Patient Information Leaflet: Information for the Patient

Montelukast Teva 5 mg Chewable Tablets EFG

Read this leaflet carefully before you or your child take this medicine, as it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or your child's doctor or pharmacist.
• This medicine has been prescribed for you or your child only, 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 doctor or pharmacist or your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Montelukast Teva and what it is used for

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

3. How to take Montelukast Teva

4. Possible side effects

5. Storage of Montelukast Teva

6. Contents of the pack 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 useMontelukast Teva

Your doctor or your child's doctor has prescribed montelukast chewable tablets to treat asthma, prevent asthma symptoms during the day and night.

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

• Montelukast helps preventairway constrictionprovoked by exercise.

Depending on symptoms and the severity of asthma in you or your child, 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 conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• inflammation of the inner layer of the airways.

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

Inform your doctor about any allergy or medical condition you or your child have now or have had.

Do not take Montelukast Teva 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 doctor or pharmacist before you or your child take Montelukast Teva 5 mg chewable tablets.

• If your asthma or your child's asthma worsens, inform your doctor or your child's doctor immediately.
• Montelukast is 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 available for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Teva should not be used in place of other asthma medications prescribed by your child's doctor.
• • If you or your child are being treated with asthma medications, be aware that if you 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, you should consult your doctor or your child's doctor.
  • You or your child should not take aspirin or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your asthma worse.
  • If you or your child have phenylketonuria, you should know 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.

Adverse neuropsychiatric events

Several neuropsychiatric events (such as changes in behavior and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you or your child develop these symptoms while taking Montelukast chewable tablets, you should contact your doctor or your child's 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 Teva with other medications

Inform your doctor, your child's doctor, or pharmacist if you or your child are taking, have taken recently, 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.

Before taking Montelukast Teva, 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 Teva 5 mg with food and drinks

Montelukast Teva chewable tablets should not be taken with food; they should be taken at night, 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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, you should consult your doctor before taking montelukast chewable tablets.

Driving and operating machinery

Montelukast 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 somnolence) reported 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 to patients with 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 indicated by your doctor, your child's doctor or pharmacist for you or your child. In case of doubt, consult your doctor, your child's 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 daily at night.

If you or your child are taking Montelukast Teva, make sure that neither your child nor you take 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 you or your child take more Montelukast Teva than they should

Seek help from your doctor or pharmacist immediately or call the Toxicological 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 with overdose were abdominal pain, drowsiness, sedation, headache, vomiting and hyperactivity.

If you forgot to take Montelukast Teva chewable tablets or forgot to give Montelukast Teva to your child

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

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

If you or your child interrupt treatment with Montelukast Teva chewable tablets

Montelukast can only treat your asthma or your child's asthma if you or your child continue taking it. It is essential to continue taking montelukast for the time prescribed by your doctor or your child's doctor. 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, your child's doctor or pharmacist.

For pediatric patients aged 2 to 5 years, Montelukast Teva 4 mg chewable tablets are available.

For adult patients aged 15 years 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 5 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:

• headache

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

• abdominal pain

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
• behavioral 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
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• 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 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,
• elevated liver enzymes.

Uncommon(may affect up to 1 in 100 people)

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, stress, agitation
• 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: attention alteration, memory alteration, 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 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 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 packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast Teva 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), carboxymethyl starch sodium (corn) (Type A) and magnesium stearate.

Appearance of the product and contents of the package

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

Montelukast Teva 5 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.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U

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

28108 Alcobendas. Madrid

Spain

Manufacturer responsible

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 5mg Kautabletten

Czech Republic: Montelukast Teva 5mg

Denmark: Montelukast Teva

Estonia: Montelukast Teva

Spain: Montelukast Teva 5 mg chewable tablets EFG

Finland: Montelukast ratiopharm 5mg, purutabletti

Hungary: Montelukast Teva 5mg rágótabletta

Ireland: Montelukast Teva 5mg Chewable Tablets

Latvia: Montelukast Teva

Norway: Montelukast Teva 5mg, Tyggetablett

Poland: Montelukast Teva, 5 mg, tabletki do rozgryzania i żucia

Portugal: Montelucaste Teva 5 mg Comprimido para Mastigar

Slovakia: Montelukast Teva 5mg

Last review date of this leaflet: August 2024

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