Montelukast Alter 5 mg chewable tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Montelukast Alter 5 mg
chewable tablets EFG
Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.
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Contents of the leaflet:
- What Montelukast Alter is and what it is used for
- What you need to know before taking Montelukast Alter
- How to take Montelukast Alter
- Possible side effects
- Storage of Montelukast Alter
- Contents of the pack and other information
1. What Montelukast Alter is and what it is used for
What is Montelukast Alter
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Alter works
Leukotrienes cause narrowing and swelling of the airways in your lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.
When to use Montelukast Alter
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 pediatric patients aged between 6 and 14 years who are not adequately controlled with their current medication and require additional treatment.
- Montelukast is used as an alternative to inhaled corticosteroids in patients aged between 6 and 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
- Montelukast also helps prevent exercise-induced narrowing of the airways.
Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how montelukast should be used.
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: coughing, wheezing, and chest tightness.
2. What you need to know before starting to take Montelukast Alter
Inform your doctor of any allergies or medical conditions you or your child currently have or have had in the past.
Do not take Montelukast Alter
- if you or your child 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 you or your child start taking montelukast.
- If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
- Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for yourself or for your child. Always have 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 be used instead of other asthma medications prescribed by your doctor for you or your child.
- 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 or your child 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.
Various neuropsychiatric events (for example, behaviour- and mood-related changes, depression, and suicide) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you should contact your doctor. |
Children and adolescents
Do not give this medicine to children under 6 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 Alter
Inform your doctor or pharmacist if you or your child are taking or have recently taken any other medicine, or might need to take any other medicine, 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 or your child 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 Alter with food and drink
Montelukast 5 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will assess whether you can take montelukast during this period.
Breastfeeding
It is unknown whether montelukast passes into breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking montelukast.
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 adverse effects (such as dizziness and drowsiness), which have been reported very rarely with montelukast, may affect a patient's ability to drive or operate machinery.
Montelukast Alter 5 mg chewable tablets contain aspartame and sodium
This medicine contains 3.0 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially “sodium-free”.
3. How to take Montelukast Alter
Follow exactly the instructions for use of this medicine as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- You or your child should take only one montelukast chewable tablet once a day, as prescribed by your doctor.
- It should be taken even when you or your child do not have symptoms or during an acute asthma attack.
For children aged 6 to 14 years:
The recommended dose is one 5 mg chewable tablet taken daily in the evening.
If you or your child are taking montelukast, make sure that neither you nor your child take any other product containing the same active substance, montelukast.
This medicine is taken orally.
The tablets must be chewed before swallowing.
Montelukast 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.
If you or your child take more Montelukast Alter 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, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forgot to take Montelukast Alter or forgot to give it to your child
Try to take montelukast as prescribed. However, if you or your child miss a dose, simply resume the usual regimen of one chewable tablet once a day.
Do not take a double dose to make up for missed doses.
If you or your child stop taking Montelukast Alter
Montelukast can only treat your asthma or your child's asthma if you or your child continue taking it. It is important to keep taking montelukast for the duration prescribed by your doctor. It will help control your asthma or your child's 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 will experience them.
In clinical trials with montelukast 5 mg chewable tablets, the adverse effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- headache
In addition, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets:
- abdominal pain
These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than in those treated with placebo (a tablet containing no active medicine).
Serious adverse effects
Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment for you or your child.
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 related to 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 related to 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 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
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes related to 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
- bedwetting (in children)
- weakness/tiredness, malaise, swelling
Rare (may affect up to 1 in 1,000 people):
- changes related to 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, most commonly appearing on the shins (erythema nodosum)
- changes related to behaviour and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects
If you or your child 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 directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Montelukast Alter
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the blister after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the indicated month.
- Store in the original packaging to protect it from light and moisture.
- Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Montelukast Alter 5 mg:
- The active substance is: montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
- The other components are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, red iron oxide (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.
Appearance of the medicine and contents of the pack
The 5 mg chewable tablets are pink, round, biconvex, with the imprint “5” on one side.
Pack size: 28 tablets.
Marketing Authorization Holder
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid, Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí, Barcelona
Spain
Date of the most recent revision of this leaflet: April 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es