NUELIN LIQUID

Țară: Africa de Sud

Limbă: engleză

Sursă: South African Health Products Regulatory Authority (SAHPRA)

Disponibil de la:

iNova Pharmaceuticals (Pty) Ltd

Dozare:

See ingredients

Forma farmaceutică:

LIQUID

Compoziție:

EACH 5,0 ml LIQUID CONTAINS THEOPHYLLINE 25,0 mg

Statutul autorizaţiei:

Registered

Data de autorizare:

1987-10-09

Prospect

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
NUELIN LIQUID, theophylline 25 mg/5 ml, liquid.
Each 5 ml liquid contains:
Theophylline 25 mg/5 ml.
Contains sugar: Sucrose 2,5 mg/5 ml
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
•
NUELIN LIQUID has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same
as yours.
WHAT IS IN THIS LEAFLET
1.
What NUELIN LIQUID is and what it is used for
2.
What you need to know before you take NUELIN LIQUID
3.
How to take NUELIN LIQUID
4.
Possible side effects
5.
How to store NUELIN LIQUID
6.
Contents of the pack and other information
1.
WHAT NUELIN LIQUID IS AND WHAT IT IS USED FOR
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Theophylline belongs to a group of medicines called bronchodilators.
Bronchodilators are
used to treat, and relieve the symptoms of diseases where the passages
in your lungs are
blocked.
NUELIN LIQUID works by widening the air passages in your lungs which
allows you to breathe
more easily and feel less tight chested.
NUELIN LIQUID is used for the maintenance treatment of bronchospasm in
asthmatic children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUELIN LIQUID
Do not take NUELIN LIQUID:
•
if you are hypersensitive (allergic) to theophylline or any of the
other ingredients of
NUELIN LIQUID (listed in section 6);
•
if you are hypersensitive to products called xanthine derivatives;
•
if you have suffered from a heart attack recently;
•
if you have acute tachyarrhythmia (fast heartbeat);
•
if you have a disease called porphyria which may cause skin problems,
chest and
stomach pains, nausea and diarrhoea;
•
if you are taking medicines called ephedrine.
WARNINGS AND PRECAUTIONS
Special care should be taken with NUELIN LIQUID:
•
if you are taking products called xanthines or x

Caracteristicilor produsului

Page 1 of 12
1.3.1.1 PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
NUELIN LIQUID, theophylline 25 mg/5 ml, liquid.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5,0 ml contains:
Theophylline 25,0 mg
Preservatives:
Methyl hydroxybenzoate 0,2 %
Propyl hydroxybenzoate 0,03 %
Contains sugar: Sucrose 2,5 g/5 ml
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
NUELIN LIQUID is a clear, colourless to almost colourless, syrupy
liquid with a characteristic
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
NUELIN LIQUID is indicated for maintenance treatment of bronchospasm
in asthmatic
children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
2-8 years:
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24 mg / kg per 24 hours, given in 4 divided doses, i.e. every 6 hours
9-12 years:
20 mg / kg per 24 hours, given in 4 divided doses, i.e. every 6 hours
13-16 years:
18 mg / kg per 24 hours, given in 4 divided doses, i.e. every 6 hours
4.3 CONTRAINDICATIONS
Hypersensitivity to theophylline, xanthine derivatives or any of the
excipients included in
NUELIN LIQUID. See 6.1.
Recent myocardial infarction. Acute tachyarrhythmia.
Porphyria.
Concomitant use with ephedrine in children.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Theophylline should not be administered to children younger than two
years of age, as they
cannot metabolize theophylline sufficiently.
After taking NUELIN LIQUID, patients should carefully rinse out their
mouths with plenty of
water. NUELIN LIQUID is unsuitable for children suffering from
diabetes mellitus.
The patient’s response to therapy should be carefully monitored.
Theophylline should not be administered concurrently with other
xanthine medications and
caution should be exercised when sympathomimetic agents are also part
of the regimen.
Theophylline clearance decreases in patients with reduced thyroid
function, congestive heart
failure, acute pulmonary oedema, chronic obstructive pulmonary
disease, severe hypoxia,
pneumonia, acute febrile episodes and during acute viral infection.
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