Montelukast Aurovitas 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Aurovitas 5 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, 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 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 they are adverse 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 asthma and to prevent asthma symptoms during the day and night.

• Montelukast Aurovitas is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Aurovitas is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Aurovitas also helps prevent exercise-induced narrowing of the airways.

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

What asthma is

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 to take Montelukast Aurovitas

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

Do not take Montelukast Aurovitas

• If you or your child 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 giving montelukast to your child:

• If your asthma or your child's 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 to you by your doctor for yourself or your child. Always keep your inhaled rescue medication for asthma attacks on hand.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Aurovitas must not be used instead of other asthma medications prescribed by your doctor for you or your child.
• 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 pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or 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 your asthma to worsen.

Children and adolescents

Do not give this medicine to children under 6 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 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 work.

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

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used for the treatment of tuberculosis and certain other infections)

Taking Montelukast Aurovitas with food, drinks and alcohol

Montelukast Aurovitas 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding and fertility

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.

Use during pregnancy

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

Breastfeeding

It is unknown whether Montelukast Aurovitas passes into breast milk. If you are breastfeeding or plan 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) reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Aurovitas contains aspartame

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

Each 5 mg chewable tablet of Montelukast Aurovitas contains aspartame equivalent to 0.842 mg of phenylalanine.

Montelukast Aurovitas contains sodium

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

3. How to take Montelukast Aurovitas

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

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

For children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet daily, taken in the evening.

If you or your child are taking Montelukast Aurovitas, make sure that neither your child nor you take any other medicine containing the same active substance, montelukast.

This medicine is taken orally.

The tablets must be chewed before swallowing.

Montelukast Aurovitas 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

If you or your child take more Montelukast Aurovitas than you should

Seek medical help immediately.

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, drowsiness, 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 or your child forget to take Montelukast Aurovitas or forget to give it to your child

Try to take Montelukast Aurovitas as prescribed. However, if you or your child miss a dose, simply resume the usual regimen of one tablet once daily.

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

If you or your child stop taking Montelukast Aurovitas

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

It is important that you continue taking Montelukast Aurovitas for as long as your doctor has prescribed it. It will help control your asthma or 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 5 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:

• headache

In addition, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets:

• abdominal pain

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

Serious adverse effects

Contact 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: agitation 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

• combination of symptoms such as flu-like illness, tingling or numbness in 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,
• severe skin reactions (erythema multiforme) which may occur without warning,
• inflammation of the liver (hepatitis).

Other adverse effects reported during the post-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 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 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Aurovitas

Keep this medicine out of 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 refers to the last day of the month indicated.

Store below 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines 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 5 mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose, 2% hydroxypropylcellulose (6 to 10 mPa.s), sodium croscarmellose, iron oxide red (E 172), aspartame (E 951), artificial cherry flavor (containing flavoring agents and modified corn starch), and magnesium stearate (E 572).

Appearance of the product and contents of the pack

Chewable tablets

Pink, speckled, biconvex, round uncoated tablets (9.5 mm in diameter), marked with “X” on one side and “53” on the other.

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

Pack sizes

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 authorized in the European Economic Area member states under the following names:

France Montelukast Aurobindo 5 mg, chewable tablets

Germany Montelukast Aurobindo 5 mg Kautabletten

Ireland MONTELUKAST Paediatric 5 mg Chewable Tablets

Italy Montelukast Aurobindo Pharma Italia 5 mg Compressa masticabile

Malta Montelukast Aurobindo 5 mg Chewable Tablets

Netherlands Montelukast Aurobindo 5 mg, kauwtabletten

Poland Montelukast Aurobindo

Spain Montelukast Aurovitas 5 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 Health Products (AEMPS) (http://www.aemps.gob.es/)