MONTELUKAST TARBIS 4 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

MONTELUKAST TARBIS 4 mg

chewable tablets EFG

montelukast

Read all of this leaflet carefully before your child starts taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. Do not pass it on to others, even if their symptoms are the same as your child's. It may harm them.
• If you think any of the side effects that your child is getting are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What MONTELUKAST TARBIS 4 mg is and what it is used for
2. Before taking MONTELUKAST TARBIS 4 mg
3. How to take MONTELUKAST TARBIS 4 mg
4. Possible side effects
5. Storage of MONTELUKAST TARBIS 4 mg
6. Further information

1. What MONTELUKAST TARBIS 4 mg is and what it is used for

MONTELUKAST TARBIS 4 mg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, MONTELUKAST TARBIS 4 mg improves asthma symptoms and helps control asthma.

Your doctor has prescribed MONTELUKAST TARBIS 4 mg to treat your child's asthma and prevent asthma symptoms during the day and night.

• MONTELUKAST TARBIS 4 mg is used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• MONTELUKAST TARBIS 4 mg 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 have demonstrated that they are unable to use inhaled corticosteroids.
• MONTELUKAST TARBIS 4 mg also helps prevent narrowing of the airways caused by exercise in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how to use MONTELUKAST TARBIS 4 mg.

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.
• airways that are sensitive to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

Asthma symptoms include: Cough, wheezing, and chest congestion.

2. Before taking MONTELUKAST TARBIS 4 mg

Tell your doctor about any allergy or medical problem that your child has now or has had.

Do not give MONTELUKAST TARBIS 4 mg to your child if

• they are allergic (hypersensitive) to montelukast or any of the other components of MONTELUKAST TARBIS 4 mg. (see 6. FURTHER INFORMATION).

Be careful with MONTELUKAST TARBIS 4 mg

• If your child's asthma or breathing worsens, tell your doctor immediately.
• MONTELUKAST oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions that your doctor has given your child. Always have your child's rescue inhalation medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. MONTELUKAST TARBIS 4 mg should not be used instead of other asthma medications that your doctor has prescribed for your child.
• 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen their asthma.
• Patient should be aware that several neuropsychiatric events have been reported with MONTELUKAST TARBIS 4 mg (such as changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS 4 mg, they should consult their doctor.

Use of other medications

Some medications may affect the functioning of MONTELUKAST TARBIS 4 mg, or MONTELUKAST TARBIS 4 mg may affect the functioning of other medications that your child is using.

Tell your doctor or pharmacist if your child is using or has recently used other medications, even those purchased without a prescription.

Before taking MONTELUKAST TARBIS 4 mg, tell your doctor if your child is taking the following medications:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Taking MONTELUKAST TARBIS 4 mg with food and drinks

MONTELUKAST TARBIS 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 and breastfeeding

This subsection is not applicable to MONTELUKAST TARBIS 4 mg as its use is indicated in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

Use during pregnancy

Women who are pregnant or plan to become pregnant should consult their doctor before taking MONTELUKAST TARBIS. Their doctor will assess whether they can take MONTELUKAST TARBIS during this period.

Use during breastfeeding

It is unknown whether MONTELUKAST TARBIS appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS.

Driving and using machines

This subsection is not applicable to MONTELUKAST TARBIS 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

MONTELUKAST TARBIS is not expected to affect the ability to drive or use machines. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with MONTELUKAST TARBIS may affect the patient's ability to drive or use machines.

Important information about some of the components of MONTELUKAST TARBIS 4 mg

MONTELUKAST TARBIS 4 mg chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare inherited disorder of metabolism), they should be aware that each 4 mg chewable tablet contains 1.35 mg of phenylalanine.

3. How to take MONTELUKAST TARBIS 4 mg

• This medication should be administered to children under adult supervision.
• Your child should only take one MONTELUKAST TARBIS 4 mg tablet 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.
• Make sure your child always takes MONTELUKAST TARBIS 4 mg as their doctor has told them.

Consult your child's doctor or pharmacist if you have any doubts.

• It should be taken orally.

For children from 2 to 5 years of age:

One 4 mg chewable tablet should be taken daily in the evening. MONTELUKAST TARBIS 4 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after meals.

If your child is taking MONTELUKAST TARBIS 4 mg, make sure they do not take any other medication that contains the same active ingredient, montelukast.

For children from 2 to 5 years of age, MONTELUKAST TARBIS 4 mg chewable tablets are available.

For children from 6 to 14 years of age, MONTELUKAST TARBIS 5 mg chewable tablets are available.

The 4 mg chewable tablet of MONTELUKAST TARBIS is not recommended for children under 2 years of age.

If your child takes more MONTELUKAST TARBIS 4 mg than they should

Seek help from your child's doctor immediately.

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

If you forget to give MONTELUKAST TARBIS 4 mg to your child

Try to give MONTELUKAST TARBIS 4 mg as prescribed. However, if your child forgets a dose, just resume the usual intake of one tablet once a day.

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

If your child stops taking MONTELUKAST TARBIS 4 mg

MONTELUKAST TARBIS 4 mg can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking MONTELUKAST TARBIS 4 mg 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 product, ask your child's doctor or pharmacist.

4. Possible side effects

Like all medications, MONTELUKAST TARBIS 4 mg can cause side effects, although not everyone gets them.

In clinical trials with 4 mg chewable tablets, the side effects related to the administration of the medication and reported most frequently (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated) were:

• abdominal pain
• thirst

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

Additionally, since the medication has been marketed, the following side effects have been reported:

• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing, itching, and hives;
• fatigue, restlessness, excitement including aggressive behavior, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, sleep disturbances, including nightmares and sleep problems, tingling/numbness, seizures;
• discomfort, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhea, hepatitis;
• increased risk of bleeding, hematoma, red painful lumps under the skin that most frequently appear on the shins (erythema nodosum), palpitations;
• swelling
• stuttering (very rare - may affect up to 1 in 10,000 people).

In asthmatic patients treated with montelukast, very rare cases of 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) have been reported. You should immediately tell your doctor if your child has one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you think any of the side effects that your child is getting is serious, or if you notice any side effects not listed in this leaflet, tell your child's doctor or pharmacist.

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 is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MONTELUKAST TARBIS 4 mg

• Keep out of the reach and sight of children.
• Do not use this medication after the expiry date stated on the blister pack. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month stated.
• Store in the original packaging to protect it from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. FURTHER INFORMATION

Composition of MONTELUKAST TARBIS 4 mg:

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are: Mannitol, microcrystalline cellulose, hydroxypropylcellulose, red iron oxide (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and packaging content

The 4 mg chewable tablets are pink, oval, biconvex, and have the inscription "4" on one side.

They are available in packs of 28 tablets.

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

(Barcelona) - 08028 - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

(Sant Joan Despi (Barcelona)) - 08970 - Spain

This leaflet was approved in July 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/