Package Insert: Information for the User

Montelukast Teva 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication, as it contains important information for you.

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

1. What is Montelukast Teva and how is it used

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

3. How to take Montelukast Teva

4. Possible adverse effects

5. Storage of Montelukast Teva

6. Contents of the package and additional information

What is Montelukast Teva

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

How Montelukast Teva 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 takeMontelukast Teva

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 with asthma for whom montelukast is indicated, it 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, 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: Stuffy nose, runny nose, sneezing; itchy nose; watery, swollen, red, and itchy eyes.

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

Do not take Montelukast Teva 10 mg

- If you are allergic to montelukast or to 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 Teva 10 mg film-coated tablets.

• If your asthma or breathing worsens, inform your doctor immediately.

• Montelukast oral is 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 asthma medications prescribed by your doctor. Montelukast Teva 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 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.

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.

Use of Montelukast Teva 10 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained 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 Teva, inform your doctor if you are taking the following medications:

• Phenobarbital (used for the treatment of epilepsy).
• Phenytoin (used for the treatment of epilepsy).
• Rifampicin (used for the treatment of tuberculosis and some other infections).
• Gemfibrozil (used for the treatment of elevated plasma lipid levels)

Taking Montelukast Teva 10 mg film-coated tablets with food and beverages

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

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Teva 10 mg film-coated tablets.

Driving and operating machinery

Montelukast is not expected to affect your ability to drive a car or operate machinery. 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 machinery.

Montelukast Teva 10 mg contains lactose

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

Montelukast Teva 10 mg contains sodium

This medication 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 Teva 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 once a day, at night.

If you are taking Montelukast Teva, 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 Teva 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.

If you forgot to take Montelukast Teva

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 Teva

Montelukast can only treat your asthma if you continue to take 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 pediatric patients aged 2 to 5 years, there are available chewable tablets of 4 mg.

For pediatric patients aged 6 to 14 years, there are available chewable tablets of 5 mg.

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:

• abdominal pain
• headache

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 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
• liver inflammation (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
• elevated liver enzymes

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
• bruises, 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, uncontrolled 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 acne (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 leaflet. 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 that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

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 pointat 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 Teva 10 mg film-coated tablets

- The active ingredient is montelukast. 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, sodium carboxymethylcellulose (Type A) from potato, magnesium stearate; coating: Opadry yellow 20A23676 containing hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

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

Montelukast Teva 10 mg film-coated tablets are available in pack sizes of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Aluminum-Aluminum blister packs.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13 (Debrecen) H-4042

Hungary

or

Pharmachemie B.V.

Swensweg,5Haarlem, 2031 GA

Netherlands

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:

Austria: Montelukast ratiopharm 10mg Filmtabletten

Czech Republic: Montelukast Teva 10mg, potahované tablety

Denmark: Montelukast Teva 10 mg, filmovertrukne tabletter

Slovakia: Montelukast Teva 10 mg

Spain: Montelukast Teva 10 mg comprimidos recubiertos con película EFG

Estonia: Montelukast Teva

Finland: Montelukast ratiopharm 10mg kalvopäällysteiset tabletit

Hungary: Montelukast Teva 10mg filmtabletta

Ireland: Montelukast Teva 10mg Film-Coated Tablets

Norway: Montelukast Teva 10 mg, filmdrasjerte tabletter

Poland: Montelukast Teva

Portugal: Montelucaste Teva 10 mg comprimidos revestidos por película

Last review date of this leaflet: August 2024

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