Montelukast Sodium 4mg Oral Granules
Page 1
Sandoz Ltd
Montelukast Sodium 4 mg Oral Granules
PL 04416/1057
Package leaflet: Information for the patient Montelukast Sodium 4 mg Oral Granules 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
1. What Montelukast is and what it is used for
2. What you need to know before Montelukast is taken
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 your child’s asthma, preventing asthma symptoms during the day and night.
■ Montelukast is used for the treatment of 6 months to 5 years old 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 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 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 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 take 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.
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.
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 can be taken without regard to the timing of food intake.
Pregnancy and breast-feeding:
This subsection is not applicable for Montelukast Oral Granules since they are intended for use in children 6 months to 5 years of age, 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 Oral Granules since they are intended for use in children 6 months to 5 years of age, 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.
3. How to take Montelukast
■ This medicine is to be given to a child under adult supervision. Your child should take Montelukast every evening.
■ 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 this medicine exactly 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 usual dose is:
For children 6 months to 5 years of age:
One sachet of Montelukast 4 mg granules to be taken by mouth each evening.
If your child is taking Montelukast, be sure that your child does not take any other products that contain the same active ingredient, montelukast.
For children 6 months to 2 years old, Montelukast are available.
For children 2 to 5 years old, montelukast 4 mg chewable tablets and Montelukast are available. The Montelukast formulation is not recommended below 6 months of age.
How should I give Montelukast to my child?
■ Do not open the sachet until ready to use.
■ Montelukast can be given either:
- directly in the mouth;
- OR mixed with a spoonful of cold or room temperature soft food (for example, applesauce, ice cream, carrots and rice).
■ Mix all of the contents of the Montelukast into a spoonful of cold or room temperature soft food, taking care to see that the entire dose is mixed with the food.
■ Be sure the child is given the entire spoonful of the granule/food mixture immediately (within 15 minutes). IMPORTANT: Never store any granule/food mixture for use at a later time.
■ Montelukast granules are not intended to be dissolved in liquid. However, your child may take liquids after swallowing Montelukast.
■ Montelukast can be taken without regard to the timing of food intake.
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 sachet 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.
In clinical studies with montelukast 4 mg granules, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast 4 mg granules were:
■ diarrhoea
■ hyperactivity
■ asthma
■ scaly and itchy skin
■ rash
Additionally, the following side effects were reported in clinical studies with either montelukast 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets:
■ abdominal pain
■ headache
■ thirst
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:
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):
■ allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
Very rare side effects (may affect up to 1 in 10,000 people):
■ 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
■ yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine caused by inflammation of the liver (hepatitis)
■ 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.
■ severe skin reactions (erythema multiforme) that may occur without warning
Other possible side effects
Very common side effects (may affect more than 1 in 10 people):
■ upper respiratory infection
Common side effects (may affect up to 1 in 10 people):
■ diarrhoea, nausea, vomiting
■ abnormal liver function test results
■ rash
■ fever
Uncommon side effects (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, seizure
■ nosebleed
■ dry mouth, indigestion
■ bruising, itching, hives
■ joint or muscle pain, muscle cramps
■ tiredness, feeling unwell, swelling
Rare side effects (may affect up to 1 in 1,000 people):
■ increased bleeding tendency
■ disturbance in attention
■ memory impairment
■ tremor
■ palpitations
Very rare side effects (may affect up to 1 in 10,000 people):
■ hallucinations, disorientation
■ swelling (inflammation) of the lungs
■ tender red lumps under the skin most commonly on your shins (erythema nodosum) 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 (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 on the label carton and the sachet 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
What Montelukast Sodium 4 mg Oral Granules contain
■ The active substance is: montelukast. Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast.
■ The other ingredients are: mannitol, hydroxypropyl cellulose and magnesium stearate.
What Montelukast Sodium 4 mg Oral Granules looks like and contents of the pack
Montelukast Oral Granules are white to off white in colour and are packed in PET/ Al/ PE sachets.
Montelukast Oral Granules are available in packs of 10, 14, 20, 28, 30, 49, 50, 56, 98 and 100 sachets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or
Salutas Pharma GmbH
Dieselstrasse 5 70839 Gerlingen, Germany.
or
Lek Pharmaceuticals d.d.
Verovskova 571526 Ljubljana Slovenia
or
Lek S.A.
Domaniewska 50 C, 02-672 Warszawa, Poland or
S.C. Sandoz,
S.R.L.Livezeni Street no 7ATargu MuresRomania or
Lek Pharmaceuticals d.d.
Trimlini 2D 9220 Lendava Slovenia
This leaflet was last revised in 01/2016.
IS
PIL.1057.005.0d 14/01/16 V007: Safety update, in line with reference
product