Montelukast Sun 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast SUN 10 mg film-coated tablets EFG

Read the entire 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, inform your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

What Montelukast SUN is

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

How Montelukast SUN works

Leukotrienes cause 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 symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When Montelukast SUN should be used

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

• Montelukast is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their current medication and require additional treatment.
• Montelukast also helps prevent narrowing of the airways caused by exercise.
• In those asthmatic patients for whom this medicine is indicated for asthma, this medicine may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use this medicine.

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.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: cough, wheezing, and chest tightness.

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. Symptoms of seasonal allergies typically include: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before you start taking Montelukast SUN

Inform your doctor of any allergies or medical conditions you currently have or have previously had.

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

Consult your doctor or pharmacist before starting to take Montelukast

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor. Always have your inhaled rescue medication available for asthma attacks.
• It is important that you or your child use all asthma medications 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 of lung symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

Neuropsychiatric events (e.g., behavior- and mood-related 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, you must consult your doctor.

Children and adolescents

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

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

Other medicines and Montelukast SUN

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

Some medicines may affect how Montelukast SUN works, or Montelukast SUN may affect how other medicines you are taking work.

Before taking 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 certain other infections)
• gemfibrozil (used to treat high plasma lipid levels)

Taking Montelukast SUN with food and drink

The 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast SUN.

Driving and using machines

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

Montelukast SUN contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Montelukast SUN

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• You should take only one Montelukast SUN tablet once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

The recommended dose is one 10 mg tablet taken daily in the evening.

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

This medicine is taken orally.

You may take montelukast 10 mg with or without food.

If you take more Montelukast SUN than you should

Seek immediate help from your doctor.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast SUN

Try to take Montelukast as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet daily.

Do not take a double dose to make up for missed doses.

If you stop taking Montelukast SUN

Montelukast can only treat your asthma if you continue taking it. It is important that you continue taking montelukast for as long as your doctor has prescribed it. It will help control your asthma.

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

4. Possible adverse effects

Like all medicines, Montelukast SUN may cause adverse effects, although not everyone experiences them.

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

• Abdominal pain
• Headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet containing no active ingredient).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse effects, as they may be serious and may require urgent medical treatment.

Uncommon (may affect up to 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 behaviour and mood: excitation including aggressive behaviour or hostility, depression
• Seizures

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

• Increased tendency to bleed
• Tremor
• Palpitations

Very rare (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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• Swelling (inflammation) of the lungs
• Severe skin reactions (erythema multiforme) which may occur without prior warning
• Inflammation of the liver (hepatitis)

Other adverse effects reported during the medicine's marketing period

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

• Upper respiratory tract infection

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

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

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

• Changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• Dizziness, somnolence, tingling/numbness
• Nosebleeds
• Dry mouth, indigestion
• Bruising, itching, urticaria
• Joint or muscle pain, muscle cramps
• Bed-wetting (in children)
• Weakness/fatigue, malaise, swelling

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

• Changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

• Painful red lumps under the skin, most frequently appearing on the shins (erythema nodosum)
• Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging and on the blister 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 stated month.

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

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your usual pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast SUN

• The active substance is montelukast. Each film-coated tablet contains montelukast sodium, equivalent to 10 mg of montelukast.

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

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

Appearance of the product and contents of the pack

Montelukast SUN 10 mg film-coated tablets are round, beige to light yellow in colour, marked with "M10" on one side and smooth on the other side.

They are available in packs of 14, 28, 30, 50, 56 and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Or

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

Date of the most recent revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/