Leaflet: information for the user

Montelukast Normon 10 mg film-coated tablets EFG

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

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

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

2. What you need to know before you start taking Montelukast Normon

3. How to take Montelukast Normon

4. Possible side effects

5. Storage of Montelukast Normon

6. Contents of the pack and additional information

What is Montelukast Normon

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

How Montelukast Normon works

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

When to use Montelukast Normon

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

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

Depending on symptoms and the severity of your asthma, your doctor will determine how to 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 conditions.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation of the inner layer of the airways.

Asthma symptoms include: coughing, wheezing, and congestion in the chest.

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.

Typical symptoms of seasonal allergies may include: a stuffy nose, runny nose, sneezing; itchy nose; watery, itchy, red, and puffy eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast Normon

• If you are allergic to montelukast or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take montelukast.

Several neuropsychiatric events (e.g., changes in behavior and mood-related, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, contact your doctor.

Children and adolescents

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

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and Montelukast Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications you are using.

Before taking montelukast, inform your doctor if you are taking the following medications:

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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Use during pregnancy

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

Use during breastfeeding

The presence of montelukast in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking montelukast.

Driving and operating machines

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

Montelukast Normon contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

For adults and adolescents 15 years of age and older

The recommended dose is one 10 mg tablet daily at night.

Make sure you are not taking any other product that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take montelukast with or without food.

If you take more Montelukast Normon than you should

Seek help from your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Montelukast Normon

Try to take montelukast as prescribed. However, if you forget a dose, limit yourself to resuming the usual regimen of one tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast Normon

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

It is essential that you continue taking montelukast for the time your doctor prescribes. It will help control your asthma.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, which may be severe and may require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• allergic reactions that include swelling in the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding.
• tremors
• palpitations

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

• a combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood 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 reported during the marketing of the drug

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
• enzymes elevated in the liver

Not common (may affect up to 1 in 100 people):

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, discomfort, swelling

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

• behavior and mood changes: attention alteration, memory alteration, involuntary muscle movements

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

• red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)

behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store below 30 °C.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Normon

- The active ingredient is montelukast. Each tablet contains montelukast sodium corresponding to 10 mg of montelukast.

• The other components are:

Core: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch (potato), low-substitution 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 packaging

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

Montelukast 10 mg is presented in a blister pack of 28 tablets.

Holder of the marketing authorization and responsible manufacturerLABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

Date of the last review of this leaflet:May 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75844/P_75844.html