Montelukast Teva 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Teva 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, as 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Montelukast Teva is

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

How Montelukast Teva works

Leukotrienes cause narrowing and inflammation of the airways in the lungs and can trigger allergy symptoms. By blocking 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 and to prevent asthma symptoms during the day and night.

• Montelukast is used to treat adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current asthma medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom montelukast is indicated for asthma, 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 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.

Asthma symptoms include: Cough, 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 starting to take Montelukast Teva

Tell your doctor about any allergies or medical conditions you currently have or have had in the past.

Do not take Montelukast Teva 10 mg

• 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 to take Montelukast Teva 10 mg film-coated tablets EFG.

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

• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication for asthma attacks on hand.

• 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.

• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

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 the age range.

Use of Montelukast Teva 10 mg with other medicines

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 Teva, inform your doctor if you are taking the following medicines:

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

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

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 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

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should 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 adverse effects (such as dizziness and somnolence) that have been reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Teva 10 mg contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him 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; therefore, it is essentially “sodium-free”.

3. How to take Montelukast Teva

Follow exactly the instructions for use of 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 have no symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years 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 substance, montelukast.

This medicine is taken orally.

You may take montelukast with or without food.

If you take more Montelukast Teva 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.

If you forget to take Montelukast Teva

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 Teva

Montelukast can treat your asthma only 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 about the use of this medicine, ask your doctor or pharmacist.

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

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

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 in breathing or swallowing
• changes in behaviour and mood: excitation 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 of arms and legs, worsening of pulmonary 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 the marketing 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
• skin 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
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

• changes in behaviour and mood: attention disturbance, memory impairment, 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components are: core: sodium lauryl sulfate, monohydrate lactose, hydroxypropyl cellulose, pregelatinized corn starch, sodium carboxymethyl starch (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 pack

Montelukast Teva 10 mg film-coated tablets are film-coated, beige-colored, round tablets, marked 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.

Aluminium-aluminium blister packs.

Some pack sizes may not be marketed.

Marketing Authorisation Holder

Teva Pharma, S.L.U.
Anabel Segura 11, Edificio Albatros B, 1st floor
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
The Netherlands

or

TEVA OPERATIONS POLAND SP.Z.O.O.
Ul. Mogilska 80, 31-546 Krakow
Poland

This medicinal product is authorised in the European Economic Area member states under 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

Date of the most recent revision of this leaflet: August 2024

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