Montelukast Stada 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Stada 5 mg chewable tablets EFG

For children aged 6 to 14 years

Read all of this leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.

• 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 or your child only and must not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If you or your child 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 Stada is and what it is used for
2. What you need to know before taking Montelukast Stada
3. How to take Montelukast Stada
4. Possible side effects
5. How to store Montelukast Stada
6. Contents of the pack and other information

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

What is montelukast

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

How montelukast 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 should be used

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

• Montelukast 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 is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma treatment and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway narrowing caused by exercise.

Depending on the symptoms and severity of your asthma or your child's 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.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

2. What you need to know before starting to take Montelukast Stada

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 Stada

• 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

Consult your doctor or pharmacist before you or your child start taking montelukast

• If your asthma or breathing, or that of your child, 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 for you or your child. 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 should not be used instead of other asthma medications prescribed for you or your child 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 pulmonary symptoms, and/or skin rash, they must consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

Several neuropsychiatric events (for example, changes in behaviour and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you or your child develop these symptoms while taking montelukast, you should contact your doctor or your child's doctor.

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, depending on the age range.

Other medicines and Montelukast Stada

Inform your doctor or pharmacist if you or your child 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 works, or montelukast may affect how other medicines work.

Before taking montelukast, inform your doctor if you or your child are taking any of 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 Stada with food and drinks

Montelukast 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 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.

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 Stada contains aspartame (E951)

This medicine contains 6 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Montelukast Stada contains sodium

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

3. How to take Montelukast Stada

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You or your child should take only one montelukast chewable 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, make sure that neither you nor your child take any other medication containing the same active substance, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

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

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

Seek immediate medical help.

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 Poison Information Service at telephone number: 91 5620420, indicating the medication and the amount ingested.

If you or your child forget to take Montelukast Stada or forget to give it to your child

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

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

If you or your child stop taking Montelukast Stada

Montelukast can only control your asthma or that of your child if you or your child continue taking it.

It is important that you continue taking montelukast for as long as your doctor prescribes it.

It will help control your asthma or that of your child.

If you have any further 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 everyone gets them.

In clinical trials with montelukast 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• headache

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets:

• abdominal pain

These side 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 side effects

Contact your doctor immediately if you notice any of the following side effects, which may be serious and may require urgent medical treatment for you or your child.

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 in 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 side 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
• 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, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (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, most commonly appearing 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 via the Spanish Pharmacovigilance System for Human Medicines at Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Stada

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Montelukast Stada

• The active substance is montelukast (as montelukast sodium).

Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.

• The other components are: microcrystalline cellulose, mannitol, crospovidone type B, red iron oxide (E172), hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E951), talc and magnesium stearate.

Nature of the product and contents of the container

Montelukast Stada 5 mg chewable tablets are pink, round, biconvex, with "M5" engraved on one side.

Montelukast Stada is available in the following pack sizes:

Nylon/Alu/PVC-Aluminum blisters:

• Blister packs (non-calendar packs): 10, 20, 30, 50, 60, 90, 100 and 250 tablets.
• Blister packs (non-calendar packs): 7, 14, 28, 56, 98, 126 and 154 tablets.

HDPE bottles:

10, 20, 30, 50, 60, 90, 100 and 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd

Waterford Road Clonmel,

Co. Tipperary

Ireland

or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Eurogenerics NV/SA

Heizel Esplanade b22

1020 Brussels

Belgium

or

STADA Arzneimittel GmbH

Stada Arzneimittel GmbH Muthgasse 36

1190 Vienna

Austria

or

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovakia

or

SANECA PHARMACEUTICALS, A.S.

Nitranska 100 - Hlohovec - 920 27

Slovakia

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14

Polígono Industrial de la Zona Franca de Barcelona

08040, Barcelona

Spain

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

Austria: Montelukast STADA 5 mg Kautabletten

Belgium: Montelukast Eurogenerics 5 mg kauwtabletten

Denmark: Montelukast Stada

Spain: Montelukast Stada 5 mg chewable tablets EFG

France: Montelukast EG 5 mg comprimé à croquer

Ireland: Montelair 5 mg chewable tablets

Luxembourg: Montelukast Eurogenerics 5 mg comprimés à croquer

Portugal: Montelucaste Ciclum

Sweden: Montelukast STADA, 5 mg tuggtablett

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

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