Montelukast Teva 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Teva 5 mg chewable tablets EFG

Read all of this leaflet carefully before you or your child take this medicine, because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist or your child's doctor or pharmacist.
• This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any side effects, talk to your doctor or pharmacist or your child's doctor or pharmacist, even if the side effects 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 you or your child take 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 is a leukotriene receptor antagonist that blocks substances known as 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 Montelukast Teva should be used

Your doctor or your child's doctor has prescribed montelukast chewable tablets for the treatment of asthma, preventing asthma symptoms during both day and night.

• Montelukast is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional therapy.

• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast helps prevent airway narrowing caused by exercise.

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

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• difficulty breathing due to narrowing of the airways. This airway narrowing 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 you or your child take Montelukast Teva

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

Do not take Montelukast Teva chewable tablets

• If you or your child 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 you or your child take Montelukast Teva 5 mg chewable tablets.

• If your asthma or breathing, or that of your child, worsens, inform your doctor or your child’s doctor immediately.
• Montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for you or your child. Always keep your child’s or your own rescue inhaler medication readily available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Teva should not be used instead of other asthma medications prescribed by your doctor for your child.
  • If you or your child are being treated with asthma medications, you should be aware that if you 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 or your child’s doctor.
  • You or 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 your asthma.
  • If you or your child have phenylketonuria, you should be aware that Montelukast Teva chewable tablets contain aspartame, which is a source of phenylalanine. Phenylalanine in the tablets may be harmful in patients with phenylketonuria.

Several neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you or your child develop these symptoms while taking Montelukast chewable tablets, you must contact your doctor or your child’s doctor.

Children and adolescents

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

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

Taking Montelukast Teva with other medicines

Tell your doctor, your child’s doctor, or pharmacist if you or your child 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 work.

Before taking Montelukast Teva, inform your doctor if you or your child are taking the following medicines:

• phenobarbital (used to treat epilepsy).
• phenytoin (used to treat epilepsy).
• rifampicin (used to treat tuberculosis and certain other infections).
• gemfibrozil (used to treat hypertriglyceridemia, hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva 5 mg with food and drink

Montelukast Teva chewable tablets should not be taken with food. They should be taken at night, 1 hour before or 2 hours after eating.

Pregnancy, breastfeeding, and fertility

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 chewable tablets pass into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast chewable 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 drowsiness) reported with montelukast may affect a patient’s ability to drive or operate machinery.

Montelukast Teva contains aspartame

This medicine contains 0.5 mg of aspartame in each chewable tablet.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Montelukast Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per chewable tablet; therefore, it is essentially “sodium-free”.

3. How to take Montelukast Teva

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

• You or your child should take only one montelukast chewable tablet once daily, as prescribed by your doctor.
• It should be taken even when you or your child are not experiencing symptoms or during an acute asthma attack.

For children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet daily, taken in the evening.

If you or your child are taking Montelukast Teva, make sure that neither you nor your child take any other medication containing the same active substance, montelukast.

This medicine is taken orally.

The tablets must be chewed before swallowing.

Montelukast should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child take more Montelukast Teva than you should

Seek immediate help from your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20. In most cases of overdose, no adverse effects were reported. The most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

If you or your child forget to take Montelukast Teva chewable tablets or forget to give them to your child

Try to take/give montelukast as prescribed. However, if you or your child miss a dose, simply resume the usual regimen of one chewable tablet once daily.

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

If you or your child stop taking Montelukast Teva chewable tablets

Montelukast can only control your asthma or your child's asthma if you or your child continue taking it. It is important that you continue taking montelukast for as long as your doctor or your child's doctor prescribes it. It will help control your asthma or your child's asthma.

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

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

For adult patients aged 15 years and older, Montelukast Teva 10 mg film-coated tablets are available.

4. Possible adverse effects

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

In clinical trials with montelukast 5 mg chewable tablets, the adverse effects related to administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• headache

Additionally, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets:

• abdominal pain

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

Serious adverse effects

Consult your doctor immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment for you or your child.

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):

• a 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
• serious skin reactions (erythema multiforme) which 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)

• Diarrhoea, nausea and vomiting
• 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, anxiety, stress, restlessness
• dizziness, somnolence, tingling/numbness of the extremities
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• muscle or joint 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 usually appear on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you or your child experience any adverse effect, consult 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 the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep the blister in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Teva 5 mg chewable tablets

• The active substance is montelukast. Each chewable tablet contains 5.20 mg of montelukast sodium, equivalent to 5 mg of montelukast.
• The other components are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, iron oxide red (E172), cherry flavour PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), sodium carboxymethyl starch (corn) (Type A) and magnesium stearate.

Appearance of the product and contents of the pack

The 5 mg chewable tablets are pink, mottled, square-shaped tablets, engraved with "93" on one side and "7425" on the other.

Montelukast Teva 5 mg chewable tablets are available in pack sizes of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U
C/ 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 2031 GA Haarlem
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 5mg Kautabletten
Czech Republic: Montelukast Teva 5mg
Denmark: Montelukast Teva
Estonia: Montelukast Teva
Spain: Montelukast Teva 5 mg chewable tablets EFG
Finland: Montelukast ratiopharm 5mg, purutabletti
Hungary: Montelukast Teva 5mg rágótabletta
Ireland: Montelukast Teva 5mg Chewable Tablets
Latvia: Montelukast Teva
Norway: Montelukast Teva 5mg, Tyggetablett
Poland: Montelukast Teva, 5 mg, tabletki do rozgryzania i zucia
Portugal: Montelucaste Teva 5 mg Comprimido para Mastigar
Slovakia: Montelukast Teva 5mg

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

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