Montelukast Aurovitas 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Aurovitas 4 mg chewable 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

When Montelukast Aurovitas should be used

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

• Montelukast Aurovitas is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional therapy.
• Montelukast Aurovitas is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Aurovitas also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how montelukast should be used.

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: coughing, wheezing, and chest tightness.

2. What you need to know before starting Montelukast Aurovitas

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Aurovitas to your child

• if he or she is 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 giving montelukast to your child:

• If your child's 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 your doctor has given you for your child. Always have your child's rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast Aurovitas must not be used instead of other asthma medications prescribed by the doctor for your child.
• If your child is being treated with asthma medications, be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of respiratory symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause worsening of his or her asthma.

Children and adolescents

Do not give this medicine to children under 2 years of age.

For paediatric patients under 18 years of age, other formulations of this medicine are available depending on the age range.

Other medicines and Montelukast Aurovitas

Inform your doctor or pharmacist if your child is taking, has recently been given, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how montelukast works, or montelukast may affect how other medicines your child is taking work.

Before taking montelukast, inform your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)

Taking Montelukast Aurovitas with food, drinks and alcohol

Montelukast Aurovitas 4 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding and fertility

This section does not apply to Montelukast Aurovitas chewable tablets, as it is indicated for use in children aged between 2 and 5 years.

Driving and using machines

This section does not apply to Montelukast Aurovitas 4 mg chewable tablets, as it is indicated for use in children aged between 2 and 5 years. However, the following information is important regarding the active substance, montelukast.

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

Montelukast Aurovitas contains aspartame

This medicine may be harmful to individuals with phenylketonuria, as it contains aspartame, a source of phenylalanine.

Each 4 mg Montelukast Aurovitas chewable tablet contains aspartame equivalent to 0.674 mg of phenylalanine.

Montelukast Aurovitas contains sodium

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

3. How to take Montelukast Aurovitas

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

• This medicine should be administered to children under the supervision of an adult.
• Your child should only take one Montelukast Aurovitas tablet once a day, as prescribed by their doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet daily, taken in the evening.

If your child is taking montelukast, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is taken by mouth.

The tablets must be chewed before swallowing.

Montelukast Aurovitas 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

If your child takes more Montelukast Aurovitas than they should

Seek immediate help from your child's doctor.

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

In case of overdose or accidental ingestion, contact 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 give Montelukast Aurovitas to your child

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

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

If your child stops treatment with Montelukast Aurovitas

Montelukast Aurovitas can only treat your child's asthma if treatment is continued.

It is important that your child continues taking Montelukast Aurovitas for as long as prescribed by their doctor. It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In clinical trials with montelukast 4 mg chewable 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
• thirst

In addition, the following adverse effect was reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with 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 related to behaviour and mood: excitation 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 lung 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,
• serious skin reactions (erythema multiforme) which may occur without warning,
• inflammation of the liver (hepatitis).

Other adverse effects reported during post-marketing 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,
• bed-wetting (in children),
• weakness/fatigue, malaise, swelling.

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

• changes related to behaviour and mood: attention disturbance, memory disturbance, uncontrolled muscle movements.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

Store below 25°C.

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

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

6. Contents of the pack and other information

Composition of Montelukast Aurovitas

• The active substance is montelukast. Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose, 2% hydroxypropylcellulose (6 to 10 mPa.s), sodium croscarmellose, red iron oxide (E 172), aspartame (E 951), artificial cherry flavour (containing flavouring ingredients and modified corn starch), and magnesium stearate (E 572).

Nature of the product and contents of the pack

Chewable tablets

Pink, speckled, biconvex, oval, uncoated tablets marked with “X” on one side and “52” on the other.

Montelukast Aurovitas chewable tablets are available in PVC/polyamide/aluminum foil – aluminum foil blisters and in high-density polyethylene (HDPE) bottles with polypropylene caps containing silica gel desiccant.

Presentations

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

High-density polyethylene (HDPE) bottles: 30, 90 and 500 chewable tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 authorised in the European Economic Area (EEA) Member States under the following names:

France Montelukast Aurobindo 4 mg, chewable tablet

Germany Montelukast Aurobindo 4 mg chewable tablets

Italy Montelukast Pharma Italia 4 mg chewable tablet

Poland Montelukast Aurobindo

Spain Montelukast Aurovitas 4 mg chewable tablets EFG

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

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