Singulair 5

Leaflet attached to the packaging: information for the user

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

Singulair 5(Singulair Junior)

5 mg, chewable tablets

Montelukast
Singulair 5 and Singulair Junior are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Singulair 5 and what is it used for

What is Singulair 5

Singulair 5 is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.

How Singulair 5 works

Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Singulair 5 alleviates the symptoms of asthma and helps control asthma.

When to use Singulair 5

The doctor has prescribed Singulair 5 for the treatment of asthma, to prevent the occurrence of asthma symptoms during the day and at night.

• Singulair 5 is used to treat children and adolescents aged 6 to 14 years, who have not achieved adequate control of asthma with previously used medicines and require additional medication.
• Singulair 5 may also be used as a substitute for inhaled glucocorticosteroids in patients aged 6 to 14 years, who have not recently taken glucocorticosteroids orally for the treatment of asthma and who are unable to use inhaled glucocorticosteroids.
• Singulair 5 also helps prevent bronchial narrowing caused by physical exertion.

The doctor will determine how to take Singulair 5, depending on the symptoms and severity of asthma in the patient.

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, plant pollen, cold air, or physical exertion;
• swelling (inflammation) of the lining of the airways. Asthma symptoms include: coughing, wheezing, and a feeling of pressure in the chest.

2. Important information before taking Singulair 5

You should inform your doctor about any current or past illnesses and allergies.

When not to take Singulair 5

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

Warnings and precautions

Before starting to take Singulair 5, you should discuss it with your doctor or pharmacist.

• In case of worsening asthma symptoms or breathing difficulties, you should immediately consult your doctor.
• Orally administered Singulair 5 is not intended for the treatment of acute asthma attacks. If such an attack occurs, you should follow your doctor's instructions. You should always carry a rescue inhaler with you in case of an asthma attack.
• It is essential that the patient takes all asthma medications prescribed by their doctor. Singulair 5 should not be used as a substitute for other asthma medications prescribed by the doctor.
• You should remember that if a patient taking asthma medications experiences symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and (or) rash, they should consult their doctor.
• The patient should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen 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 such symptoms occur in the patient while taking

montelukast, they should consult their doctor.

Children and adolescents

This medicine should not be used in children under 6 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 5 and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may affect the action of Singulair 5 or Singulair 5 may affect the action of other medicines taken by the patient.
Before starting to take Singulair 5, you should inform your doctor if the patient 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 5 with food and drink

Singulair 5 chewable tablets 5 mg should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking Singulair 5.
Pregnancy
The doctor will assess whether the patient can take Singulair 5 during this period.
Breastfeeding
It is not known whether Singulair 5 passes into breast milk. If a woman is breastfeeding or plans to breastfeed, she should consult her doctor before taking Singulair 5.

Driving and using machines

You should not expect Singulair 5 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 the use of Singulair 5, may affect the ability to drive and use machines.

Singulair 5 in the form of chewable tablets 5 mg contains aspartame, sodium, and benzyl alcohol

The medicine contains 1.5 mg of aspartame in each 5 mg chewable tablet, which corresponds to 0.842 mg of phenylalanine. Aspartame is a source of phenylalanine. It may be harmful to patients or children 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 0.45 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Women who are pregnant or breastfeeding should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before taking 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 take Singulair 5

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, you should consult your doctor or pharmacist.

• You should take only one Singulair 5 chewable tablet once a day, as recommended by your doctor.
• The medicine should be taken even when the patient does not experience asthma symptoms, as well as in the event of an acute asthma attack.

Use in children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet once a day, in the evening.
You should ensure that the patient taking Singulair 5 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 5 chewable tablets 5 mg should not be taken during meals; the medicine should be taken at least 1 hour before a meal or 2 hours after a meal.

Taking a higher dose of Singulair 5 than recommended

You should immediately consult your doctor.
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: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Singulair 5

Singulair 5 should be taken according to the doctor's recommendation. However, if the patient forgets to take a dose, they should return to their usual dosing schedule - one chewable tablet once a day.
You should not take a double dose to make up for a missed dose.

Stopping Singulair 5

Singulair 5 is effective in treating asthma only when taken regularly.
It is essential to continue taking Singulair 5 for as long as the doctor recommends.
This will help keep the patient's asthma under control.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Singulair 5 can cause side effects, although not everybody gets them.
During clinical trials with Singulair 5 chewable tablets 5 mg, the most commonly reported side effect (which may occur in less than 1 in 10 people), which was considered related to the use of Singulair 5, was:

• headache Additionally, in clinical trials with Singulair 10 mg film-coated tablets, the following side effects were reported:
• abdominal pain 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 your doctorif you experience 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: excitement, including aggressive or hostile behavior, depression
• seizures

Rare: may occur in less than 1 in 1000 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)
• low 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
• nocturnal enuresis 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 nodules under the skin, most commonly on the shins (erythema nodosum)
• changes in behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects will help gather more information on the safety of the medicine.

5. How to store Singulair 5

• Store in a temperature below 30°C. Store in the original packaging to protect from light and moisture.
• 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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Singulair 5 contains

• The active substance of the medicine is montelukast. Each chewable tablet contains 5 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.
• aspartame (E 951) and magnesium stearate.

What Singulair 5 looks like and what the packaging contains

Singulair 5 chewable tablets 5 mg are pink, round, biconvex tablets with the inscription SINGULAIR on one side and MSD 275 on the other side.
Blisters in packs of 14 or 28 tablets in a cardboard box.
For more detailed information, you should consult 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:14/350/99-C

Parallel import authorization number: 172/23

Date of leaflet approval: 24.08.2023

[Information about the trademark]