INVENTED NAME

Transcription

INVENTED NAME

Package leafletACKAGE LEAFLET: Information for the user
INFORMATION FOR THE USER
[INVENTED NAME]
4 mg / 5 mg chewable tablets
Mmontelukast
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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, 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 doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for your child. Do not pass it on to others. It may harm
them, even if their symptoms are the same as your child’s.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1.
What [INVENTED NAME] is and what it is used for
2.
What you need to know before your child takes Before you take [INVENTED NAME]
3.
How to take [INVENTED NAME]
4.
Possible side effects
How to store [INVENTED NAME]
5.
6.
Contents of the pack and other information
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Further information
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1.
Wwhat [INVENTED NAME] is and what it is used for
The active substance in [INVENTED NAME] is montelukast, which is a leukotriene receptor antagonist. It blocks naturally occurring chemicals in the lungs called leukotrienes, which cause narrowing of
the airways and inflammation in the lungs which can lead to asthma symptoms.
Leukotrienes also contribute to the symptoms of allergy. Blocking leukotrienes reduces the
symptoms of seasonal allergy (also known as seasonal allergic rhinitis or hay fever).
When used regularly, [INVENTED NAME] relieves asthma symptoms e.g. shortness of breath and
prevents asthma attacks.
Your doctor has prescribed [INVENTED NAME] to treat your child's asthma, preventing asthma
symptoms during the day and night.
•
•
•
[Invented name] is used for the treatment of 2 to 5 year old patients who are not adequately
controlled on their medication and need additional therapy.
[Invented name] 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.
[Invented name] also helps prevent the narrowing of airways triggered by exercise for patients 2
years of age and older.
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You have been prescribed [INVENTED NAME] for one of the following reasons:
Adequate treatment of your child’s asthma with other medicines has not been poss ible and your
child needs additional treatment.
To prevent narrowing of the bronchial tubes, triggered by physical exertion.
As an alternative treatment in children aged between 2 and 14 who are unable to use sprays containing cortisone.
2.
What you need to know before your child takes before you take [INVENTED NAME]
Do not givetake [INVENTED NAME] to your child:
if your child is allergic (hypersensitive) to montelukast sodium (the active substance) or any
of the other ingredients of this medicine ( listed in section 6).f [INVENTED NAME].
Warning and precautions
Take special care with [INVENTED NAME] before and during use
Please note that [INVENTED NAME] is not intended for the treatment of acute asthma attacks. It
will not help in this situation and should never be taken for this purpose. If you experience an
asthma attack, please take your child’s ‘rescue’ medication intended for such an emergency and
follow exactly the instructions given to you by your doctor for this event. It is very important to
have the medication needed for such an attack (ie. a short acting inhaled beta-agonist, also known
as bronchodilator or reliever inhaler) readily accessible at all times.
If your child needs to use its beta-agonist inhaler more often than usual, you should consult your doctor as soon as possible.
It is important that your child uses all the asthma medication prescribed by the doctor as intended.
[INVENTED NAME] should not replace steroid medications (whether inhaled or taken by mouth) that
your child may is already using.
Also, please tell your doctor if your child experiences any of the following symptoms during treatment
with [INVENTED NAME]: flu-like symptoms, abnormal sensations such as pins and needles in the
arms or legs, skin rash, swelling of the facial region, lips, tongue and/or throat, resulting in shortness
of breath or difficulty in swallowing. Your doctor will then decide on the next course of action to take.
Patients with aspirin-sensitive asthma taking [INVENTED NAME] must continue to avoid taking
aspirin or other non-steroidal anti-inflammatory drugs.
Children and adolescents
For children 6 to 14 years old, [INVENTED NAME] 5 mg chewable tablets are available.
OTaking other medicines and [INVENTED NAME]
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other
medicines.
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[INVENTED NAME] may be taken together with other medicines taking for the treatment of
asthma.
However, some medicines can affect the way how [INVENTED NAME] works. Conversely,
[INVENTED NAME] can affect the way how some other medicines work. This may result in interactions. It is important to tell your doctor about all other medicines that are taken or have recently have recently been taken, including medicines obtained without a prescription. It is particularly
important that you should Ttell your doctor if your child is taking:
- phenobarbital (used for treatment of epilepsy)or
- phenytoin (used for the treatment of epilepsy)
- or rifampicin (used to treat tuberculosis and some other infections)
- gemfibrozil (used to help lower fats (triglycerides) and raise "good" cholesterol (HDL) in
the blood).
If this is the case, caution should be exercised, particularly in children.
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[INVENTED NAME] with food and drink
[INVENTED NAME] 4 mg and 5 mg chewable tablets should be taken 1 hour before or 2 hours
after food.
Pregnancy and breast-feeding
This subsection is not applicable for the [INVENTED NAME] 4 mg 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.
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If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Limited data concerning the exposed pregnancies do not suggest a causal relationship between
montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post
marketing experience.
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking
[INVENTED NAME]. Your doctor will assess whether you can take [INVENTED NAME] during this time.
If there is any suspicion of pregnancy in a female patient, please ask your doctor for advice before
taking [INVENTED NAME].
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Breast-feeding
It is not known whether [INVENTED NAME] passes into breast milk. Therefore, if a female patient is breast feeding or intending to breast feed a baby, please ask your doctor for advice before
taking [INVENTED NAME].
Your doctor will discuss with you what to do next.
Children and adolescents
Children below the age of 2 may not take [INVENTED NAME].
[INVENTED NAME] 4 mg chewable tablets are designed for children aged between 2 and 5 years.
Driving and using machines
[INVENTED NAME] does not normally impair your ability to drive and use machines. However, its
effect can vary from patient to patient. In very rare cases, dizziness and drowsiness have been reported, which might affect your ability to react.
Important information about some of the ingredients of [INVENTED NAME]
[INVENTED NAME] contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4-mg
chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable
tablet).
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[INVENTED NAME] 4 mg / 5 mg chewable tablets contain a source of phenylalanine. May be harmful for people with phenylketonuria
3.
Hhow to take [INVENTED NAME]
Always have your child take this medicine as your doctor has told you. Check with your child's doctor
or pharmacist if you are not sure.
Your doctor will decide how to use [INVENTED NAME], based on the symptoms and s everity of
your asthma.
It is important that your child takes [INVENTED NAME] every day in the evening exactly as your
doctor has told you. This applies even if your child has no symptoms, or on days when your child
has an asthma attack.
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Please also take all other asthma medications prescribed to your child by your doctor. [INVENTED
NAME] is not designed to replace other medications.
The usual dose is:
Use in cChildren aged between 2 and 5 years:
One1 [INVENTED NAME] 4 mg chewable tablet once daily in the evening. Your child should
take the tablet at least 1 hour before or 2 hours after a meal.
The [INVENTED NAME] 4 mg chewable tablets is not recommended below 2 years of age.
Children aged between 6 and 14 years:
1 [INVENTED NAME] 5 mg chewable tablet once daily in the evening. Your child should take the
tablet at least 1 hour before or 2 hours after a meal.
If you child takes more [INVENTED NAME] than you should
If your child has accidentally taken too much [INVENTED NAME], or if someone else has taken
your medicine by mistake, contact your doctor immediately.
If you forget to givetake [INVENTED NAME] to your child
If you forget to giver child has forgotten to take [INVENTED NAME] to your child, skip that dose
and carry on with the treatment at the next due time, as prescribed. Do not take a double dose.
If your child stop taking [INVENTED NAME]
Do not stop your child’s treatment without talking to your doctor first. It is important that your
child keeps taking [INVENTED NAME] for as long as your doctor has prescribed even in the presence or absence of symptoms. [INVENTED NAME] can treat asthma only with continued use.
If you have any further questions on the use of this medicineproduct, ask your doctor or pharmacist.
4.
Ppossible side effects
Like all medicines, this medicine [INVENTED NAME] can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
If you notice any of the following serious side effects that have been reported with montelukast, stop
taking [INVENTED NAME] and contact a doctor immediately:
flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary
symptoms and/or rash (Churg-Strauss syndrome); vary rare side effect which may affect up to
1 in 10,000 people;

severe allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing; uncommon side effect which may affect up to 1 in 100
people.



In clinical studies with montelukast, 4 mg, 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 were:
abdominal pain and thirst (for montelukast 4mg chewable tablets)
hyperkinesia, asthma, diarrhoea, eczematous dermatitis, rash (for montelukast 4 mg granules)
Additionally, the following side effect was reported in clinical studies with montelukast, 10 mg filmcoated tablets and 5 mg chewable tablets:
 headache
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 abdominal pain (for montelukast 10 mg film-coated tablets)
These were usually mild and occurred at a greater frequency in patients treated with montelukast tablets
than placebo (a pill containing no medication).
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Additionally, while the medicine has been on the market, the following have been reported:
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
 increase in liver enzymes in the blood
 rash
 fever
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, seizure
 dry mouth, indigestion
 nosebleed
 bruising, itching, hives
 joint or muscle pain, muscle cramps
 tiredness, feeling unwell, swelling
Rare (may affect up to 1 in 1,000 people)
 increased bleeding tendency
 tremor
 palpitations
Very rare (may affect up to 1 in 10,000 people)
 hallucinations, disorientation, suicidal thoughts and actions
 hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration)
 tender red lumps under the skin most commonly on your shins (erythema nodosum), severe
skin reactions (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V*. By reporting side effects you can help provide more information on the safety
of this medicine. In clinical studies with montelukast 4 mg 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 [Name] were:
abdominal pain
thirst
Additionally, the following side effect was reported in clinical studies with montelukast 5 mg 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).
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The assessment of undesirable effects is based on the following frequency data:
Very common
more than one in 10 patients treated
Common
less than one in 10, but more than one in 100 patients treated
Uncommon
less than one in 100, but more than one in 1,000 patients treated
Rare
less than one in 1,000, but more than one in 10,000 patients treated
Very rare
less than one in 10,000 patients treated, including isolated cases
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Additionally, while the medicine has been on the market, the following have been reported:
upper respiratory infection (Very common)
increased bleeding tendency (Rare)
allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may
cause difficulty in breathing or swallowing (Uncommon)
behaviour and mood related changes [dream abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor (Rare); hallucinations, disorientation, suicidal thoughts and actions (Very rare)]
dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
palpitations (Rare)
nosebleed (Uncommon)
diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
hepatitis (inflammation of the liver) (Very rare)
rash (Common), bruising, itching, hives (Uncommon); tender red lumps under the skin most
commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme)
(Very rare)
joint or muscle pain, muscle cramps (Uncommon)
fever (Common); tiredness, feeling unwell, swelling (Uncommon).
Possible side effects:
Common:
Stomach pain, headache, thirst
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Very rare:
Hypersensivity reactions (anaphylaxis) e.g.:
 Skin rash
 Swelling of the facial region, lips, tongue and/or throat, resulting in shortness of breath or difficulty in swallowing.
Flu-like illness, increasing breathlessness, pins and needles or numbness of
limbs, and/or rash (known as Churg-Strauss-Syndrome).
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If your child experiences a combination of any of these symptoms, particularly if
they are persistent or worsening, seek medical attention immediately.
Itching, nettle rash (hives), tiredness, weakness, restlessness, agitation including aggressive behaviour, irritability, dizziness, drowsiness, hallucinations,
abnormal dreams (e.g. nightmares), insomnia, paraesthesia (pins and needles/numbness), diarrhoea, seizures, general feeling of being unwell, painful
joints, muscle pain, muscle spasms, dry mouth, nausea, vomiting, digestive
disorders, hepatitis (inflammation of the liver), increased liver enzyme levels,
changes in liver tissue, increased tendency to bleed, bruising, palpitations,
swelling (oedema)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V*. By reporting side effects you can help provide more information on the safety
of this medicine.
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5.
Hhow to store [INVENTED NAME]
Keep this medicine out of the sight reach and reach sight of children.
Store in the original package, in order to protect from light.
Do not use this medicine[INVENTED NAME] after the expiry date which is stated on the blister and
outer package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
Contents of the pack and otherFurther information
What [INVENTED NAME] contains
The active substance is: montelukast (as montelukast sodium).
4 mg Chewable tablet:
One chewable tablet contains montelukast sodium, which is equivalent to 4 mg mont elukast.
5 mg Chewable tablet:
One chewable tablet contains montelukast sodium, which is equivalent to 5 mg mont elukast.
The other ingredients are:
[INVENTED NAME] 4 mg / 5 mg chewable tablets
Microcrystalline cellulose , mannitol , crospovidone type B, red iron oxide (E172), hydroxypropylcellulose, disodium edetate, cherry flavour, aspartame (E951) , talc , magnesium stearate .
What [INVENTED NAME] looks like and contents of the pack
[INVENTED NAME] 4 mg chewable tablets are pink, oval tablets embossed with "M4" on one
side.
[INVENTED NAME] 5 mg chewable tablets are pink, round tablets embossed with "M5" on one
side.
[INVENTED NAME] is available in packs of Aluminium/Aluminium blisters which contain 28
chewable tabltes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally.]
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following
names:
This leaflet was last approved in

INVENTED NAME

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