MONTELUKAST KERN PHARMA 10 mg FILM-COATED TABLETS

2. BEFORE TAKING MONTELUKAST KERN PHARMA

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Kern Pharma if you

• 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 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 given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Kern Pharma should not replace other asthma medications prescribed by your doctor.
• Any patient being treated with asthma medications 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.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Use in children

For children aged 2 to 5 years, Montelukast Kern Pharma 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast Kern Pharma 5 mg chewable tablets are available.

Use of other medications

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications you are using.

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Before taking Montelukast Kern Pharma, tell your doctor if you are 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 can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or plan to become pregnant should consult their doctor before taking Montelukast Kern Pharma. Your doctor will assess whether you 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

Montelukast Kern Pharma is not expected to affect your 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 reported very rarely 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 film-coated tablets of Montelukast Kern Pharma contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• You should only take one Montelukast Kern Pharma tablet once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or when you have an acute asthma attack.
• Always take Montelukast Kern Pharma as your doctor has told you. Consult your doctor or pharmacist if you are unsure.
• It should be taken orally.

For adults aged 15 years and older:

One 10 mg tablet should be taken daily in the evening. Montelukast can be taken with or without food.

If you are taking Montelukast, make sure you do not take any other medication that contains the same active ingredient, montelukast.

If you take more Montelukast Kern Pharma than you should

Seek immediate medical attention from your doctor.

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 take Montelukast Kern Pharma

Try to take Montelukast as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once daily.

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

If you stop taking Montelukast Kern Pharma

Montelukast can only treat your asthma if you continue to take it. It is essential that you continue taking montelukast for as long as your doctor prescribes it. It will help control your asthma.

If you have any further questions about the use of this product, ask your 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, 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
• 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 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
• mood-related changes and behavioral 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
• nosebleeds
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruises, itching, hives, red painful bumps under the skin that occur most frequently 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 you have one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you experience any side effects not listed in this leaflet, or if you experience any side effect that is severe or worsening, tell your doctor or pharmacist.

5. Storage of 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.
• Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. 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 Kern Pharma

• The active ingredient is montelukast. Each film-coated tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate, and Opadry AMB TAN.

Appearance of the product and packaging contents

The film-coated tablets of Montelukast Kern Pharma 10 mg are round, beige, and biconvex.

They are available in packs of 28 tablets.

Marketing authorization holder

KERN PHARMA, S.L.

Venus, 72 - Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Manufacturer

PHARMATHEN S.A.

Dervenakion 6

Pallini 15351

Attikis (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/