MONTELUKAST AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Aurovitas 10 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Montelukast Aurovitas and what is it used for
2. What you need to know before you take Montelukast Aurovitas
3. How to take Montelukast Aurovitas
4. Possible side effects

5. Storage of Montelukast Aurovitas

6. Contents of the Pack and Further Information

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

What is Montelukast Aurovitas

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

How Montelukast Aurovitas Works

Leukotrienes cause the airways in the lungs to narrow and swell, and they can also cause allergy symptoms. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to Use Montelukast Aurovitas

Your doctor has prescribed montelukast to treat asthma and 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 medication and need additional treatment.
• Montelukast also helps prevent exercise-induced narrowing of the airways.
• In patients with asthma who are indicated for montelukast for asthma, montelukast 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 Montelukast Aurovitas.

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

The symptoms of asthma include: Cough, wheezing, and chest congestion.

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; sneezing; itchy, watery, swollen, red, and painful eyes.

2. What you need to know before you take Montelukast Aurovitas

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Aurovitas

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

Warnings and Precautions

Consult your doctor or pharmacist before starting Montelukast Aurovitas.

• If your asthma or breathing worsens, tell your doctor immediately.
• Montelukast Aurovitas oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhalation medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Aurovitas should not be substituted for 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

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 the age range.

Taking Montelukast Aurovitas with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines work.

Before taking Montelukast, tell your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high blood lipid levels)

Taking Montelukast Aurovitas with Food and Drinks

Montelukast Aurovitas can 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, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether montelukast passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Aurovitas.

Driving and Using Machines

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect your ability to drive or operate machinery.

Montelukast Aurovitas Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Montelukast Aurovitas Contains Sodium

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

3. How to Take Montelukast Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You should only take one Montelukast Aurovitas tablet once daily, as prescribed by your doctor.
• It should be taken 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 in the evening.

If you are taking Montelukast Aurovitas, make sure you do not take any other product containing the same active ingredient, montelukast.

This medicine is taken orally.

Montelukast Aurovitas can be taken with or without food.

If You Take More Montelukast Aurovitas Than You Should

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

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

If You Forget to Take Montelukast Aurovitas

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

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

If You Stop Taking Montelukast Aurovitas

Montelukast Aurovitas will only treat your asthma if you continue taking it.

It is essential that you continue taking Montelukast Aurovitas for the time your doctor prescribes. It will help control your asthma.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• abdominal pain,
• headache.

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

Serious Side Effects

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

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

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing,
• mood-related changes: excitement including aggressive or hostile behavior, depression,
• seizures.

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

• increased risk of bleeding,
• 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 of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2),
• low platelet count,
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions,
• inflammation (inflammation) of the lungs,
• severe skin reactions (erythema multiforme) that can occur without warning,
• inflammation of the liver (hepatitis).

Other Side Effects Reported During the Marketing of the Medicinal Product

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

• upper respiratory tract infection.

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

• diarrhea, nausea, vomiting,
• skin rash,
• fever,
• elevated liver enzymes.

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

• mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, hives,
• joint or muscle pain, muscle cramps,
• bedwetting (in children),
• weakness/tiredness, discomfort, swelling.

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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements.

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

• painful red lumps under the skin that most frequently appear on the shins (erythema nodosum).
• mood-related changes: obsessive-compulsive symptoms.
• stuttering.

Reporting of Side Effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton/label/bottle after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

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

Use within 30 days of first opening the PEAD bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Montelukast Aurovitas

• The active ingredient is montelukast. Each tablet contains montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, hydroxypropylcellulose (E 463), magnesium stearate (E 572).

Coating: hydroxypropylcellulose (E 463), hypromellose 6cp (E 464), titanium dioxide (E 171), yellow iron oxide (E 172), carnauba wax (E 903), red iron oxide (E 172).

Appearance of the Product and Contents of the Pack

Film-Coated Tablets

Film-coated tablets of beige color, square shape with rounded edges, marked with "X" on one face and "54" on the other face of the tablet.

Blister packs of Polyamide / Aluminum foil / PVC - Aluminum foil

Package sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 tablets.

High-density polyethylene (PEAD) bottles with a polypropylene cap containing silica gel desiccant

Package sizes: 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

France MONTELUKAST ARROW 10 mg, film-coated tablet

Germany Montelukast Aurobindo 10 mg Filmtabletten

Ireland MONTELUKAST 10 mg Film-Coated Tablets

Italy Montelukast Aurobindo 10mg film-coated tablets

Malta Montelukast Aurobindo 10mg film-coated tablets

Netherlands Montelukast Aurobindo 10 mg, film-coated tablets

Poland Montelukast Aurovitas

Spain Montelukast Aurovitas 10 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet: February 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)