Montelukast UR 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast UR 10 mg film-coated tablets EFG

Read the entire leaflet carefully before your child starts 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, pharmacist or nurse.
• This medicine has been prescribed for your child and must not be given to other people, even if they have the same symptoms as your child, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Montelukast UR is and what it is used for
2. What you need to know before your child starts taking Montelukast UR
3. How to take Montelukast UR
4. Possible adverse effects
5. How to store Montelukast UR
6. Contents of the pack and other information

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

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

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

• Montelukast UR is used to treat patients whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast UR also helps prevent airway narrowing caused by exercise.
• In patients with asthma for whom Montelukast UR is indicated for the treatment of asthma, Montelukast UR 10 mg may also provide relief from symptoms of seasonal allergic rhinitis.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Montelukast UR should be used.

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 triggers.

• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways. Symptoms of asthma include: coughing, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose, sneezing; and watery, swollen, red, and itchy eyes.

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

Tell your doctor about any allergies or medical conditions you currently have or have had in the past

Do not take Montelukast UR if

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

Warnings and precautions

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child's rescue inhaled medication available for asthma attacks.
• It is important that you use all asthma medications prescribed by your doctor. Montelukast UR should not replace other asthma medications prescribed by your doctor.
• If you are being treated for asthma, be aware that if you develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Various neuropsychiatric events (for example, behavior- and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you must contact your doctor.

Use in children

Montelukast UR is indicated for patients aged 15 years and older.

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

Use of other medicines

Some medicines may affect how Montelukast UR works, or Montelukast UR may affect how other medicines you are taking work.

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

Before taking Montelukast UR, inform 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 certain other infections)

Taking Montelukast UR with food and drinks

Montelukast UR may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

It is unknown whether montelukast is excreted in breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast UR.

Driving and use of 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 adverse effects (such as dizziness and drowsiness), which have been very rarely reported with montelukast, may affect a patient's ability to drive or operate machinery.

Important information about some of the components of Montelukast UR

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Montelukast UR

• Always take Montelukast exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are unsure.
• The usual dose is one Montelukast UR tablet once daily, as prescribed by your doctor.
• It should be taken even when you have no symptoms or during an acute asthma attack.
• It must be taken orally.

For children aged 15 years and older:

One Montelukast UR tablet at night. The film-coated tablet should be swallowed with sufficient liquid (e.g., water). Montelukast UR may be taken with or without food.

If you are taking Montelukast UR, make sure you do not take any other medication containing the same active substance, montelukast.

If you take more Montelukast UR than you should

Seek medical help immediately.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Montelukast UR

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

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

If you stop taking Montelukast UR

Montelukast UR can only control asthma if you continue taking it.

It is important that you continue taking Montelukast UR for as long as your doctor has prescribed it. It will help control your asthma.

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

4. Possible adverse effects

Like all medicines, Montelukast UR may cause adverse effects, although not everyone experiences them.

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

Very common adverse effects (may affect more than 1 in 10 people)
Common adverse effects (may affect up to 1 in 10 people)
Uncommon adverse effects (may affect up to 1 in 100 people)
Rare adverse effects (may affect up to 1 in 1,000 people)
Very rare adverse effects (may affect up to 1 in 10,000 people)
Adverse effects with unknown frequency (cannot be estimated from available data)

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

• abdominal pain
• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active ingredient).

Additionally, since the medicine has been marketed, the following adverse effects have been reported:

• upper respiratory tract infection
• increased tendency to bleeding
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing
• changes in behaviour and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhoea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruising, itching, hives, painful red lumps under the skin that usually appear on the shins (erythema nodosum)
• joint or muscle pain, muscle cramps
• tiredness, malaise, swelling, fever

In asthmatic patients treated with Montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must immediately inform your doctor if your child experiences one or more of these symptoms.

Ask your doctor or pharmacist for more information about adverse effects. If you consider any of the adverse effects experienced to be severe, or if you notice adverse effects not listed in this leaflet, inform your child's doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast UR 10 mg

• 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 indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast

• The active substance is Montelukast.

Each tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.

• The other components are:

Monohydrate lactose (130.6 mg), microcrystalline cellulose, croscarmellose sodium, magnesium stearate and anhydrous colloidal silica.

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

Appearance of the medicinal product and contents of the pack

Montelukast 10 mg film-coated tablets are pale yellowish-pink in colour, round, biconvex, with “M10” engraved on one side.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Iberia, S.L
C/ Solana, 26
28850 – Torrejón de Ardoz (Madrid), Spain

Manufacturer

Siegfried Generics Malta Ltd
HHF070 Hal Far Industrial Estate, (PO Box 14), BBG 3000 Hal Far
Malta

Or

Laboratorios de Medicamentos Internacionales, S.A.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid, Spain

This leaflet was approved in February 2026

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