MONTELUKAST PAEDIATRIC 4 MG CHEWABLE TABLETS - patient leaflet, side effects, dosage

Patient leaflet - MONTELUKAST PAEDIATRIC 4 MG CHEWABLE TABLETS

Package leaflet: Information for the user Montelukast Paediatric 4mg chewable tablets

Read all of this leaflet carefully before you or your child starts taking this medicine because it contains important information for you or your child.

The product name Montelukast Paediatric 4mg chewable tablets is also referred as Montelukast Paediatric in the leaflet.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your or your child’s 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.
1. What Montelukast Paediatric is and what it is used for
2. What you need to know before you or your child takes Montelukast Paediatric
3. How to take Montelukast Paediatric
4. Possible side effects
5. How to store Montelukast Paediatric
6. Contents of the pack and other information

1. what montelukast paediatric is and what it is used for

Montelukast Paediatric contains the active substance montelukast. Montelukast Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Paediatric improves asthma symptoms and helps control asthma.

Your child’s doctor has prescribed Montelukast Paediatric to treat your child’s asthma, preventing asthma symptoms during the day and night.

Montelukast Paediatric 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 Paediatric 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 Paediatric also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.

Your child’s doctor will determine how Montelukast Paediatric should be used depending on the symptoms and severity of your 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 your child takes montelukast paediatric

Tell your or your child's doctor about any medical problems or allergies your child has now or has had.

Do not give Montelukast Paediatric to your child if he/she

are/ is allergic (hypersensitive) to montelukast or any of the other ingredients of Montelukast Paediatric (listed in section 6).

Warnings and precautions

Talk to your or your child’s doctor or pharmacist before you or your child takes Montelukast Paediatric.

If your child’s asthma or breathing gets worse, tell your doctor immediately.
Oral Montelukast Paediatric is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your child’s 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 take all asthma medications prescribed by your child’s doctor.

Montelukast Paediatric should not be used instead of other asthma medications your or your child's 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 or your child’s 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.

Children

Montelukast Paediatric should not be prescribed to children below 2 years of age because safety and effectiveness in children have not been established.

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 Paediatric 4mg chewable tablets (see section 4). If your child develop(s) such symptoms while taking Montelukast Paediatric 4mg chewable tablets, you should consult your child’s doctor.

Other medicines and Montelukast Paediatric

Tell your child's doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription.

Some medicines may affect how Montelukast Paediatric works, or Montelukast Paediatric may affect how your child’s other medicines work.

Tell your child’s doctor if your child is taking the following medicines before starting Montelukast Paediatric:

Phenobarbital (used for treatment of epilepsy)
Phenytoin (used for treatment of epilepsy)
Rifampicin (used to treat tuberculosis and some other infections).

Montelukast Paediatric with food

Montelukast Paediatric 4mg chewable tablets 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 the Montelukast Paediatric 4mg 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.

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast Paediatric. Your doctor will assess whether you can take Montelukast Paediatric during this time.

Breast-feeding

It is not known if Montelukast appears in breast milk. You should consult your doctor before taking Montelukast Paediatric if you are breast-feeding or intend to breast-feed.

Driving and using machines

Montelukast Paediatric 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 with montelukast may affect some patients’ ability to drive or operate machinery.

Montelukast Paediatric contains aspartame and mannitol

This medicine contains 1.2mg aspartame in each tablet which is equivalent to 0.674mg phenylalanine per dose. 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 mannitol, which may have a mild laxative effect.

3. how to take montelukast paediatric

Always take Montelukast Paediatric exactly as your child's doctor or pharmacist has told you. Check with your child's doctor or pharmacist if you are not sure.

This medicine is to be given to a child under adult supervision.
Your child should take only one tablet of Montelukast Paediatric once a day as prescribed by your doctor.
It should be taken even when your child has no symptoms if he/she has an acute asthma attack.
To be taken by mouth.

Use in children and adolescents:

For children 2 to 5 years of age:

One Montelukast Paediatric 4mg chewable tablet daily to be taken in the evening. Montelukast Paediatric 4mg chewable tablets 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 Paediatric, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.

For children 2 to 5 years old, Montelukast Paediatric 4mg chewable tablets are available.

For children 6 to 14 years old, Montelukast Paediatric 5mg chewable tablets are available. The Montelukast Paediatric 4mg chewable tablet is not recommended below 2 years of age.

If you or your child takes more Montelukast Paediatric than he/she should

Contact your or 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 take Montelukast Paediatric to your child

Try to take Montelukast Paediatric 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 your child stops taking Montelukast Paediatric

Montelukast Paediatric can treat your child’s asthma only if your child continues taking it.

It is important to continue taking Montelukast Paediatric for as long as your or your child's doctor prescribes. It will help control you or 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 Montelukast Paediatric 4mg 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 Paediatric were:

Abdominal pain.
Thirst.

Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated tablets and 5mg 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).

Serious side effects

Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.

Uncommon: the following may affect up to 1 in 100 people

allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression seizure.

Rare : the following may affect up to 1 in 1,000 people

increased bleeding tendency
tremor
palpitations.

Very rare : the following may affect up to 1 in 10,000 people

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) (see section 2)
low blood platelet count
behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
swelling (inflammation) of the lungs
severe skin reactions (erythema multiforme) that may occur without warning
inflammation of the liver (hepatitis), signs include yellowing of the skin or eyes.

Other side effects while the medicine has been on the market

Very common: may affect more than 1 in 10 people

upper respiratory infection

Common: may affect up to 1 in 10 people

diarrhoea, nausea, vomiting
rash
fever
elevated liver enzymes.

Uncommon : may affect up to 1 in 100 people

behaviour and mood related changes [dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
dizziness, drowsiness, pins and needles/numbness
nosebleed
dry mouth, indigestion
bruising, itching, hives
joint or muscle pain, muscle cramps
tiredness, feeling unwell, swelling
bedwetting in children.

Rare: may affect up to 1 in 1,000 people

behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements.

Very rare: may affect up to 1 in 10,000 people

tender red lumps under the skin most commonly on your shins (erythema nodosum)
behaviour and mood related changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If you or your child get any side effects, talk to your or your child’s doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store montelukast paediatric

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 label/ carton/ blister. 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 informationwhat montelukast paediatric contains the active substance is montelukast. each tablet contains montelukast sodium which corresponds to 4 milligram of montelukast.

The other ingredients are:

Mannitol, microcrystalline cellulose, hydroxypropyl cellulose (E463), red iron oxide (E172), croscarmellose sodium, cherry flavour (contains maltodextrin (Maize), nature identical flavouring substance, acacia gum (E414), propylene glycol, flavouring preparation and natural flavouring substance), aspartame (E951), and magnesium stearate.

What Montelukast Paediatric looks like and contents of the pack

Montelukast Paediatric 4mg chewable tablets are pink-coloured, circular, biconvex, uncoated chewable tablets that are plain on both sides.

Blisters in packages of: 10, 14, 28, 56 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Relonchem Limited,

Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, United Kingdom.

|POM|

This leaflet was last revised in November 2021.

Product License number: PL 20395/0274