Patient Information Leaflet

Montelukast Sandoz 10 mg Film-Coated Tablets

montelukast

Read this 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 are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, 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 is it used for

2.What you need to know before taking Montelukast

3.How to take Montelukast Sandoz

4.Possible side effects

1. Storage of Montelukast Sandoz

6.Contents of the pack and additional information

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 cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast Sandoz

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

• Montelukast is used to treat adults and adolescents 15 years of age and older who are not adequately controlled and require additional treatment.
• Montelukast also helps prevent airway constriction caused by exercise.
• In patients with asthma for whom montelukast is indicated, 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 to use montelukast.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to narrowing of the airways. Airway narrowing worsens and improves in response to various situations.
• Sensitive airways that react to numerous situations, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner layer of the airways.

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

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response caused by airborne pollen from trees, grass, and weeds. Seasonal allergy symptoms often include: nasal congestion, runny nose, itchy nose, and watery, red, or itchy eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast Sandoz:

-if you are allergic 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 starting to take montelukast tablets:

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

• Montelukast tablets for oral administration are not indicated for treating asthma attacks. In case of an attack, follow the instructions provided by your doctor. Always carry your rescue medication for inhaling in case of an asthma attack.

• It is essential that you or your child take all asthma medications prescribed by your doctor. Montelukast tablets should not be substituted for other asthma medications prescribed by your doctor.

• Patients undergoing treatment with asthma medications should be aware that if they develop a combination of symptoms such as pseudogripal illness, tingling or numbness in the arms or legs, worsening of respiratory symptoms, and/or rash, they should consult their doctor.

• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if your asthma worsens.

Children and adolescents

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

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and Montelukast Sandoz

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

Some medications may affect the functioning of montelukast tablets or montelukast tablets may affect the functioning of other medications.

Inform your doctor if you are taking the following medications before starting to take montelukast tablets:

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used to treat tuberculosis and other infections)
• gemfibrozil (used to treat elevated lipid levels in plasma)

Taking Montelukast Sandoz with food and beverages

Montelukast tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will inform you if you can take montelukast tablets during this period.

Breastfeeding

The excretion of montelukast tablets in breast milk is unknown. You should consult your doctor before taking montelukast tablets if you are breastfeeding or intend to breastfeed.

Driving and operating machinery

Montelukast tablets are not expected to affect your ability to drive or operate machinery. However, individual responses to medication may vary. Some reported side effects (such as dizziness and somnolence) associated 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 that you have an intolerance to some sugars, consult them before taking this medication.

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

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

• You should only take one montelukast 10 mg tablet once a day as prescribed by your doctor.
• You should take it even if you do not have symptoms or have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet per day at night.

If you are taking montelukast, make sure not to take any other medication that contains the same active ingredient, montelukast.

This medication is for oral use.

You can take montelukast with or without food.

Montelukast should not be used in children under 15 years of age due to the high content of active ingredient.

There are other formulations with suitable concentrations for younger children.

If you take more Montelukast Sandoz than you should

Consult your doctor immediately.

No adverse effects were reported in most overdose notifications. The most frequent symptoms associated with overdose in adults and children included abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

If you have taken more Montelukast Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Montelukast Sandoz

Try to take montelukast as prescribed. However, if you forget a dose, simply resume the usual schedule of one tablet per day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast Sandoz

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

If you have any other questions 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.

Consult your doctor immediately if you notice any of the following serious side effects, as you may need emergency medical treatment:

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

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

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

• increased tendency to bleed,
• shaking,
• seizures.

Side effectsvery rare(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 talking about suicide, isolating from social contact, wanting to be alone or feeling trapped or desperate about a situation,
• yellowing of the skin and eyes, unusual tiredness or fever, dark-colored urine caused by liver inflammation (hepatitis),
• swelling (inflammation) of the lungs,
• a combination of symptoms with pseudo-influenza, tingling or numbness in the arms and legs, worsening of respiratory symptoms and/or rash (Churg-Strauss syndrome). Inform your doctor immediately if your child experiences one or more of these symptoms,
• severe skin reactions (erythema multiforme) that 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 side effects reported very frequently (may affect up to 1 in 10 people) that could be related to montelukast were:
• abdominal pain,
• headache,
• thirst,
• diarrhea,
• hyperactivity,
• asthma,
• scaly skin and itching,
• rash.

They were generally mild and occurred more frequently in patients treated with montelukast than in those who received a placebo (an inactive pill).

Additionally, during the marketing of the medicine, the following have been reported:

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

• upper respiratory tract infections.

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

• diarrhea, nausea, vomiting,
• abnormal liver function test results,
• skin rash,
• fever.

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

• behavioral and mood-related changes (sleep anomalies, including nightmares, difficulty sleeping, sleepwalking, irritability, anxiety),
• dizziness, drowsiness, tingling/numbness,
• nasal bleeding,
• dry mouth, indigestion,
• hematoma, itching, hives,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• tiredness, feeling unwell, swelling.

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

• shaking,
• attention disturbances, memory disorders
• uncontrolled muscle movements.

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

• red, painful lumps under the skin, more frequently on the shin (erythema nodosum),
• stammering,
• obsessive-compulsive symptoms.

Reporting 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 blister pack and on the carton packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°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 medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Sandoz

• The active ingredient is montelukast.

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

• The other components are:

Core:Lactose monohydrate, hydroxypropylcellulose type EF, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Covering: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 package

Coated tablet, beige in color, round, biconvex, and smooth on both faces.

The tablets are packaged inOPA/Al/PVC/Al blisters inserted in a cardboard package.

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

Only some package sizes may be commercially available.

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

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

Last review date of this leaflet:May 2024

Other sources of information:

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