Montelukast Alter 4 mg chewable tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Montelukast Alter 4 mg
chewable tablets EFG
Read the entire leaflet carefully before giving this medicine to your child, as it contains important information.
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Package leaflet contents:
- What Montelukast Alter is and what it is used for
- What you need to know before your child takes Montelukast Alter
- How to take Montelukast Alter
- Possible side effects
- How to store Montelukast Alter
- Contents of the pack and other information
1. What Montelukast Alter is and what it is used for
What Montelukast Alter is
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Alter works
Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast 4 mg improves asthma symptoms and helps control asthma.
When Montelukast Alter should be used
Your doctor has prescribed montelukast 4 mg to treat your child's asthma and to prevent asthma symptoms during the day and night.
- Montelukast is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional therapy.
- Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 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 in patients aged 2 years and older.
Depending on your child's symptoms and the severity of their 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.
Symptoms of asthma include: coughing, wheezing, and chest tightness.
2. What you need to know before starting Montelukast Alter
Inform your doctor of any allergies or medical conditions your child currently has or has had.
Do not give Montelukast Alter to your child
- if he or she is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before giving montelukast 4 mg to your child.
- If your child's 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 your doctor has given you for your child. Always keep your child's rescue inhaled medication available for asthma attacks.
- It is important that your child uses all asthma medications prescribed by the doctor. Montelukast should not be used instead of other asthma medications prescribed for your child.
- If your child is being treated with asthma medications, be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
- Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his or her asthma.
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 other adolescents
Do not give this medicine to children under 2 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 your child is taking, has recently been given, or might need to take any other medicine, including those obtained without a prescription.
Some medicines may affect how montelukast 4 mg works, or montelukast 4 mg may affect how other medicines your child is taking work.
Before taking montelukast, inform your doctor if your child is taking the following medicines:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and certain other infections)
Taking Montelukast Alter with food and drink
Montelukast 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after eating.
Pregnancy and breastfeeding
This section does not apply to montelukast 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.
Driving and using machines
This section does not apply to montelukast 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years. However, the following information is important regarding the active substance, montelukast.
Montelukast is not expected to affect the 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, could affect a patient's ability to drive or operate machinery.
Montelukast Alter 4 mg chewable tablets contain aspartame and sodium
This medicine contains 2.40 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful if the patient has 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, which means it is essentially "sodium-free".
3. How to take Montelukast Alter
Follow exactly the administration instructions for this medicine as given by your child's doctor or pharmacist. If in doubt, consult your child's doctor or pharmacist again.
- This medicine should be administered to children under adult supervision. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
- Your child should only take one montelukast chewable tablet once daily, as prescribed by the doctor.
- It should be taken even when your child has no symptoms or during an acute asthma attack.
For children aged 2 to 5 years:
The recommended dose is one 4 mg chewable tablet taken once daily in the evening.
If your child is taking montelukast, make sure they do not take any other medicine containing the same active substance, montelukast.
This medicine is taken orally.
The tablets must be chewed before swallowing.
Montelukast 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after meals.
If your child takes more Montelukast Alter than they should
Seek immediate help from your child's 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, stating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
If you forget to give Montelukast Alter to your child
Try to give montelukast 4 mg as prescribed. However, if your child misses a dose, simply resume the usual schedule of one tablet once daily.
Do not give a double dose to make up for missed doses.
If your child stops treatment with Montelukast Alter
Montelukast can only treat your child's asthma if treatment is continued.
It is important that your child continues taking montelukast for the length of time prescribed by the doctor. It will help control your child's asthma.
If you have any further questions about using this product, ask your child's 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 4 mg chewable tablets, the adverse effects related to administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- abdominal pain
- thirst
Additionally, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:
- headache
These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than in those treated with placebo (a pill containing no active medicine).
Serious adverse effects
Consult your doctor immediately if you notice any of the following adverse effects in your child, as they may be serious and your child 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 behavior and mood: excitation including aggressive behavior 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 behavior 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):
- diarrhea, nausea, vomiting
- skin rash
- fever
- elevated liver enzymes
Uncommon (may affect up to 1 in 100 people):
- changes in behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
- dizziness, drowsiness, 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 in 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, most commonly appearing on the shins (erythema nodosum)
- changes in behavior and mood: obsessive-compulsive symptoms, stuttering
Reporting of adverse effects
If your child experiences any 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 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 stated 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 packaging at the SIGRE point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Montelukast Alter:
- The active substance is montelukast. Each tablet contains sodium montelukast equivalent to 4 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.
Description of the product and contents of the pack
The 4 mg chewable tablets are pink, oval-shaped, biconvex, and marked with the number "4" on one side.
They are packed in containers of 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
This patient information leaflet was approved in: March 2025
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/