Montelukast Stada 10 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Montelukast Stada 10 mg film-coated tablets EFG
For adolescents and adults from 15 years of age
Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- 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 only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Montelukast Stada is and what it is used for
- What you need to know before taking Montelukast Stada
- How to take Montelukast Stada
- Possible side effects
- How to store Montelukast Stada
- Contents of the pack and other information
1. What Montelukast Stada is and what it is used for
What is Montelukast
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How montelukast works
Leukotrienes cause narrowing and swelling of the airways in the lungs and may also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).
When montelukast should be used
Your doctor has prescribed montelukast to treat asthma and to prevent asthma symptoms during the day and night.
- Montelukast is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their current medication and require additional treatment.
- Montelukast also helps prevent airway narrowing caused by exercise.
- In asthmatic patients for whom montelukast is indicated for asthma, montelukast 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.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- difficulty breathing due to narrowing of the airways. This narrowing of the airways 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: cough, 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: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.
2. What you need to know before starting to take Montelukast Stada
Inform your doctor of any allergies or medical conditions you currently have or have had in the past.
DO NOT take Montelukast Stada
- if you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Montelukast Stada
- If your asthma or breathing worsens, inform 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 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 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they must consult their doctor.
- You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.
Several neuropsychiatric events (for example, changes in behaviour and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If you or your child develop these symptoms while taking montelukast, you should contact your doctor or your child's 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 depending on the age range.
Other medicines and Montelukast Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Some medicines may affect how montelukast works, or montelukast may affect how other medicines you are taking work.
Before taking montelukast, inform 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 certain other infections)
- gemfibrozil (used to treat elevated lipid levels in plasma)
Taking Montelukast Stada with food and drink
Montelukast 10 mg film-coated 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will assess whether you can take this medicine during this period.
Breastfeeding
It is unknown whether montelukast is excreted in breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast.
Driving and operating machinery
Montelukast is not expected to affect your ability to drive or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and drowsiness) that have been reported with montelukast may affect a patient's ability to drive or operate machinery.
Montelukast Stada contains lactose
Montelukast 10 mg film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Montelukast Stada contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Montelukast Stada
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- You should take only one montelukast tablet once daily, as prescribed by your doctor.
- It should be taken even when you do not have symptoms or during an acute asthma attack.
For adults and adolescents aged 15 years and older:
The recommended dose is one 10 mg tablet daily, taken at night.
If you are taking montelukast, make sure you do not take any other medicine containing the same active substance, montelukast.
This medicine is taken orally.
You may take montelukast 10 mg with or without food.
If you take more Montelukast Stada than you should
Seek immediate help from your doctor.
In most overdose cases, 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.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medication and the amount ingested.
If you forget to take Montelukast Stada
Try to take montelukast as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet once daily.
Do not take a double dose to make up for missed doses.
If you stop taking Montelukast Stada
Montelukast can only treat your asthma if you continue taking it.
It is important that you continue taking montelukast 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, this medicine can cause 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 most frequently (may affect up to 1 in 10 people) 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 medicine).
Serious adverse effects
Contact your doctor immediately if you experience any of the following adverse 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, which may cause difficulty breathing or swallowing
- changes in behaviour and mood: excitation including aggressive behaviour or hostility, depression
- seizures
Rare: may affect up to 1 in 1,000 people
- increased tendency to 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 in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
- swelling (inflammation) of the lungs
- severe skin reactions (erythema multiforme), which may occur without warning
- inflammation of the liver (hepatitis)
Other adverse effects reported during post-marketing use of the medicine
Very common: may affect more than 1 in 10 people
- upper respiratory tract infection
Common: may affect up to 1 in 10 people
- diarrhoea, nausea, vomiting
- rash
- fever
- increased liver enzymes
Uncommon: may affect up to 1 in 100 people
- changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, somnolence, tingling/numbness
- nosebleeds
- dry mouth, indigestion
- bruising, itching, urticaria
- joint or muscle pain, muscle cramps
- bed-wetting (in children)
- weakness/tiredness, malaise, swelling
Rare: may affect up to 1 in 1,000 people
- changes in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements
Very rare: may affect up to 1 in 10,000 people
- painful red lumps under the skin, which usually appear on the shins (erythema nodosum)
- changes in behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicines at Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Montelukast Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Montelukast Stada
- The active substance is montelukast (as montelukast sodium).
Each film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
- The other components are:
Tablet core:
Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, disodium edetate, and magnesium stearate.
Tablet coating:
Hypromellose, hydroxypropylcellulose, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
Appearance of the product and contents of the pack
Montelukast Stada 10 mg film-coated tablets are beige, round, and biconvex.
Montelukast Stada is available in the following pack sizes:
Nylon/Alu/PVC-Aluminum blisters:
- Blister packs (non-calendar): 10, 20, 30, 50, 60, 90, 100, and 250 tablets.
- Blister packs (non-calendar): 7, 14, 28, 56, 98, 126, and 154 tablets.
HDPE bottles:
10, 20, 30, 50, 60, 90, 100, and 250 tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 – Sant Just Desvern (Barcelona)
Spain
Manufacturer
STADA Arzneimittel AG
Stadastraße 2 – 18
61118 Bad Vilbel
Germany
or
Clonmel Healthcare Ltd
Waterford Road
Clonmel, Co. Tipperary
Ireland
or
LAMP SANPROSPERO S.p.A.
Via della Pace, 25/A
41030 San Prospero (Modena)
Italy
or
Eurogenerics NV/SA
Heizel Esplanade b22
1020 Brussels
Belgium
or
STADA Arzneimittel GmbH
Stada Arzneimittel GmbH Muthgasse 36
1190 Vienna
Austria
or
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
or
SANECA PHARMACEUTICALS, A.S.
Nitranska 100 - Hlohovec - 920 27
Slovakia
or
Laboratori Fundació Dau
Calle Lletra C de la Zona Franca 12-14
Polígono Industrial de la Zona Franca de Barcelona
08040, Barcelona
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Montelukast STADA 10 mg Filmtabletten
Belgium: Montelukast Eurogenerics 10 mg filmomhulde tabletten
Germany: Montelukast STADA 10 mg Filmtabletten
Denmark: Montelukast Stada
Spain: Montelukast STADA 10 mg comprimidos recubiertos con película EFG
France: Montelukast EG 10 mg comprimé pelliculé
Ireland: Montelair 10 mg film-coated tablets
Luxembourg: Montelukast Eurogenerics 10 mg comprimés pelliculés
Portugal: Montelucaste Ciclum
Sweden: Montelukast STADA 10 mg filmdragerade tabletter
Date of the most recent revision of this leaflet: March 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/