Patient Information Leaflet: Information for the Patient

Montelukast Sandoz 4 mg Granules

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

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

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

3.How to take Montelukast Sandoz

4.Possible side effects

5.Storage of Montelukast Sandoz

6.Contents of the pack and additional information

Montelukast is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce bronchial constriction and inflammation 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 and prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients between 6 months and 5 years of age who are not adequately controlled with their medication and need additional treatment,
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for asthma treatment and who have demonstrated an inability to use inhaled corticosteroids,
• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

The dosage of montelukast will depend on your child's symptoms and the severity of their asthma, as determined by your doctor.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to bronchial constriction. This bronchial constriction worsens and improves in response to various conditions,

• Bronchial airways that are sensitive and react to multiple triggers, such as cigarette smoke, pollen, cold air, or exercise,
• Inflammation of the inner lining of the bronchial airways.

Asthma symptoms include: coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Montelukast Sandoz to your child:

• if they are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before starting to take Montelukast Sandoz.

• if your child's asthma or breathing worsens, inform your child's doctor immediately,
• montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication handy in case of an asthma attack,
• it is essential that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used in place of other asthma medications prescribed by your child's doctor,

• if your child is being treated with asthma medications, be aware that if your child develops a combination of symptoms similar to the flu or well, numbness or tingling of arms or legs, worsening of respiratory symptoms and/or skin rash, consult your child's doctor,
• your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.
• patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking montelukast, consult your child's doctor.

Children and adolescents

Do not administer this medication to children and adolescents under 6 months.

There are other available formats of this medication for children under 18 years of age, based on age range.

Taking Montelukast Sandoz with other medications

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

Inform your child's doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medication, including those purchased without a prescription.

Before taking montelukast, inform your child's doctor if your child is taking the following medications:

• phenobarbital (used for epilepsy treatment),
• phenytoin (used for epilepsy treatment),
• rifampicin (used for tuberculosis and some other infections treatment),
• gemfibrozil (used for treating high lipid levels in plasma).

Taking Montelukast Sandoz with food and drinks

Montelukast can be taken regardless of meal times.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Sandoz 4 mg granulated EFG, as its use is indicated in children between 6 months and 5 years of age, however, the following information is important for the active ingredient, montelukast.

Use during pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking montelukast. Their doctor will evaluate if they can take montelukast during this period.

Use during breastfeeding

The presence of montelukast in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking montelukast.

Driving and operating machines

This subsection is not applicable to Montelukast Sandoz 4 mg granulated EFG, as its use is indicated in children between 6 months and 5 years of age, however, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) that have been reported rarely with montelukast may affect the patient's ability to drive or use machines.

Montelukast Sandoz contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your child's doctor or pharmacist. If in doubt, consult the doctor or pharmacist again.

• This medication should be administered to children under the supervision of an adult. Your child should take montelukast every night.
• It should be taken even when your child does not have symptoms or when having an acute asthma attack.
• Make sure your child takes montelukast as instructed by their doctor. Consult the doctor or pharmacist if unsure.
• It should be taken orally.

The usual dose is:

For children from 6 months to 5 years of age

Take one packet of montelukast 4 mg granule orally every night.

If your child is taking montelukast, make sure they do not take any other medication that contains the same active ingredient, montelukast.

For children from 2 to 5 years of age, Montelukast Sandoz 4 mg chewable tablets are available. The Montelukast Sandoz 4 mg granule formulation is not recommended for children under 6 months of age.

How to give Montelukast Sandoz to your child?

• Do not open the packet until the time of use.

• Montelukast can be administered:
• directly in the mouth;
• or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix the entire content of Montelukast Sandoz with a spoonful of cold or room temperature soft food, carefully ensuring the full dose is mixed with the food.
• Make sure to administer the entire spoonful with the food mixture to the child immediately (within 15 minutes). IMPORTANT: Never store leftover food mixture for later use.
• Montelukast granule is not intended to dissolve in liquids. However, your child can take liquids after ingesting the medication.
• Montelukast can be taken regardless of meal times.

If your child takes more Montelukast Sandoz than they should

If they have taken more Montelukast Sandoz than they should, consult their doctor, pharmacist, or call the Toxicological Information Service, phone: 91562 04 20, indicating the medication and the amount used.

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

If you forgot to give Montelukast Sandoz to your child

Try to give montelukast as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual once-a-day packet regimen.

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

If your child interrupts treatment with Montelukast Sandoz

Montelukast can only treat your child's asthma if they continue taking it. It is essential that your child continues taking montelukast for the time their doctor prescribes. It will help control your child's asthma.

If you have any other doubts about using this medication, ask your child's doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if your child experiences any of the following serious side effects, which may require urgent medical attention.

Side effectsinfrequent(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 mood and behavior: restlessness, including aggressive or hostile behavior, depression,
• seizures.

Side effectsrare(may affect up to 1 in 1,000 people):

• increased tendency to bleed,
• shakiness,
• palpitations.

Side effectsvery rare(may affect up to 1 in 10,000 people):

• reduction of blood platelets (thrombocytopenia),
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions. Warning signs include talking about suicide, social isolation, desire to be alone, or feeling trapped or desperate about a situation,
• yellowing of the skin and eyes, unusual fatigue or fever, dark-colored urine caused by liver inflammation (hepatitis),
• swelling (inflammation) of the lungs,
• combination of symptoms similar to the flu, tingling or numbness of the arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome). Inform your doctor immediately if your child experiences one or more of these symptoms,
• severe allergic reactions (erythema multiforme) that may appear without warning.

The clinical trials conducted with montelukast 4 mg granules, 4 mg chewable tablets, 5 mg chewable tablets, or 10 mg tablets, the most frequently reported side effects (may affect up to 1 in 10 people) related to montelukast were:

• headache,
• abdominal pain,
• thirst,

• diarrhea,
• hyperactivity,
• asthma,
• dry, itchy skin,
• skin rash.

These were usually mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain medication).

In addition, while the medication is marketed, the following side effects have been reported:

Side effectsvery frequent(may affect more than 1 in 10 people):

• upper respiratory tract infection.

Side effectsfrequent(may affect up to 1 in 10 people):

• diarrhea, nausea, and vomiting,
• altered liver function test results,
• erythema,
• fever.

Side effectsinfrequent(may affect up to 1 in 100 people):

• behavioral and mood changes (sleep disturbances, including nightmares, sleep disturbances, somnambulism, irritability, anxiety, restlessness),
• dizziness, somnolence, tingling/numbness,
• nasal bleeding,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• fatigue, discomfort, swelling.

Side effectsrare(may affect up to 1 in 1,000 people):

• loss of attention,
• loss of memory,
• shakiness,
• uncontrolled muscle movements.

Side effectsvery rare(may affect up to 1 in 10,000 people):

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum),
• obsessive-compulsive symptoms,
• stuttering.

Reporting of 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 theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the date indicated after CAD/EXP that appears on the packaging and the overwrap. The expiration date is the last day of the month indicated.

Store below 25 °C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast Sandoz

• The active ingredient is: montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: mannitol, hydroxypropylcellulose and magnesium stearate.

Appearance of the product and contents of the package

White or almost white granules.

Montelukast Sandoz 4 mg granules are packaged in PET/Alu/PE sachets and included in a cardboard package.

Package sizes:

7, 10, 14, 20, 28, 30 and 100 sachets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek S.A.

Ul. Domaniewska 50C,

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2d,

9220 Lendava

Slovenia

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures jud. mures

Romania

or

Lek S.A.

Ul. Podlipie Str.16

95-010 Strykow

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Montelukast Sandoz 4 mg-Granulat

Slovenia:Mofenstra 4 mg zrnca

Finland:Montelukast Sandoz 4 mg rakeet

Hungary:Montelukast Sandoz 4 mg granulátum

Poland:Montelukast Sandoz

Portugal:Montelucaste Sandoz

United Kingdom:Montelukast Sodium 4 mg Oral Granules

Sweden:Montelukast Sandoz 4 mg granulat

This leaflet was approved in April 2020

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