Montelukast Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Aurovitas 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Montelukast Aurovitas

3. How to take Montelukast Aurovitas

4. Possible side effects

5. How to store Montelukast Aurovitas

6. Contents of the pack and other information

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

What Montelukast Aurovitas is

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

How Montelukast Aurovitas works

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

When Montelukast Aurovitas should be used

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

• Montelukast is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom montelukast is indicated 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 triggers.
• 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: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Aurovitas

Inform your doctor of any allergies or medical conditions you currently have or have had in the past.

Do not take Montelukast Aurovitas

• 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 or pharmacist before starting to take Montelukast Aurovitas.

• If your asthma or breathing worsens, inform 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 inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Aurovitas 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 the arms or legs, worsening of pulmonary 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.

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 depending on age range.

Taking Montelukast Aurovitas with other medicines

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

Some medicines may affect how montelukast works, or montelukast may affect how other medicines work.

Before taking Montelukast, 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 levels of lipids in the blood)

Taking Montelukast Aurovitas with food and drink

Montelukast Aurovitas 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 intend to breastfeed, you should 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 adverse effects (such as dizziness and somnolence) that have been reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Aurovitas contains lactose

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

Montelukast Aurovitas contains sodium

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

3. How to take Montelukast Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You should take only one Montelukast Aurovitas tablet once daily, 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 Aurovitas, make sure you do not take any other product containing the same active substance, montelukast.

This medicine is taken orally.

You may take Montelukast Aurovitas 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 most frequently reported symptoms in cases of 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, simply resume your usual regimen 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 can only treat your asthma if you continue taking it.

It is important that you continue taking Montelukast Aurovitas 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, consult 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 more frequently in patients treated with montelukast than with placebo (a pill containing no active ingredient).

Serious side effects

Consult your doctor immediately if you notice any of the following side effects, as they may be serious and you 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 related to behaviour and mood: agitation including aggressive behaviour or hostility, depression,
• seizures.

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

• increased tendency to bleeding,
• tremor,
• palpitations.

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

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

Other side effects reported during post-marketing use of the medicine

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,
• rash,
• fever,
• elevated liver enzymes.

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

• changes related to 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,
• bedwetting (in children),
• weakness/tiredness, malaise, swelling.

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

• changes related to 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 which most commonly appear on the shins (erythema nodosum).
• changes related to behaviour and mood: obsessive-compulsive symptoms.
• stuttering.

Reporting of side effects:

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 refers to the last day of the month indicated.

Store below 25°C.

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

Use within 30 days after first opening the HDPE bottle.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Aurovitas

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

Tablet core: lactose monohydrate, microcrystalline cellulose (E 460), croscarmellose sodium, 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

Beige, square-shaped, film-coated tablets with rounded edges, marked with "X" on one side and "54" on the other side of the tablet.

Blister packs made of Polyamide / Aluminium foil / PVC - Aluminium foil

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

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

Pack sizes: 30 tablets.

Only some pack sizes may be commercially available.

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 medicinal product is authorized in the member states of the European Economic Area under the following names:

France MONTELUKAST ARROW 10 mg, comprimé pelliculé

Germany Montelukast Aurobindo 10 mg Filmtabletten

Ireland MONTELUKAST 10 mg Film-Coated Tablets

Italy Montelukast Aurobindo 10mg compresse rivestite con film

Malta Montelukast Aurobindo 10mg film-coated tablets

Netherlands Montelukast Aurobindo 10 mg, filmomhulde tabletten

Poland Montelukast Aurovitas

Spain Montelukast Aurovitas 10 mg comprimidos recubiertos con película EFG

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

Detailed 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/)