Monkasta 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Monkasta 10 mg film-coated tablets EFG

For adults and adolescents from 15 years of age

montelukast

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Monkasta is and what it is used for
2. What you need to know before taking Monkasta
3. How to take Monkasta
4. Possible side effects
5. How to store Monkasta
6. Contents of the pack and other information

1. What Monkasta is and what it is used for

What is Monkasta

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

How Monkasta works

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

When Monkasta should be used

Your doctor has prescribed Monkasta for the treatment of asthma and to prevent asthma symptoms during the day and night.

• Monkasta is used for the treatment of adults and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Monkasta also helps prevent exercise-induced narrowing of the airways.
• In asthmatic patients for whom Monkasta is indicated for asthma, Monkasta may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use Monkasta.

What is asthma?

Asthma is a chronic disease.

Asthma involves:

• Difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various triggers.
• Sensitive airways that react to many stimuli, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

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. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; and watery, swollen, red, and itchy eyes.

2. What you need to know before starting to take Monkasta

Inform your doctor about any medical conditions or allergies you currently have or have had in the past.

Do not take Monkasta

• if you are allergic to montelukast or to any of the other ingredients of this medicine (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.
• Oral Monkasta is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor. Always keep your rescue inhaled medication for asthma attacks on hand.
• It is important that you or your child use all asthma medications 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 in arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children

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

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

Taking Monkasta with other medicines

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

Some medicines may affect how Monkasta works, or Monkasta may affect how other medicines you are taking work.

Before taking Monkasta, inform your doctor if you are taking any of the following medicines:

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

Taking Monkasta with food

Monkasta 10 mg may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether Monkasta passes into breast milk. If you are breastfeeding or plan to breastfeed, you must consult your doctor before taking Monkasta.

Driving and using machines

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

Monkasta contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Monkasta

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• You should take only one Monkasta tablet once daily, as prescribed by your doctor.
• It should be taken even when you have no symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

The recommended dose is 1 tablet of 10 mg taken once daily in the evening.

If you are taking Monkasta, make sure you do not take any other product containing the same active substance, montelukast.

This medicine is for oral use.

You may take Monkasta 10 mg with or without food.

If you take more Monkasta than you should

Seek medical help immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 652 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Monkasta

Try to take Monkasta as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet once daily.

Do not take a double dose to make up for missed doses.

If you stop taking Monkasta

Monkasta can only control asthma if you continue taking it. It is important to keep taking Monkasta for as long as your doctor has instructed. It will help you manage your asthma.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• abdominal pain,
• headache.

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

Serious side effects

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

Uncommon: 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 behaviour and mood: agitation, including aggressive behaviour or hostility, depression,
• seizures.

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

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

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

• combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2),
• low platelet count in blood,
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions,
• swelling (inflammation) of the lungs,
• serious skin reactions (erythema multiforme) which may occur without warning,
• inflammation of the liver (hepatitis).

Other side effects reported since the medicine 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

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

Uncommon: may affect up to 1 in 100 people

• changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feeling, restlessness,
• dizziness, somnolence, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bed-wetting in children,
• weakness/tiredness, malaise, swelling.

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

• changes in behaviour and mood: difficulty in attention, memory impairment, uncontrolled muscle movements.

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

• painful red lumps under the skin which most frequently appear on the shins (erythema nodosum),
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If you experience any kind of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Monkasta

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Monkasta

• The active substance 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, iron oxide red (E172) and iron oxide yellow (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 apricot-coloured, round, slightly biconvex and with bevelled edges.

Available in blisters 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

Manufacturer

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. Równoległa 5, 02-235 Warsaw, Poland

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: February 2024

"Updated and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"