Montelukast Teva-Ratiopharm 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Teva-ratiopharm 4 mg chewable tablets EFG

For children aged 2 to 5 years

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, consult your child's doctor or pharmacist.
• This medicine has been prescribed for your child only, and you should 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 effects, consult your child's doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Montelukast Teva-ratiopharm 4 mg chewable tablets are and what they are used for
2. What you need to know before your child takes Montelukast Teva-ratiopharm 4 mg chewable tablets
3. How to take Montelukast Teva-ratiopharm 4 mg chewable tablets
4. Possible side effects
5. How to store Montelukast Teva-ratiopharm 4 mg chewable tablets
6. Contents of the pack and other information

1. What Montelukast Teva-ratiopharm 4 mg Chewable Tablets Are and What They Are Used For

What Montelukast Teva-ratiopharm 4 mg Chewable Tablets Are

Montelukast Teva-ratiopharm 4 mg chewable tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Teva-ratiopharm 4 mg Chewable Tablets Work

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Teva-ratiopharm 4 mg chewable tablets improve asthma symptoms and help control the disease.

When Montelukast Teva-ratiopharm 4 mg Chewable Tablets Are Used

Your doctor has prescribed Montelukast Teva-ratiopharm 4 mg chewable tablets to treat your child's asthma and to prevent asthma symptoms during the day and night.

• Montelukast Teva-ratiopharm 4 mg chewable tablets are used to treat patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast Teva-ratiopharm 4 mg chewable tablets are also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.

• Montelukast Teva-ratiopharm 4 mg chewable tablets also help prevent exercise-induced asthma symptoms 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 Teva-ratiopharm 4 mg chewable tablets 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-ratiopharm 4 mg chewable tablets

Inform your child's doctor of any allergies or medical conditions your child has now or has previously had.

Do not give Montelukast Teva-ratiopharm 4 mg chewable tablets 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 child's doctor or pharmacist before giving Montelukast Teva-ratiopharm 4 mg chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Teva-ratiopharm 4 mg chewable tablets are not intended to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has provided 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-ratiopharm should not be used instead of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, 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 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 these worsen their asthma.

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 Teva-ratiopharm 4 mg, you should consult 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 the age range.

Taking Montelukast Teva-ratiopharm 4 mg chewable tablets with other medicines

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

Some medicines may affect how Montelukast Teva-ratiopharm chewable tablets work, or montelukast may affect how other medicines your child is taking work.

Before taking Montelukast Teva-ratiopharm chewable tablets, inform your doctor if your child is taking any of 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-ratiopharm 4 mg chewable tablets with food and drinks

Montelukast Teva-ratiopharm 4 mg 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-ratiopharm 4 mg chewable tablets, as this medicine is indicated for use in children aged between 2 and 5 years.

Driving and using machines

This section does not apply to Montelukast Teva-ratiopharm 4 mg chewable tablets, as it is indicated for use in children aged between 2 and 5 years. However, the following information is relevant for the active substance, montelukast.

Montelukast Teva-ratiopharm 4 mg chewable tablets are 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 somnolence), which have been reported very rarely with montelukast, may affect a patient's ability to drive or operate machinery.

Montelukast Teva-ratiopharm contains aspartame

This medicine contains 0.5 mg of aspartame per 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 eliminate it properly.

Montelukast Teva-ratiopharm contains sodium

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

3. How to take Montelukast Teva-ratiopharm 4 mg chewable tablets

Follow exactly the instructions given by your child's doctor or pharmacist for administering this medicine. If you have any doubts, please consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
• Your child should take only one montelukast chewable tablet once daily, 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 chewable tablet taken once daily in the evening.

If your child is taking Montelukast Teva-ratiopharm, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is taken by mouth.

The tablets must be chewed before swallowing.

Montelukast Teva-ratiopharm 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.

For children aged 2 to 5 years who have difficulty taking the chewable tablet, a 4 mg granule formulation is available.

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

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

If your child takes more Montelukast Teva-ratiopharm 4 mg chewable tablets than they should

Seek immediate help from your child's 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, drowsiness, thirst, headache, vomiting, and hyperactivity.

Take this leaflet, any remaining tablets, and the packaging to the hospital or doctor so they can see how many tablets have been consumed.

You may also contact your pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give Montelukast Teva-ratiopharm 4 mg chewable tablets to your child

Try to give Montelukast Teva-ratiopharm chewable tablets as prescribed. However, if your child misses a dose, simply resume the usual schedule 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-ratiopharm 4 mg chewable tablets

Montelukast Teva-ratiopharm 4 mg chewable tablets can only control your child's asthma with continued use.

It is important that your child continues taking montelukast for as long as prescribed by the 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 with montelukast 4 mg chewable tablets, the adverse reactions related to the 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 without active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects in your child, which 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 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 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 the medicine's marketing period

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

• upper respiratory tract infections

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

• diarrhoea, nausea, and vomiting
• fever
• rash
• increased 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, fatigue, general malaise, swelling

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

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements

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

• painful red lumps under the skin, most commonly appearing on the shins (erythema nodosum)
• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements

Reporting of adverse effects

If you experience any type of 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-ratiopharm 4 mg Chewable Tablets

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

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

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

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your 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-ratiopharm 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, red iron oxide (E172), cherry flavour PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), sodium starch glycolate Type A (from potato) and magnesium stearate.

Appearance of the product and contents of the pack

The 4 mg chewable tablets are pink, speckled, triangular-shaped tablets, marked with “93” on one side and “7424” on the other.

Montelukast Teva-ratiopharm 4 mg chewable tablets are available in pack sizes of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Aluminum-Aluminum blister packs.

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 út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

or

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spain

or

Teva Operations Poland Sp.z.o.o.

Ul. Mogilska 80, Krakow - 31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Montelucaste ratiopharm

Spain: Montelukast Teva-ratiopharm 4 mg chewable tablets EFG

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/

You can access detailed information about this medicinal product 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/76680/P_76680.html

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