Montelukast 5mg Chewable Tablets
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Package leaflet: Information for the user
Montelukast 5 mg chewable tablets
montelukast
Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet See section 4.
What is in this leaflet:
1. What Montelukast is and what it is used for
2. What you need to know before you take Montelukast
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 asthma, preventing your asthma symptoms during the day and night.
• Montelukast is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast may also be used as an alternative treatment to inhaled corticosteroids for 6 to14 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 also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of you or 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 you take Montelukast
Tell your doctor about any medical problems or allergies you or
your child has now or has had.
Do not take Montelukast if you or your child
• is allergic 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 you or 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 or your child. Always have your inhaled rescue medicine for asthma attacks with you.
• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications your doctor has prescribed for you or your child.
• Any patient on anti-asthma medicines should be aware that if you develop 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.
• You or your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
Use in children
For children 2 to 5 years old, Montelukast 4 mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available.
Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.
Please tell your doctor or pharmacist if you or your child is taking or has recently taken other medicines, including those obtained without a prescription.
Tell your doctor if you or 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)
• gemfibrozil (used for treatment of high lipid levels in plasma)
Montelukast with food and drink and alcohol
Montelukast 5 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding and fertility
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 breastfeeding or intend to breast-feed.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
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 contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).
3. How to take Montelukast
• You or your child should take only one tablet of Montelukast once a day as prescribed by your doctor.
• It should be taken even when you or your child has no symptoms or has an acute asthma attack.
• Always take Montelukast as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• To be taken by mouth
For children 6 to 14 years of age:
One Montelukast 5 mg chewable tablet daily to be taken in the evening. Montelukast 5 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If you or your child is taking Montelukast, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast.
If you or your child takes more Montelukast than you should
Contact your 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.
Colour: ■ Black
If you forget to take Montelukast or give Montelukast to your child
Try to take Montelukast as prescribed. However, if you or your child misses a dose, just resume the usual schedule of one tablet once daily.
Do not take a double dose to make up for a forgotten dose.
If you or your child stops taking Montelukast
Montelukast can treat you or your child’s asthma only if you or your child continues to take it.
It is important to continue taking Montelukast for as long as your doctor prescribes. It will help control you or your child’s asthma.
If you have any further questions on the use of this product, 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 studies with montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were:
• headache
Additionally, the following side effect was reported in clinical studies with montelukast10 mg film-coated tablets:
• abdominal pain
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects at least 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Additionally, while the medicine has been on the market, the following have been reported:
• upper respiratory infection (very common)
• increased bleeding tendency (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor , disturbance in attention, memory impairment (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common);bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); weakness/tiredness, feeling unwell, swelling (Uncommon).
In asthmatic patients treated with montelukast, very rare cases of 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 you get one or more of these symptoms.
Ask your doctor or pharmacist for more information about side effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.By reporting side effects you
can help provide more information on the safety of this medicine.
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 after ‘EXP’ on the blister and carton. The expiry date refers to the last day of that month.
Store below 25°C.
Store in the original package in order to protect from light and moisture.
[HDPE bottle of 500 tablets]
Use within 12 months after first opening the HDPE bottle.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Montelukast contains
- The active substance is montelukast. Each chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast.
- The other ingredients are mannitol (E421), cellulose, microcrystalline, hydroxypropyl cellulose 2% (6 to 10 mpaS), croscarmellose sodium, iron oxide red (E172), aspartame (E951), artificial cherry flavour (contains flavouring ingredients and modified food starch) and magnesium stearate.
What Montelukast looks like and contents of the pack
Chewable tablets
Pink colored, mottled, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘53’ on other side.
Montelukast chewable tablets are available in PVC/ Polyamide/ Aluminium foil/ PVC blister pack and HDPE bottle with polypropylene closure containing silica gel desiccant.
Presentations
Blister pack: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140 and 200 chewable tablets.
HDPE bottle pack: 30, 90 and 500 chewable tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom