What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL30306/0242.


Montelukast 5mg chewable Tablets

Package leaflet: Information for the patient

Montelukast 5mg chewable Tablets

For children 6 to 14 years of age

Read all of this leaflet carefully before you or your child 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, please ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child’s.
  • If you or your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • The full name of this medicine is Montelukast 5mg chewable Tablets but within the leaflet it will be referred to as Montelukast tablets.

What is in this leaflet

1 What Montelukast tablets are and what they are used for
2 What you need to know before you or your child take Montelukast tablets
3 How to take Montelukast tablets
4 Possible side effects
5 How to store Montelukast tablets
6 Contents of the pack and other information

1 What Montelukast tablets are and what they are used for

Montelukast tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast tablets improve asthma symptoms and help control asthma.

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

  • Montelukast tablets are used for the treatment of 6 to 14 year old patients who are not adequately controlled on their medication and need additional therapy.
  • Montelukast tablets may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 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 tablets also help prevent the narrowing of airways triggered by exercise for patients 6 to 14 years of age.

Your or your child’s doctor will determine how Montelukast tablets should be used depending on the symptoms and severity of your or your child’s asthma.

2 What you need to know before you or your child take Montelukast tablets

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

Do not use Montelukast tablets

  • 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 or your child’s doctor, pharmacist or nurse before using Montelukast tablets

  • If your or your child’s asthma or breathing gets worse, tell your or your child’s doctor immediately.
  • Oral Montelukast tablets are 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 or your child’s inhaled rescue medicine for asthma attacks with you/him/her.

  • It is important that you or your child take all asthma medications prescribed by your or your child’s doctor. Montelukast tablets should not be used instead of other asthma medications your or your child’s doctor has prescribed for you/him/her.
  • If you or your child is on anti-asthma medicines, be aware that if you or 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.
  • You or your child should not take acetyl-salicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) if they make your or his/her asthma worse.

Other medicines and Montelukast tablets

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

Please tell your or your child’s doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.

Tell your doctor if you or your child is taking the following medicines before starting Montelukast tablets:

  • 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 tablets with food and drink

Montelukast tablets should not be taken immediately with food; they should be taken at least one hour before or two hours after food.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

It is not known if Montelukast tablets appears in breast milk. You should consult your doctor before taking Montelukast tablets if you are breast-feeding or intend to breast-feed. Your doctor will assess whether you can take Montelukast tablets during this time.

Driving and using machines

Montelukast tablets are 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 tablets may affect some patients’ ability to drive or operate machinery.

Montelukast tablets contain aspartame, a source of phenylalanine (an amino acid). May be harmful for people with phenylketonuria (a genetic disorder affecting the metabolism).

Montelukast tablets contain lactose. If you have been told by your or your child’s doctor that you/he/she has an intolerance to some sugars, contact your/his/her doctor before this medicinal product is taken.

3 How to take Montelukast tablets

  • Always use this medicine exactly as your or your child’s doctor has told you/him/her. Check with your or your child’s doctor or pharmacist if you are not sure.
  • The recommended dose is one tablet of Montelukast once a day as prescribed by your or your child’s doctor.
  • It should be taken even when you or your child has no symptoms or if you or your child has an acute asthma attack.
  • To be taken by mouth.

For children 6 to 14 years of age

One Montelukast tablet daily to be taken in the evening. Montelukast tablets should not be taken immediately with food; it should be taken at least one hour before or two hours after food.

If you or your child is taking Montelukast tablets, be sure that you or your child does not take any other medicines that contain the same active ingredient, montelukast.

For other age groups

For other age groups, other strengths and pharmaceutical forms of montelukast may be available.

If you or your child takes more Montelukast tablets than you/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 tablets or give Montelukast tablets to your child

Try to take/give Montelukast tablets as prescribed. However, if you or your child misses a dose, just resume the usual schedule of one tablet once daily.

Do not take/give a double dose to make up for a forgotten dose.

If you or your child stops taking Montelukast tablets

Montelukast tablets can treat your or your child’s asthma only if you or your child continues taking it.

It is important for you or your child to continue taking Montelukast tablets for as long as your or your child’s doctor prescribes. It will help control your or your child’s asthma.

If you have any further questions on the use of this product, ask your or your child’s doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects that have been reported with montelukast, stop using Montelukast tablets and contact a doctor immediately:

  • sudden wheezing, swelling of lips, tongue and throat or body, rash, fainting or difficulties to swallow (severe allergic reaction). This side effect is uncommon (may affect up to 1 in 100 people).
  • flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
  • suicidal thoughts and actions. This side effect is very rare (may affect up to 1 in 10,000 people).
  • severe skin reactions (erythema multiforme) that may occur without warning. This side effect is very rare (may affect up to 1 in 10,000 people).

The following side effects have also been reported with montelukast:

Very common: may affect more than 1 in 10 people

  • Colds (upper respiratory infection)

Common: may affect up to 1 in 10 people

  • Headache
  • Abdominal pain
  • Thirst
  • Diarrhoea, nausea, vomiting
  • Rash
  • Fever
  • Asthma
  • Hyperactivity
  • Red, itchy skin (eczema)
  • Increased amounts of certain substances in the blood (transaminases)

Uncommon: may affect up to 1 in 100 people

  • Behaviour and mood related changes (dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression)
  • Dizziness, drowsiness, pins and needles/numbness, seizures (fits)
  • Nosebleed
  • Dry mouth, indigestion
  • Bruising, itching, hives
  • Joint or muscle pain, muscle cramps
  • Tiredness, feeling unwell, swelling

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

  • Tremor, disturbance in attention, memory impairment
  • Increased bleeding tendency
  • Shaking
  • Feeling your heartbeat (palpitations)
  • Swelling of the skin

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

  • Hallucinations, confusion
  • Hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration)
  • Tender red lumps under the skin most commonly on your shins (erythema nodosum)

Reporting of side effects

If you or your child gets any side effects, talk to your doctor, 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

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Montelukast tablets

  • 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 and blister 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 store above 30°C.
  • 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

What Montelukast tablets contain

  • The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 5mg of montelukast.
  • The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate, iron oxide red (E172), mannitol, silarom cherry flavour (nature-identical flavouring substances, flavouring preparations, natural flavouring substances, maltodextrin (potato), gum arabic (acacia) (E414), triacetin (E1518), ethyl maltol, maltol, alpha-tocopherol (E307)), aspartame (E951), magnesium stearate.

What Montelukast tablets look like and contents of the pack

Montelukast 5mg chewable tablets are pink, mottled, round, biconvex tablets with M5 engraved on one side.

Blisters in packages of:

28 chewable tablets

Marketing Authorisation Holder

Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This leaflet was last revised in June 2015.

If you would like a leaflet with larger text, please contact 01271 385257.

Actavis
Barnstaple
EX32 8NS
UK

AAAI0423