Singulair 10

Package Leaflet: Information for the User

Singulair 10, 10 mg, Film-Coated 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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, which blocks the action of substances called leukotrienes.

How Singulair 10 works

Leukotrienes cause the airways to narrow and swell, 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

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

• Singulair 10 is used in the treatment of adult and adolescent patients 15 years and older who have not achieved adequate control of asthma with their current medications and require additional treatment.
• Singulair 10 also helps prevent narrowing of the airways caused by exercise.
• In patients with asthma, Singulair 10 may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to take Singulair 10, 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, pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways. Asthma symptoms 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 that occur frequently due to airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies may include: stuffy nose, runny nose; sneezing; tearing, swelling, redness, and itching of the eyes.

2. Important information before taking Singulair 10

Inform your doctor about any current or past illnesses and allergies.

When not to take Singulair 10

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

Warnings and precautions

Before starting treatment with Singulair 10, discuss it with your doctor or pharmacist.

• If your asthma symptoms worsen or you experience breathing difficulties, seek medical attention immediately.
• Singulair 10 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 to take all asthma medications prescribed by your doctor. Do not take Singulair 10 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 consult your doctor.
• Do 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 treated with montelukast (see section 4). If you experience such symptoms while taking montelukast, consult your doctor.

If you experience any of these symptoms while taking montelukast, consult your doctor.

Children and adolescents

Do not give this medicine to 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

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 10 or Singulair 10 may affect the action of other medicines you are taking. Before starting treatment with Singulair 10, 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 film-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 baby, ask your doctor or pharmacist for advice 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, consult your doctor before taking Singulair 10.

Driving and using machines

Singulair 10 is not expected 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 10, may affect your ability to drive or use machines.

Singulair 10, 10 mg, film-coated tablets contain lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Singulair 10

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 10 tablet once daily, as advised by your doctor.
• Take the medicine even when you do not have asthma symptoms, and in case of an acute asthma attack.

Use in adults and adolescents 15 years and older

The recommended dose is one 10 mg film-coated tablet once daily, in the evening. Ensure that the patient taking Singulair 10 does not take other medicines containing the same active substance, montelukast. This medicine is for oral use. Singulair 10 can be taken with or without food.

Taking a higher dose of Singulair 10 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 common symptoms observed were: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Missing a dose of Singulair 10

Take Singulair 10 as advised by your doctor. However, if you miss a dose, return to your normal dosing schedule - one tablet once daily. Do 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 essential 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 questions about taking this medicine, ask 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 film-coated tablets, the most common side effects (which may occur in less than 1 in 10 people) 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

Contact your doctor 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 1000 people

• increased tendency to bleed
• tremor
• 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 (inflammation) of the lungs
• severe skin reactions (erythema multiforme), which may occur without prior symptoms
• liver inflammation

Other side effects reported after marketing

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 1000 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 often 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, please inform 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 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 10 contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast as montelukast sodium.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate (89.3 mg), croscarmellose sodium, hydroxypropyl cellulose (E 463), and magnesium stearate. The coating contains: hypromellose, hydroxypropyl cellulose (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, 10 mg film-coated tablets are beige, square-shaped with rounded edges, film-coated tablets with the inscription SINGULAIR on one side and MSD 117 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: [email protected]

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