Montelukast Teva 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Teva 4 mg chewable tablets EFG

Read the entire leaflet carefully before giving this medicine to your child, as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any adverse reactions, consult your child's 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 give Montelukast Teva to your child
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 for the treatment of patients aged 2 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 the treatment of their asthma and who have demonstrated inability 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 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.

Asthma symptoms include: coughing, wheezing, and chest tightness.

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

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

Do not give Montelukast Teva 4 mg to your child:

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

Warnings and precautions

Talk to your child's doctor or pharmacist before giving Montelukast Teva 4 mg chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep 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 Teva should not replace other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, you should be aware that if he or she develops 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 child's 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 his or her asthma.
• If your child has 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 to patients with phenylketonuria.

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

Children and adolescents

Do not give this medicine to children under 2 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 4 mg with other medicines

Tell your child's 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 works, or montelukast may affect how other medicines your child is taking work.

Before taking Montelukast Teva, inform your doctor if your child is 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 4 mg with food and drinks

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

Pregnancy, breastfeeding and fertility

This section does not apply to Montelukast Teva 4 mg chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast Teva chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Montelukast is not expected to affect the ability to drive a car or operate machinery in adults. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and drowsiness) that have been 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 per chewable tablet.

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

Montelukast Teva contains sodium

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

3. How to take Montelukast Teva

Follow exactly the instructions given by your child's doctor or pharmacist regarding the administration of this medicine. If in doubt, please consult your child's doctor or pharmacist again.

• This medicine should be administered to children under the supervision of an adult. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
• Your child should take only one chewable tablet of montelukast per day, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years

The recommended dose is one 4 mg Montelukast Teva chewable tablet daily, taken in the evening.

If your child is taking Montelukast Teva, make sure they do not 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 meals.

If your child takes more Montelukast Teva than they should

Seek immediate help from your child's doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20.

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 give Montelukast Teva to your child

Try to administer montelukast as prescribed. However, if your child misses a dose, simply resume the usual regimen of one chewable tablet once daily. Do not give a double dose to make up for missed doses.

If your child stops treatment with Montelukast Teva

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

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

For pediatric patients aged 6 to 14 years, Montelukast Teva 5 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 4 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:

• abdominal pain
• thirst

In addition, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those receiving placebo (a tablet 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: 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 in 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 post-marketing use 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
• 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, anxiety, stress
• dizziness, somnolence, tingling/numbness in 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 disturbance, uncontrolled muscle movements

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

• painful red lumps under the skin, which most commonly appear 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, consult 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 blister and 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in 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 4 mg chewable tablets

• The active substance is montelukast. Each chewable tablet contains 4.16 mg of montelukast sodium, equivalent to 4 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 4 mg chewable tablets are pink, speckled, triangular-shaped tablets, imprinted with "93" on one side and "7424" on the other.

Montelukast Teva 4 mg chewable tablets are available in pack sizes of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the European Economic Area member states under the following names:

Austria: Montelukast ratiopharm 4mg Kautabletten
Czech Republic: Montelukast Teva
Denmark: Montelukast Teva
Estonia: Montelukast Teva
Spain: Montelukast Teva 4 mg chewable tablets EFG
Finland: Montelukast ratiopharm 4mg, purutabletti
Hungary: Montelukast Teva 4mg rágótabletta
Ireland: Montelukast Teva 4mg Chewable Tablets
Norway: Montelukast Teva 4mg, tyggetablett
Poland: Montelukast Teva, 4 mg, tabletki do rozgryzania i zucia
Portugal: Montelucaste Teva 4 mg Comprimido para Mastigar
Slovakia: Montelukast Teva 4mg

Date of the most recent review of this leaflet: August 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/