Montelukast Cinfa 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

montelukast cinfa 5 mg chewable tablets EFG

montelukast sodium

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only, and must not be given to other people, even if they have the same symptoms as you or your child, since it could harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What montelukast cinfa is and what it is used for

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

How montelukast cinfa works

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

When to use montelukast cinfa

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

• montelukast 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 therapy.
• montelukast is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• montelukast also helps prevent airway narrowing caused by exercise.

Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how montelukast cinfa 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. Asthma symptoms include: coughing, wheezing, and chest tightness.

2. What you need to know before taking montelukast cinfa

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

Do not take montelukast cinfa

If you or your child

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

Warnings and precautions

Talk to your doctor or pharmacist before you or your child start taking montelukast cinfa.

• If your asthma or breathing, or your child's, worsens, inform your doctor immediately.
• montelukast cinfa is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for yourself or your child. Always keep your rescue inhaled medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. montelukast cinfa must not be used instead of other asthma medications prescribed by your doctor for you or your child.
• 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 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 worsen your asthma.

Neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you must consult your doctor.

Children and adolescents

Do not give this medicine to children under 6 years of age. For children aged 2 to 5 years, montelukast cinfa 4 mg chewable tablets and montelukast cinfa 4 mg granules are available.

For children aged 6 to 14 years, montelukast cinfa 5 mg chewable tablets are available.

Taking montelukast cinfa 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.

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

Before taking montelukast, inform your doctor if you or your child are taking the following medicines:

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

Taking montelukast cinfa with food and drink

montelukast cinfa 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is not known whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast cinfa.

Driving and using machines

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

montelukast cinfa contains aspartame (E-951)

This medicine contains 1.50 mg of aspartame per tablet.

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

montelukast cinfa contains sodium

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

3. How to take montelukast cinfa

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

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

For children aged 6 to 14 years:

The recommended dose is one 5 mg chewable tablet once daily in the evening.

montelukast cinfa 5 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after meals. The tablets should be chewed before swallowing.

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

If you or your child take more montelukast cinfa than you should

Seek immediate help from your doctor.

In most overdose cases, 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you or your child forget to take montelukast cinfa

Try to take montelukast cinfa 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 a double dose to make up for missed doses.

If you or your child stop taking montelukast cinfa

montelukast cinfa can control your asthma or your child's asthma only if you or your child continue taking it. It is important that you continue taking montelukast for the length of time prescribed by your doctor. It will help control your asthma 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 will experience them.

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

• headache

Additionally, the following adverse effects were 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 receiving placebo (a tablet containing no active ingredient).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse effects, as they 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 related to 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes related to 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 during post-marketing of the medicine

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

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

• changes related to 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 frequently appearing on the shins (erythema nodosum)
• changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you or your child experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of montelukast cinfa

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of montelukast cinfa

• The active substance is montelukast. Each montelukast cinfa 5 mg tablet contains 5 mg of montelukast base (as 5.20 mg of montelukast sodium).
• The other components are: microcrystalline cellulose (E-460), mannitol (E-421), sodium carboxymethylstarch (type A) (from potato), aspartame (E-951), magnesium stearate (E-572), cherry flavour, and red iron oxide (E-172).

Appearance of the product and contents of the pack

The tablets are reddish in colour, cylindrical, biconvex, and marked with the code "MO2" on one side. They are presented in aluminium/aluminium blisters. Each pack contains 28 or 200 (EC) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: April 2024

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

You can access detailed and current information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74196/P_74196.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74196/P_74196.html