Monkasta

Package leaflet: Information for the patient

Monkasta, 10 mg, film-coated tablets
For adults and adolescents aged 15 years and older
Montelukastum
Please read the following information carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Monkasta is and what it is used for
2. Important information 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 Monkasta is
Monkasta is a leukotriene receptor antagonist that blocks the action of substances called leukotrienes.
How Monkasta works
Leukotrienes cause narrowing and swelling of the airways and trigger allergy symptoms. By inhibiting the activity of leukotrienes, Monkasta relieves asthma symptoms, helps control asthma, and alleviates 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 to prevent daytime and nighttime asthma symptoms.

• Monkasta is used in the treatment of adults and adolescents aged 15 years and older who have not achieved adequate control with previously used medications and require additional therapy.
• Monkasta also helps prevent exercise-induced narrowing of the airways.
• In patients with asthma for whom Monkasta is indicated, it may also relieve symptoms of seasonal allergic rhinitis.

Your doctor will determine how to use Monkasta based on your symptoms and the severity of asthma.
What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing varies in intensity in response to various triggers.
• Heightened sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways.

Asthma symptoms include coughing, wheezing, and a feeling of tightness in the chest.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are allergic reactions commonly triggered by airborne pollen from trees, grasses, and weeds. Typical symptoms of seasonal allergies include: nasal congestion, runny nose, itchy nose, sneezing; watery, swollen, red, itchy eyes.

2. Important information before using Monkasta

Inform the doctor about any health problems and allergies currently present or experienced in the past by the patient.

When not to use Monkasta

• if the patient is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Inform your doctor or pharmacist before starting to take Monkasta.

• If asthma or breathing worsens, inform your doctor immediately.
• Monkasta for oral use is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the instructions provided by your doctor. Always have your reliever inhaler available for use during asthma attacks.
• It is important to take all anti-asthma medicines as prescribed by your doctor. Do not replace other anti-asthma medicines prescribed by your doctor with Monkasta.
• Every patient taking anti-asthma medicines should know that if symptoms such as flu-like illness, tingling or numbness in hands and feet, worsening of respiratory symptoms and/or rash occur, medical advice should be sought.
• Do not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they cause worsening of asthma.

Various neuropsychiatric events (e.g. behavioral and mood changes, depression, and suicidal ideation) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in the patient while taking montelukast, consult a doctor.

Children

This medicine should not be given to children under 15 years of age.
Different formulations of this medicine are available for use in children under 18 years of age, depending on age.

Other medicines and Monkasta

Inform your doctor or pharmacist about all medicines currently or recently taken, including those obtained without a prescription.

Some medicines may affect the action of Monkasta, or Monkasta may affect the action of other medicines.

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

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and certain other infections),
• gemfibrozil (used to treat high plasma lipid levels).

Monkasta with food and drink

Monkasta 10 mg may be taken during or between meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

The doctor will assess whether Monkasta can be taken during this period.

Breastfeeding

It is not known whether montelukast passes into human milk. If a woman is breastfeeding or intends to breastfeed, she should consult her doctor before using Monkasta.

Driving and operating machinery

Monkasta is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with montelukast may affect the ability to drive or operate machinery in some patients.

Monkasta contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Monkasta

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult
your doctor or pharmacist.

• Take only one Monkasta tablet once daily as directed by your doctor.
• This medicine should be taken even when you have no symptoms or during an acute asthma attack.

Adults and adolescents aged 15 years and above:
The recommended dose is one 10 mg tablet taken once daily in the evening.
When taking Monkasta, ensure that you are not taking any other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
Monkasta 10 mg may be taken with or without food.

Taking more Monkasta than prescribed
Seek medical advice immediately.
In most cases, no adverse effects have been observed. The most commonly reported symptoms in adults and children have been: abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Monkasta
Take Monkasta as prescribed by your doctor. If you miss a dose, continue with your regular dosing schedule—take one tablet once daily.
Do not take a double dose to make up for a missed dose.

Stopping Monkasta
Monkasta is effective in treating asthma only when taken regularly. It is important to continue taking Monkasta for as long as your doctor has instructed. This will help keep your asthma under control.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical trials with montelukast 10 mg film-coated tablets, the most frequently reported side effects
(possibly occurring in up to 1 in 10 people), considered to be related to montelukast treatment, were:

• abdominal pain,
• headache.

These symptoms were usually mild and occurred more frequently in patients treated with montelukast
than in patients receiving placebo (a tablet containing no active medicine).

Serious side effects
You should contact your doctor immediately if any of the following side effects occur, as they may be serious
and may require immediate medical attention.

Uncommon: may occur in up to 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing,
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression,
• seizures.

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

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

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

• a group of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening of respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2),
• decreased platelet count,
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and suicide attempts,
• swelling (inflammation) of the lungs,
• severe skin reactions (erythema multiforme), which may occur without prior warning symptoms,
• hepatitis (inflammation of the liver).

Other side effects reported after the medicine was marketed

Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections.

Common: may occur in up to 1 in 10 people

• diarrhoea, nausea, vomiting,
• rash,
• fever,
• increased liver enzyme levels.

Uncommon: may occur in up to 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling and numbness,
• nosebleeds,
• dryness of the mouth, dyspepsia,
• bruising, itching, urticaria (hives),
• muscle or joint pain, muscle cramps,
• nocturnal enuresis (bedwetting) in children,
• weakness and (or) fatigue, malaise, oedema (swelling).

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

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements.

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

• tender, red nodules under the skin, usually appearing on the shins (erythema nodosum),
• changes in behaviour and mood: obsessive-compulsive symptoms,
• stuttering.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Monkasta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Monkasta contains

• The active substance is montelukast. Each film-coated tablet contains 10 mg of montelukast (as montelukast sodium).
• The other ingredients are: cellactose (monohydrate lactose, cellulose, powder), microcrystalline cellulose, sodium croscarmellose and magnesium stearate in the tablet core; and hypromellose 6 cP (E 464), titanium dioxide (E 171), talc, propylene glycol, red iron oxide (E 172) and yellow iron oxide (E 172) in the tablet coating (coating Opadry Orange 03H32599). See section 2 "Monkasta contains lactose and sodium".

What Monkasta looks like and contents of the pack
The film-coated tablets are apricot-coloured, round, slightly biconvex with bevelled edges.
Pack: 28 and 90 film-coated tablets in blisters, packed in a cardboard box.

Marketing Authorisation 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
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on the names under which the medicinal product is registered in the other European Economic Area (EEA) and United Kingdom (Northern Ireland) countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500