Montelukast Sun

Package leaflet: Information for the patient

Montelukast SUN 10 mg film-coated tablets

montelukast
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist, see section 4.

Contents of this leaflet

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

1. What Montelukast SUN is and what it is used for

Montelukast SUN is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause the narrowing and swelling of the airways in the lungs, as well as allergy symptoms. Montelukast SUN blocks leukotrienes, improves asthma symptoms, helps keep asthma under control, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast SUN for the treatment of asthma, to prevent asthma symptoms during the day and night.

• Montelukast SUN is used for the treatment of patients aged 15 years and older whose disease is not adequately controlled with their current medications and who require additional therapy.
• Montelukast SUN also helps prevent the narrowing of the airways caused by physical exercise.
• In asthmatic patients aged 15 years and older for whom Montelukast SUN is indicated for asthma, Montelukast SUN may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine the dose of Montelukast SUN you should take based on your symptoms and the severity of your asthma.
What is asthma?
Asthma is a long-term condition.
Asthma involves:

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways improves and worsens in response to various triggers.
• Increased sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exercise.
• Swelling (inflammation) of the inner 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 an allergic response often caused by airborne pollen from trees, grass, or weeds. Symptoms of seasonal allergies usually include: blocked or runny nose, itchy nose, sneezing, watery, swollen, red eyes, and itchy eyes.

2. What you should know before taking Montelukast SUN

Inform your doctor if you have had or currently have any medical problems or allergies.
Do not take Montelukast SUN

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

Warnings and precautions
Talk to your doctor before taking Montelukast SUN:

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast SUN is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor. Always carry your inhaled medicine for asthma attacks.
• It is important that you or your child take all the asthma medications prescribed by your doctor. Montelukast SUN must not be used instead of other asthma medications prescribed by your doctor.
• Any patient taking anti-asthma medications should be informed that if they develop a set of symptoms such as flu-like symptoms, tingling or numbness in the arms or legs, worsening of lung symptoms and/or skin rash, they must contact their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Patients should be aware that various neuropsychiatric events (e.g., changes in behaviour and mood) have been reported in adults, adolescents and children treated with Montelukast SUN (see section 4). If you develop these symptoms during treatment with Montelukast SUN, you must consult your doctor.

Other medicines and Montelukast SUN
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the activity of Montelukast SUN, or Montelukast SUN may affect the activity of other medicines.
Before starting Montelukast SUN, inform your doctor if you are taking any of the following medicines:

• phenobarbital (used to treat epilepsy).
• phenytoin (used to treat epilepsy).
• rifampicin (used to treat tuberculosis and other infections).
• gemfibrozil (used to treat high levels of lipids in the blood).

Montelukast SUN with food and drink
Montelukast SUN 10 mg can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast SUN. Your doctor will assess whether you can take Montelukast SUN during this time.
Breastfeeding
It is not known whether Montelukast SUN is excreted in breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast SUN.
Driving and using machines
No effects on your ability to drive vehicles or operate machinery are expected.
However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and somnolence), which have been reported with Montelukast SUN, may affect the ability of some patients to drive or operate machinery.
Montelukast SUN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Montelukast SUN

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Take only one Montelukast SUN tablet once daily as prescribed by your doctor.
• You should continue taking it even when you have no symptoms or during an acute asthma attack.

For adults and adolescents from 15 years of age
One 10 mg tablet to be taken every evening. Montelukast SUN 10 mg may be taken with or without food.
If you are taking Montelukast SUN, be careful not to take other medicines containing the same active substance, montelukast.
This medicine is for oral use.
You may take Montelukast 10 mg with or without food.

If you take more Montelukast SUN than you should
Contact your doctor immediately. In most reported overdose cases, no adverse effects were observed.
The most frequently reported symptoms in overdose cases in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Montelukast SUN
Try to take Montelukast SUN as prescribed. However, if you miss a dose, take one tablet once daily at your usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking Montelukast SUN
Montelukast SUN will only work for asthma if you continue taking it.
It is important to keep taking Montelukast SUN for as long as your doctor prescribes it.
It will help you keep your asthma under control.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast SUN can cause side effects, although not everyone gets them.
In clinical studies with Montelukast 10 mg film-coated tablets, the most common side effects
(occurring in 1 out of 10 people), considered related to Montelukast, were:

• abdominal pain
• headache

These were usually mild and occurred more frequently in patients treated with Montelukast than in those receiving placebo (a pill containing no active medicine).

Serious side effects
Contact your doctor immediately if you experience any of the following side effects. They may be serious and may require urgent medical treatment.

Uncommon: the following side effects may affect up to 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: the following side effects may affect up to 1 in 1,000 people

• increased tendency to bleed
• tremor
• palpitations

Very rare: the following side effects may affect up to 1 in 10,000 people

• a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count in the blood
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported since the medicine has been marketed

Very common: the following side effects may affect more than 1 in 10 people

• upper respiratory tract infection

Common: the following side effects may affect up to 1 in 10 people

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

Uncommon: the following side effects may affect up to 1 in 100 people

• changes in behaviour and mood: abnormal dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, pruritus, urticaria
• joint or muscle pain, muscle cramps
• enuresis in children
• weakness/tiredness, malaise, swelling

Rare: the following side effects may affect up to 1 in 1,000 people

• behaviour and mood-related changes: attention disorders, memory disorders, uncontrolled muscle movements

Very rare: the following side effects may affect up to 1 in 10,000 people

• painful red nodules under the skin, most frequently on the shins (erythema nodosum)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Montelukast SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Montelukast SUN contains

• The active substance is montelukast. Each tablet contains montelukast sodium, equivalent to 10 mg of montelukast.
• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate. Coating: Opadry Yellow 03B 52874 (hypromellose, titanium dioxide, macrogol, yellow iron oxide, red iron oxide).

Description of the appearance of Montelukast SUN and contents of the pack
The 10 mg tablets of Montelukast SUN are beige to light yellow in colour, square-shaped with rounded edges, film-coated, marked with "M10" on one side and smooth on the other.
Blister packs containing 14, 28, 30, 50, 56, or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands

Legal representative in Italy:
Sun Pharma Italia Srl - Viale Giulio Richard, 1 - 20143 Milano

Manufacturers responsible for batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Str.
400 632 – Cluj Napoca - Romania

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