Montelukast - 1 A Pharma 4 Mg Chewable Tablets
Package leaflet: Information for the patient
Montelukast 1 A Pharma 4 mg Chewable Tablets
Montelukast
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Montelukast is and what it is used for
2. What you need to know before Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information
1. WHAT MONTELUKAST IS AND WHAT IT IS USED FOR
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night.
• Montelukast 4 mg is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 4 mg may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
• Montelukast 4 mg also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your child's asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed airways. This narrowing of airways worsens and improves in response to various conditions.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) in the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest tightness.
2. WHAT YOU NEED TO KNOW BEFORE MONTELUKAST IS TAKEN
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast to your child:
• if he/she is allergic (hypersensitive) to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Montelukast:
• If your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always have your child’s inhaled rescue medicine for asthma attacks with you.
• It is important that your child takes all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for your child.
• If your child is on anti-asthma medicines, be aware that if he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how your child’s other medicines work.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those obtained without a prescription.
Tell your doctor if your child is taking the following medicines before starting Montelukast:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Montelukast with food and drink
Montelukast should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for Montelukast since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take Montelukast during this time.
Use in breast-feeding
It is not known if montelukast appears in breast milk. You should consult your doctor before taking Montelukast if you are breast-feeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for Montelukast 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with montelukast may affect some patients’ ability to drive or operate machinery.
Montelukast contains:
• aspartame, which_contains a source of phenylalanine. This may be harmful for people with phenylketonuria (a rare, hereditary disorder of the metabolism).
• phenylalanine (equivalent to 0.539 mg phenylalanine per 4 mg chewable tablet).
• Allura Red (E129). This may cause allergic reactions.
3. HOW TO TAKE MONTELUKAST
• This medicine is to be given to a child under adult supervision.
• Your child should take only one tablet of Montelukast once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
• Always have your child take this medicine exactly as your doctor has told you. Check with your child’s doctor or pharmacist if you are not sure.
• To be taken by mouth
The usual dose is:
For children 2 to 5 years of age:
One 4 mg chewable tablet daily to be taken in the evening. Montelukast should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If your child is taking Montelukast, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
Montelukast is not recommended below 2 years of age.
Different strengths and dosage forms may be available for the other age groups:
• 5 mg chewable tablets are available for children 6 to 14 years of age.
• 10 mg tablets are available for adults and adolescents 15 years of age and older.
If your child takes more Montelukast than he/she should
Contact your child’s doctor immediately for advice.
There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to give Montelukast to your child
Try to give Montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one tablet once daily.
Do not give a double dose to make up for a forgotten dose.
If your child stops taking Montelukast
Montelukast can treat your child’s asthma only if he/she continues taking it.
It is important for your child to continue taking Montelukast for as long as your doctor prescribes. It will help control your child’s asthma.
If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with 4 mg chewable tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with 10 mg filmcoated tablets and 5 mg chewable tablets:
• headache
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).
Additionally, while the medicine has been on the market, the following have been reported:
Very common side effects (may affect more than 1 in 10 people):
• upper respiratory infection
Common side effects (may affect up to 1 in 10 people):
• diarrhoea, nausea, vomiting
• abnormal liver function test results
• rash
• fever
Uncommon side effects (may affect up to 1 in 100 people):
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes (dream abnormalities including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behavior or hostility, depression)
• dizziness, drowsiness, pins and needles/numbness, seizure
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell, swelling
Rare side effects (may affect up to 1 in 1,000 people):
• increased bleeding tendency
• tremor
• palpitations
Very rare side effects (may affect up to 1 in 10,000 people):
• inflammation of the liver (hepatitis)
• hallucinations, suicidal thoughts and actions
• a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) have been reported. You must tell your doctor right away if your child gets one or more of these symptoms.
• tender red lumps under the skin most commonly on your shins (erythema nodosum) • severe skin reactions (erythema multiforme) that may occur without warning
Ask your doctor or pharmacist for more information about side effects. If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE MONTELUKAST
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Montelukast contains
• The active substance is montelukast.
Each tablet contains 4 mg montelukast as montelukast sodium.
• The other ingredients are:
Mannitol (E421), cellulose microcrystalline, hydroxypropylcellulose (E 463), iron oxide, red (E 172), croscarmellose sodium, flavour (Cherry Flavour AP0551, Cherry Durarome TD0990B [contains Allura Red, E129]), aspartame (E 951) and magnesium stearate.
What Montelukast looks like and contents of the pack
4 mg Montelukast chewable tablets are pink to slightly speckled pink, oval with ‘4’ encoded on one side Montelukast is available in packs of:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 chewable tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland
LEK S.A., Ul. Domaniewska 50, 02-672 Warszawa, Poland
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania