Leaflet: information for the user

Montelukast ratiopharm 10 mg film-coated tablets

For adolescents aged 15 years and older and adults

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 ratiopharm is and for what it is used

2. What you need to know before starting to take Montelukast ratiopharm

3. How to take Montelukast ratiopharm

4. Possible side effects

5. Storage of Montelukast ratiopharm

6. Contents of the pack and additional information

Montelukast ratiopharm belongs to a group of medicines called leukotriene receptor antagonists.

How Montelukast ratiopharm works

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

When to use Montelukast ratiopharm

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

• Montelukast is used to treat adults and adolescents 15 years of age or older who are not adequately controlled with their asthma medication and need additional treatment.
• Montelukast also helps prevent airway constriction caused by exercise in patients 15 years of age or older.
• In patients with asthma for whom montelukast is indicated, 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 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.
• Reactive airways that 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, swollen, red, and itchy eyes.

Do not take Montelukast ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Montelukast ratiopharm.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast ratiopharm tablets are not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all the asthma medications prescribed by your doctor. Montelukast ratiopharm 10 mg 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related changes) in adults, adolescents, and children (see section 4). If you or your child develops these symptoms while taking Montelukast ratiopharm, you should consult your doctor or your child's doctor.

Children and adolescents

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

For pediatric patients aged 6 months to 14 years, other presentations of this medicine are available based on age range.

Taking Montelukast ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or might have to take/use any other medicine, including those obtained without a prescription.

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

Before taking Montelukast ratiopharm, inform your doctor if you are taking the following medicines:

• phenobarbital (used for epilepsy treatment).
• phenytoin (used for epilepsy treatment).
• rifampicin (used for tuberculosis and some other infections treatment).
• gemfibrozil(used for treating elevated lipid levels in plasma)

Taking Montelukast ratiopharm with food and drinks

Montelukast ratiopharm can be taken at night with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan 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

The presence of montelukast in breast milk is unknown.If you are breastfeeding or plan to breastfeed, you should consult your doctor before takingMontelukast ratiopharm.

Driving and operating machinery

Montelukast ratiopharm 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 somnolence) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast ratiopharm 10 mg contains lactose

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

Montelukast ratiopharm 10 mg contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated 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.

• You should only take one montelukast tablet once a day, as prescribed by your doctor.
• You should take it 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 daily at night.

If you are taking this medication, make sure you do not take 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 ratiopharm 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 who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Montelukast ratiopharm

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 ratiopharm

Montelukast 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.

For children aged 2 to 5 years, chewable tablets of 4 mg are available.

For children aged 2 to 5 years who have difficulty taking a chewable tablet, a granulated formulation of 4 mg is available.

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

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

In clinical trials conducted with montelukast, the side effects related to the administration of the drug and reported most frequently (may affect more than 1 in 10 people), were:

• abdominal pain
• headache

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

Severe side effects

Consult your doctorimmediately if you observe 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 of 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 of 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
• lung inflammation
• 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 infections

Common (may affect up to 1 in 10 people)

• diarrhea, nausea, and vomiting
• fever
• skin rash

enzymes in the liver elevated

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
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness, fatigue, malaise, 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)

• behavior and mood changes: obsessive-compulsive symptoms, stuttering
• red, painful bumps under the skin that more frequently appear on the acne (erythema nodosum)

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: http://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, which appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast ratiopharm 10 mg film-coated tablets

- The active ingredient is montelukast sodium. Each film-coated tablet contains 10.40 mg of montelukast sodium equivalent to 10 mg of montelukast.

- The other components are: core: sodium lauryl sulfate, lactose monohydrate, hydroxypropyl cellulose, pregelatinized cornstarch, carboxymethylcellulose sodium type A (potato starch), magnesium stearate; coating: Opadry yellow 20A23676 containing hydroxypropylcellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Montelukast ratiopharm 10 mg are film-coated tablets, beige in color, round, engraved on one side with “93” and on the other side with “7426”.

Montelukast ratiopharm 10 mg is available in pack sizes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Also available are calendar packs of 10, 14, 20, and 28 tablets.

Aluminum-Aluminum blister packs.

Some pack sizes may not be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer responsible

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Or

Teva Pharma S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

Or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp. z.o.o.

Ul. Mogilska 80 31-546 Krakow,

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: MonteluBronch 10mg Filmtabletten

Portugal: Montelucaste ratiopharm

Spain: Montelukast ratiopharm 10 mg film-coated tablets EFG

Last review date of this leaflet:July 2023

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