NUELIN SA 200 TABLET

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Gulf Drug Company (Pty) Ltd

Annus:

See ingredients

Ravimvorm:

TABLET

Koostis:

EACH TABLET CONTAINS THEOPHYLLINE 200,0 mg

Volitamisolek:

Registered

Loa andmise kuupäev:

2002-07-07

Infovoldik

iNova Pharmaceuticals (Pty) Ltd
1.3.2
Nuelin SA, tablet
Theophylline 250 mg/tablet
________________________________________________________________________________
Date: 2022/04/10
Page 1 of 10
1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
NUELIN SA 250 mg tablets
Theophylline
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
NUELIN SA is available without a doctor’s prescription, for you to
treat a mild illness. Nevertheless, you still
need to use NUELIN SA carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share NUELIN SA with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5 days.
WHAT IS IN THIS LEAFLET
1.
What NUELIN SA is and what it is used for
2.
What you need to know before you take NUELIN SA
3.
How to take NUELIN SA
4.
Possible side effects
5.
How to store NUELIN SA
6.
Contents of the pack and other information
1.
WHAT NUELIN SA IS AND WHAT IT IS USED FOR
iNova Pharmaceuticals (Pty) Ltd
1.3.2
Nuelin SA, tablet
Theophylline 250 mg/tablet
________________________________________________________________________________
Date: 2022/04/10
Page 2 of 10
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 SA works by widening the air passages in your lungs which
allows you to breathe more easily and
feel less tight chested.
NUELIN SA is used for the treatment of bronchospasm.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUELIN SA
Do not take NUELIN SA:
•
if you are hypersensitive (allergic) to theophylline or any of the
other ingredients of NUELIN SA
(listed in section 6);
•
if you are receiving any other theophylline therapy;
•
if you are hypersensitive to products called xanthine derivatives
(e.g.: caffeine, theobromine and
meth

Toote omadused

iNova Pharmaceuticals (Pty) Ltd
1.3.1.1
Nuelin SA, tablet
Theophylline 250 mg/tablet
________________________________________________________________________________
Date: 2022/04/10
Page 1 of 14
1.3.1.1 PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
NUELIN SA 250 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg theophylline (anhydrous) in a slow release
formulation.
Sugar free.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, round biconvex tablets – markings N/L on one side and 250 on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
NUELIN SA tablets are indicated for the treatment of bronchospasm.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: One NUELIN SA tablet orally twice daily (i.e. 12 hourly), to
be increased gradually to
two tablets twice daily (i.e. 12 hourly), if necessary and if
tolerated.
Children:
5 to 8 years:
24 mg/kg/24 hours
9 to 12 years:
20 mg/kg/24 hours
13 to 16 years:
18 mg/kg/24 hours
The
average
maintenance
dose
is
15
to
18
mg/kg/day.
However,
the
individual
biotransformation varies and it is advisable to monitor theophylline
therapy with serum assays
of theophylline.
NUELIN SA tablets may be halved but should not be crushed or chewed.
UNUELIN SA tablets are not recommended for administration to children
under 2 years of
age.
S2
iNova Pharmaceuticals (Pty) Ltd
1.3.1.1
Nuelin SA, tablet
Theophylline 250 mg/tablet
________________________________________________________________________________
Date: 2022/04/10
Page 2 of 14
For children taking NUELIN SA tablets, NUELIN LIQUID may be considered
as an alternative.
4.3 CONTRAINDICATIONS
No other theophylline therapy should be administered concurrently with
NUELIN SA.
Hypersensitivity to theophylline, aminophylline, xanthine derivatives
or any of the excipients
included in NUELIN SA. See section 6.1.
Recent myocardial infarction.
Acute tachydysrythmia.
Porphyria.
Concomitant use with ephedrine in children.
Children under 2 years of age (They can