Montelukast Teva 4 mg granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Teva 4 mg granules EFG

Read all of this leaflet carefully before giving this medicine to your child, because it contains important information.

• 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 your child only and must not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If you notice any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Montelukast Teva is and what it is used for
2. What you need to know before your child takes 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 is Montelukast Teva

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

How Montelukast Teva works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

When to use Montelukast Teva

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

• Montelukast is used to treat patients aged 6 months to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for treatment of their asthma and who have been shown to be unable to use inhaled corticosteroids.
• Montelukast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how montelukast granules should be used.

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.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

2. What you need to know before your child takes Montelukast Teva

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Teva to your child:

• if they 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 giving Montelukast Teva to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child’s rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used instead of other asthma medications prescribed for your child.
• If your child is being treated with asthma medications, you 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 lung symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

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

Children and adolescents

Do not give this medicine to children under 6 months of age.

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

Taking Montelukast Teva with other medicines

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how Montelukast Teva works, or Montelukast Teva may affect how other medicines your child is taking work.

Before starting montelukast, inform your doctor if your child is 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 hypertriglyceridemia, mixed hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva with food and drinks

Montelukast Teva granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This section does not apply to Montelukast Teva 4 mg granules, as it is indicated for use in children aged between 6 months and 5 years.

Driving and using machines

This section does not apply to Montelukast Teva 4 mg granules, as it is indicated for use in children aged between 6 months and 5 years. However, the following information is important regarding the active substance, montelukast.

Montelukast is not expected to affect the ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and somnolence), which have been very rarely reported with montelukast, may affect a patient’s ability to drive or operate machinery.

Montelukast Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; this is essentially “sodium-free”.

3. How to take Montelukast Teva

Follow exactly the dosing instructions for this medicine provided by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. Your child should take Montelukast Teva every night.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

Use in children from 6 months to 5 years of age:

The recommended dose is one sachet of Montelukast Teva 4 mg oral granules each night.

If your child is taking montelukast, make sure they do not take any other product containing the same active substance, montelukast.

For children aged 6 months to 2 years, Montelukast Teva 4 mg granules are available.

For children aged 2 to 5 years, Montelukast Teva 4 mg chewable tablets and Montelukast Teva 4 mg granules are available. The Montelukast Teva 4 mg granules formulation is not recommended for children under 6 months of age.

How should I give Montelukast Teva granules to my child?

This medicine is taken orally.

• Do not open the sachet until the time of use.
• Montelukast Teva granules may be administered:
• directly into the mouth;
• or mixed with one spoonful of soft food at cool or room temperature (e.g., applesauce, ice cream, carrots, or rice).
• Mix the entire contents of the montelukast granules sachet with one spoonful of cool or room-temperature soft food, taking care to ensure the full dose is mixed with the food.
• Make sure to administer the entire spoonful of the food/granule mixture immediately to the child (within 15 minutes). IMPORTANT: Never store any leftover mixture of food/granules for later use.
• Montelukast granules are not intended to be dissolved in liquids. However, your child may drink liquids after swallowing the montelukast granules.
• Montelukast granules may be taken regardless of meal times.

If your child takes more Montelukast Teva than they should

Contact your child's doctor immediately.

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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give Montelukast Teva to your child

Try to give the montelukast granules as prescribed. However, if your child misses a dose, simply resume the usual regimen of one sachet once daily.

Do not give a double dose to make up for missed doses.

If your child stops treatment with Montelukast Teva

Montelukast will only treat your child's asthma if treatment is continued. It is important that your child continues taking montelukast for the duration prescribed by their doctor. It will help control your child's asthma.

If you have any further questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• diarrhea
• hyperactivity
• asthma
• itchy or scaly skin
• rash

Additionally, the following adverse effects were reported in clinical trials with Montelukast 10 mg film-coated tablets and Montelukast 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• thirst

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill containing no active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects in your child, as they may be serious and your child 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 breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to bleed
• tremor
• palpitations

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

• combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung symptoms and/or 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 post-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

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

Uncommon: may affect up to 1 in 100 people

• changes in behaviour and mood: sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (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, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects:

If your child experiences any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and outer box after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Teva granules

• The active substance is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components (excipients) are: mannitol, hydroxypropylcellulose, sodium lauryl sulfate and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Montelukast Teva 4 mg granules are white or almost white granules.

Packs containing 7, 20, 28, 30 and 98 sachets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

Spain

Manufacturer:

PHARMACHEMIE B.V.

Swensweg, 5, 2031 GA Haarlem

The Netherlands

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

(Blaubeuren) - D-89143

Germany

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY

Pallagi ut 13 (Debrecen) - H-4042

Hungary

TEVA OPERATIONS POLAND, S.P. Z.O.O

ul. Mogilska 80, 31546 Kraków

Poland

TEVA PHARMA, S.L.U.

C/ C, n 4 Polígono Industrial Malpica (Zaragoza) - 50016

Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany: Montelukast-ratiopharm 4mg Granulat
Bulgaria: Ephyra 4 mg granules
Spain: Montelukast Teva 4 mg granulado EFG
Slovakia: Montelukast Teva 4 mg granulát
France: Montelukast Teva
Hungary: Montelukast Teva 4 mg granulátum
Ireland: Montelukast Teva
Italy: Montelukast Dorom 4 mg granulato
Norway: Montelukast Teva
United Kingdom (Northern Ireland): Montelukast 4 mg granules
Sweden: Montelukast Teva

Date of the most recent review of this leaflet: February 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74856/P_74856.html

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