Montelukast Teva-Ratiopharm 5 mg chewable tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Montelukast Teva-ratiopharm 5 mg chewable tablets EFG

For children aged 6 to 14 years

Read the entire leaflet carefully before you or your child start taking this medicine, 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 only for you or your child. Do 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 adverse effects, consult your child's doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Montelukast Teva-ratiopharm 5 mg Chewable Tablets Are and What They Are Used For

What Are Montelukast Teva-ratiopharm 5 mg Chewable Tablets?

Montelukast Teva-ratiopharm 5 mg chewable tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Teva-ratiopharm 5 mg Chewable Tablets Work

Leukotrienes cause narrowing and swelling of the airways in your lungs. By blocking leukotrienes, Montelukast Teva-ratiopharm 5 mg chewable tablets improve asthma symptoms and help control the disease.

When to Use Montelukast Teva-ratiopharm 5 mg Chewable Tablets

Your doctor has prescribed Montelukast Teva-ratiopharm 5 mg chewable tablets to treat asthma and to prevent asthma symptoms during the day and night.

• Montelukast Teva-ratiopharm 5 mg chewable tablets are used to treat pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast Teva-ratiopharm 5 mg chewable tablets are 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 Teva-ratiopharm 5 mg chewable tablets also help prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your or your child's asthma, your doctor will determine how Montelukast Teva-ratiopharm 5 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 you or your child take Montelukast Teva-ratiopharm 5 mg chewable tablets

Inform your child's doctor of any allergies or current or past medical conditions your child may have.

Do not take/give Montelukast Teva-ratiopharm 5 mg 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 child's doctor or pharmacist before you or your child take Montelukast Teva-ratiopharm 5 mg chewable tablets.

• If your asthma or breathing, or your child's, worsens, inform your doctor immediately.
• Montelukast Teva-ratiopharm 5 mg chewable tablets are NOT indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for yourself or for your child. Always keep your child's or your own rescue inhaler medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Teva-ratiopharm should not be used instead of other asthma medications prescribed for your child by the doctor.
• Some patients 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 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.

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 5 mg, you should consult your 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 based on age range.

Taking Montelukast Teva-ratiopharm 5 mg chewable tablets 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 Teva-ratiopharm 5 mg chewable tablets or montelukast work, or montelukast may affect how other medicines work.

Before taking Montelukast Teva-ratiopharm 5 mg chewable tablets, inform your doctor if you or your child 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 hypertriglyceridemia, hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva-ratiopharm 5 mg chewable tablets with food and drinks

Montelukast Teva-ratiopharm 5 mg chewable tablets should not be taken immediately with food. The tablet should be taken in the evening, 1 hour before or 2 hours after meals.

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 passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast Teva-ratiopharm.

Driving and using machines

Montelukast Teva-ratiopharm 5 mg 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-ratiopharm contains aspartame

This medicine contains 0.5 mg of aspartame per chewable tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have 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 23 mg of sodium (1 mmol) per chewable tablet; therefore, it is essentially "sodium-free".

3. How to take Montelukast Teva-ratiopharm 5 mg chewable tablets

Follow exactly the dosing instructions for this medicine given to you by your doctor or pharmacist, either for yourself or for your child. If in doubt, consult your 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 have no 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-ratiopharm 5 mg chewable tablets, make sure that neither you nor your child take any other product containing the same active substance, montelukast.

This medicine is taken by mouth.

The tablets should be chewed before swallowing.

Montelukast Teva-ratiopharm 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.

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

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

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

If you or your child take more Montelukast Teva-ratiopharm 5 mg chewable tablets than you should

Seek medical help 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, drowsiness, thirst, headache, vomiting, and hyperactivity.

Take this leaflet, any remaining tablets, and the packaging with you to the hospital or doctor so they know how many tablets were consumed.

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

If you or your child forget to take Montelukast Teva-ratiopharm 5 mg 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-ratiopharm 5 mg chewable tablets

Montelukast Teva-ratiopharm 5 mg chewable tablets can only control your asthma or your child's asthma if you or your child continue taking them. It is important to keep taking this medicine for as long as your doctor or your child's doctor has prescribed 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 or pharmacist.

4. Possible adverse effects

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

In clinical trials with montelukast 5 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:

• headache
• abdominal pain
• drowsiness

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet that does not contain any medicine).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse effects, which may be serious and you or 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: excitability 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) which 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 infections

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

• diarrhoea, nausea and vomiting
• fever
• skin rash
• increased levels of 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, agitation
• dizziness, somnolence, tingling/numbness of the limbs
• nosebleeds, dry mouth
• indigestion
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• weakness, fatigue, general 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 patients):

• painful red lumps under the skin, usually appearing on the shins (erythema nodosum)
• changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

Reporting of adverse effects

If you or your child experience any type of 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 Medicinal Products: 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 5 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 CAD or EXP. 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 must 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 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 starch glycolate Type A (from potato) and magnesium stearate.

Appearance of the product and contents of the pack

The 5 mg chewable tablets are pink speckled, square-shaped tablets, marked with “93” on one side and “7425” on the other.

Montelukast Teva-ratiopharm 5 mg chewable tablets are available in pack sizes of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Aluminium-aluminium blister packs.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp.z.o.o.

Ul. Mogilska 80, Krakow - 31-546

Poland

or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA PHARMA S.L.U.

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

Spain

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

Portugal: Montelucaste ratiopharm

Spain: Montelukast Teva-ratiopharm 5 mg chewable tablets EFG

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/

You can access detailed information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76681/P_76681.html

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