MONTELUKAST STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Stada 10 mg Film-Coated Tablets EFG

For adolescents and adults from 15 years of age

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Montelukast Stada and what is it used for
2. What you need to know before you take Montelukast Stada
3. How to take Montelukast Stada
4. Possible side effects
5. Storage of Montelukast Stada
6. Contents of the pack and other information

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

What is Montelukast

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

How Montelukast works

Leukotrienes cause the airways to narrow and swell, and can cause symptoms of asthma and allergic rhinitis. By blocking the leukotrienes, Montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergic rhinitis (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 exercise-induced narrowing of the airways.
• In patients with asthma who are indicated for Montelukast for asthma, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should 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.
• airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: Coughing, wheezing, and chest congestion.

What are Seasonal Allergies?

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

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

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Stada

• if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before taking Montelukast Stada

• If your asthma or breathing gets worse, tell your doctor right away.
• Oral Montelukast is not indicated for the treatment of 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 important that you or your child use all asthma medications 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 of arms and legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.

Children and Adolescents

Do not give this medicine to children under 15 years of age.

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

Other Medicines and Montelukast Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, tell your doctor if you are taking the following medicines:

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

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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will assess whether you can take this medicine during this period.

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, 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 side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect your ability to drive or operate machinery.

Montelukast Stada contains Lactose

The film-coated tablets of montelukast 10 mg contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Montelukast Stada contains Sodium

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

3. How to take Montelukast Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should only take one Montelukast tablet once a day, as prescribed by your doctor.
• It should be taken 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 in the evening.

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

This medicine 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 occurred most frequently in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

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

If you forget to take Montelukast Stada

Try to take Montelukast as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once daily.

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

If you stop taking Montelukast Stada

Montelukast may only treat your asthma if you 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.

If you have any further questions on 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 everybody gets them.

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

• abdominal pain
• headache

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine). Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, 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 that can cause difficulty breathing or swallowing
• mood-related changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of 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 of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

Very common: may affect more than 1 in 10 people

• upper respiratory infection

Common: may affect up to 1 in 10 people

• diarrhea, nausea, vomiting
• rash
• fever
• increased liver enzymes

Uncommon: may affect up to 1 in 100 people

• mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

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

• painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)
• mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return all unused medicines and packaging to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 film-coated tablet contains montelukast sodium, equivalent to 10 mg of montelukast.

• The other ingredients are:

Core of the tablet:

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

Coating of the tablet:

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

Appearance of the product and contents of the pack

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

Montelukast Stada is available in the following packs:

Nylon/Alu/PVC-Aluminum blisters:

• Blisters (without calendar): 10, 20, 30, 50, 60, 90, 100, and 250 tablets.
• Blisters (without calendar): 7, 14, 28, 56, 98, 126, and 154 tablets.

HDPE bottles:

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

Not all 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 Brussel

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 under the following names:

Austria: Montelukast STADA 10 mg Filmtabletten

Belgium: Montelukast Eurogenerics 10 mg filmomhulde tabletten

Czech Republic: Montelukast STADA 10 mg potahované 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

Date of last revision of this leaflet:March 2024

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