Montelukast Sandoz 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Sandoz 4 mg chewable tablets EFG

Please read this 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 others, even if they have the same symptoms as your child, as 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 your child starts taking 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 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 for your child to treat asthma, preventing asthma symptoms during both day and night.

• Montelukast Sandoz is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast Sandoz is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast Sandoz also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

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

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

2. What you need to know before starting 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 components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 rescue inhaled 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 cause worsening of asthma.

Children and adolescents

Do not administer this medicine to children under 2 years of age.

Other formulations of this medicine are available for paediatric 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 to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and certain other infections),
• gemfibrozil (used to treat high lipid levels in plasma).

Taking Montelukast Sandoz with food and drink

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 relevant for 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 relevant for 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 somnolence), which have been reported very rarely with montelukast, may affect a patient's ability to drive or operate machinery.

Montelukast Sandoz 4 mg chewable tablets contain aspartame, the azo dye Allura Red (E129), sodium, and sucrose

This medicine contains 0.96 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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., 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 administering this medicine. If in doubt, consult your doctor or pharmacist again.

• Your child should only take one Montelukast Sandoz tablet once daily, as prescribed by their doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• Always ensure your child takes Montelukast Sandoz exactly as directed by their doctor. Consult your child’s doctor or pharmacist if you have any doubts.

Recommended dose:

For children aged 2 to 5 years

One 4 mg chewable tablet should be taken daily at night. 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 eating. The tablets must be chewed before swallowing.

This medicine should be administered to children under adult supervision.

If your child is taking Montelukast Sandoz 4 mg chewable tablets, make sure they do not take any other medication containing the same active substance, montelukast.

This medicine is for oral use.

Montelukast Sandoz 4 mg chewable tablets are not recommended for children under 2 years of age.

• For children aged 2 to 5 years, 4 mg chewable tablets and 4 mg granules (for children who have difficulty swallowing chewable tablets) are available.
• For children aged 6 to 14 years, 5 mg chewable 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: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to give Montelukast Sandoz to your child

Try to give Montelukast Sandoz 4 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 taken continuously.

It is important that your child continues taking montelukast for the length of time prescribed by their doctor. 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 experiences 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 solitude, or feeling trapped and hopeless in a given situation,
• yellowing of the skin and eyes, unusual tiredness or fever, dark-coloured urine caused by 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 pulmonary 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.
• severe skin reactions which may occur without prior 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) related to 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 with placebo (a tablet containing no active medicine).

In addition, 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, fatigue, malaise, swelling

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

• Changes related to behaviour and mood: attention disturbances, 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 frequently 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 4 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 dye Allura red, E129]), aspartame (E951) and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Montelukast Sandoz is pink, oval, chewable tablets imprinted with "4" on one side.

The chewable tablets are packaged in OPA/ALU/PVC/ALU blisters and packed in cardboard cartons.

Montelukast Sandoz is available in pack sizes of: 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 chewable tablets.

Only certain pack sizes may be commercially available.

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

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 on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/