MONTELUKAST TEVA 4 mg GRANULES

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

Tell your doctor about any allergies or medical problems your child has now or has had.

Do not give Montelukast Teva to your child:

• if they are allergic to montelukast or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before giving Montelukast Teva to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for your child.
• If your child is being treated with asthma medications, they 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 lung symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make their 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 section 4). If your child develops these symptoms while taking montelukast, they should contact their doctor.

Children and adolescents

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

For pediatric patients under 18 years of age, other formulations of this medicine are available based on the age range.

Using Montelukast Teva with other medicines

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take another medicine, including those obtained without a prescription.

Some medicines may affect how Montelukast Teva works, or Montelukast Teva may affect how other medicines your child is using work.

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

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat hypertriglyceridemia, mixed hyperlipidemia, and primary hypercholesterolemia).

Taking Montelukast Teva with food and drinks

Montelukast Teva granules can be taken without regard to 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 using machines

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 child's ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Teva contains sodium

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

3. How to take Montelukast Teva

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

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

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

The recommended dose is one sachet of Montelukast Teva 4 mg granules orally every night.

If your child is taking montelukast, ensure they do 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 granules are available.

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

How should I give Montelukast Teva granules to my child?

This medicine is taken orally.

• Do not open the sachet until the time of use.
• Montelukast Teva granules can be administered:
• directly into the mouth;
• or mixed with a spoonful of soft cold or room-temperature food (e.g., apple sauce, ice cream, carrots, and rice).
• Mix the entire contents of montelukast granules in a spoonful of soft cold or room-temperature food, taking care to observe that the complete dose is mixed with the food.
• Ensure the child is given the entire spoonful of the food/granule mixture immediately (within 15 minutes). IMPORTANT: Never save any leftover mixture for later use.
• Montelukast granules are not intended to be dissolved in liquids. However, your child can drink liquids after swallowing montelukast granules.
• Montelukast granules can be taken without regard to 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 occurred most frequently 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give Montelukast Teva to your child

Try to give montelukast granules as prescribed. However, if your child forgets a dose, simply resume the regular schedule of one sachet once a day.

Do not give a double dose to make up for forgotten doses.

If your child stops taking Montelukast Teva

Montelukast can only treat your child's asthma if they continue taking it. It is essential that your child continues taking montelukast for the time their doctor prescribes it. It will help control your child's asthma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast granules, the side effects related to the administration of the medicine and reported most frequently (may affect more than 1 in 10 people) were:

• diarrhea
• hyperactivity
• asthma
• itchy or scaly skin
• skin rash

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 with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and require urgent medical treatment.

Uncommon; may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 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 lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• inflammation of the lungs (pneumonia)
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

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, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon: may affect up to 1 in 100 people

• behavior and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness, seizures
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

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

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

• painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)
• behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting side effects:

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Teva

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

Do not use this medicine after the expiration date stated on the package and sachet after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

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 ingredients (excipients) are mannitol, hydroxypropylcellulose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and package contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid

Spain

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 Polígono Industrial Malpica (Zaragoza) - 50016

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Montelukast-ratiopharm 4mg Granulat

Bulgaria: Ephyra 4 mg granules

Spain: Montelukast Teva 4 mg granulado 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

Date of the last revision of this prospectus: February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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

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