Leaflet: information for the user

Montelukast Stada 4 mg chewable tablets EFG

For children aged 2 to 5 years

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

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

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.Storage of Montelukast Stada

6.Contents of the pack and additional information

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 your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients between 2 and 5 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 2 and 5 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

Depending on the symptoms and severity of 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 situations.
• 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 child's doctor about any allergy or medical condition your child has now or has had.

Do not give Montelukast Stada to your child

• If he/she is allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before giving montelukast to your child.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication available for asthma attacks.
• It is essential that your child uses all medications for asthma prescribed by their doctor. Montelukast should not be used in place of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.

Children and adolescents

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

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

Other medications and Montelukast Stada

Inform your child's doctor or pharmacist if your child is taking, has recently taken, 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 your child is using.

Before taking montelukast, inform your child's doctor if your child is taking the following medications:

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

Taking Montelukast Stada with food and drinks

Montelukast 4 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

This subsection is not applicable to montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years.

Driving and operating machines

This subsection is not applicable to montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machines. 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 machines.

Montelukast Stada contains aspartame (E951)

This medication contains 4.8 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 because the body is unable to eliminate it correctly.

Montelukast Stada contains sodium

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

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

• This medication 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 chewable tablet of montelukast once a day as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet daily at night.

Make sure your child does not take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Stada than they should

Seek help from your child's 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 give Montelukast Stada to your child

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

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

If your child interrupts treatment with Montelukast Stada

Montelukast can only treat your child's asthma if they continue taking it.

It is essential that your child continues to take montelukast for the time prescribed by their doctor. It will help control your child's asthma.

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

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

In clinical trials conducted with montelukast 4 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:

• abdominal pain
• sedation

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

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 in your child, which may be severe and 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
• behavioral 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
• behavioral and mood changes: 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 side effects reported during the marketing of the drug

Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

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

Rare: may affect up to 1 in 100 people

• behavioral 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
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements

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

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)
• behavioral 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 trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging 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).

Cada comprimido masticable contiene montelukast sódico, que equivale a 4 mg de 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

The chewable tablets of Montelukast Stada 4 mg are pink, oval, biconvex, with “M4” engraved on one face.

Montelukast Stada is available in the following packages:

Packages of Nylon/Alu/PVC-Aluminum:

- Packages (without calendar): 10, 20, 30, 50, 60, 90, 100, and 250 tablets.

- Packages (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 marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

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

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

Austria:Montelukast STADA 4 mg Kautabletten

Belgium:Montelukast Eurogenerics 4 mg kauwtabletten

Czech Republic:Montelukast STADA 4 mg žvýkací tablety

Denmark:Montelukast Stada

Spain:Montelukast Stada 4 mg comprimidos masticables 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 last review of this leaflet:March 2024

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