MONTELUKAST ALTER 5 mg CHEWABLE TABLETS
Ask a doctor about a prescription for MONTELUKAST ALTER 5 mg CHEWABLE TABLETS
How to use MONTELUKAST ALTER 5 mg CHEWABLE TABLETS
Introduction
Package Leaflet: Information for the User
Montelukast Alter 5 mg
chewable tablets EFG
Read all of this leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.Keep this leaflet, as you may need to read it again.
|
Contents of the package leaflet:
- What is Montelukast Alter and what is it used for
- What you need to know before taking Montelukast Alter
- How to take Montelukast Alter
- Possible side effects
- Storage of Montelukast Alter
- Package contents and further information
1. What is Montelukast Alter and what is it used for
What isMontelukast Alter
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How it worksMontelukast Alter
Leukotrienes cause narrowing and swelling of the airways in your lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.
When to useMontelukast Alter
Your doctor has prescribed montelukast to treat asthma and prevent asthma symptoms during the day and night.
- Montelukast is used to treat pediatric patients between 6 and 14 years of age who are not adequately controlled with their medication and need additional treatment.
- Montelukast is used as an alternative treatment to inhaled corticosteroids in patients between 6 and 14 years of age who have not recently taken oral corticosteroids for their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
- Montelukast also helps prevent narrowing of the airways caused by exercise.
Depending on the symptoms and severity of your asthma or your child's asthma, your doctor will determine how to 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 diseases.
- airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
- swelling (inflammation) of the inner layer of the airways.
Asthma symptoms include: coughing, wheezing, and chest congestion.
2. What you need to know before taking Montelukast Alter
Tell your doctor about any allergy or medical problem that you or your child have now or have had.
Do not takeMontelukast Alter
- if you or your child 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 you or your child start taking montelukast.
- If your asthma or breathing or your child's asthma or breathing worsen, 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 for you or your child. Always have your rescue inhaler medication for asthma attacks.
- It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications that your doctor has prescribed 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
- You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.
Various neuropsychiatric events (such as changes related to behavior and mood, 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 presentations of this medicine are available based on the age range.
Other medicines and Montelukast Alter
Tell your doctor or pharmacist if you or your child are taking or have recently taken 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 or your child are taking the following medicines:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
TakingMontelukast Alterwith food and drinks
Montelukast 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.
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 not known whether montelukast appears in 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 machines. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with montelukast may affect the patient's ability to drive or operate machines.
Montelukast Alter5 mgchewable tablets contain aspartame and sodium
This medicine contains 3.0 mg of aspartame in each tablet.
Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.
This medicine contains less than 23 mg of sodium (1mmol) per tablet, which is essentially "sodium-free".
3. How to take Montelukast Alter
Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- You or your child should only take one chewable tablet of montelukast once a day, as prescribed by your doctor.
- It should be taken even when you or your child do not have symptoms or when you or your child have an acute asthma attack.
For children from6 to14 years of age:
The recommended dose is one 5 mg chewable tablet daily in the evening.
If you or your child are taking montelukast, make sure that neither you nor your child take any other product that contains the same active ingredient, montelukast.
This medicine is taken orally.
The tablets should 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 food.
If you or your child take moreMontelukast Alterthan you should
Seek help from your doctor immediately.
In most cases of overdose, no side 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, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.
If you forget to takeMontelukast Alteror forget to giveMontelukast Alterto your child
Try to take montelukast as prescribed. However, if you or your child forget a dose, just resume the usual routine of one chewable tablet once a day.
Do not take a double dose to make up for forgotten doses.
If you or your child stop takingMontelukast Alter
Montelukast may only treat your asthma or your child's asthma if you or your child continue to take it. It is essential that you continue taking montelukast for as long as your doctor prescribes it. 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical trials with montelukast 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:
- headache
Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets:
- abdominal pain
These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast tablets than with placebo (a pill that does not contain medicine).
Severe side effects
Consult your doctor immediatelyif you notice any of the following side effects, which may be severe and you or your child may need 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 can cause difficulty breathing or swallowing
- changes related to behavior and mood: 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):
- combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
- low platelet count
- changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions
- swelling (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):
- changes related to behavior and mood: 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):
- changes related to 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 that most frequently appear on the shins (erythema nodosum)
- changes related to behavior and mood: obsessive-compulsive symptoms, stuttering
Reporting of side effects
If you or your child experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 that appears on the 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.
- Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
6. Package contents and further information
Composition of Montelukast Alter 5 mg:
- The active ingredient is: montelukast. Each tablet contains montelukast sodium equivalent to 5 mg of montelukast.
- The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, red iron oxide (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.
Appearance of the product and package contents
The 5 mg chewable tablets are pink, round, biconvex, and have the inscription "5" on one side.
They are available in packs 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
Date of last revision of this leaflet:April 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
How much does MONTELUKAST ALTER 5 mg CHEWABLE TABLETS cost in Spain ( 2025)?
The average price of MONTELUKAST ALTER 5 mg CHEWABLE TABLETS in November, 2025 is around 21.06 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
- Country of registration
- Average pharmacy price21.06 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to MONTELUKAST ALTER 5 mg CHEWABLE TABLETSDosage form: TABLET, 10 mgActive substance: montelukastManufacturer: Krka D.D. Novo MestoPrescription requiredDosage form: CHEWABLE TABLET, 4 mgActive substance: montelukastManufacturer: Krka D.D. Novo MestoPrescription requiredDosage form: CHEWABLE TABLET, 5 mgActive substance: montelukastManufacturer: Krka D.D. Novo MestoPrescription required
Alternatives to MONTELUKAST ALTER 5 mg CHEWABLE TABLETS in other countries
The best alternatives with the same active ingredient and therapeutic effect.
Alternative to MONTELUKAST ALTER 5 mg CHEWABLE TABLETS in Poland
Alternative to MONTELUKAST ALTER 5 mg CHEWABLE TABLETS in Ukraine
Online doctors for MONTELUKAST ALTER 5 mg CHEWABLE TABLETS
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for MONTELUKAST ALTER 5 mg CHEWABLE TABLETS – subject to medical assessment and local rules.
Get updates and exclusive offers
Be the first to know about new services, marketplace updates, and subscriber-only promos.
