Singulair paediatric

How does it work?

Singulair paediatric chewable tablets and Singulair paediatric granules contain the active ingredient montelukast, which is a type of medicine known as a leukotriene receptor antagonist. It works by blocking the action of leukotrienes, which are chemicals released by the body as part of allergic and inflammatory reactions.

Leukotrienes have effects in many areas of the body. In the lungs, they cause inflammation and increased mucous production in the airways. They also cause the muscles lining the airways to contract, which narrows the airways. All of this makes it difficult for air to get in and out of the lungs.

Montelukast blocks leukotriene receptors in the lungs and, as a result, blocks the actions of the leukotrienes. This prevents the excess mucous production, inflammation and narrowing of the airways and so prevents asthma attacks. It is also useful for preventing asthma triggered by exercise.

Montelukast is used for people whose asthma is not fully controlled by using regular inhaled corticosteroids and short-acting beta agonist relievers such as salbutamol. It is used in addition to these medicines.

Montelukast may also be used as an alternative to low-dose inhaled corticosteroids for children aged 2-14 years who have mild persistant asthma but are not capable of using inhaled corticosteroids. In this case, montelukast is only suitable if the child has not recently had serious asthma attacks that needed treatment with corticosteroid tablets. (Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nighttime symptoms more than twice a month but less than once a week and normal lung function between episodes. If montelukast doesn't control the asthma within a month then additional or different medicines will be needed.)

Montelukast should be taken regularly to prevent asthma attacks. It should be continued even when the symptoms are under control.

What is it used for?

Asthma (see above for more information)

Prevention of asthma mainly triggered by exercise

Singulair paediatric 5mg chewable tablets are suitable for children aged 6 to 14 years. Singulair paediatric 4mg chewable tablets are suitable for children aged 2 to 5 years. Singulair paediatric granules are suitable for children aged 6 months to 5 years. The dose should be taken once daily, in the evening.

Warning!

Singulair paediatric chewable tablets should be taken on an empty stomach (at least an hour before or two hours after food). The tablets should be sucked or chewed.

Singulair paediatric granules should be taken immediately after opening the sachet (at least within 15 minutes). The granules are not intended to be dissolved in liquid, but liquid can be taken after taking the granules. The granules can be administered directly into the mouth, or mixed with a spoonful of cold or room temperature soft food (eg apple sauce, ice cream, carrots or rice). If mixed with food, you should not save this for later use.

This medicine should never be used to treat asthma attacks - you should keep your normal reliever inhaler, eg salbutamol or terbutaline, ready for this. Consult your doctor if your child needs to use their reliever more frequently than normal, or if it becomes less effective at treating asthma attacks.

If you find that your child's asthma is improved after receiving treatment with this medicine, you may find that they need to use their reliever inhaler less frequently. However, they should not stop taking any of the other medicines your doctor has prescribed, in particular any corticosteroid inhalers or tablets.

In rare cases, people taking asthma medications may experience a rare condition known as Churg-Strauss syndrome. Consult your doctor if your child experiences any of the following while taking this medicine; flu-like symptoms, increasing breathlessness, pins and needles, numbness of the limbs or rash.

Singulair paediatric chewable tablets contain aspartame, which is a source of phenylalanine. They should be used with caution in children with an inherited disorder of protein metabolism called phenylketonuria.

Not to be used in

Singulair paediatric 5mg chewable tablets are not suitable for children under six years of age.

Singulair paediatric 4mg chewable tablets are not suitable for children under two years of age.

Singulair paediatric granules are not suitable for babies aged under six months.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.

It is not known if this medicine passes into breast milk. It is not recommended for use during breastfeeding unless considered essential by your doctor. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Thirst

Abdominal pain

Hyperactivity

Diarrhoea

Nausea and vomiting

Dry mouth

Dizziness

Difficulty in sleeping (insomnia)

Nightmares

Drowsiness

Fatigue

Pain in the muscles and joints

Pins and needles or numb sensations

Irritability

Agitation

Skin rashes

Awareness of your heart beat (palpitations)

Increased bleeding tendency

Jaundice related to inflammation in the liver (cholestatic hepatitis)

Seizures

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines your child is already taking, including those bought without a prescription and herbal medicines, before they start treatment with this medicine. Similarly, check with your doctor or pharmacist before giving any new medicines in combination with this one, to ensure that the combination is safe.

No significant interactions have so far been reported with montelukast.

However, the manufacturer recommends that the following are used with caution in combination with this medicine, as they may decrease the blood level of montelukast:

phenobarbital

phenytoin

rifampicin.

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