Patient Information Leaflet: Package Insert

Montelukast SUN 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, tell your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Montelukast SUN

3. How to take Montelukast SUN

4. Possible side effects

5. Storage of Montelukast SUN

6. Contents of the pack and additional information

What is Montelukast SUN

Montelukast SUN is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast SUN works

Leukotrienes produce narrowing and swelling of the airways in the lungs and can also cause allergy symptoms.

By blocking leukotrienes, Montelukast SUN improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast SUN

Your doctor has prescribed Montelukast SUN to treat asthma and prevent asthma symptoms during the day and night.

• Montelukast is used for treatment in adults and adolescents aged 15 years and older who are not adequately controlled with their medication and need additional treatment.

• Montelukast also helps prevent airway constriction caused by exercise.

• In patients with asthma for whom this medication is indicated, this medication may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on symptoms and the severity of asthma, your doctor will determine how to use this medication.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various conditions.

• airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.

• inflammation of the inner layer of the airways.

Asthma symptoms include: coughing, wheezing, and congestion 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, and weeds. Typical symptoms of seasonal allergies may include: a stuffy nose, runny nose, sneezing; itchy nose; watery, swollen, red, and itchy eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast SUN

• If you are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Montelukast.

• If your asthma or breathing worsens, inform your doctor immediately.

• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks available.

• It is essential that you or your child use all medications for asthma prescribed by your doctor. Montelukast SUN should not replace other asthma medications prescribed by your doctor.

• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.

• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Several neuropsychiatric events (e.g., behavioral and mood changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking Montelukast Sun, consult your doctor.

Children and adolescents

Do not give this medication to children under 15 years of age.

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and Montelukast SUN

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of Montelukast SUN, or Montelukast SUN may affect the functioning of other medications you are using.

Before taking Montelukast SUN, inform your doctor if you are taking the following medications:

• phenobarbital (used for epilepsy treatment)

• phenytoin (used for epilepsy treatment)

• rifampicin (used for tuberculosis and some other infections treatment)

• gemfibrozil (used for high plasma lipid levels treatment)

Taking Montelukast SUN with food and beverages

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast SUN.

Driving and operating machinery

Montelukast SUN is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast SUN contains lactose and sodium

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• You should only take one Montelukast SUN tablet once a day, as prescribed by your doctor.

• You should take it even when you do not have symptoms or when you have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily at night.

If you are taking Montelukast SUN, make sure you do not take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take montelukast 10 mg with or without food.

If you take more Montelukast SUN than you should

Seek help from your doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children with overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Montelukast SUN

Try to take Montelukast as prescribed. However, if you forget a dose, simply resume the usual regimen of one tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast SUN

Montelukast can only treat your asthma if you continue to take it. It is essential that you continue taking montelukast for the time your doctor prescribes. It will help control your asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Montelukast SUN can cause side effects, although not everyone will experience them.

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

• Abdominal pain
• Headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they may be severe and require urgent medical treatment.

Infrequent (may affect up to 1 in 100 people):

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• Behavioral and mood changes: excitement including aggressive or hostile behavior, depression
• Seizures

Rare (may affect up to 1 in 1,000 people):

• Increased risk of bleeding
• Tremors
• Palpitations

Very rare (may affect up to 1 in 10,000 people):

• A combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• Pulmonary edema
• Severe skin reactions (erythema multiforme) that may occur without warning
• Liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

Very frequent (may affect more than 1 in 10 people):

• Upper respiratory tract infection

Frequent (may affect up to 1 in 10 people):

• Diarrhea, nausea, vomiting
• Skin rash
• Fever
• Elevated liver enzymes

Infrequent (may affect up to 1 in 100 people):

• Behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• Dizziness, somnolence, tingling/numbness
• Nasal bleeding
• Dry mouth, indigestion
• Bruising, itching, urticaria
• Muscle or joint pain, muscle cramps
• Bedwetting (in children)
• Weakness/fatigue, malaise, swelling

Rare (may affect up to 1 in 1,000 people):

• Behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• Red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)
• Behavioral and mood changes: obsessive-compulsive symptoms, stuttering

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast SUN

• The active ingredient is montelukast. Each film-coated tablet contains montelukast sodium, which corresponds to 10 mg of montelukast.

• The other components are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hydroxypropyl cellulose, and magnesium stearate.

Coating: Opadry Yellow 03B 52874 (hypromellose, titanium dioxide, macrogol, yellow iron oxide, red iron oxide).

Appearance of the product and content of the packaging

The film-coated tablets of Montelukast SUN mg are rounded, beige to light yellow in color, engraved with “M10” on one side and smooth on the other side.

They are presented in packaging of 14, 28, 30, 50, 56, and 98 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for manufacturing:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

O

Terapia, S.A.

124 Fabricii Street

400 632 Cluj Napoca

Romania

Local representative:

Sun Pharma Laboratorios S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Last review date of this leaflet: March 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/