Patient Information

Montelukast Teva 4 mg Granule

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 questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for your child and should not be given to others, even if they have the same symptoms as your child, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

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 and helps control asthma.

When to use Montelukast 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 between 6 months and 5 years of age 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 between 2 and 5 years of age 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 also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

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

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 about any allergy or medical condition your child has now or has had.

Do not give Montelukast Teva 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 Teva to your child.

- If your child's asthma or breathing worsens, inform your child's doctor immediately.

- Montelukast is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your child's doctor has given for your child. Always have your child's rescue inhaler medication for asthma attacks available.

- It is essential that your child uses all asthma medications prescribed by your child's doctor. Montelukast 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 your child develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, 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 make your child's asthma worse.

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 section4). If you develop these symptoms while taking montelukast, contact your child's doctor.

Children and adolescents

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

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

Use of Montelukast Teva with other medications

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

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

Before starting to take montelukast, inform your child's doctor if your child is taking the following medications:

- phenobarbital (used for epilepsy treatment)

- phenytoin (used for epilepsy treatment)

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

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

Taking Montelukast Teva with food and beverages

Montelukast Teva granules can be taken regardless of meal times.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Teva 4 mg granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and operating machinery

This subsection is not applicable to Montelukast Teva 4 mg granules, as its use is indicated in children between 6 months and 5 years of age, 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. 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 Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg); that is, it is essentially “sodium-free”.

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

• This medication should be administered to children under the supervision of an adult. Your child should take Montelukast Teva every night.
• It should be taken even when your child does not have symptoms or when having an acute asthma attack.

Use in children from 6 months to 5 years of age:

The recommended dose is one packet of Montelukast Teva 4 mg granule by oral route every night.

Make sure your child does not take any other product containing the same active ingredient, montelukast.

For children from 6 months to 2 years of age, Montelukast Teva 4 mg granule is available.

For children from 2 to 5 years of age, Montelukast Teva 4 mg chewable tablets and Montelukast Teva 4 mg granule are available. The Montelukast Teva 4 mg granule formulation is not recommended for children under 6 months of age.

How should I give Montelukast Teva granule to my child?

This medication is taken orally.

• Do not open the packet until the time of use.
• Montelukast Teva granule can be administered:
• directly in the mouth;
• Or mixed with a spoonful of cold or room temperature soft food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix all the content of montelukast granule in a spoonful of cold or room temperature soft food, taking care to observe that the full dose is mixed with the food.
• Make sure to administer immediately to the child the entire spoonful with the food/granule mixture (within 15 minutes). IMPORTANT: Never keep leftovers of the food/granule mixture for later use.
• Montelukast granule is not intended to dissolve in liquids. However, your child can take liquids after swallowing montelukast granule.
• Montelukast granule can be taken regardless of meal times.

If your child takes more Montelukast Teva than they should

Contact your child's 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, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or 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 Teva to your child

Try to give montelukast granule as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one packet per day.

Do not give a double dose to compensate for 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 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 conducted with montelukast granules, the side effects related to the administration of the drug and reported most frequently (may affect more than 1 in 10 people), were:

• diarrhea
• hyperactivity
• asthma
• skin with itching or scaly skin
• skin eruption

Additionally, the following side effects were reported in clinical trials with Montelukast 10 mg film-coated tablets and Montelukast 5 mg or 4 mg chewable tablets:

• abdominal pain
• headache
• 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 in your child, which may be severe and your child may require urgent medical treatment.

Rare; 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
• tremors
• 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 eruption (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
• 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 infection

Frequent: may affect up to 1 in 10 people

• diarrhea, nausea, vomiting
• skin eruption
• fever
• enzymes elevated in the liver

Rare: may affect up to 1 in 100 people

• behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness
• dizziness, drowsiness, tingling/numbness, seizures
• nasal bleeding
• dry mouth, indigestion
• bruises, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, 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 bumps under the skin that more frequently appear on the face (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 packaging and over after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and humidity.

Medicines 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 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Teva Granules

- The active ingredient is montelukast.Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.

- The other components (excipients) are, mannitol, hydroxypropylcellulose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the package

Montelukast Teva 4 mg granules are a white or almost white granule.

Packages of 7, 20, 28, 30, and 98 sachets.

Only some package sizes may be commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Madrid

Spain

Responsible manufacturer:

PHARMACHEMIE B.V.

Swensweg, 5. , 2031 GA Haarlem, –

Netherlands

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

(Blaubeuren) - D-89143

Germany

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY

Pallagi ut 13 (Debrecen) - H-4042

Hungary

TEVA OPERATIONS POLAND, S.P. Z.O.O

ul.Mogilska 80, 31546 Kraków

Poland

TEVA PHARMA, S.L.U.

C/ C, n 4 Industrial Estate Malpica (Zaragoza) - 50016

Spain

This medicine is authorized in the member states of the European Economic Areaandin the United Kingdom (Northern Ireland) with the following names:

Germany: Montelukast-ratiopharm 4mg Granules

Bulgaria: Ephyra 4 mg granules

Spain: Montelukast Teva 4 mg granulated EFG

Slovakia: Montelukast Teva 4 mg granulát

France: Montelukast Teva

Hungary: Montelukast Teva 4 mg granulátum

Ireland: Montelukast Teva

Italy:Montelukast Dorom 4 mg granulato

Norway: Montelukast Teva

United Kingdom (Northern Ireland): Montelukast 4 mg granules

Sweden:Montelukast Teva

Last review date of this leaflet: February 2024

More 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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74856/P_74856.html

QR code+ URL