MONTELUKAST SUN 10 mg FILM-COATED TABLETS

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

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

Do not take Montelukast SUN

• If you 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 starting to take Montelukast

• If your asthma or breathing gets worse, tell 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. Always have your rescue inhaler medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast SUN 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 and 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 medications or NSAIDs) if they make your asthma worse.

Several neuropsychiatric events (such as changes related to behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking Montelukast Sun, you should consult your doctor.

Children and adolescents

Do not give this medicine to children under 15 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 SUN

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way Montelukast SUN works, or Montelukast SUN may affect the way other medicines work.

Before taking Montelukast SUN, tell your doctor if you are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used to treat high lipid levels in plasma)

Taking Montelukast SUN with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will assess whether you can take montelukast during this period.

Breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast SUN.

Driving and using machines

Montelukast SUN is not expected to affect your 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 SUN contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Montelukast SUN

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

• You should only take one Montelukast SUN 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.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily in the evening.

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

This medicine is taken orally.

Montelukast 10 mg can be taken with or without food.

If you take more Montelukast SUN than you should

Ask your doctor for help 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.

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 ingested.

If you forget to take Montelukast SUN

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

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

If you stop taking Montelukast SUN

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Montelukast SUN can cause side effects, although not everybody gets them.

In clinical trials conducted with montelukast 10 mg film-coated tablets, the side effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people), were:

• Abdominal pain
• 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 notice 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
• 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
• Swelling (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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast SUN

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 carton and blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast SUN

• The active substance is montelukast. Each film-coated tablet contains montelukast sodium, which corresponds to 10 mg of montelukast.

• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose, and magnesium stearate.

Coating: Opadry Yellow 03B 52874 (hypromellose, titanium dioxide, macrogol, yellow iron oxide, red iron oxide).

Appearance of the product and contents of the pack

Montelukast SUN 10 mg film-coated tablets are round, beige to light yellow in color, engraved with “M10” on one side and smooth on the other side.

They are available in packs of 14, 28, 30, 50, 56, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Or

Terapia, S.A.

124 Fabricii Street

400 632 Cluj Napoca

Romania

Local representative:

Sun Pharma Laboratorios S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Date of last revision of this leaflet: March 2024

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