Package Leaflet: Information for the User

Monkasta 10 mg Film-Coated Tablets

For adults and adolescents from 15 years

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 have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Monkasta is and what it is used for

2. What you need to know before you start taking Monkasta

3. How to take Monkasta

4. Possible side effects

5. Storage of Monkasta

6. Contents of the pack and additional information

What is Montelukast

Montelukast 10 mg is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast works

Leukotrienes produce narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma and reduces seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast

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

• Montelukast is used for the treatment of 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 asthmatic patients for whom Montelukast is indicated for asthma, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on 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. 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, cold air, or exercise.
• Inflammation (swelling) 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, swollen, red, and itchy eyes.

Inform your doctor about any medical problems or allergies you have now or have had.

Do not take Monkasta

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

Warnings and precautions

Before taking Monkasta, talk to your doctor or pharmacist.

• If your asthma or breathing worsens, inform your doctor immediately.
• Monkasta 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.
• It is essential that you or your child use all medications for asthma prescribed by your doctor. Monkasta should not replace 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 of 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.

Use in children

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

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

Taking Monkasta with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those purchased without a prescription.

Some medications may affect the functioning of Monkasta, or Monkasta may affect the functioning of other medications you are using.

Before taking Monkasta, 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 plasma lipid levels treatment).

Taking Monkasta with food

Monkasta 10 mg 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 taking this medication.

Pregnancy

Your doctor will evaluate whether you can take Monkasta during this period.

Breastfeeding

We do not know if Monkasta appears in milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Monkasta.

Driving and operating machinery

Monkasta 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 drowsiness) reported with Monkasta may affect the patient's ability to drive or operate machinery.

Monkasta contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

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

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

• You should only take one Monkasta tablet once a day, as prescribed by your doctor.
• It should be taken 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 Monkasta, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medication should be taken orally.

You can take Monkasta 10 mg with or without food.

If you take more Monkasta than you should

Seek help from your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 652 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 forgot to take Monkasta

Try to take Monkasta 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 Monkasta

Monkasta can only treat asthma if you continue taking it. It is essential to continue taking Monkasta for the time indicated 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 may cause side effects, although not everyone will experience them.

In clinical trials conducted with montelukast 10 mg film-coated tablets, side effects related to the administration of the drug and reported with greater frequency (may affect 1 in 10 patients), were:

• abdominal pain,
• headache.

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

Severe side effects

Talk to your doctor immediatelyif you notice any of the following side effects, which may be severe, and may require urgent medical treatment.

Rare: 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: agitation, including aggressive or hostile behavior, depression,
• seizures.

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

• increased tendency to bleed,
• 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 in blood,
• 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 have been reported while the drug has been marketed

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,
• skin rash,
• fever,
• elevated liver enzymes.

Rare: may affect up to 1 in 100 people

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

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

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

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

• red, painful bumps under the skin that more frequently appear on the buttocks (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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: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 blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Keep in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Monkasta

• The active ingredient is montelukast. Each tablet contains 10 mg of montelukast (as montelukast sodium).
• The other components are lactose monohydrate, powdered cellulose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), talc, propylene glycol, red iron oxide (E172), and yellow iron oxide (E172) in the film coating. See section 2 “Monkasta 10 mg contains lactose and sodium”

Appearance of the product and contents of the pack

The film-coated tablets are orange in color, round, slightly biconvex, and have beveled edges.

Available in blister packs of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, and 200 film-coated tablets per pack.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warsaw, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet: February 2024

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