Package Insert: Information for thePatient

Montelukast Teva 4 mg Chewable Tablets EFG

Read this package insert carefully before giving this medicine to your child, as it contains important information.

• Keep this package insert, 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 your child, and should not be given to others who have the same symptoms, 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 package insert. See section 4.

1. What is Montelukast Teva and how is it used

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

3. How to take Montelukast Teva

4. Possible side effects

5. Storage of Montelukast Teva

6. Contents of the package and additional information

What is Montelukast Teva

Montelukast is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast Teva works

Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma.

When to use Montelukast TevaMontelukast Teva

Your doctor has prescribed montelukast to treat your child's asthma and 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 medication and need additional treatment.

• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.

• Montelukast also helps prevent airway constriction caused by exercise in patients aged 2 years and older.

Depending on symptoms and the severity of your child's asthma, your doctor will determine how to use montelukast.

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.
• Swelling (inflammation) of the inner layer of the airways.

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

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

Do not give Montelukast Teva 4 mg to your child:

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

Warnings and precautions

Consult your child's doctor or pharmacistbefore giving Montelukast Teva 4 mg chewable tablets to your child.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukastis 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 available for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by your child's doctor.Montelukast Teva should not replace 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 their doctor.
• Your child should not take aspirin or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen their asthma.
• If your child has phenylketonuria, be aware that Montelukast Teva chewable tablets contain aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to patients with phenylketonuria.

Several 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 chewable tablets, they should contact their doctor.

Children and adolescents

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

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

Taking Montelukast Teva 4 mg with other medications

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

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

Before taking Montelukast Teva, inform your child's 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 Teva 4 mg with food and drinks

Montelukast Teva 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 Teva 4 mg chewable tablets since its use is indicated in children aged 2 to 5 years.

Driving and operating machinery

This subsection is not applicable to Montelukast Teva chewable tablets, as its use is indicated in children aged 2 to 5years. However, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your 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)notified with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Teva 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 the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Montelukast Teva 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 Montelukast Teva 4 mg daily, which should be taken at night.

Make sure your child is not taking any other medication that contains the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Teva than they should

Seek help from your child's doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

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

If you forgot to give Montelukast Teva to your child

Try to give montelukast 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 Teva

Montelukast can only treat your child's asthma if they continue taking it.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 questions about the use of this medication, 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 15 years of age and older, Montelukast Teva 10 mg film-coated tablets are available.

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

In clinical trials conducted with montelukast 4 mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:

•abdominal pain

•fatigue

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

•headache

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

Uncommon (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 and actions

•lung inflammation

•severe skin reactions (erythema multiforme) that may occur without warning

•liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

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

• Upper respiratory tract infection.

Common(may affect up to 1 in 10 people)

• Diarrhea, nausea, and vomiting,
• skin rash,
• fever,
• enzymes elevated in the liver.

Uncommon(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
• bruising, itching, urticaria
• muscle or joint pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, discomfort, swelling.

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

• Behavioral and mood changes: alteration of attention, alteration of memory, uncontrolled muscle movements

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

• Red, painful lumps under the skin that more frequently appear on the acne (erythema nodosum)
• Behavioral and mood changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects:

If your child experiences 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 blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.Store the blister pack in the original packaging to protect it from light.

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

Composition of Montelukast Teva 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 aroma PHS-143671: maltodextrins (corn) and modified starch E1450, aspartame (E951), carboxymethylstarch sodium (corn) (Type A) 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 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 some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U

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

28108 Alcobendas. Madrid

Spain

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13 (Debrecen) - H-4042

Hungary

or

Pharmachemie B.V.

Swensweg, 5 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80, 31-546 Krakow

Poland

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: August 2024

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