MONTELUKAST ACCORD 4 mg CHEWABLE TABLETS

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

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

Do not give Montelukast Accord 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 Accord to your child:

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor or your child's doctor. 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 prescribed by your child's doctor.
• 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 worsen their asthma.

Several neuropsychiatric events (such as changes in behavior and mood, depression, and suicide) 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 2 years of age.

There are different forms of this medicine available for pediatric patients under 18 years of age, depending on the age range.

Taking Montelukast Accord with Other Medicines

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

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

Before taking montelukast, tell your doctor if your child is taking the following medicines:

• 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)

Taking Montelukast Accord with Food and Drinks

Montelukast Accord should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and Breastfeeding

This subsection is not applicable to Montelukast Accord 4 mg, as its use is indicated in children between 2 and 5 years.

Driving and Using Machines

This subsection is not applicable to Montelukast Accord 4 mg, as its use is indicated in children between 2 and 5 years. However, the following information is important for the active substance, montelukast.

Montelukast Accord 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 with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast Accord contains Aspartame

This medicine contains 1.2 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Montelukast Chewable Tablets contain Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Montelukast Accord

Make sure your child always takes montelukast as their doctor has told them. Check with your child's doctor or pharmacist if you are not sure.

• This medicine should be given to children under adult supervision.
• Your child should only take one montelukast 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.

This medicine is for oral use. The tablets should be chewed before swallowing.

For Children from 2 to 5 Years

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

Montelukast should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals. The tablets should be chewed before swallowing.

If your child is taking Montelukast Accord, make sure they do not take any other medicine that contains the same active substance, montelukast.

If your child takes more Montelukast Accord 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 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, telephone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to give Montelukast Accord to your child

Try to give Montelukast Accord as prescribed. However, if your child misses a dose, just resume the regular schedule of one tablet once a day.

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

If your child stops taking Montelukast Accord

Montelukast Accord may only treat your child's asthma if they continue taking it.

It is essential that your child continues taking montelukast for as long as their doctor prescribes it.

This will help control your child's asthma.

If you have any further 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 effects were reported in clinical studies with Montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• Headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious Side Effects

Consult your doctor immediatelyif you notice any of the following side effects in your child, as they may be serious and your child may need urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing.
• Changes related to behavior and mood: 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.
• Changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions.
• Inflammation (inflammation) of the lungs.
• Severe skin reactions (erythema multiforme) that can occur without warning.
• Liver inflammation (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):

• Changes related to behavior and mood: 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):

• Changes related to behavior and mood: 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).
• Changes related to behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting of Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Accord

• Keep out of sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

• Store below 30°C. Store in the original package to protect from light and moisture.

• Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Montelukast Accord

The active substance is montelukast. Each chewable tablet contains montelukast sodium, which is equivalent to 4 mg of montelukast.

The other ingredients are: mannitol (E421) (SD 200), microcrystalline cellulose (PH 112), sodium croscarmellose, cherry flavor (501027 AP0551), red iron oxide (E172), aspartame (E 951), and magnesium stearate.

Appearance of the Product and Contents of the Pack

Pink, speckled, oval, biconvex tablet with "M4" engraved on one side and smooth on the other side.

Packaged in OPA-Al-PVC/Al blister packs.

Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140, and 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

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

Date of the Last Revision of this Leaflet:September 2024

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