Singulair 10

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Singulair 10
10 mg, film-coated tablets
Montelukastum
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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 that blocks the action of substances called leukotrienes.
How Singulair 10 works
Leukotrienes cause narrowing and swelling of the airways and also trigger allergy symptoms.
By blocking the action of leukotrienes, Singulair 10 relieves asthma symptoms, helps control asthma, and also 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 daytime and nighttime asthma symptoms.

• Singulair 10 is used in the treatment of asthma in adults and adolescents 15 years of age and older who have not achieved adequate asthma control with previously used medications and who require additional therapy.
• Singulair 10 also helps prevent airway narrowing caused by physical exercise.
• In patients with asthma for whom Singulair 10 is prescribed for asthma treatment, the medicine may also relieve symptoms of seasonal allergic rhinitis.

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

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 physician about any medical conditions and allergies you currently have or have had in the past.

When not to use Singulair 10

• Do not use 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 Singulair 10, discuss this with your doctor or pharmacist.

• If asthma symptoms worsen or you experience difficulty breathing, contact your physician immediately.
• Singulair 10 tablets for oral use are not intended for the treatment of acute asthma attacks. If an asthma 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 you continue taking all asthma medications prescribed by your physician. Do not use Singulair 10 as a substitute for other asthma medications prescribed by your doctor.
• Be aware that if you experience symptoms such as flu-like illness, tingling or numbness in hands or feet, worsening respiratory symptoms, and/or skin rash while taking asthma medications, you should contact your doctor.
• Do not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen your asthma symptoms.

Various neuropsychiatric events (for example, changes in behavior and mood, depression, and suicidal tendencies) 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 15 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 10 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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 Singulair 10, inform your doctor if you are 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 lipid levels in plasma)

Singulair 10 with food and drink

Singulair 10, 10 mg film-coated tablets, may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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 you are breastfeeding or plan to breastfeed, consult your doctor before using Singulair 10.

Driving and operating machinery

Singulair 10 is not expected to affect your 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 your ability to drive or operate machinery.

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

If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free."

3. How to use Singulair 10

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.

• Take only one Singulair 10 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 adults and adolescents 15 years of age 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 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 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 included: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and increased motor activity.

If you forget to take Singulair 10
Singulair 10 should be taken as prescribed by your 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 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 experience them.

During clinical trials with Singulair 10 tablets, 10 mg, the most commonly reported side effects (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 severity and occurred more frequently in patients taking Singulair 10 than in patients taking placebo (a tablet containing no active ingredient).

Serious side effects
Contact your doctor immediately if any of the following side effects 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 1,000 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, sensation of pins and needles or numbness 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 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 less than 1 in 10 people

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

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, sensation of pins and needles or numbness
• nosebleeds
• dry mouth, dyspepsia
• bruising, itching, urticaria (hives)
• muscle or joint pain, muscle cramps
• nocturnal enuresis (bedwetting) in children
• weakness and (or) fatigue, malaise, swelling

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

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

Very rare: may occur in less 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 side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 10

• 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 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 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, lactose monohydrate (89.3 mg), sodium croscarmellose, hydroxypropylcellulose (E 463), and magnesium stearate.
  Coating ingredients: hypromellose, 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 mg tablets are beige, square-shaped, film-coated tablets with rounded edges,
imprinted with "SINGULAIR" on one side and "MSD 117" on the other.
Available in blister packs of 14 or 28 tablets.
For more detailed information, please contact the responsible party 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., Waardereweg 39, 2031 BN Haarlem, the Netherlands
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 14/351/99-C
Parallel Import Licence Number: 183/23