MONTELUKAST KERN PHARMA 4 mg CHEWABLE TABLETS

2. BEFORE TAKING MONTELUKAST KERN PHARMA CHEWABLE TABLETS

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

Do not give Montelukast Kern Pharma to your child if

• they are allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast Kern Pharma (see 6. FURTHER INFORMATION).

Be careful with Montelukast Kern Pharma

• If your child's asthma or breathing worsens, tell your doctor immediately.
• Oral montelukast 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 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 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 drugs or NSAIDs) if they make their asthma worse.

Use of other medications

Some medications may affect the functioning of Montelukast, or Montelukast 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, 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 Kern Pharma with food and drinks

Montelukast Kern Pharma 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 Kern Pharma 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. Their doctor will assess whether they can take montelukast during this period.

Use during breastfeeding

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

Driving and using machines

This subsection is not applicable to Montelukast Kern Pharma 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.

Montelukast Kern Pharma is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been rarely reported with montelukast may affect the patient's ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast Kern Pharma

The chewable tablets of Montelukast Kern Pharma 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 phenylalanine (equivalent to 0.674 mg of phenylalanine per 4 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• This medication should be administered 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.
• Make sure your child always takes montelukast as their doctor has indicated. Consult your child's doctor or pharmacist if you have any doubts.
• It should be taken orally.

For children between 2 and 5 years of age:

One 4 mg chewable tablet should be taken 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.

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

For children between 2 and 5 years of age, Montelukast Kern Pharma 4 mg chewable tablets are available.

For children between 6 and 14 years of age, Montelukast Kern Pharma 5 mg chewable tablets are available.

The chewable tablet of Montelukast is not recommended in children under 2 years of age.

If your child takes more Montelukast Kern Pharma 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.

If you forget to give Montelukast Kern Pharma to your child

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

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

If your child stops taking Montelukast Kern Pharma

Montelukast Kern Pharma can 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. 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 medicines, Montelukast Kern Pharma can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast 4 mg, 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 and 5 mg:

• 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 medication).

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

• upper respiratory infection
• increased risk of bleeding
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• behavioral and mood-related changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, tingling/numbness, seizures
• palpitations
• nasal bleeding
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruises, itching, hives, painful red lumps under the skin that most frequently appear on the shins (erythema nodosum)
• joint or muscle pain, muscle cramps
• fatigue, discomfort, swelling, fever
• 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 inform 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, please inform your child's doctor or pharmacist.

5. Storing MONTELUKAST KERN PHARMA

• Keep out of the reach and sight of children.
• Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.
• Medications should not be disposed of via wastewater or household waste. 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 Kern Pharma

• The active ingredient is montelukast. Each 4 mg chewable tablet contains 4.15 mg of montelukast sodium, which corresponds to 4 mg of montelukast.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, red iron oxide, cherry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and packaging contents

The chewable tablets of Montelukast Kern Pharma 4 mg are pink, oval, and biconvex. They are presented in blister packs of 28 tablets.

Marketing authorization holder

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

PHARMATEN S.A.

Dervenakion 6

Pallini 15351

Attica (Greece)

This leaflet was approved in May 2024

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