Singulair 5

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Singulair 5 (Singulair Junior)
5 mg, chewable tablets
Montelukastum
Singulair 5 and Singulair Junior are different brand names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to 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. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

What Singulair 5 is
Singulair 5 is a leukotriene receptor antagonist, which 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 relieves asthma symptoms and helps control asthma.
When Singulair 5 should be used
Your doctor has prescribed Singulair 5 for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

• Singulair 5 is used in the treatment of children and adolescents aged 6 to 14 years whose asthma is not adequately controlled with currently used medications and who require additional therapy.
• Singulair 5 may also be used instead of inhaled glucocorticosteroids in patients aged 6 to 14 years who have not recently taken oral glucocorticosteroids for asthma treatment and who are unable to use inhaled glucocorticosteroids.
• Singulair 5 also helps prevent exercise-induced narrowing of the airways.

Your doctor will determine how to take Singulair 5 based on the patient's symptoms and 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 factors;
• Airway hyperresponsiveness, in which the airways react to many triggers such as cigarette smoke, pollen, cold air, or physical exertion;
• Swelling (inflammation) of the mucous membrane lining the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before taking Singulair 5

Inform your physician about any medical conditions and allergies currently present or experienced in the past.

When not to use 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 Singulair 5, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing becomes difficult, contact your physician immediately.
• Singulair 5 tablets for oral use are not intended for the treatment of acute asthma attacks. If an attack occurs, follow your doctor's instructions. Always keep a rescue inhaler available for immediate use during an asthma attack.
• It is important that the patient continues to take all anti-asthma medications prescribed by the physician. Singulair 5 should not be used as a substitute for other anti-asthma medications prescribed by the physician.
• Be aware that if a patient taking anti-asthma medications develops symptoms such as flu-like symptoms, tingling or numbness in the hands or feet, worsening respiratory symptoms and/or rash, medical advice should be sought.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if these medications worsen asthma symptoms.

Various neuropsychiatric events (e.g. changes in behavior and mood, depression, and suicidal
ideation) have been reported in patients of all ages treated with montelukast (see section 4). If
such symptoms occur while taking montelukast, consult your doctor.
Children and adolescents
Do not use this medicine in children under 6 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 5 and other medicines
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 the patient is taking.
Before starting Singulair 5, inform your doctor if the patient is taking any of the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections).

Singulair 5 with food and drink
Singulair 5, 5 mg chewable tablets, should not be taken with food; the medicine should be taken at least one hour before or two hours after a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking Singulair 5.

Pregnancy
Your physician will assess whether the patient may take Singulair 5 during this period.

Breastfeeding
It is not known whether Singulair 5 passes into human milk. If a woman is breastfeeding or intends to breastfeed, she should consult her physician before taking Singulair 5.

Driving and operating machinery
Singulair 5 is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary.
Some adverse effects (such as dizziness and drowsiness) reported during treatment with Singulair 5 may affect the ability to drive and operate machinery.

Singulair 5 5 mg chewable tablets contain aspartame, sodium, and benzyl alcohol
The medicine contains 1.5 mg of aspartame in each 5 mg chewable tablet, equivalent 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 impaired 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 0.45 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.

Pregnant or breastfeeding women should contact their doctor before taking this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Patients with liver or kidney disease should contact their doctor before taking this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Singulair 5

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.

• Take only one Singulair 5 chewable tablet once daily, as directed by your doctor.
• This medicine should be taken even when the patient does not have asthma symptoms, and also during an acute asthma attack.

Use in children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet once daily in the evening.
Ensure that the patient taking Singulair 5 is not also taking other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablet must be chewed before swallowing.
Singulair 5 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least one hour before, or two hours after, a meal.

Taking more Singulair 5 than recommended
Contact your 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 have been: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If you miss a dose of Singulair 5
Singulair 5 should be taken as prescribed by your doctor. However, if a dose is missed, return to the usual dosing schedule – one chewable tablet once daily.
Do 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 important to continue taking Singulair 5 for as long as your doctor has instructed.
This will help keep the patient's asthma under control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

During clinical trials with Singulair 5 chewable tablets 5 mg, the most commonly reported side effect (which may occur in fewer than 1 in 10 people), considered related to taking Singulair 5, was:

• headache

Additionally, in clinical trials with Singulair 10 mg coated tablets, the following were reported:

• abdominal pain

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

Serious side effects
You should contact your doctor immediately if any of the following side effects occur, as they may be serious and you may require immediate medical attention.

Uncommon: may occur in fewer than 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

Rare: may occur in fewer than 1 in 1 000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: may occur in fewer than 1 in 10 000 people

• a group of symptoms such as flu-like symptoms, tingling, numbness or pins and needles in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and suicide attempts
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior warning symptoms
• hepatitis (inflammation of the liver)

Other side effects 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 fewer than 1 in 10 people

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzymes

Uncommon: may occur in fewer than 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling, numbness or pins and needles
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• nocturnal enuresis in children
• weakness and (or) fatigue, malaise, swelling

Rare: may occur in fewer than 1 in 1 000 people

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements

Very rare: may occur in fewer than 1 in 10 000 people

• tender, red lumps under the skin, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also 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 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Singulair 5

• Store below 30°C. Keep in the original packaging to protect from light and moisture.
• Keep this medicine out of the 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 refers to the last day of the stated month.
• Keep in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 flavour containing benzyl alcohol (E 1519), aspartame (E 951) and magnesium stearate.

What Singulair 5 looks like and contents of the pack
Singulair 5 mg chewable tablets are pink, round, biconvex tablets, with "SINGULAIR" embossed on one side and "MSD 275" on the other.
The tablets are supplied in blisters packed in cardboard boxes containing 14 or 28 tablets.
For further 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
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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in the Czech Republic, country of export: 14/350/99-C
Parallel Import Licence Number: 172/23