Montelukast Tarbis 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST TARBIS 10 mg
film-coated tablets EFG
montelukast
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What MONTELUKAST TARBIS 10 mg is and what it is used for
- Before you take MONTELUKAST TARBIS 10 mg
- How to take MONTELUKAST TARBIS 10 mg
- Possible side effects
- How to store MONTELUKAST TARBIS 10 mg
- Further information
1. What MONTELUKAST TARBIS 10 mg is and what it is used for
MONTELUKAST TARBIS 10 mg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, MONTELUKAST TARBIS 10 mg improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed MONTELUKAST TARBIS 10 mg to treat your asthma and to prevent asthma symptoms during the day and night.
- MONTELUKAST TARBIS 10 mg is used to treat patients whose asthma is not adequately controlled with their current medication and who require additional treatment.
- MONTELUKAST TARBIS 10 mg also helps prevent airway narrowing caused by exercise.
- In asthmatic patients for whom MONTELUKAST TARBIS 10 mg is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.
Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use MONTELUKAST TARBIS 10 mg.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- difficulty breathing due to narrowing of the airways. This airway narrowing worsens and improves in response to various triggers.
- sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
- swelling (inflammation) of the inner lining of the airways.
Asthma symptoms include: coughing, wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose, sneezing; watery, swollen, red, and itchy eyes.
2. BEFORE TAKING MONTELUKAST TARBIS 10 mg
Inform your doctor of any allergies or medical conditions you currently have or have previously had.
Do not take MONTELUKAST TARBIS 10 mg if you
- are allergic (hypersensitive) to montelukast or to any of the other ingredients of MONTELUKAST TARBIS 10 mg. (see section 6. INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL).
Take special care with MONTELUKAST TARBIS 10 mg
- If your asthma or breathing worsens, inform your doctor immediately.
- MONTELUKAST TARBIS 10 mg oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication available for asthma attacks.
- It is important that you or your child use all asthma medications prescribed by your doctor. MONTELUKAST TARBIS 10 mg must 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
- You should not take aspirin or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
- Patients should be aware that various neuropsychiatric events (e.g., behavioral changes and mood-related events) have been reported with MONTELUKAST TARBIS 10 mg in adults, adolescents, and children (see section 4). If your child develops these symptoms while taking MONTELUKAST TARBIS 10 mg, you should consult your child's doctor.
Use in children
This formulation is not suitable for children.
Use of other medicines
Some medicines may affect the way MONTELUKAST TARBIS 10 mg works, or MONTELUKAST TARBIS 10 mg may affect the way other medicines work.
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Before taking MONTELUKAST TARBIS 10 mg, inform your doctor if you are 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 TARBIS 10 mg with food and drink
MONTELUKAST TARBIS 10 mg may be taken with or without food.
Pregnancy and breastfeeding
Use during pregnancy
Women who are pregnant or planning to become pregnant should consult their doctor before taking MONTELUKAST TARBIS 10 mg. Your doctor will assess whether you can take MONTELUKAST TARBIS 10 mg during this period.
Use during breastfeeding
It is unknown whether MONTELUKAST TARBIS 10 mg passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking MONTELUKAST TARBIS 10 mg.
Driving and use of machines
MONTELUKAST TARBIS 10 mg is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and somnolence), which have been reported very rarely with MONTELUKAST TARBIS 10 mg, may affect the patient's ability to drive or operate machinery.
Important information about some of the ingredients of MONTELUKAST TARBIS 10 mg
MONTELUKAST TARBIS 10 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to TAKE MONTELUKAST TARBIS 10 mg
- Take only one tablet of MONTELUKAST TARBIS 10 mg once daily, as prescribed by your doctor.
- You should take it even when you do not have symptoms or during an acute asthma attack.
- Always take MONTELUKAST TARBIS 10 mg exactly as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.
- MONTELUKAST TARBIS 10 mg must be taken by mouth.
For adults aged 15 years and older:
One 10 mg tablet should be taken daily at night. MONTELUKAST TARBIS 10 mg may be taken with or without food.
If you are taking MONTELUKAST TARBIS 10 mg, make sure you do not take any other product containing the same active substance, montelukast.
If you take more MONTELUKAST TARBIS 10 mg than you should
Seek immediate medical help.
In most cases of overdose, no adverse effects were reported. The most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take MONTELUKAST TARBIS 10 mg
Try to take MONTELUKAST TARBIS 10 mg as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet once daily.
Do not take a double dose to make up for a missed dose.
If you stop taking MONTELUKAST TARBIS 10 mg
MONTELUKAST TARBIS 10 mg will only control your asthma if you continue taking it. It is important to continue taking MONTELUKAST TARBIS 10 mg for as long as your doctor has prescribed it. It will help control your asthma.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, MONTELUKAST TARBIS 10 mg may produce adverse effects, although not everyone experiences them.
In clinical trials with montelukast 10 mg film-coated tablets, the adverse effects related to the administration of the medicine and reported more frequently (in more than 1 in 100, or in fewer than 1 in 10 patients treated) were:
- abdominal pain
- headache
These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active substance).
In addition, since the medicine has been marketed, the following adverse effects have been reported:
- allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing, itching, and hives
- tiredness, restlessness, excitation including aggressive behavior, irritability, tremor, depression, and suicidal actions (in very rare cases), dizziness, drowsiness, hallucinations, sleep disturbances, including nightmares and sleep problems, tingling/numbness, seizures
- malaise, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhea, hepatitis
- increased tendency to bleeding, bruising, painful red lumps under the skin which more frequently appear on the shins (erythema nodosum), palpitations
- swelling
- stuttering (very rare – may affect up to 1 in 10,000 people).
In asthmatic patients treated with montelukast, cases of 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) have been reported. You must immediately inform your doctor if you experience one or more of these symptoms.
Ask your doctor or pharmacist for more information about adverse effects. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of MONTELUKAST TARBIS 10 mg
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Keep out of the reach and sight of children.
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Do not use this medicine after the expiry date indicated by the six digits following "CAD" on the blister. The first two digits indicate the month; the last four digits indicate the year. The expiration date refers to the last day of the month shown.
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Store in the original packaging to protect from light and moisture.
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Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of MONTELUKAST TARBIS 10 mg:
- The active substance is montelukast.
- The 10 mg tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
- The other components are:
Monohydrate lactose (85.81 mg), microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin (soy), xanthan gum, and yellow and red iron oxide (E 172).
Appearance of the product and contents of the pack
The 10 mg tablets are orange-colored, round, biconvex, film-coated tablets, marked with "10" on one side.
Packaged in packs of 28 tablets.
Marketing Authorization Holder
TARBIS FARMA, S.L.
Gran Via Carlos III, 94
(Barcelona) - 08028 - Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona, 69
(Sant Joan Despi (Barcelona)) - 08970 - Spain
This summary of product characteristics was approved in July 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/