Montelukast Stada 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Stada 4 mg chewable tablets EFG

For children aged between 2 and 5 years

Read the entire leaflet carefully before giving this medicine to your child, as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only and must not be given to other people, even if they have the same symptoms as your child, as it could harm them.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Montelukast Stada is and what it is used for
2. What you need to know before starting to take 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 your child's asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma treatment and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast 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: Cough, wheezing, and chest tightness.

2. What you need to know before starting Montelukast Stada

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

DO NOT give Montelukast Stada to your child

• If he/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.
• Oral montelukast is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep 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 should not be used instead of other asthma medications prescribed by your doctor for your child.
• If your child is being treated with asthma medications, be aware that if he/she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary 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 his/her asthma to worsen.

Various neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, you should contact your child's doctor.

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 Stada

Tell your doctor or pharmacist if your child is taking, has 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 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 Stada with food and drinks

Montelukast 4 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

This section does not apply to Montelukast 4 mg chewable tablets, as it is indicated for use in children aged 2 to 5 years.

Driving and using machines

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

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 4.8 mg of aspartame per chewable tablet. Aspartame contains a source of phenylalanine which may be harmful if the person has 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 tablet, i.e., essentially "sodium-free".

3. How to take Montelukast Stada

Follow exactly the dosing instructions for this medicine provided by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under the supervision of an adult.
• For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one montelukast chewable tablet once daily, as prescribed by the 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 Stada, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is taken orally.

The tablets must be chewed before swallowing.

Montelukast 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 Stada than they should

Seek immediate help from your child's doctor.

In most overdose cases, no adverse effects were reported. The most commonly 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 5620420, stating the name of the medicine and the amount ingested.

If you forget to give Montelukast Stada to your child

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

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

If your child stops treatment with Montelukast Stada

Montelukast can only treat your child's asthma if it is taken continuously.

It is important that your child continues taking montelukast for as long as prescribed by the 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

Additionally, the following adverse effects were 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 in those treated with placebo (a pill containing no active ingredient).

Serious adverse effects

Consult your doctor immediately if you notice any of the following adverse effects in your child, which 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 in 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

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

Other adverse 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 in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• changes in 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 in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines at Website: www.notificaram.es. By reporting adverse 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. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 4 mg of montelukast.

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

Nature of the product and contents of the container

Montelukast Stada 4 mg chewable tablets are pink, oval, biconvex tablets, marked with “M4” on one side.

Montelukast Stada is available in the following pack sizes:

Nylon/Alu/PVC-Aluminium blisters:

• Blister packs (without calendar): 10, 20, 30, 50, 60, 90, 100 and 250 tablets.
• Blister packs (without calendar): 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 SANPROSPERO 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

SANECA PHARMACEUTICALS, A.S.

Nitranska 100 - Hlohovec - 920 27

Slovakia

or

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

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 4 mg Kautabletten

Belgium: Montelukast Eurogenerics 4 mg kauwtabletten

Denmark: Montelukast Stada

Spain: Montelukast Stada 4 mg chewable tablets EFG

Ireland: Montelair 4 mg chewable tablets

Luxembourg: Montelukast Eurogenerics 4 mg comprimés à croquer

Portugal: Montelucaste Ciclum

Sweden: Montelukast STADA, 4 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/