Singulair 5 mg
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Singulair 5 (Singulair Junior 5 mg)
5 mg, chewable tablets
Montelukastum
Singulair 5 and Singulair Junior 5 mg are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents
- What Singulair 5 is and what it is used for
- Important information before taking Singulair 5
- How to take Singulair 5
- Possible side effects
- How to store Singulair 5
- 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 to use Singulair 5
Your doctor has prescribed Singulair 5 for the treatment of asthma, to prevent asthma symptoms during the day and at night.
- 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 as an alternative to 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 airway narrowing caused by physical exercise.
Your doctor will determine how to use Singulair 5 based on the patient's symptoms and the 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 triggers.
- Airway sensitivity, which react 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 chest tightness.
2. Important information before using Singulair 5
You should inform your doctor about any medical conditions and allergies currently present or experienced in the past by the patient.
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 treatment with Singulair 5, discuss it with your doctor or pharmacist.
- If asthma symptoms worsen or breathing difficulties occur, contact your doctor 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 reliever inhaler available for immediate use in case of an asthma attack.
- It is important that the patient takes all anti-asthma medications prescribed by the doctor. Singulair 5 should not be used as a substitute for other anti-asthma medications prescribed by the doctor.
- Remember that if the 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 (NSAIDs) if they worsen asthma symptoms.
Neuropsychiatric events (for example, changes in behaviour and mood, depression and suicidal
behaviour) have been reported in patients of all ages treated with montelukast (see section 4). If
such symptoms occur in the patient during treatment with montelukast, consult a 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 with 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 over-the-counter medicines.
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 treatment with Singulair 5, inform your doctor if the patient is taking any of the following medicines:
- phenobarbital (used in the treatment of epilepsy)
- phenytoin (used in the treatment of epilepsy)
- rifampicin (used in the treatment of tuberculosis and certain other infections).
Singulair 5 with food and drink
Singulair 5, 5 mg chewable tablets, should not be taken during meals. The medicine should be taken at least one hour before a meal 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 baby, she should consult her doctor or pharmacist before using Singulair 5.
Pregnancy
Your doctor will decide whether the patient can 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 doctor before using 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 (E 951), sodium and benzyl alcohol (E 1519)
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 improper excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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 using the 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 using the 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 as directed by a doctor or pharmacist. If in doubt,
consult a 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 taking other medicines containing the same active substance, montelukast.
This medicine is for oral use.
The tablet must be chewed before swallowing.
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.
Taking more Singulair 5 than prescribed
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 were: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.
If you forget to take Singulair 5
Singulair 5 should be taken as directed 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 adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During clinical trials with Singulair 5 chewable tablets containing 5 mg, the most commonly reported adverse reaction (which may occur in fewer than 1 in 10 people), considered related to the use of Singulair 5, was:
- headache
Additionally, in clinical trials using Singulair 10 mg coated tablets, the following were reported:
- abdominal pain
These symptoms were usually mild in severity and occurred more frequently in patients taking Singulair than in patients receiving placebo (a tablet containing no active ingredient).
Serious adverse reactions
Contact your doctor immediately if any of the following adverse reactions occur, as they may be serious and the patient 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 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, sensations of pricking, tingling or numbness in hands and feet, worsening respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and attempts
- swelling (inflammation) of the lungs
- severe skin reactions (erythema multiforme), which may occur without prior warning symptoms
- hepatitis (inflammation of the liver)
Other adverse reactions 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 enzyme levels
Uncommon: may occur in fewer than 1 in 100 people
- changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, restlessness, akathisia (motor restlessness)
- dizziness, drowsiness, sensations of pricking, tingling or numbness
- nosebleeds
- dry mouth, dyspepsia
- bruising, itching, urticaria
- muscle or joint pain, muscle cramps
- nocturnal enuresis (bedwetting) in children
- weakness and (or) fatigue, malaise, oedema
Rare: may occur in fewer than 1 in 1,000 people
- changes in behaviour and mood: attention disorders, memory impairment, uncontrolled muscle movements
Very rare: may occur in fewer than 1 in 10,000 people
- tender, red nodules under the skin, most commonly appearing on the shins (erythema nodosum)
- changes in behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can 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 adverse reactions helps provide more information on the safety of this medicine.
5. How to store Singulair 5
- Store below 30°C, in the original packaging to protect from light and moisture.
- Keep the medicine out of the 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 stated month.
- Medicines must 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), iron oxide red (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, embossed with "SINGULAIR" on one side and "MSD 275" on the other.
Blister packs containing 14 or 28 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in the Czech Republic, country of export: 14/350/99-C
Parallel Import Licence Number: 106/24