Leaflet: information for the user

Montelukast Stada 10 mg film-coated tablets EFG

For adolescents and adults from 15 years

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Montelukast Stada 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 and can also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast

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

• Montelukast is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent airway constriction caused by exercise.
• In patients with asthma for whom Montelukast is indicated, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

The use of Montelukast will depend on your symptoms and the severity of your asthma, which your doctor will determine.

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.
• Respiratory airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation (swelling) of the inner layer of the airways.

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

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: Stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast Stada

• if you 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 taking Montelukast Stada

• If your 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. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all medications for asthma prescribed by your doctor. Montelukast should not replace other asthma medications prescribed 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do 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 15 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 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 are taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)
• gemfibrozil (used for high plasma lipid levels treatment)

Taking Montelukast Stada with food and drinks

Montelukast 10 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will evaluate whether you can take this medication 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 somnolence) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Stada contains lactose

The film-coated tablets of montelukast 10 mg contain lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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 doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You should only take one montelukast tablet once a day, as prescribed by your doctor.
• You should take it even when you do not have symptoms or when you have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily at night.

If you are taking montelukast, make sure you do not take any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take montelukast 10 mg with or without food.

If you take more Montelukast 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 adults and children with overdose 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 Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forget to take Montelukast Stada:

Try to take montelukast as prescribed. However, if you forget a dose, limit yourself to resuming the usual regimen of one tablet once a day.

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

If you interrupt treatment with Montelukast Stada:

Montelukast can only treat your asthma if you continue taking it.

It is essential that you continue taking montelukast for the time your doctor prescribes. It will help control your asthma.

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

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

In clinical trials conducted with montelukast 10 mg film-coated 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
• 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 notice any of the following side effects, which may be severe and 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
• 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
• increased 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
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, discomfort, swelling

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

• behavioral and mood changes: attention alteration, memory alteration, involuntary muscle movements

Very rare: may affect up to 1 in 1,000 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.

No special storage conditions are required.

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

Montelukast Stada Composition

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

Each film-coated tablet contains montelukast sodium, equivalent to 10 mg of montelukast.

• The other components are:

Tablet core:

Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, disodium edetate, and magnesium stearate.

Tablet coating:

Hydroxypropylcellulose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Product appearance and packaging contents

Montelukast Stada 10 mg film-coated tablets are beige, round, and biconvex.

Montelukast Stada is available in the following packaging:

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 packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

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

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 European Economic Area member states with the following names:

Austria:Montelukast STADA 10 mg Filmtabletten

Belgium:Montelukast Eurogenerics 10 mg filmomhulde tabletten

Czech Republic:Montelukast STADA 10 mg potahovane tablety

Germany:Montelukast STADA 10 mg Filmtabletten

Denmark:Montelukast Stada

Spain:Montelukast STADA 10 mg comprimidos recubiertos con película EFG

France:Montelukast EG 10 mg comprimé pelliculé

Ireland:Montelair 10 mg film-coated tablets

Luxembourg:Montelukast Eurogenerics 10 mg comprimés pelliculés

Portugal:Montelucaste Ciclum

Sweden:Montelukast STADA 10 mg filmdragerade tabletter

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/