Montelukast Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Sandoz 10 mg film-coated tablets EFG

montelukast

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Montelukast

3. How to take Montelukast Sandoz

4. Possible side effects

5. How to store Montelukast Sandoz

6. Contents of the pack and other information

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

What is Montelukast Sandoz

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

How Montelukast Sandoz works

Leukotrienes cause narrowing and swelling of the airways in the lungs, and can also trigger allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When Montelukast Sandoz should be used

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

• Montelukast is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled and who require additional therapy.
• Montelukast also helps prevent narrowing of the airways caused by exercise.
• In asthmatic patients for whom montelukast is indicated 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 involves:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various triggers.
• Sensitive airways that react in many situations, such as exposure to tobacco smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: coughing, wheezing, and chest tightness.

What are seasonal allergies?

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

2. What you need to know before you start taking Montelukast Sandoz

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

Do not take Montelukast Sandoz:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take montelukast tablets:

• If your asthma or breathing worsens, inform your doctor immediately.

• Montelukast oral tablets are not intended to treat asthma attacks. If you experience an asthma attack, follow the instructions provided by your doctor. Always carry your rescue medication for inhalation in case of an asthma attack.

• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast tablets should not replace other asthma medications prescribed by your doctor.

• Patients receiving asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening of pulmonary symptoms and/or rash, they should consult their doctor.

• You should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma.

Several neuropsychiatric events (for example, behaviour 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 these symptoms while taking montelukast, you should contact your doctor.

Children and adolescents

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

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

Other medicines and Montelukast Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how montelukast tablets work, or montelukast tablets may affect how other medicines work.

Inform your doctor if you are taking any of the following medicines before starting montelukast tablets:

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

Taking Montelukast Sandoz with food and drink

Montelukast tablets may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will advise you whether you can take montelukast tablets during this period.

Breastfeeding

It is unknown whether montelukast tablets are excreted in breast milk. You should consult your doctor before taking montelukast tablets if you are breastfeeding or plan to breastfeed.

Driving and using machines

Montelukast tablets are not expected to affect your ability to drive or operate machinery. However, individual responses to medication may vary. Some adverse effects (such as dizziness and somnolence) reported with Montelukast Sandoz 10 mg may affect the ability of some patients to drive or operate machinery.

Montelukast Sandoz tablets contain lactose and sodium.

If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Montelukast Sandoz

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

• Take only one 10 mg montelukast tablet once daily as prescribed by your doctor.
• You should continue taking it even if you do not have symptoms or are experiencing an acute asthma attack.

For adults and adolescents aged 15 years and older:

The recommended dose is one 10 mg tablet taken once daily in the evening.

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

This medicine is for oral use.

You may take montelukast with or without food.

Montelukast must not be used in children under 15 years of age due to the high concentration of active substance.

Other formulations with appropriate concentrations are available for younger children.

If you take more Montelukast Sandoz than you should

Contact your doctor immediately.

No adverse effects were reported in most cases of overdose. The most commonly reported symptoms associated with overdose in adults and children include abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you have taken more Montelukast Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Montelukast Sandoz

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

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

If you stop taking Montelukast Sandoz

Montelukast can only treat your asthma if you continue taking it. It is important to keep taking montelukast for the entire duration prescribed by your doctor. It will help you control your asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you notice any of the following serious adverse effects, as urgent medical treatment may be required:

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

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing,
• changes in behavior and mood: restlessness including aggressive behavior and hostility, depression,
• seizures.

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

• increased tendency to bleeding,
• tremors,
• seizures.

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

• reduction in blood platelets (thrombocytopenia),

• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and actions. Warning signs include, for example, talking about suicide, withdrawing from social contact, wanting to be alone, or feeling trapped or hopeless about a situation,

• yellowing of the skin and eyes, unusual tiredness or fever, dark-colored urine caused by inflammation of the liver (hepatitis),

• swelling (inflammation) of the lungs,

• a combination of symptoms including flu-like illness, tingling or numbness in the arms and legs, worsening of lung symptoms and/or rash (Churg-Strauss syndrome). You should inform your doctor immediately if your child develops one or more of these symptoms,

• severe skin reactions (erythema multiforme) which may occur without warning.

• In clinical studies with montelukast 4 mg oral granules, 4 mg chewable tablets, 5 mg chewable tablets, or 10 mg film-coated tablets, the following adverse effects were reported as very common (may affect up to 1 in 10 people) and possibly related to montelukast:

  • abdominal pain,
  • headache,
  • thirst,
  • diarrhea,
  • hyperactivity,
  • asthma,
  • scaly and itchy skin,
  • rash.

These were generally mild and occurred more frequently in patients treated with montelukast than in those who received placebo (a tablet without active ingredient).

Additionally, during post-marketing use of the medicine, the following adverse effects have been reported:

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

• upper respiratory tract infection.

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

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

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

• behavior- and mood-related changes (sleep disturbances, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious),
• dizziness, drowsiness, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, hives,
• joint or muscle pain, muscle cramps,
• enuresis (bedwetting) in children,
• weakness, fatigue, malaise, swelling.

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

• Behavior- and mood-related changes: attention disorders, memory impairment, uncontrolled muscle movements.

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

• painful red lumps under the skin, most commonly on the lower legs (erythema nodosum),
• stuttering,
• obsessive-compulsive symptoms.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after EXP/CAD. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your doctor or pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Sandoz

• The active substance is montelukast.

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

• The other components are:

Core: Monohydrate lactose, hydroxypropylcellulose type EF, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating: Polyvinyl alcohol, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the pack

Film-coated tablet, beige in colour, round, biconvex and smooth on both sides.

The tablets are packed in OPA/Al/PVC/Al blisters placed in cardboard cartons.

Pack sizes: 7, 10, 14, 20, 21, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek S.A.

Ul. Domaniewska 50C

02-672 Warszawa

Poland

or

Lek S.A.

Ul. Podlipie 16

95-010 Strykow

Poland

or

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu-Mures Jud. Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Date of the most recent revision of this leaflet: December 2025

Other sources of information:

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.