Nuelin-SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Theophylline 250mg;  ; Theophylline 250mg

Available from:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Theophylline 250 mg

Dosage:

250 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Theophylline 250mg   Excipient: Cellacefate Lactose monohydrate Magnesium stearate Active: Theophylline 250mg Excipient: Guar gum Magnesium stearate

Units in package:

Blister pack, PVC/PVDC, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Siegfried PharmaChemikalien Minden GmbH

Therapeutic indications:

NUELIN-SR tablets are indicated for the relief and prophylaxis of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1979-07-16

Patient Information leaflet

NUELIN-SR™
1
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 PR

Summary of Product characteristics

NEW ZEALAND DATA SHEET
NEULIN
TM
-SR
NUELIN-SR
Page 1 of 8
1 PRODUCT NAME
NUELIN-SR 250 mg sustained release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains theophylline BP 250 mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Sustained release tablet.
White, round, biconvex tablets marked 250 on one face and no markings
on the other face.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
NUELIN-SR tablets are indicated for the relief and prophylaxis of
reversible bronchospasm
associated with asthma, chronic bronchitis and emphysema.
4.2
Dose 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 recommended,
in particular when dose levels exceed 1g daily in adults or 24 mg/kg
daily in children.
NUELIN-SR doses should be adjusted for factors known to affect
theophylline clearance (see
sections 4.4 and 4.5).
Dose
Adults: 13 mg/kg per 24 hours.
_Paediatric Population _
Children over 2 years: Starting dose 16 mg/kg every 24 hours to a mean
20 mg/kg every 24
hours.
Children under 2 years: Not to be given except on the advice of a
physician.
Children (from 6 months to 16 years) have a more rapid clearance of
theophylline resulting in
the need for higher per kg doses.
_Special Populations _
Where possible patients should be commenced on a lower dose and
gradually increased to the
maintenance dose to minimise the incidence of side effects. Extra
caution is required with the
elderly as they may have slower clearance rates. Obese patients should
be dosed on the basis of
ideal rather than actual body weight. Smokers often require higher
doses than non-smokers due to
more rapid clearance of theophylline.
_ _
NEW ZEALAND DATA SHEET
NEULIN
TM