Leaflet: information for the user

Montelukast ratiopharm 4 mg chewable tablets EFG

For children aged 2 to 5 years

Read this 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 doubts, consult your child's doctor or pharmacist.
• This medicine has been prescribed only for your child, and should not be given to other people even if they have the same symptoms as your child, as it may harm them.
• If your child experiences 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 4 mg chewable tablets and what it is used for

2. What you need to know before your child takes Montelukast ratiopharm 4 mg chewable tablets

3. How to take Montelukast ratiopharm 4 mg chewable tablets

4. Possible side effects

5. Storage of Montelukast ratiopharm 4 mg chewable tablets

6. Contents of the pack and additional information

What is Montelukast ratiopharm 4 mg chewable tablets

Montelukast ratiopharm 4 mg chewable tablets is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast ratiopharm 4 mg chewable tablets works

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast ratiopharm 4 mg chewable tablets improves asthma symptoms, helps control the disease.

When is Montelukast ratiopharm 4 mg chewable tablets used

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

• Montelukast ratiopharm 4 mg chewable tablets is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their medication and need additional treatment.

• Montelukast ratiopharm 4 mg chewable tablets is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 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 4 mg chewable tablets also helps prevent asthma symptoms caused by exercise in patients aged 2 years and older.

Depending on the symptoms and severity of your child's asthma, your doctor will determine how to use Montelukast ratiopharm 4 mg chewable tablets.

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, or cold air, or exercise.
• Inflammation (swelling) of the inner layer of the airways.

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

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

Do not give Montelukast ratiopharm 4 mg chewable tablets to your child:

• If your child is 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 giving Montelukast ratiopharm 4 mg chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast ratiopharm 4 mg chewable tablets are not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor.Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all medications for asthma prescribed by your child's doctor. Montelukast ratiopharm should not be used in place 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 respiratory symptoms, and/or skin rash, they should consult your child's doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Children and adolescents

Do not give this medication to children under 2 years of age.

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

Taking Montelukast ratiopharm 4 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 chewable tablets or montelukast may affect the functioning of other medications your child is using.

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

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

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast ratiopharm 4 mg chewable tablets since its use is indicated in children between 2 and 5 years of age.

Driving and operating machinery

This subsection is not applicable to Montelukast ratiopharm 4 mg chewable tablets since its use is indicated in children between 2 and 5 years of age, however, the following information is important for the active ingredient, montelukast.

Montelukast 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 medication may vary. Certain adverse effects (such as dizziness and somnolence) that have been reported rarely 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 because the body is unable to eliminate it correctly.

Montelukast ratiopharm contains sodium

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

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

•This medication 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 only take one chewable tablet of montelukast once a day, as prescribed by their doctor.

•It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one chewable tablet of 4 mg daily at night.

If your child is taking Montelukast ratiopharm, ensure they do not take any other medication containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

Montelukast ratiopharm 4 mg chewable tablets should not be taken with meals; it 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 oral granule formulation is available.

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

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

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

Seek help from your child's doctor immediately.

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

Carry this leaflet, the remaining tablets, and the packaging to the hospital or doctor so they know how many tablets 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 give Montelukast ratiopharm 4 mg chewable tablets to your child:

Try to give Montelukast ratiopharm chewable tablets as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day. Do not give your child a double dose to compensate for the missed doses.

If your child interrupts treatment with Montelukast ratiopharm 4 mg chewable tablets:

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

It is essential that your child continues to take montelukast for the time their doctor prescribes. It will help control your child's asthma.

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

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

In clinical trials with montelukast 4 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:

• abdominal pain
• sedation

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

• headache

These adverse reactions 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 in your child, which may be severe and your child may require urgent medical treatment.

Infrequent (may affect up to 1 in 100 people)

•allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing

•behavioral and mood changes: excitement including aggressive or hostile behavior, depression

•seizures

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

•increased risk of 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 of arms and legs, worsening of respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)

•low platelet count

•behavioral and mood changes: hallucinations, disorientation, suicidal thoughts andactions

•lung inflammation

•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 frequent (may affect more than 1 in 10 people)

• upper respiratory tract infections

Frequent (may affect up to 1 in 10 people)

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

Infrequent (may affect up to 1 in 100 people)

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, stress
• dizziness, somnolence, tingling/numbness of the extremities
• nasal bleeding
• dry mouth, indigestion
• bruises, itching, urticaria
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness, fatigue, general feeling of malaise, swelling

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

• behavioral and mood changes: alteration of attention, alteration of memory, uncontrolled movements of the muscles

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)
• behavioral and mood changes: alteration of attention, alteration of memory, uncontrolled movements of the muscles.

Reporting of side effects

If you 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. Deposit 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 4 mg chewable tablets

- The active ingredient is montelukast. Each chewable tablet contains 4.16 mg of montelukast sodium, which is equivalent to 4 mg of montelukast.

- The other components are: mannitol (E421), sodium lauryl sulfate, hydroxypropylcellulose, iron oxide red (E172), cherry flavor 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 package

The 4 mg chewable tablets are pink speckled tablets, triangular in shape, engraved with “93” on one face and “7424” on the other.

Montelukast 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.

Packaged in Aluminio-Aluminio blister packs.

Only some pack sizes may be commercially available.

Marketing authorization holder and responsible manufacturerand responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Spain

Responsible manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

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

Portugal: Montelucaste ratiopharm

Spain: Montelukast ratiopharm 4 mg chewable tablets EFG

Last review date of this leaflet: August 2024

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