MONTELUKAST AUROVITAS 4 mg CHEWABLE TABLETS

2. What you need to know before you take Montelukast Aurovitas

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

Do not give Montelukast Aurovitas to your child

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

Warnings and precautions

Consult your doctor or pharmacist before giving montelukast to your child:

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Aurovitas oral is not indicated for the treatment of 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 Aurovitas 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, 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 drugs or NSAIDs) if they make their asthma worse.

Children and adolescents

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

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

Other medicines and Montelukast Aurovitas

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those bought without a prescription.

Some medicines may affect how montelukast works, or montelukast may affect how other medicines work that your child is using.

Before taking montelukast, tell 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)

Taking Montelukast Aurovitas with food, drinks, and alcohol

Montelukast Aurovitas 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast Aurovitas chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast Aurovitas 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 substance, 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 Aurovitas contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Each 4 mg chewable tablet of Montelukast Aurovitas has an aspartame content equivalent to 0.674 mg of phenylalanine.

Montelukast Aurovitas contains sodium

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

3. How to take Montelukast Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• This medicine should be administered to children under adult supervision.
• Your child should only take one Montelukast Aurovitas 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.

For children from 2 to 5 years of age:

The recommended dose is one 4 mg chewable tablet daily in the evening.

If your child is taking montelukast, ensure they do not take any other medicine that contains the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Montelukast Aurovitas 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If your child takes more Montelukast Aurovitas than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no adverse 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.

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 taken.

If you forget to give Montelukast Aurovitas to your child

Try to give Montelukast Aurovitas as prescribed. However, if you forget to give your child a dose, just resume the usual routine of one tablet once a day.

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

If your child stops taking Montelukast Aurovitas

Montelukast Aurovitas can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking Montelukast Aurovitas for as long as 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 4 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• thirst

Additionally, the following side effect was 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 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, as they may be serious and may 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,
• mood-related 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

• 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,
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions,
• inflammation (inflammation) of the lungs,
• 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

• mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling/numbness,
• 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

• mood-related 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).
• mood-related changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Aurovitas

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

Store below 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Aurovitas

• The active substance is montelukast. Each chewable tablet contains montelukast sodium, equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, 2% hydroxypropylcellulose (6-10 mPa.s), sodium croscarmellose, red iron oxide (E 172), aspartame (E 951), artificial cherry flavor (with its flavoring ingredients and modified cornstarch) and magnesium stearate (E 572).

Appearance of the product and pack contents

Chewable tablets

Uncoated pink tablets, speckled, biconvex, oval and marked with "X" on one face and "52" on the other face of the tablet.

Montelukast Aurovitas chewable tablets are available in PVC/polyamide/aluminum foil/PVC - aluminum foil blister packs and high-density polyethylene (HDPE) bottles with a polypropylene cap containing silica gel desiccant.

Presentation

Blister packs: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 chewable tablets.

High-density polyethylene (HDPE) bottles: 30, 90, and 500 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

France Montelukast Aurobindo 4 mg, chewable tablet

Germany Montelukast Aurobindo 4 mg chewable tablets

Italy Montelukast Pharma Italia 4 mg chewable tablet

Poland Montelukast Aurobindo

Spain Montelukast Aurovitas 4 mg chewable tablets EFG

Date of the last revision of this leaflet:February 2024

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