MONKASTA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Monkasta

Tell 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 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 gets worse, 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. Always have your rescue inhalation medication for asthma attacks.
• 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Use in children

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

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

Taking Monkasta with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 you are taking the following medicines:

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

Taking Monkasta with food

Monkasta 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether Monkasta appears in 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 or use machines. 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 use machines.

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 medicine.

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

3. How to take Monkasta

Follow exactly the administration instructions of this medicine given 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 in the evening.

If you are taking Monkasta, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medicine should be taken orally.

You can take Monkasta 10 mg with or without food.

If you take more Monkasta than you should

Seek immediate medical attention.

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 adverse effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you forget to take Monkasta

Try to take Monkasta as prescribed. However, if you forget a dose, just resume your regular schedule of one tablet once a day.

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

If you stop taking Monkasta

Monkasta may only treat asthma if you continue to take it. It is important to continue taking Monkasta for as long as your doctor indicates. It will help you control your asthma.

If you have any further questions on 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 everybody gets them.

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

• abdominal pain,
• headache.

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

Serious side effects

Talk to your doctor immediatelyif 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 in breathing or swallowing,
• mood-related 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,
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions,
• swelling (inflammation) of the lungs,
• severe skin reactions (erythema multiforme) that may 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,
• elevated liver enzymes.

Uncommon: may affect up to 1 in 100 people

• mood-related 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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled movements of the muscles.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at 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 which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Monkasta contains

• The active substance is montelukast. Each tablet contains 10 mg of montelukast (as montelukast sodium).
• The other ingredients 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 and packaging

The film-coated tablets are apricot-colored, round, slightly biconvex, and with 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 box.

Not all 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. Równolegla 5, 02-235 Warsaw, Poland

You can ask for more information about this medicine from 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 last revision of this leaflet: February 2024

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/”