Patient leaflet - MONTELUKAST HEXAL 4 MG CHEWABLE TABLETS
Montelukast HEXAL 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 child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet
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1. What Montelukast is and what it is used for
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2. What you need to know before Montelukast is taken
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3. How to take Montelukast
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4. Possible side effects
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5. How to store Montelukast
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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.
- Patients should be aware that various neuropsychiatric events (for example, behaviour and mood-related changes) have been reported in adults, adolescents and children with Montelukast (see section 4). If your child develops such symptoms while taking Montelukast, you should consult your child’s doctor.
Children and adolescents
Do not give this medicine to children under the age of 2 years.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
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)
- gemfibrozil (used for treatment of high lipid levels in plasma)
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, 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, 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 4 mg chewable tablets contain aspartame, azo colouring agent Allura Red (E 129), sodium, sucrose and ethanol.
This medicine contains 0.96 mg aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains azo colouring agent Allura Red (E 129). This may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per chewable tablet, that is to say essentially ‘sodium-free’.
This medicine contains 0.74 mg of sucrose per chewable tablet. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains up to 0.24 microgram of alcohol (ethanol) per chewable tablet. The amount per chewable tablet of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
3. how to take montelukast
- 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 Montelukast 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 recommended dose is:
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. The tablets are to be chewed before swallowing.
This medicine is to be given to a child under adult supervision.
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.
- For children 2 to 5 years old, 4 mg chewable tablets and 4 mg granules are available (for children who have problems consuming a chewable tablet).
- For children 6 to 14 years old, 5 mg chewable tablets are available.
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.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Uncommon side effects (may affect up to 1 in 100 people):
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■ allergic reactions which may cause difficulty in breathing or swallowing
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■ seizures
Rare side effects (may affect up to 1 in 1,000 people):
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■ serious allergic reaction which causes swelling of the face or throat
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■ increased bleeding tendency
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■ tremble
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■ palpitations
Very rare side effects (may affect up to 1 in 10,000 people):
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■ reduction in blood platelets (thrombocytopenia)
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■ suicidal thoughts and actions. Warning signs are e.g. talking about suicide, withdrawing from social contact and wanting to be left alone or feeling trapped or hopeless about a situation
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■ yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine caused by inflammation of the liver (hepatitis)
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■ 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.
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■ severe skin reactions (erythema multiforme) that may occur without warning
In clinical studies with either montelukast 4 mg oral granules, 4 mg chewing tablets, 5 mg chewing tablets or 10 mg film-coated tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:
- headache
- abdominal pain
- thirst
- diarrhoea
- hyperactivity
- asthma
- dry and itchy skin
- rash
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):
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■ upper respiratory infection
Common side effects (may affect up to 1 in 10 people):
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■ diarrhoea, nausea, vomiting
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■ abnormal liver function test results
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■ rash
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■ fever
Uncommon side effects (may affect up to 1 in 100 people):
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■ behaviour and mood related changes (dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression)
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■ dizziness, drowsiness, pins and needles/numbness
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■ nosebleed
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■ dry mouth, indigestion
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■ bruising, itching, hives
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■ joint or muscle pain, muscle cramps
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■ bedwetting in children
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■ tiredness, feeling unwell, swelling
Rare side effects (may affect up to 1 in 1,000 people):
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■ increased bleeding tendency
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■ tremor
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■ disturbance in attention, memory impairment
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■ tic
Very rare side effects (may affect up to 1 in 10,000 people):
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■ hallucinations, disorientation
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■ swelling (inflammation) of the lungs
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■ tender red lumps under the skin most commonly on your shins (erythema nodosum)
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■ stuttering
Reporting of 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.
You can also report side effects directly via the Yellow Card Scheme. 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 on the carton after EXP. 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 protect the environment.
6. contents of the pack and other information
- The active substance is montelukast.
Each chewable tablet contains montelukast sodium equivalent to 4 mg montelukast.
- The other ingredients are mannitol (E421), cellulose microcrystalline, hydroxypropylcellulose (E 463), iron oxide, red (E 172), croscarmellose sodium, flavour (Cherry Flavour AP0551 [contains ethanol and sodium], Cherry Durarome TD0990B [contains azo colouring agent Allura Red E129, sucrose, ethanol and sodium]), 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 tablets with ‘4’ encoded on one side.
The chewable tablets are packed in OPA/ALU/PVC/ALU blister or OPA/ALU/PE/ALU blister and inserted in a carton.
Pack sizes:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140, 200 chewable tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, 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
This leaflet was last revised in 07/2020.
PIL.1593.009.0d
V023: Update PI with excipient guidance
RDS