Singulair 5

Package Leaflet: Information for the User

Singulair 5, 5 mg, Chewable Tablets

Montelukast

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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, which blocks the action of substances called leukotrienes.

How Singulair 5 works

Leukotrienes cause the airways to narrow and become inflamed. By blocking the action of leukotrienes, Singulair 5 relieves asthma symptoms and helps control asthma.

When to use Singulair 5

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

• Singulair 5 is used in the treatment of children and adolescents aged 6 to 14 years, who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Singulair 5 may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years, who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Singulair 5 also helps prevent narrowing of the airways caused by physical exercise.

Your doctor will determine how to take Singulair 5, depending on the symptoms and severity of 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, plant pollen, cold air, or physical exercise.
• inflammation (swelling) of the lining of the airways. Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.

2. Important information before taking Singulair 5

Tell your doctor about any illnesses and allergies you have now or have had in the past.

When not to take Singulair 5

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

Warnings and precautions

Before taking Singulair 5, discuss it with your doctor or pharmacist.

• If your asthma symptoms worsen or you have difficulty breathing, seek medical attention immediately.
• Singulair 5 taken orally is not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential that you take all asthma medications prescribed by your doctor. Do not take Singulair 5 instead of other asthma medications prescribed by your doctor.
• Remember that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness in your hands or feet, worsening respiratory symptoms, and/or rash, you should see a doctor.
• You should not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen your 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 you experience such symptoms while taking montelukast, consult your doctor.

If you experience such symptoms while taking montelukast, consult your doctor.

Children and adolescents

Do not give this medicine to 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

Some medicines may affect the action of Singulair 5 or Singulair 5 may affect the action of other medicines you are taking.

Before taking Singulair 5, tell your doctor if you are taking:

• 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

Do not take Singulair 5 chewable tablets 5 mg during meals; take the medicine at least 1 hour before meals or 2 hours after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking Singulair 5.

Pregnancy

Your doctor will assess whether you can take Singulair 5 during this period.

Breastfeeding

It is not known whether Singulair 5 passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Singulair 5.

Driving and using machines

You should not expect Singulair 5 to affect your ability to drive or use machines.

However, individual responses to the medicine may vary.

Some side effects (such as dizziness and drowsiness), which have been reported with Singulair 5, may affect your ability to drive or use machines.

Singulair 5 chewable tablets 5 mg contain 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 with phenylketonuria.

This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

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.

Pregnant or breastfeeding women 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

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

If you are not sure, ask your doctor or pharmacist.

• Take only one Singulair 5 chewable tablet per day, as directed by your doctor.
• Take the medicine even when you do not have asthma symptoms, and in case 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.

Make sure the patient taking Singulair 5 does not take any other medicines containing the same active substance, montelukast.

This medicine is for oral use.

Chew the tablet before swallowing.

Do not take Singulair 5 chewable tablets 5 mg during meals; take the medicine at least 1 hour before meals or 2 hours after meals.

Taking a higher dose of Singulair 5 than recommended

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: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missing a dose of Singulair 5

Take Singulair 5 as directed by your doctor.

However, if you miss a dose, return to your normal dosing schedule - one chewable tablet per day.

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

Stopping treatment with Singulair 5

Singulair 5 is effective in treating asthma only if taken regularly.

It is essential to continue taking Singulair 5 for as long as your doctor recommends.

This will help keep your asthma under control.

If you have any further questions about taking this medicine, ask 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) considered to be related to 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

Seek medical attention immediatelyif you experience 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 in 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 (infection) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation

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 spasms
• bedwetting in children
• weakness and/or fatigue, feeling unwell, 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 you experience any side effects, including those not listed in this leaflet, tell your 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Singulair 5

• Store in a temperature not exceeding 30°C, in the original packaging.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton 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 stated.
• 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 required.
• This will help protect the environment.

6. Contents of the pack and other information

What Singulair 5 contains

• The active substance 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 contents of the pack

Singulair 5 chewable tablets 5 mg are pink, round, biconvex tablets with the inscription SINGULAIR on one side and MSD 275 on the other.

Blisters in packs of 14, 28, or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Manufacturer/Importer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of last revision of the leaflet: 04/2023