Uniphyllin Continus 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Theophylline

Available from:

Ennogen Healthcare Ltd

ATC code:

R03DA04

INN (International Name):

Theophylline

Dosage:

200mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010300; GTIN: 5012854070042

Patient Information leaflet

6152-15
460X148MM (LSN-NAPP-02) (L) V1
V10-2018
_ITEM DESCRIPTION:_
_TEMPLATE NO.:_
_MANUFACTURER / PACKER:_
_ITEM CODE 2:_
_DIMENSIONS:_
_SECURITY CODE TYPE:_
_UNWIND NO.:_
_PMS NO.:_
_CREATED BY:_
_DATE CREATED:_
_VERSION:_
_POR NO.:_
COLOUR(S):
NON-PRINTING COLOURS
PINK
BLUE
PURPLE
BUFF
_PACKAGI NG _
_ARTWORK _
_TEAM_
_Bard Pharmaceuticals Ltd._
_Cambridge Science Park, Milton Road, _
_Cambridge CB4 0GW, UK_
_Tel: [phone]_
cgr01
31-01-19
V1
N/A
460X148mm
Datamatrix
N/A
PRD-PMS-005
460x148mm (LSN-NAPP-02)(L) V1
LSN-NAPP-02
N/A
148x36,34mm
6152-15
N/A
UNIPHYLLIN TABS PIL UK 6152-15
BARD
7542
PMS 280
PMS 280 @ 20%
UNIPHYLLIN TABS PIL UK 6152-15 V1.indd 1
31/01/2019 17:00
6152-15
_ UNIPHYLLIN_
_®_ _CONTINUS_
_®_ 200 MG, 300 MG AND
400 MG PROLONGED-RELEASE TABLETS
Theophylline
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
Always take this medicine exactly
as described in this leaflet or as your
doctor, pharmacist or nurse has told you.
•
Keep this leaflet. You may need to
read it again.
•
Ask your pharmacist if you need
more information or advice.
•
If you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
•
You must talk to a doctor if you do
not feel better or if you feel worse
after 3 days.
1. WHAT _UNIPHYLLIN_ _CONTINUS_ TABLETS
ARE AND WHAT THEY ARE USED FOR
These tablets are used to treat asthma,
long-term breathing difficulties such
as chronic obstructive pulmonary
disease and chronic bronchitis, and are
sometimes used to treat heart failure.
They contain the active ingredient
theophylline which belongs to a group
of medicines called bronchodilators.
Bronchodilators help stop you wheezing
and being breathless. Theophylline also
reduces swelling in the lungs of asthma
patients and relieves the feeling of
‘tightness’ in their chest.
These tablets may be taken by adults

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
UNIPHYLLIN CONTINUS 200mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 200 mg theophylline as 220 mg
theophylline monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release tablet
White, capsule shaped tablet, plain on one side and marked ‘U200’
on the other.
4.1
THERAPEUTIC INDICATIONS
For the treatment and prophylaxis of bronchospasm associated with
asthma, chronic
obstructive pulmonary disease and chronic bronchitis. Also indicated
for the
treatment of left ventricular and congestive cardiac failure.
UNIPHYLLIN CONTINUS tablets are indicated for use in adults and
children aged 6
years and above.
Theophylline should not be used as first drug of choice in the
treatment of asthma in
children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and the elderly _
The usual maintenance dose is 200 mg 12 hourly. This may be titrated
to either 300
mg or 400 mg dependent on the therapeutic response.
_ _
_Paediatric population aged 6 years and above _
The usual paediatric maintenance dose is 9 mg/kg twice daily. Some
children with
chronic asthma require and tolerate much higher doses (10-16 mg/kg
twice daily).
Clearance is increased in children compared to values observed in
adult subjects. The
rapid clearance observed in children decreases towards adult values in
late teens.
Therefore, lower dosages (based on usual adult dose) may be required
for
adolescents.
UNIPHYLLIN CONTINUS tablets should not be used in children below 6
years of
age. Other dosage forms are available that are more suitable for
children aged less
than 6 years.
Theophylline distributes poorly into body fat, therefore mg/kg doses
should be
calculated on the basis of lean (ideal) bodyweight.
Plasma theophylline concentrations should ideally be maintained
between 5 and 12
micrograms/ml. A plasma level of 5 micrograms/ml probably represents
the lower
level of clinical