Montelukast Normon 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Normon 10 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Montelukast Normon is and what it is used for

What is Montelukast Normon

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

How Montelukast Normon works

Leukotrienes cause narrowing and swelling of the airways in the lungs and may also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When to use Montelukast Normon

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

• Montelukast is used for the treatment of asthma in adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent narrowing of the airways caused by exercise.
• In asthmatic patients for whom montelukast is indicated for asthma, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use montelukast.

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: coughing, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds.

Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Normon

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

Do not take Montelukast Normon

• If you 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 starting montelukast

• If your asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Several 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 contact your doctor.

Children and adolescents

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

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

Other medicines and Montelukast Normon

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

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

Before taking montelukast, inform 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 certain other infections)
• gemfibrozil (used to treat elevated plasma lipid levels)

Taking Montelukast Normon with food and drinks

Montelukast Normon 10 mg film-coated tablets can be taken with or without food.

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.

Use during pregnancy

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

Use during breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast.

Driving and using machines

Montelukast 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 montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Montelukast Normon

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

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

For adults and adolescents aged 15 years and older

The recommended dose is one 10 mg tablet taken once daily in the evening.

If you are taking montelukast, make sure you do not take any other product containing the same active substance, montelukast.

This medicine is taken orally.

Montelukast may be taken with or without food.

If you take more Montelukast Normon 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 medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Montelukast Normon

Try to take montelukast as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet once daily.

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

If you stop taking Montelukast Normon

Montelukast Normon can only treat your asthma if you continue taking it.

It is important that you continue taking montelukast for the duration prescribed by your doctor. It will help control your 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 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

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

Consult your doctor immediately if you experience any of the following adverse 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 breathing or swallowing
• changes in behaviour and mood: excitability 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 lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: 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 adverse effects reported during post-marketing use 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
• 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, 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/tiredness, malaise, swelling

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

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

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

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Normon

Keep this medicine out of sight and reach of children.

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

Store below 30 °C.

Keep in the original packaging to protect from light and moisture.

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 you are in doubt, please ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Montelukast Normon

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
  • The other components are:

Core: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (from potato), low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E-464), magnesium stearate.
Coating: hypromellose, macrogol 6000, titanium dioxide (E-171), talc, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Montelukast 10 mg tablets are cream-colored, round, biconvex, and printed.

Montelukast 10 mg is available in a 28-tablet blister pack.

Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

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

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75844/P_75844.html