Singulair 10

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Singulair 10 (Singulair)
10 mg, film-coated tablets
Montelukastum
Singulair 10 and Singulair are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Singulair 10 is and what it is used for
2. What you need to know before taking Singulair 10
3. How to take Singulair 10
4. Possible side effects
5. How to store Singulair 10
6. Contents of the pack and other information

1. What Singulair 10 is and what it is used for

What Singulair 10 is
Singulair 10 is a leukotriene receptor antagonist, which blocks the action of substances called leukotrienes.
How Singulair 10 works
Leukotrienes cause narrowing and swelling of the airways and also trigger allergic symptoms.
By blocking the action of leukotrienes, Singulair 10 relieves asthma symptoms, helps control asthma, and alleviates symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When Singulair 10 should be used
Your doctor has prescribed Singulair 10 for the treatment of asthma, to prevent asthma symptoms during the day and at night.

• Singulair 10 is used in the treatment of adults and adolescents aged 15 years and older whose asthma is not adequately controlled with previously used medications and who require additional therapy.
• Singulair 10 also helps prevent exercise-induced narrowing of the airways.
• In patients with bronchial asthma who are being treated with Singulair 10 for asthma, the medicine may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Singulair 10 based on the symptoms and severity of asthma present in the patient.
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.
• Increased sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways. Symptoms of asthma include coughing, wheezing, and a feeling of tightness in the chest.

What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions commonly triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. Important information before using Singulair 10

Inform your doctor about any symptoms and allergies currently present or experienced in the past.

When not to use Singulair 10

• 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 10, discuss it with your doctor or pharmacist.

• If asthma symptoms worsen or breathing becomes difficult, contact your doctor immediately.
• Singulair 10 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 in case of an asthma attack.
• It is important that the patient takes all anti-asthma medications prescribed by the doctor. Singulair 10 should not be used as a substitute for other anti-asthma medications prescribed by the doctor.
• 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 of respiratory symptoms and/or rash, contact your doctor.
• The patient should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen asthma symptoms.

Inform the patient that in adults, adolescents, and children treated with Singulair 10, various neuropsychiatric events (e.g. changes in behavior and mood) have been reported (see section 4). If such symptoms occur during treatment with Singulair 10, consult your doctor.

Children and adolescents
Do not use this medicine in children under 15 years of age.
Other dosage forms of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Singulair 10 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, and any medicines the patient plans to take.
Some medicines may affect the action of Singulair 10, or Singulair 10 may affect the action of other medicines the patient is taking.
Before starting Singulair 10, 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)
• gemfibrozil (used in the treatment of high plasma lipid levels)

Singulair 10 with food and drink
Singulair 10, 10 mg coated tablets, may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using Singulair 10.

Pregnancy
Your doctor will decide whether you can take Singulair 10 during this period.

Breastfeeding
It is not known whether Singulair 10 passes into human milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using Singulair 10.

Driving and operating machinery
Singulair 10 is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary.
Some adverse reactions (such as dizziness and drowsiness) reported during treatment with Singulair 10 may affect the ability to drive or operate machinery.

Singulair 10, 10 mg coated tablets contain lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to use Singulair 10

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

• Take only one Singulair 10 tablet once daily, as prescribed by the doctor.
• The medicine should be taken even when the patient does not have asthma symptoms, as well as during an acute asthma attack.

Use in adults and adolescents aged 15 years and older
The recommended dose is one 10 mg coated tablet once daily in the evening.
Ensure that the patient taking Singulair 10 is not also taking other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
Singulair 10 may be taken with or without food.

Taking more Singulair 10 than recommended
Contact the 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 included: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Singulair 10 is missed
Singulair 10 should be taken as directed by the doctor. However, if a dose is missed, resume the regular dosing schedule—one tablet once daily.
Do not take a double dose to make up for the missed dose.

Stopping Singulair 10
Singulair 10 is effective in treating asthma only when taken regularly.
It is important to continue taking Singulair 10 for as long as directed by the doctor.
This will help keep the patient's asthma under control.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
In clinical trials with Singulair 10 film-coated tablets, 10 mg, the most commonly reported adverse reactions (may occur in less than 1 in 10 people), considered to be related to the use of Singulair 10, were:

• abdominal pain
• headache

These symptoms were usually mild in intensity and occurred more frequently in patients taking Singulair 10 than in patients receiving placebo (a tablet containing no active medicine).

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 less 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 less than 1 in 1000 people):

• increased tendency to bleed
• tremor
• palpitations

Very rare (may occur in less than 1 in 10,000 people):

• a group of symptoms such as flu-like symptoms, sensations of pricking, tingling or numbness in the 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 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 less than 1 in 10 people):

• diarrhoea, nausea, vomiting
• rash
• fever
• increased liver enzyme levels

Uncommon (may occur in less than 1 in 100 people):

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, sensations of pricking, tingling or numbness
• 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 less than 1 in 1000 people):

• changes in behaviour 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, usually 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Singulair 10

• Store below 30°C.
• Keep the medicine out of 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 stated month.
• Store in the original packaging, protected 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. This will help protect the environment.

6. Contents of the packaging and other information

What Singulair 10 contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: microcrystalline cellulose, monohydrate lactose (89.3 mg), sodium croscarmellose, hydroxypropylcellulose (E 463), and magnesium stearate.
  Coating ingredients: hypromellose 2910/6, hydroxypropylcellulose (E 463), titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and carnauba wax.

What Singulair 10 looks like and contents of the pack
Singulair 10 tablets are beige, square, film-coated tablets with rounded edges, imprinted with "SINGULAIR" on one side and "MSD 117" on the other.
Supplied in Al/Al blisters containing 14 or 28 tablets per cardboard box.
For further 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
Schering-Plough Labo NV
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation number in the Czech Republic, country of export: 14/351/99-C
Parallel Import Licence number: 27/23