SINGULAIR 10 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER
2. Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
3. Singulair 10 (Singulair)
4. 10 mg, coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Singulair 10 and what is it used for
   1. What is Singulair 10
   2. How Singulair 10 works
   3. When to use Singulair 10
   4. What is asthma?
   5. What are seasonal allergies?
6. Important information before taking Singulair 10
   1. When not to take Singulair 10
   2. Warnings and precautions
   3. Children and adolescents
   4. Singulair 10 and other medicines
   5. Singulair 10 with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Singulair 10, 10 mg, in the form of coated tablets contains lactose and sodium
7. How to take Singulair 10
   1. Use in adults and adolescents aged 15 years and older
   2. Taking a higher dose of Singulair 10 than recommended
   3. Missing a dose of Singulair 10
   4. Stopping treatment with Singulair 10
8. Possible side effects
   1. Severe side effects
   2. Other side effects reported after the medicine was marketed
   3. Reporting side effects
9. How to store Singulair 10
10. Contents of the package and other information
    1. What Singulair 10 contains
    2. What Singulair 10 looks like and what the package contains
    3. Marketing authorization holder in the Czech Republic, the country of export
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 27/23 Date of approval of the leaflet: 28.02.2023

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Singulair 10 (Singulair)

10 mg, coated tablets

Montelukast
Singulair 10 and Singulair are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

What is Singulair 10

Singulair 10 is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.

How Singulair 10 works

Leukotrienes cause narrowing and swelling of the airways and also cause allergy symptoms. By blocking the action of leukotrienes, Singulair 10 relieves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Singulair 10

The doctor has prescribed Singulair 10 for the treatment of asthma, to prevent the occurrence of asthma symptoms during the day and at night.

• Singulair 10 is used in the treatment of adult patients and adolescents aged 15 years and older, in whom adequate control of asthma has not been achieved with the medications used so far, and additional medications are necessary.
• Singulair 10 also helps prevent bronchospasm caused by physical exertion.
• In patients with bronchial asthma, in whom Singulair 10 is used to treat asthma, Singulair 10 may also relieve symptoms of seasonal allergic rhinitis.

The doctor will determine how to take Singulair 10, 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.
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, plant 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.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions of the body, often caused by airborne tree, grass, and weed pollen. Typical symptoms of seasonal allergies may include: feeling of nasal congestion, runny nose; itching of the nose; sneezing; tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Singulair 10

You should inform your doctor about any current or past illnesses and allergies.

When not to take Singulair 10

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Singulair 10.

• In case of worsening asthma symptoms or breathing difficulties, you should immediately consult your doctor.
• Orally taken Singulair 10 is not intended for the treatment of acute asthma attacks. If such an attack occurs, you should follow your doctor's instructions. You should always carry a rescue inhaler with you in case of an asthma attack.
• It is important that you take all asthma medications prescribed by your doctor. You should not take Singulair 10 instead of other asthma medications prescribed by your doctor.
• You should remember that if you are taking asthma medications and experience symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening respiratory symptoms, and (or) rash, you should consult your doctor.
• You should not take aspirin or non-steroidal anti-inflammatory drugs (also called NSAIDs) if they worsen your asthma symptoms.

You should inform the patient that in adults, adolescents, and children treated with Singulair 10, various neuropsychiatric events (such as changes in behavior and mood) have occurred (see section 4). If the patient experiences such symptoms while taking Singulair 10, they should consult their doctor.

Children and adolescents

This medicine should not be used in children under 15 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 10 and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. Some medicines may affect the action of Singulair 10 or Singulair 10 may affect the action of other medicines you are taking. Before taking Singulair 10, you should inform 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)
• gemfibrozil (used to treat high lipid levels in the blood).

Singulair 10 with food and drink

Singulair 10, 10 mg coated tablets, can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking Singulair 10. Pregnancy Your doctor will assess whether you can take Singulair 10 during this period. Breastfeeding It is not known whether Singulair 10 passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Singulair 10.

Driving and using machines

You should not expect Singulair 10 to affect your ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness), which have been reported during treatment with Singulair 10, may affect your ability to drive or use machines.

Singulair 10, 10 mg, in the form of coated tablets contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Singulair 10

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

• You should take only one Singulair 10 tablet once a day, as directed by your doctor.
• The medicine should be taken even when you do not have asthma symptoms, as well as in the event of 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. You should ensure that the patient taking Singulair 10 does not take other medicines that contain the same active substance, montelukast. This medicine is intended for oral use. Singulair 10 can be taken with or without food.

Taking a higher dose of Singulair 10 than recommended

You should immediately consult your doctor. 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 10

Singulair 10 should be taken as directed by your doctor. However, if you miss a dose, you should return to your usual dosing schedule - one tablet once daily. You should not take a double dose to make up for the missed dose.

Stopping treatment with 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 your doctor has prescribed. This will help keep your asthma under control. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Singulair 10 can cause side effects, although not everybody gets them. During clinical trials with Singulair 10, 10 mg coated tablets, the most commonly reported side effects (which may occur in less than 1 in 10 people) that were considered to be related to Singulair 10 were:

• abdominal pain
• headache These symptoms were usually mild and occurred more frequently in patients taking Singulair 10 than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

You should immediately consult your doctorif you 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 1,000 people):

• increased tendency to bleeding
• 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 of 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
• bedwetting in children
• weakness and (or) fatigue, malaise, swelling

Rare (may occur in less than 1 in 1,000 people):

• changes in behavior and mood: attention disorders, memory disorders, uncontrolled 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 any side effects not listed in this leaflet, you should 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 10

• Store in a temperature below 30°C.
• The medicine should be stored 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 month.
• Store in the original package, protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Singulair 10 contains

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

What Singulair 10 looks like and what the package contains

Singulair 10 tablets are beige, square with rounded edges, coated tablets with the inscription SINGULAIR on one side and MSD 117 on the other. Al/Al blisters in packs of 14 or 28 tablets in a cardboard box. For more detailed information, you 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, 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

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, Marketing authorization number in the Czech Republic, the country of export: 14/351/99-C

Parallel import authorization number: 27/23 Date of approval of the leaflet: 28.02.2023

[Information about the trademark]