MONKASTA 4 mg CHEWABLE TABLETS

2. What you need to know before giving Monkasta to your child

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Monkasta to your child

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

Warnings and Precautions

Consult your doctor or pharmacist before giving Monkasta to your child

• If your child's asthma or breathing worsens, tell your doctor immediately.
• Monkasta oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor to your child. Always keep your child's rescue inhaler with them for asthma attacks.
• It is essential that your child takes all asthma medications prescribed by their doctor. Monkasta should not be used instead of other asthma medications prescribed by your doctor for your child.
• If your child is being treated with asthma medications, be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.

Children and Adolescents

Do not give this medicine to children under 2 years of age.

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

Taking Monkasta with Other Medicines

Tell your doctor or pharmacist if your child is using, has recently used, or might use any other medicines, including those obtained without a prescription.

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

Before taking Monkasta, tell your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy),
• phenytoin (used to treat epilepsy),
• rifampicin (used to treat tuberculosis and some other infections).

Taking Monkasta with Food and Drinks

Monkasta 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and Breastfeeding

This subsection is not applicable to Monkasta 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and Using Machines

This subsection is not applicable to Monkasta 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age. However, the following information is important for the active substance, montelukast.

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

Monkasta Contains Aspartame and Sodium

This medicine contains 1.2 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine that may be harmful to your child if they have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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 administration instructions of this medicine given by your doctor or pharmacist for your child. In case of doubt, consult your doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. For children who have problems taking a chewable tablet, an oral granule formulation is available.

• Your child should only take one Monkasta chewable tablet once a day, as prescribed by their doctor.
• It should be taken even when you or your child do not have symptoms or when they have an acute asthma attack.

Use in Children from 2 to 5 Years of Age:

The recommended dose is one 4 mg chewable tablet at night.

If your child is taking Monkasta, ensure they do not take any other medicine that contains the same active substance, montelukast.

This medicine should be taken orally.

The tablets should be chewed before swallowing.

Monkasta 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If Your Child Takes More Monkasta Than They Should

Seek help from your child's doctor immediately.

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

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

If You Forget to Give Monkasta to Your Child

Try to give Monkasta as prescribed. However, if your child misses a dose, just resume the usual routine of one chewable tablet once a day.

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

If Your Child Stops Taking Monkasta

Monkasta can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking this medicine for as long as their doctor prescribes it. It will help control your child's asthma.

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

4. Possible Side Effects

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

In clinical trials conducted with Monkasta 4 mg chewable 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,

• thirst.

Additionally, the following side effect was reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache.

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain the active substance).

Serious Side Effects

Talk to Your Child's Doctor Immediatelyif you notice any of the following side effects, which may be serious and for which your child may need urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

• allergic reactions including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing,
• behavior and mood changes: agitation, including aggressive behavior 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 lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see Section 2),
• low platelet count in blood,
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions,
• swelling (inflammation) of the lungs,
• severe skin reactions (erythema multiforme) that can occur without warning,
• inflammation of the liver (hepatitis).

Other Side Effects Have Been Reported While the Medicine Has Been on the Market

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,
• liver enzymes elevated.

Uncommon: may affect up to 1 in 100 people

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling/numbness,
• nosebleed,
• dry mouth, indigestion,
• bruising, itching, hives,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• weakness/tiredness, malaise, swelling.

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

• behavior and mood changes: attention disturbance, memory disturbance, uncontrolled movements of the muscles.

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

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: 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 that appears on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.

Keep in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Monkasta

• The active substance is montelukast.

Each chewable tablet contains 4 mg of montelukast (as montelukast sodium).

• The other ingredients are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E951), red iron oxide (E172), black cherry flavor (also contains glycerol triacetate (E1518)), and magnesium stearate (see section 2 "Monkasta 4 mg contains aspartame and sodium").

Appearance of the Product and Contents of the Pack

The tablets are pink, speckled, round, slightly biconvex, with bisected edges and engraved with "4" on one side.

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

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

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 authorisation holder:

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

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of Last Revision of this Leaflet: February 2024

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"