Montelukast Sandoz 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Sandoz 5 mg chewable 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, consult your doctor or pharmacist.

• This medicine has been prescribed for your child; do not give it to other people, even if they have the same symptoms as your child, as it may 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 your child takes Montelukast Sandoz
3. How to take Montelukast Sandoz
4. Possible adverse 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

Montelukast Sandoz 5 mg chewable tablets is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

Your doctor has prescribed montelukast to treat your child's asthma, preventing asthma symptoms during both day and night.

• Montelukast Sandoz 5 mg is used for the treatment of patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Sandoz 5 mg is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Sandoz also helps prevent airway narrowing caused by exercise.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how
to 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 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.

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

2. What you need to know before your child starts taking Montelukast Sandoz

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Sandoz to your child if

• He or she is allergic (hypersensitive) 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 your child takes Montelukast Sandoz:

• 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 keep your child's inhaled rescue medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast should not be used instead of other asthma medications prescribed for your child by the doctor.
• If your child is being treated with asthma medications, be aware that if he or she develops a combination of symptoms such as: flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his or her asthma.

Several neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal ideation) 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 administer this medicine to children under 2 years of age.

Other forms of this medicine are available for pediatric patients under 18 years of age, based on age ranges.

Other medicines and Montelukast Sandoz

Some medicines may affect how Montelukast Sandoz works, or Montelukast Sandoz may affect how other medicines your child is taking work.

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

Before taking Montelukast Sandoz, inform your doctor if your child is taking any of the following medicines:

• phenobarbital (used for the treatment of epilepsy),
• phenytoin (used for the treatment of epilepsy),
• rifampicin (used for the treatment of tuberculosis and certain other infections),
• gemfibrozil (used for the treatment of high plasma lipid levels).

Taking Montelukast Sandoz with food and drinks

Montelukast Sandoz 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

This section does not apply to Montelukast Sandoz 4 mg chewable tablets, as this formulation is indicated for use in children. However, the following information is important regarding the active substance, montelukast.

Use during pregnancy

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

Use during breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast.

Driving and using machines

This section does not apply to Montelukast Sandoz 4 mg and 5 mg chewable tablets, as these formulations are indicated for use in children. However, the following information is important regarding the active substance, montelukast.

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 reported very rarely with montelukast, may affect a patient's ability to drive or operate machinery.

Montelukast Sandoz contains aspartame, the azo dye Allura Red (E129), sodium, and sucrose.

This medicine contains 1.2 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains an azo dye because it contains Allura Red. It may cause allergic-type reactions.

This medicine contains less than 1 mmol of sodium (23 mg), i.e., it is essentially "sodium-free".

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

3. How to take Montelukast Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

• Your child should only take one tablet of Montelukast Sandoz per day, as prescribed by your doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• Make sure your child always takes Montelukast Sandoz as directed by the doctor. Consult your child's doctor or pharmacist if you have any doubts.

Recommended dose:

For children aged 6 to 14 years:

One 5 mg chewable tablet should be taken daily in the evening. Montelukast Sandoz 5 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating. The tablets must be chewed before swallowing.

If your child is taking Montelukast Sandoz, make sure they do not take any other medicine containing the same active substance.

This medicine is for oral use.

Montelukast Sandoz 5 mg chewable tablets are not recommended for children under 6 years of age.

• For children aged 2 to 5 years, 4 mg formulations are available as chewable tablets and granules.
• For adolescents over 15 years of age and adults, 10 mg tablets are available.

If your child takes more Montelukast Sandoz than they should

Contact your child's doctor immediately for assistance.

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, drowsiness, thirst, headache, vomiting, and hyperactivity.

If your child has taken more Montelukast Sandoz than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forgot to give Montelukast Sandoz to your child

Try to give Montelukast Sandoz 5 mg chewable tablets as prescribed. However, if your child misses a dose, simply resume the usual dosing schedule of one tablet once daily.

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

If your child stops taking Montelukast Sandoz

Montelukast can only treat your child's asthma if treatment is continued.

It is important that your child continues taking montelukast for as long as the doctor prescribes it. It will help control your child's 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 will experience them.

Tell your doctor immediately if you notice any of the following adverse effects in your child, as urgent medical treatment may be needed.

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 related to behaviour and mood: agitation, including aggressive behaviour or hostility, depression,
• seizures.

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

• increased risk of bleeding,
• tremor,
• palpitations.

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

• reduction in blood platelets (thrombocytopenia),
• changes related to behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions. For example, talking about suicide, withdrawing from social contact and preferring to be alone, or feeling trapped and hopeless in a particular situation,
• yellowing of the skin and eyes, unusual tiredness or fever, darkening of the urine due to inflammation of the liver (hepatitis),
• swelling (inflammation) of the lungs,
• cases of a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if your child develops one or more of these symptoms,
• serious skin reactions which may occur without warning (erythema multiforme).

In clinical studies with 10 mg montelukast film-coated tablets and 4 mg or 5 mg chewable tablets, the most frequently reported adverse effects (may affect up to 1 in 10 people) associated with montelukast were:

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

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

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

Very common: may affect more than 1 in 10 people

• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• diarrhoea, nausea, vomiting,
• elevated liver enzymes,
• skin rash,
• fever

Uncommon: may affect up to 1 in 100 people

• changes related to behaviour and mood (sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, feeling anxious, restlessness),
• dizziness, somnolence, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• enuresis in children,
• weakness, tiredness, malaise, swelling

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

• changes related to behaviour and mood: attention disturbances, memory impairment, involuntary muscle movements.

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

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

Reporting of adverse effects

If your child experiences any 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.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 the sight and reach of children.

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

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

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

6. Package contents and additional information

Composition of Montelukast Sandoz

• The active substance is montelukast.

Each tablet contains sodium montelukast equivalent to 5 mg of montelukast.

• The other components are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), sodium croscarmellose, flavouring (cherry flavour AP0551, cherry aroma TD0990B [contains the azo colouring agent Allura Red, E129]), aspartame (E951) and magnesium stearate.

Appearance of the product and contents of the pack

Montelukast Sandoz are pink, round, chewable tablets, marked with "5" on one side.

The chewable tablets are packed in OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU blisters and presented in a cardboard pack.

Montelukast Sandoz is available in pack sizes of: 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 and 200 chewable tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2 D, 9220

Lendava

Slovenia

or

Lek S.A.

Ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

or

Lek, S.A.

Ul Podlipie, 16

95-010 Strykow

Poland

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

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/