Singulair 5

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Singulair 5 (Singulair Junior 5 mg)

5 mg, chewable tablets

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

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform their doctor, pharmacist, or nurse. 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 in the treatment of children and adolescents aged 6 to 14 years, in whom adequate control of asthma has not been achieved with previously used medications and additional medications are necessary.
• Singulair 5 may also be used as a substitute for inhaled glucocorticosteroids in patients aged 6 to 14 years who have not recently taken oral glucocorticosteroids for the treatment of asthma and who are unable to use inhaled glucocorticosteroids.
• Singulair 5 also helps prevent bronchospasm 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.
• hypersensitivity of the airways, which react to many factors, such as cigarette smoke, pollen, cold air, or physical exertion.
• inflammation (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

The patient should inform their 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 treatment with Singulair 5, the patient should discuss it with their doctor or pharmacist.

• In case of worsening asthma symptoms or breathing difficulties, the patient should immediately consult their doctor.
• Orally administered Singulair 5 is not intended for the treatment of acute asthma attacks. If such an attack occurs, the patient should follow their doctor's instructions. The patient should always carry a rescue inhaler with them in case of an asthma attack.
• It is essential for the patient to take all asthma medications prescribed by their doctor. Singulair 5 should not be used as a substitute for other asthma medications prescribed by the doctor.
• The patient should be aware that if they are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness in 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 their 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 the patient experiences such symptoms while taking montelukast, they should consult their doctor.

While taking montelukast, the patient should consult their doctor if they experience any such symptoms.

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, tailored to the patient's age.

Singulair 5 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 treatment with Singulair 5, the patient should inform their doctor if they are 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 with food; the medicine should be taken at least 1 hour before 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

It is not expected that Singulair 5 will affect the ability to drive or use machines. However, individual reactions to the medicine may vary.
Some side effects (such as dizziness and drowsiness) that have been reported with Singulair 5 may affect the ability to drive or use machines.

Singulair 5 in the form of chewable tablets 5 mg contains aspartame (E 951), sodium, and benzyl alcohol (E 1519)

The medicine contains 1.5 mg of aspartame per 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 (such as 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 (such as metabolic acidosis).

3. How to take Singulair 5

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

• The patient should take only one Singulair 5 chewable tablet per day, as directed by the 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 per day, in the evening.
The patient should ensure that they are not taking any 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 with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Taking a higher dose of Singulair 5 than recommended

The patient should immediately consult their doctor.
In most cases of overdose, no side 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.

Missing a dose of Singulair 5

Singulair 5 should be taken as directed by the doctor. However, if the patient forgets to take a dose, they should return to their usual dosing schedule - one chewable tablet per day.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with 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 has prescribed.
This will help keep the patient's asthma under control.
In case of any further doubts about taking this medicine, the patient should consult their 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) considered to be related to Singulair 5 was:

• headache In addition, 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

The patient should immediately consult their doctorif they 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: agitation, 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 in 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 marketed

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
• nosebleeds
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, State Institute for Drug Control: Šrobárova 48, 100 41 Prague 10, Czech Republic, Phone: +420 272 185 111, Fax: +420 272 185 112, Website: https://www.sukl.cz.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Singulair 5

• Store in a temperature below 30°C, 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 expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.

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.
For more detailed information, the patient should contact 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 14/350/99-C

Parallel import authorization number: 106/24

Date of approval of the leaflet: 13.03.2024

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