Leaflet: information for the user

Montelukast UR 10 mg film-coated tablets EFG

Read this leaflet carefully before your child starts taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed 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 you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4

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

2. What you need to know before starting to take Montelukast UR

3. How to take Montelukast UR

4. Possible side effects

5. Storage of Montelukast UR

6. Contents of the pack and additional information

Montelukast is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce bronchospasm and inflammation of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast UR improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis)

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

• Montelukast UR is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.

• Montelukast UR also helps prevent airway constriction caused by exercise.

• In asthmatic patients with Montelukast UR indicated for asthma treatment, Montelukast UR 10 mg may also provide relief from seasonal allergic rhinitis symptoms

Depending on symptoms and the severity of your child's asthma, your doctor will determine how to use Montelukast UR

What is asthma?

Asthma is a chronic disease

Asthma includes

• difficulty breathing due to bronchospasm. This bronchospasm worsens and improves in response to various conditions

• airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.

• inflammation of the inner lining 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 seasonal allergy symptoms may include: nasal congestion, runny nose, sneezing; itchy, red, watery, and swollen eyes

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

Do not take Montelukast UR if

• you are allergic to Montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

• If 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 your child. Always have your child's rescue inhaler medication available for asthma attacks.

• It is essential to use all medications for asthma prescribed by your doctor. Montelukast UR should not substitute other asthma medications prescribed by your doctor.

• If you are being treated with asthma medications, be aware that if you 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, you should consult your doctor.

• Do not take acetylsalicylic acid (aspirin) or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma.

Use in children

Montelukast UR is indicated for patients 15 years of age and older.

For children 6 to 14 years, Montelukast UR 5 mg chewable tablets are available. For children 2 to 5 years, Montelukast UR 4 mg chewable tablets are available.

Use of other medications

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

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Before taking Montelukast UR, inform your doctor if you 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 UR with food and beverages

Montelukast UR can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast UR. Your doctor will evaluate whether you can take Montelukast UR during this period.

Lactation

The excretion of Montelukast in breast milk is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast UR.

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) that have been rarely reported with Montelukast may affect the patient's ability to drive or operate machinery.

Important information about some of the components of Montelukast UR

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

• Always take Montelukast exactly as your doctor has instructed. Check with your doctor or pharmacist if you are unsure.

• The usual dose is one Montelukast UR 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.

• It should be taken orally.

For children 15 years of age and older:

One Montelukast UR tablet at night. The coated tablet should be taken with sufficient liquid (e.g. water). Montelukast UR can be taken with or without food.

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

If you take more Montelukast UR than you should:

Immediately seek help from your child's doctor.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children who experienced an 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: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast UR:

Try to take Montelukast UR as prescribed. However, if you forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you interrupt treatment with Montelukast UR:

Montelukast UR can only treat asthma if you continue to take it.

It is essential to continue taking Montelukast UR for the time your doctor prescribes. It will help control your asthma.

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

Like all medicines, Montelukast UR can cause side effects, although not everyone will experience them.

The possible side effects are listed according to the following categories:

Very common side effects (may affect more than 1 in 10 people)

Common side effects (may affect up to 1 in 10 people)

Uncommon side effects (may affect up to 1 in 100 people)

Rare side effects (may affect up to 1 in 1,000 people)

Very rare side effects (may affect up to 1 in 10,000 people)

Side effects of unknown frequency (cannot be estimated from available data)

In clinical trials conducted with Montelukast, the side effects related to the administration of the medication and reported most frequently (occur in at least 1 in 100 patients and less than 1 in 10 patients treated), were:

• abdominal pain

• headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medication).

Additionally, since the medication has been marketed, the following side effects have been reported:

• upper respiratory tract infection

• increased risk of bleeding

• allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing

• behavior and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, somnambulism, suicidal thoughts and actions (in very rare cases)]

• dizziness, drowsiness, tingling/numbness, seizures

• palpitations

• nasal bleeding

• diarrhea, dry mouth, indigestion, nausea, vomiting

• hepatitis (inflammation of the liver)

• bruises, itching, urticaria, painful red lumps under the skin that more frequently appear on the skin (erythema nodosum)

• joint or muscle pain, muscle cramps

• fatigue, discomfort, swelling, fever

In asthmatic patients treated with Montelukast, very rare cases of 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) have been reported. Inform your doctor immediately if your child has one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you are experiencing are severe or if you notice side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 directly through the national notification system:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

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

• Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Montelukast

• The active ingredient is Montelukast.

Cada tablet contains 10.4 mg of Montelukast sodium equivalent to 10 mg of Montelukast.

• The other components are:

Lactose monohydrate (130.6 mg), microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and anhydrous colloidal silica

.

Coating: hypromellose, hyprolosa (E-463), titanium dioxide (E-171), iron oxide red and yellow (E-172)

Appearance of the product and content of the packaging

The film-coated tablets of Montelukast UR 10 mg are pale yellow-pink in color, round, biconvex with “M10” engraved on one face.

Montelukast UR 10 mg is available in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L

c/ Solana, 26

28850– Torrejon de Ardoz. (Madrid) Spain

Responsible for manufacturing

Siegfried Generics Malta Ltd

HHF070 Hal Far Industrial Estate, (PO Box 14), BBG 3000 Hal Far

Malta

O

Laboratorios de Medicamentos Internacionales, S.A.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This leaflet was approved in April 2011

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