MONTELUKAST TEVA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Teva 10 mg Film-Coated Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Montelukast Teva

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

How Montelukast Teva works

Leukotrienes cause the airways to narrow and inflame, which can lead to symptoms of asthma. By blocking the leukotrienes, montelukast improves asthma symptoms, helps control asthma, and reduces symptoms of seasonal allergies (also known as seasonal allergic rhinitis or hay fever).

When to take Montelukast Teva

Your doctor has prescribed montelukast to treat asthma, to 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 asthma medication and need additional treatment.
• Montelukast also helps prevent the narrowing of airways caused by exercise.
• In patients with asthma who are indicated for montelukast, 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 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 diseases.
• airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: Coughing, wheezing, and chest congestion.

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: stuffy nose, runny nose; sneezing; itchy, watery, red, and swollen eyes.

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

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Teva 10 mg

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

Warnings and precautions

Consult your doctor or pharmacist before starting Montelukast Teva 10 mg film-coated tablets EFG.

• If your asthma or breathing gets worse, tell your doctor immediately

• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is important 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 of lung symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.

Children and adolescents

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

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

Using Montelukast Teva 10 mg with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

Before taking Montelukast Teva, tell 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 some other infections).
• Gemfibrozil (used to treat high plasma lipid levels)

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

Montelukast Teva 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Teva 10 mg film-coated tablets.

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 side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Teva 10 mg contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Montelukast Teva 10 mg contains sodium

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

3. How to take Montelukast Teva

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You should only take one tablet of montelukast once a day, as prescribed by your doctor.
• It should be taken 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 daily, in the evening.

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

This medicine is taken orally.

Montelukast can be taken with or without food.

If you take more Montelukast Teva than you should

Seek immediate medical attention from your doctor.

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

If you forget to take Montelukast Teva

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

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

If you stop taking Montelukast Teva

Montelukast may only treat your asthma if you continue taking it. It is important that you continue taking montelukast for as long as your doctor prescribes it. It will help control your asthma.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

For pediatric patients 2 to 5 years of age, chewable tablets of 4 mg are available.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• abdominal pain
• headache

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

Serious side effects

Consult your doctor immediatelyif you observe any of the following side 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 in breathing or swallowing
• changes related to behavior and mood: excitement including aggressive behavior or hostility, depression
• seizures

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

• increased risk of bleeding
• tremor
• 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 lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• liver inflammation (hepatitis)

Other side effects reported during the post-marketing use of the medicine

Very common (may affect more than 1 in 10 people):

• upper respiratory infection

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• changes related to behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

• changes related to behavior 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 that most frequently appear on the shins (erythema nodosum)
• changes related to behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Teva

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Teva 10 mg film-coated tablets

• The active substance is montelukast. Each film-coated tablet contains 10.40 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are: core: sodium lauryl sulfate, lactose monohydrate, hydroxypropyl cellulose, pregelatinized corn starch, sodium carboxymethyl cellulose (Type A) of 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 pack contents

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 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.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13 (Debrecen) H-4042

Hungary

or

Pharmachemie B.V.

Swensweg, 5 Haarlem, 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 under the following names:

Austria: Montelukast ratiopharm 10mg Filmtabletten

Czech Republic: Montelukast Teva 10mg, film-coated tablets

Denmark: Montelukast Teva 10 mg, film-coated tablets

Slovakia: Montelukast Teva 10 mg

Spain: Montelukast Teva 10 mg film-coated tablets 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, film-coated tablets

Poland: Montelukast Teva

Portugal: Montelucaste Teva 10 mg film-coated tablets

Date of last revision of this leaflet: August 2024

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