MONTELUKAST OPKO 10 mg TABLETS

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

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

DO NOT TAKEMontelukast OPKO

• 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 this medication.

• 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 should not replace other asthma medications that your doctor has prescribed.
• 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 pulmonary 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 make your asthma worse.

Several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related, depression, and suicidal thoughts) in patients of all ages (see section 4). If you develop these symptoms while taking montelukast, 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 OPKO

Tell your doctor or pharmacist if you are using, have recently used, or might use 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.

Before taking montelukast, 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 plasma lipid levels).

Taking Montelukast OPKO with food and drinks

Montelukast 10 mg 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 this medicine.

Driving and using machines

Montelukast 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 OPKO contains aspartame and sodium

Montelukast OPKO contains 0.75 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Montelukast OPKO

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

• You should only take one tablet of montelukast 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 once daily, in the evening.

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

This medicine is taken orally.

You can take montelukast with or without food.

If you take more Montelukast OPKO than you should

Contact your 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast OPKO

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

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

If you stop taking Montelukast OPKO

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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with montelukast 10 mg 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 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, which 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 may 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):

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of pulmonary 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 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):

• red painful 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 Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast OPKO

• 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. This medicine does not require any special storage temperature.
• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Contents of the pack and other information

Composition ofMontelukast OPKO

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 10 mg of montelukast.
• The other ingredients (excipients) are: mannitol (E421), microcrystalline cellulose (E460i), sodium croscarmellose (E468), aspartame (E951), cherry flavor, red iron oxide (E172), yellow iron oxide (E172), and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Montelukast OPKO 10 mg are uncoated, round, biconvex tablets, light brown in color, with score lines on both sides, measuring 9.4 mm to 9.8 mm. The score lines are only to facilitate breaking for easier swallowing and not to divide into equal doses.

Montelukast OPKO 10 mg is available in a cardboard box containing 2 Al/Al blisters with 14 tablets each.

Marketing authorization holder and manufacturer

Marketing authorization holder:

OPKO Health Spain S.L.U

Plaza Europa 13-15, 08908

L`Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Laboratori Fundació Dau

Calle C De La Zona Franca 12-14

Polígono Industrial de la Zona Franca De Barcelona,

08040, Barcelona

Spain

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

Netherlands: Montelukast OPKO

Spain: Montelukast OPKO 10 mg tablets EFG

Date of last revision of this leaflet: June 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