Leaflet: information for the user

Montelukast ratiopharm 5 mg chewable tablets EFG

For children aged 6 to 14 years

Read this 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, and should not be given to others 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, consult your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Montelukast ratiopharm 5 mg chewable tablets and what is it used for

2. What you need to know before you or your child take Montelukast ratiopharm 5 mg chewable tablets

3. How to take Montelukast ratiopharm 5 mg chewable tablets

4. Possible side effects

5. Storage of Montelukast ratiopharm 5 mg chewable tablets

6. Contents of the pack and additional information

What is Montelukast ratiopharm 5 mg chewable tablets

Montelukast ratiopharm 5 mg chewable tablets is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast ratiopharm 5 mg chewable tablets works

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast ratiopharm 5 mg chewable tablets improves asthma symptoms, helps control the disease.

When to use Montelukast ratiopharm 5 mg chewable tablets

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

• Montelukast ratiopharm 5 mg chewable tablets is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their medication and need additional treatment.

• Montelukast ratiopharm 5 mg chewable tablets is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not taken oral corticosteroids recently for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.

• Montelukast ratiopharm 5 mg chewable tablets also helps prevent airway narrowing caused by exercise.

The use of Montelukast ratiopharm 5 mg chewable tablets will depend on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how to use it.

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 diseases.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner layer of the airways.

Asthma symptoms include: coughing, wheezing, and congestion in the chest.

Inform your child's doctor of any allergy or medical condition your child has now or has had.

Do not take/dé Montelukast ratiopharm 5 mg chewable tablets:

• If you or your child are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before you or your child take Montelukast ratiopharm 5 mg chewable tablets.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast ratiopharm 5 mg chewable tablets are not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your child's or your rescue inhaler medication available for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast ratiopharm should not be used in place of other asthma medications prescribed by your child's 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 of arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their child's doctor.
• You or your child should not take aspirin or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your child's asthma.

Neuropsychiatric events (e.g., changes in behavior and mood, depression, and suicidal tendencies)have been reported in patients of all ages treated with montelukast(see section 4). If your child develops these symptoms while taking Montelukast ratiopharm 5 mg, consult your doctor.

Children and adolescents

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

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

Taking Montelukast ratiopharm 5 mg chewable tablets with other medications

Inform your child's doctor or pharmacist if your child is taking/using, has taken/recently used, or may need to take/use any other medication, including those purchased without a prescription.

Some medications may affect the functioning of Montelukast ratiopharm 5 mg chewable tablets or montelukast may affect the functioning of other medications.

Before taking Montelukast ratiopharm 5 mg chewable tablets, inform your doctor if you or your child are taking the following medications:

- phenobarbital (used for the treatment of epilepsy).

- phenytoin (used for the treatment of epilepsy).

- rifampicin (used for the treatment of tuberculosis and some other infections).

- gemfibrozil (used for the treatment of hypertriglyceridemia, hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast ratiopharm 5 mg chewable tablets with food and drinks

Montelukast ratiopharm 5 mg chewable tablets should not be taken immediately with meals. They should be taken in the afternoon 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

Breastfeeding

The presence of montelukast in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast ratiopharm.

Driving and operating machinery

Montelukast ratiopharm 5 mg is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and drowsiness) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast ratiopharm contains aspartame

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

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Montelukast ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist for you or your child. In case of doubt, consult your doctor or pharmacist again.

• You or your child should only take one chewable tablet of montelukast once a day, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or when they have an acute asthma attack.

For children aged 6 to 14 years

The recommended dose is one chewable tablet of 5 mg dailythat should be taken at night.

If you or your child are taking Montelukast ratiopharm 5 mg chewable tablets, make sure that neither your child nor you take any other product containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

Montelukast ratiopharm 5mg chewable tablets should not be taken with meals; it should be taken at least 1hour before or 2hours after eating.

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

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

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

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

Seek help from your doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in overdose in adults and children were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

Carry this leaflet, the remaining tablets, and the packaging to the hospital or doctor so they know how manytablets were consumed.

You can also consult your pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Montelukast ratiopharm 5 mg chewable tablets or forgot to give Montelukast ratiopharm 5 mg chewable tablets to your child

Try to take/give montelukast as prescribed. However, if you or your child forget a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

Do not take/double a dose to compensate for missed doses.

If you or your child interrupt treatment with Montelukast ratiopharm 5 mg chewable tablets

Montelukast ratiopharm 5 mg chewable tablets can only treat your asthma or your child's asthma if you or your child continue taking it. It is essential to continue taking this medication for the time your doctor or your child's doctor prescribes it. It will help control your asthma or your child's asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side 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 drug and reported most frequently (may affect up to 1 in 10 people), were:

• headache
• abdominal pain
• thirst

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

Severe side effects

Consult your doctor immediatelyif you observe any of the following side effects, which may be severe andyou or your childmay require urgent medical treatment.

Uncommon (may affect up to 1 in 100people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section2)
• low platelet count
• behavior and mood changes: 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 side effects reported during the marketing of the drug

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

• upper respiratory tract infections

Common (may affect up to 1 in 10 people)

• diarrhea, nausea, and vomiting
• fever
• skin rash
• increased levels of liver enzymes

Uncommon (may affect up to 1 in 100 people)

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, agitation
• dizziness, somnolence, tingling/numbness of the extremities
• nasal bleeding, dry mouth
• indigestion
• bruises, itching, urticaria
• muscle or joint pain, muscle cramps
• weakness, fatigue, general feeling of discomfort, swelling

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

• behavior and mood changes: altered attention, altered memory, uncontrolled muscle movements

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

• red, painful lumps under the skin that more frequently appear on the acne (erythema nodosum)
• behavior and mood changes: altered attention, altered memory, uncontrolled muscle movements

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD or EXP. The expiration date is the last day of the month indicated.

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

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Montelukast ratiopharm 5 mg chewable tablets

- The active ingredient is montelukast. Each chewable tablet contains 5.20 mg of montelukast sodium, which is equivalent to 5 mg of montelukast.

- The other components are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, iron oxide red (E172), cherry aroma PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), sodium glycolate starch Type A (from potato) and magnesium stearate.

Appearance of the product and contents of the packaging

The 5 mg chewable tablets are pink speckled tablets, square in shape, engraved with “93” on one side and “7425” on the other.

Montelukast 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.

Packaging with aluminum-aluminum blister.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing

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

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 medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Montelucaste ratiopharm

Spain: Montelukast ratiopharm 5 mg chewable tablets EFG

Last review date of this leaflet: August 2024

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