NEULIN SR 200 theophylline 200mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

theophylline, Quantity: 200 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: Guar Gum; magnesium stearate; purified water

Administration route:

Oral

Units in package:

100, 60, 500, 1000 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions.

Product summary:

Visual Identification: White round biconvex tablet N/L on one side and 200 on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1997-05-16

Patient Information leaflet

NUELIN-SR™ TABLETS
_(NEW-LIN)_
_Theophylline (thee-off-o-lin) Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nuelin-SR tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
IF YOU NEED ANY MORE INFORMATION
ABOUT NUELIN-SR TABLETS, PLEASE ASK
YOUR DOCTOR OR PHARMACIST.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Nuelin-SR
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NUELIN-SR
TABLETS ARE USED FOR
Nuelin-SR tablets are used to treat
asthma and other conditions where
breathing is difficult. It also helps to
prevent asthma attacks. The active
ingredient in Nuelin-SR tablets is
theophylline, which causes the
muscle lining of the airways to relax.
Nuelin-SR tablets are a slow release
medicine which means each tablet
works for about 12 hours.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may prescribe Nuelin-
SR tablets for another purpose.
Nuelin-SR tablets are available only
with a doctor's prescription.
IF YOU ARE NOT SURE WHY YOU ARE
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
BEFORE YOU TAKE
NUELIN-SR TABLETS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NUELIN-SR TABLETS IF
YOU HAVE AN ALLERGY TO:
•
Any medicine containing
theophylline, aminophylline or
caffeine
•
Any of the ingredients listed at
the end of this leaflet
•
Any other similar medicines used
to treat asthma and other
conditions where breathing is
difficult
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue,
or other parts of the body
•
Rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
NUELIN
®
-SR (THEOPHYLLINE) TABLETS AND
NUELIN
®
(THEOPHYLLINE) SYRUP
1
NAME OF THE MEDICINE
Theophylline.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nuelin-SR Tablets contain 200 mg, 250 mg or 300 mg anhydrous
theophylline in the form of sustained
release tablets. Nuelin-SR Tablets also contain guar gum, magnesium
stearate and purified water.
Nuelin Syrup contains 133.3 mg anhydrous theophylline per 25 mL in
immediate release form. Nuelin
Syrup also contains methyl hydroxybenzoate, propyl hydroxybenzoate,
sorbitol, berry citrus
flavouring, sucrose and purified water.
3
PHARMACEUTICAL FORM
NUELIN SR 200 theophylline 200mg tablet bottle – white round
biconvex tablet N/L on one side and
200 on the other.
NUELIN SR 250 theophylline 250mg tablet bottle – white, round
biconvex tablets marked N/L 250.
NUELIN SR 300 theophylline 300mg tablet bottle – white round
biconvex tablet N/L on one side and
300 on the other.
NUELIN Syrup theophylline 26.67mg/5mL bottle – clear liquid, berry
flavour.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the relief and prophylaxis of reversible bronchospasm associated
with bronchial asthma,
bronchitis, emphysema and related conditions.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Desirable therapeutic levels are considered to be between 10-20 µg/mL
(55-110 µmol/L). Higher
levels may produce toxic effects. Toxic effects may also occur at
therapeutic levels. When maximum
response is required, dose levels should be individually titrated.
Serum theophylline may be
monitored to confirm that levels are within the therapeutic range.
Monitoring is particularly
recommended when dose levels exceed 1 g daily in adults or 24 mg/kg
daily in children.
Appropriate dosage adjustments should be made for smoking, heart
failure, acute pulmonary oedema,
chronic alcohol ingestion, established hepatic cirrhosis, severe
airways obstruction, severe
pneumonia, severe hypoxia, thyroid function, adolescence (12-18
years), children (8-12 years) and
concomitant use