediately.
• Singulair 4 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 the child.
• It is essential that the child takes all asthma medications prescribed by the doctor. Do not use Singulair 4 instead of other asthma medications prescribed by the doctor.
• If the 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 taking montelukast (see section 4). If such symptoms occur while taking montelukast, consult a doctor.

Consult a doctor if the patient experiences any of these symptoms while taking montelukast.

Children and adolescents

Do not use this medicine in children under 2 years 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 4 and other medicines

Tell the doctor or pharmacist about all medicines given to the child currently or recently, including those obtained without a prescription.

• 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

Do not take Singulair 4 chewable tablets 4 mg during meals; take the medicine at least 1 hour before or 2 hours after meals.

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 to the active substance, montelukast.

Do not expect Singulair 4 to affect the ability to drive or use machines. However, individual responses to the medicine may vary.

Some side effects (such as dizziness and drowsiness) reported with Singulair 4 may affect the ability to drive or use machines.

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

The medicine contains 1.2 mg of aspartame per 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.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially '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, consult a doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to take Singulair 4

Always take this medicine exactly as the doctor or pharmacist has told you.

• This medicine should be given to the child under adult supervision. For children who have difficulty swallowing the chewable tablet, a granule formulation is available.
• Give the child only one Singulair 4 chewable tablet per day, as directed by the doctor.
• Give the medicine even when 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.

Ensure the child taking Singulair 4 does not take any other medicines containing the same active substance, montelukast.

This medicine is for oral use only.

Chew the tablet before swallowing.

Do not take Singulair 4 chewable tablets 4 mg during meals; take the medicine at least 1 hour before or 2 hours after meals.

Overdose of Singulair 4

Seek medical attention 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.

Missed dose of Singulair 4

Take Singulair 4 as directed by the doctor. However, if the child misses a dose, resume the usual dosing schedule – one chewable tablet per day.

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

Stopping Singulair 4

Singulair 4 is effective in treating asthma in a child only when taken regularly.

It is essential to continue taking 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 questions about using this medicine in a child, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, Singulair 4 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) considered to be related to Singulair 4 were:

• stomach pain
• excessive thirst
• headache

Severe side effects

Seek medical attention immediatelyif the child experiences any of the following severe side effects, which may 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 behavior and mood: agitation, including aggressive behavior or hostility, depression
• seizures

Rare: may occur in less than 1 in 1,000 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
• liver inflammation

Other side effects reported after marketing

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 1,000 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 not listed in this leaflet, tell the doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, 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 4

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack 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.
• Store in the original package to protect from light and moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 as 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 contents of the pack

Singulair 4 chewable tablets 4 mg are pink, oval, biconvex tablets with the inscription SINGULAIR on one side and MSD 711 on the other.

Blisters in packs of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140, or 200 tablets.

Blisters (divisible into single doses) in packs of: 49x1, 50x1, and 56x1 tablets.

In Poland, the following pack sizes are authorized: 14, 28, 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

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 last revision of the leaflet: 04/2023

Marketing authorization holder

Organon Polska Sp. z o.o.

ul. Marszałkowska 126/134

00-008 Warsaw

Tel.: +48 22 105 50 01

e-mail: organonpolska@organon.com