Leaflet: information for the user

Montelukast Aurovitas 10 mg film-coated tablets EFG

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 have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, 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 Montelukast Aurovitas is and what it is used for

2.What you need to know before you start taking Montelukast Aurovitas

3.How to take Montelukast Aurovitas

4.Possible side effects

5Storage of Montelukast Aurovitas

6. Contents of the pack and additional information

What is Montelukast Aurovitas

Montelukast is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast Aurovitas worksMontelukast Aurovitas

Leukotrienes produce 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 useMontelukast Aurovitas

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 with their medication and need 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.

The dosage of Montelukast Aurovitas will depend on your symptoms and the severity of your asthma, as determined by your doctor.

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 conditions.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation of the inner layer of the airways.

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

What are seasonal allergies?

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

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

Do not take Montelukast Aurovitas

• 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 Aurovitas.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Aurovitas oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Aurovitas should not be substituted for other asthma medications prescribed by your doctor.
• Any patient being treated with asthma medications should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

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

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

Taking Montelukast Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Before taking Montelukast, inform your doctor if you are 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 high blood lipid levels treatment)

Taking Montelukast Aurovitas with food and drinks

Montelukast Aurovitas 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 evaluate whether you can takemontelukastduring this period.

Breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or intend to breastfeed, you must consult your doctor before taking Montelukast Aurovitas.

Driving and operating machinery

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

Montelukast Aurovitas contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Montelukast Aurovitas contains sodium

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 Aurovitas tablet once a day, as prescribed by your doctor.
• You should take it even when you do not have symptoms or when you 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 Aurovitas, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take Montelukast Aurovitas with or without food.

If you take more Montelukast Aurovitas than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone: 91 562 04 20) indicating the medication and the amount ingested.

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 forget to take Montelukast Aurovitas:

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

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

If you interrupt treatment with Montelukast Aurovitas:

Montelukast Aurovitas can only treat your asthma if you continue taking it.

It is essential that you continue taking Montelukast Aurovitas for the time your doctor prescribes. It will help control your asthma.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

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

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of Montelukast Aurovitas and reported most frequently (may affect up to 1 in 10 people), were:

• abdominal pain,
• headache.

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

Severe side effects

Consult your doctor immediatelyif you observe any of the following side effects, as they may be severe and require urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

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

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

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

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

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2),
• low platelet count,
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions,
• lung inflammation,
• severe skin reactions (erythema multiforme) that may occur without warning,
• inflammation of the liver (hepatitis).

Other side effects reported during the marketing of the medicine

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infections.

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting,
• skin rash,
• fever,
• elevated liver enzymes.

Uncommon (may affect up to 1 in 100 people):

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

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

• behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements.

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

• red, painful lumps under the skin that more frequently appear on the face (erythema nodosum).
• behavioral and mood changes: 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 the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 box/label/bottle after CAD. 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.

Use within 30 days following the first opening of the PEAD bottle.

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

Composition of Montelukast Aurovitas

• The active ingredient is montelukast. Each tablet contains montelukast sodium, equivalent to 10 mg of montelukast.
• The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, hydroxypropylcellulose (E 463), magnesium stearate (E 572).

Covering: hydroxypropylcellulose (E 463), 6cp hypromellose (E 464), titanium dioxide (E 171), yellow iron oxide (E 172), carnauba wax (E 903), red iron oxide (E 172).

Appearance of the product and contents of the package

Film-coated tablets

Beige-colored film-coated tablets, square in shape with rounded edges, marked with "X" on one face and "54" on the other face of the tablet.

Poliamide / Aluminum foil / PVC - Aluminum foil blisters

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

High-density polyethylene (PEAD) bottles with polypropylene stopper containing silica gel desiccant

Package sizes: 30 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

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

FranceMONTELUKAST ARROW 10 mg, coated tablet

GermanyMontelukast Aurobindo 10 mg Filmtabletten

IrelandMONTELUKAST 10 mg Film-Coated Tablets

ItalyMontelukast Aurobindo 10mgfilm-coated tablets

MaltaMontelukast Aurobindo 10mg film-coated tablets

NetherlandsMontelukast Aurobindo 10 mg, filmomhulde tabletten

PolandMontelukast Aurovitas

SpainMontelukast Aurovitas 10 mg film-coated tablets

Last review date of this leaflet: February 2024

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