Leaflet: information for the user

Montelukast Stada 5 mg chewable tablets EFG

For children aged 6 to 14 years

Read this leaflet carefully before you or your child start taking this medicine, as 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, consult your doctor or pharmacist.
• This medicine has been prescribed only for you or your child and should not be given to others even if they have the same symptoms as your child, as it may harm them.
• If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is montelukast

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

How montelukast works

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

When to use montelukast

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

• Montelukast is used to treat pediatric patients between 6 and 14 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 6 and 14 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise.

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

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 diseases.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your doctor of any allergy or medical condition you or your child may have now or have had.

Do not take Montelukast Stada

• If you or your child are allergic to montelukast or any of the other components of this medication (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 your child's asthma or breathing, worsens, inform your doctor immediately.
• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all the asthma medications prescribed by your doctor. Montelukast should not be used in place 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 of arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

Do not give this medication to children under 6 years of age.

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and Montelukast Stada

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications you are using.

Before taking montelukast, inform your doctor if you or your child are taking the following medications:

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

Taking Montelukast Stada with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

Breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking montelukast.

Driving and operating machinery

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and drowsiness) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Stada contains aspartame (E951)

This medication contains 6 mg of aspartame in each chewable tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Montelukast Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per chewable tablet; it is essentially "sodium-free."

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You or your child should only take one chewable tablet of montelukast once a day, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or when they have an acute asthma attack.

For children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet daily at night.

If you or your child are taking montelukast, make sure neither you nor your child take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If you or your child take moreMontelukast Stada than you should

Seek help from your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Montelukast Stada or forgot to give Montelukast Stada to your child

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

Do not take a double dose to compensate for missed doses.

If you or your child interrupt treatment with Montelukast Stada

Montelukast can only treat your asthma or your child's asthma if you or your child continue to take it.

It is essential to continue taking montelukast for the time your doctor prescribes.

This will help control your asthma or your child's asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• headache

In addition, 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 with placebo (a tablet that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you observe any of the following side effects, which may be severe and you or your child may require urgent medical treatment.

Rare: may affect up to 1 in 100 people

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

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

Other side effects reported during the marketing of the drug

Very frequent: may affect more than 1 in 10 people

• upper respiratory tract infection

Frequent: may affect up to 1 in 10 people

• diarrhea, nausea, vomiting
• skin rash
• fever
• enzymes elevated in the liver

Rare: may affect up to 1 in 100 people

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• 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

• behavior and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

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

• red, painful lumps under the skin that more frequently appear on the face (erythema nodosum)
• behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Montelukast Stada

• The active ingredient 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 aroma, aspartame (E951), talc, and magnesium stearate.

Appearance of the product and contents of the package

Montelukast Stada 5 mg chewable tablets are pink, round, biconvex, with “M5” engraved on one face.

Montelukast Stada is available in the following packages:

Nylon/Alu/PVC-Aluminum Blister Packs:

- 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 some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible 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

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Montelukast STADA 5 mg Kautabletten

Belgium:Montelukast Eurogenerics 5 mg kauwtabletten

Czech Republic:Montelukast STADA 5 mg žvýkací tablety

Denmark:Montelukast Stada

Spain:Montelukast Stada 5 mg comprimidos masticables 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

Last review date of this leaflet:March 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/