Patient Information Leaflet: Package Leaflet

Montelukast Sandoz 5 mg Chewable Tablets EFG

Read this 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 or pharmacist.
• This medicine has been prescribed 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 you experience 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 it is 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 Sandoz 5 mg chewable tablets is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce 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 the day and night.

• Montelukast Sandoz 5 mg is used for the treatment of patients between 6 and 14 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast Sandoz 5 mg is also used as an alternative treatment to inhaled corticosteroids in patients between 6 and 14 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Sandoz also helps prevent airway constriction caused by exercise.

Depending on symptoms and the severity of your child's 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 situations.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner layer of the 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 (hypersensitive) to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Montelukast Sandoz:

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for your child. Always have your child's rescue inhaler medication available for asthma attacks.
• 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 they develop a combination of symptoms such as: flu-like illness, numbness or tingling of arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.

Children and adolescents

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

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

Other medications and Montelukast Sandoz

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

Inform your 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 Sandoz, inform your doctor if your child is taking the following medications:

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

Taking Montelukast Sandoz with food and beverages

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

Pregnancy and lactation

This subsection is not applicable to Montelukast Sandoz 4 mg chewable tablets, as its use is indicated in children, however, the following information is important for the active ingredient, montelukast.

Use in pregnancy

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

Use in lactation

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

Driving and operating machines

This subsection is not applicable to Montelukast Sandoz 4 mg chewable tablets, as its use is indicated in children, 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 operate machines.

Montelukast Sandoz contains aspartame, azoic red colorant (E129), sodium, and sucrose.

This medication contains 1.2 mg of aspartame in each chewable tablet. Aspartame contains a source of phenylalanine that may be detrimental in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains azoic colorant because it contains red allura. It may cause allergic-type reactions.

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

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay..

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

• Your child should only take one Montelukast Sandoz tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.
• Make sure your child takes Montelukast Sandoz as instructed by their doctor. Consult your child's doctor or pharmacist if you have any doubts.
• It should be taken orally.

The recommended dose is:

For children aged 6 to 14 years:

The daily dose is one chewable tablet of 5 mg at night. Montelukast Sandoz 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.Chewable tablets should be chewed before swallowing.

If your child is taking Montelukast Sandoz, make sure they are not taking any other medication that contains the same active ingredient.

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

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

If your child takes more Montelukast Sandoz than they should:

Contact your child's doctor immediately for help.

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

If your child has taken more Montelukast Sandoz than they should, consult your child's doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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 forgets a dose, simply resume the usual dosage of one tablet once a day.

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

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 prescribed by their doctor. It will help control your child's asthma.

If you have any other doubts about the use of this medication, ask your 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 side effects, as they may require urgent medical treatment.

Rare side effects (may affect up to 1 in 100 people):

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Behavioral and mood-related changes: agitation, including aggressive or hostile behavior, depression,
• Seizures.

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

• Increased risk of bleeding,
• Tremors,
• Palpitations.

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

• Reduced platelet count (thrombocytopenia),
• Behavioral and mood-related changes: 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 particular situation,
• Yellowing of the skin and eyes, unusual fatigue or fever, dark-colored urine caused by liver inflammation (hepatitis),
• Pulmonary inflammation (pneumonitis),
• A combination of symptoms similar to the flu, tingling or numbness in the arms and legs, worsening respiratory symptoms and/or skin rash (Churg-Strauss syndrome). Inform your doctor immediately if your child experiences one or more of these symptoms.
• Severe skin reactions that can occur without warning (erythema multiforme)

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

• Abdominal pain
• Headache
• Thirst
• Hypertension,
• Diarrhea,
• Asthma,
• Itching and dry skin,
• Rash.

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

Additionally, since montelukast has been marketed, the following side 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

• Diarrhea, nausea, vomiting,
• Abnormal liver function test results,
• Rash,
• Fever,

Rare: may affect up to 1 in 100 people

• Behavioral and mood-related changes (sleep disturbances, including nightmares, difficulty falling asleep, sleepwalking, irritability, anxiety, restlessness),
• Dizziness, somnolence, tingling/numbness,
• Nasal bleeding,
• Dry mouth, indigestion,
• Bruising, itching, urticaria,
• Muscle or joint pain, muscle cramps,
• Bedwetting in children,
• Fatigue, discomfort, swelling

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

• Tremors,
• Attention and memory impairment,
• Uncontrolled muscle movements.

Very rare side effects: 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 side effects

If your child experiences 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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 expiration date that appears on the packaging after

the CAD/EXP. The expiration date is the last day of the month indicated.

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

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

Composition of Montelukast Sandoz

• The active ingredient is montelukast.

Each chewable tablet contains montelukast sodium corresponding to 5 mg of montelukast.

• The other components are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose (E463), red iron oxide (E172), croscarmellose sodium, flavoring (cherry flavor AP0551, cherry aroma TD0990B [contains the azoic red colorant allura, E129]), aspartame (E951) and magnesium stearate

Appearance of the product and contents of the package

Montelukast Sandoz are pink, round, chewable tablets engraved with 5 on one face.

The chewable tablets are packaged in OPA/ALU/PVC/ALU or OPA/ALU/PE/ALU blisters and packaged in a cardboard box.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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

Last review date of thisleaflet:May 2024

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