Monkasta 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Monkasta 5 mg chewable tablets EFG

For children from 6 to 14 years of age

montelukast

Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.

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

Leaflet contents

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 adverse 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 is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Monkasta works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Monkasta improves asthma symptoms and helps control asthma.

When Monkasta should be used

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

• Monkasta is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
• Monkasta is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Monkasta also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how Monkasta should be used.

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 triggers.
  • Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
  • Swelling (inflammation) of the inner lining of the airways.

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

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

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

Do not take Monkasta

• if you or your child are allergic to montelukast sodium or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you or your child start taking Monkasta:

• If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
• Oral Monkasta is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you or your child. Always keep your rescue inhaled medication for asthma attacks with you.
• It is important that you or your child take all asthma medications prescribed by your doctor. Monkasta should not be used instead of other asthma medications prescribed by your doctor for you or your child.
• Any patient 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 pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

Children and adolescents

Do not give this medicine to children under 6 years of age.

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

Taking Monkasta with other medicines

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

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

Before taking Monkasta, inform your doctor if you or your child 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)

Taking Monkasta with food

Monkasta 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

It is unknown whether Monkasta passes into breast milk. If you are breastfeeding or plan to breastfeed, you should 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 drowsiness) reported with Monkasta may affect a patient's ability to drive or operate machinery.

Monkasta contains aspartame and sodium

This medicine contains 1.5 mg of aspartame in each chewable tablet.

Aspartame is a source of phenylalanine, which may be harmful to you or your child if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

3. How to take Monkasta

Always take this medicine exactly as your doctor or pharmacist has instructed you. Consult your doctor or pharmacist if you have any doubts.

• You or your child must take only one Monkasta chewable tablet once daily, as prescribed by your doctor.
• It must be taken even when you or your child do not have symptoms or during an acute asthma attack.

Use in children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet at night.

If you or your child are taking Monkasta, make sure that neither your child nor you take any other medicine containing the same active substance, montelukast.

This medicine is for oral use.

The tablets must be chewed before swallowing.

Monkasta 5 mg chewable tablets should not be taken with food; they must be taken at least 1 hour before or 2 hours after meals.

If you or your child 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 91 652 04 20, stating the medicine and the amount ingested.

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

If you or your child forget to take Monkasta

Try to take/give Monkasta as prescribed. However, if you or your child miss a dose, simply resume the usual regimen of one chewable tablet once daily.

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

If you or your child stop taking Monkasta

Monkasta can only treat your or your child's asthma if taken continuously. It is important to continue taking Monkasta for as long as your doctor prescribes it. It will help control your or your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In clinical trials with Monkasta 5 mg chewable tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 patients) were:

• headache.

Additionally, the following adverse effect was reported in clinical trials with montelukast 10 mg film-coated tablets:

• abdominal pain.

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active ingredient).

Serious adverse effects

Talk to your doctor or your child's doctor immediately if you notice any of the following side effects, which may be serious and for which your child 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 bleeding,
• 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,
• severe skin reactions (erythema multiforme) which may occur without warning,
• inflammation of the liver (hepatitis).

Other adverse effects reported after 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,
• 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 feelings, restlessness,
• dizziness, somnolence, tingling/numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• weakness/tiredness, malaise, swelling.

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

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

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

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

Reporting of adverse effects

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

5. Storage of 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 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. Unused medicines and their packaging should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, please 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 chewable tablet contains 5 mg of montelukast (as montelukast sodium).

• The other components are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E951), red iron oxide (E172), black cherry flavour (also contains glyceryl triacetate (E1518)) and magnesium stearate (See section 2 “Monkasta 5 mg contains aspartame and sodium”).

Appearance of the product and contents of the pack

The tablets are pink, mottled, round, slightly biconvex, with bevelled edges and engraved with “5” on one side.

Available in packs of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 chewable tablets in blisters.

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 more information about this medicine, 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 medicine 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 most recent review of this leaflet: February 2024

"Detailed and up-to-date information about this medicinal product is available on the eeb website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"