DHC Continus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dihydrocodeine hydrogen tartrate 60mg equivalent to dihydrocodeine 40 mg

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Dihydrocodeine hydrogen tartrate 60 mg (Equiv to dihydrocodeine 40 mg)

Dosage:

60 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Dihydrocodeine hydrogen tartrate 60mg equivalent to dihydrocodeine 40 mg Excipient: Cetostearyl alcohol Hyetellose Lactose monohydrate Magnesium stearate Purified talc

Units in package:

Bottle, plastic, HDPE with PP child resistant closure, 60 tablets

Class:

Class C2 Controlled Drug

Prescription type:

Class C2 Controlled Drug

Manufactured by:

Macfarlan Smith Ltd

Therapeutic indications:

DHC CONTINUS is indicated for the management of severe pain where: - other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and -the pain is opioid-responsive, and -requires daily, continuous, long term treatment. DHC CONTINUS is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. DHC CONTINUS is not indicated as an as-needed (PRN) analgesia.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant closure - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, Polypropylene - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1989-10-17

Patient Information leaflet

DHC
CONTINUS
®
TABLETS
_Dihydrocodeine hydrogen tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you start
using DHC CONTINUS
®
.
This leaflet answers some
common questions about
DHC CONTINUS
®
. It does
not contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
using DHC CONTINUS
®
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT DHC
CONTINUS
® TABLETS
ARE TAKEN FOR
DHC CONTINUS
®
tablets
contain Dihydrocodeine
hydrogen tartrate.
Dihydrocodeine, belongs to a
class of medicines called
opioids, which are ‘pain
relievers’.
DHC CONTINUS® is used
for the management of
severe pain where other
forms of treatment have
failed, or should not be used
or are not tolerated or are
otherwise inappropriate to
provide adequate
management of pain. DHC
CONTINUS® is used
where the pain is responsive
to opioids, and where the
pain requires daily,
continuous, long term
treatment.
Your doctor may have
prescribed DHC CONTINUS
®
for another reason.
Ask your doctor if you have
any questions about why
DHC CONTINUS
®
has been
prescribed for you.
As with all strong painkillers,
your body may become used
to you taking DHC
CONTINUS
®
tablets. Taking
it may result in physical
dependence. Physical
dependence means that you
may experience withdrawal
symptoms if you stop taking
DHC CONTINUS
®
tablets
suddenly, so it is important to
take it exactly as directed by
your doctor.
This medicine is available
only with a doctor's
prescription.
BEFORE YOU TAKE DHC
CONTINUS
®
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE DHC
CONTINUS
® IF YOU:

are allergic
(hypersensitive) to
dihydrocodeine or any of
the ingredients listed at
the end of this leaflet;

have severe breathing
problems such as

Summary of Product characteristics

NEW ZEALAND DATA SHEET
DHC Continus tabs
Jan 2024
Page 1 of 11
DHC CONTINUS® 60MG TABLETS
Dihydrocodeine hydrogen tartrate
1 PRODUCT NAME
DHC CONTINUS® 60mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine hydrogen tartrate 60mg equivalent to 40mg
dihydrocodeine
Excipient(s) with known effect:
Lactose anhydrous
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets: White, biconvex, capsule-shaped 12mm in length and 5mm wide,
plain on one side and
embossed DHC 60 on the other.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DHC CONTINUS®
is indicated for the management of severe pain where:
•
other treatment options have failed, are contraindicated, not
tolerated or are otherwise
inappropriate to provide sufficient management of pain, and
•
the pain is opioid-responsive, and
•
requires daily, continuous, long term treatment.
DHC CONTINUS®
is not indicated for use in chronic non-cancer pain other than in
exceptional
circumstances.
DHC CONTINUS® is not indicated as an as-needed (PRN) analgesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS AND CHILDREN OVER 12 YEARS OF AGE: _
The tablets should be taken at twelve-hourly intervals at a dose of
60-120mg twice daily depending
on the severity of the patient’s pain.
The maximum recommended dose is 240mg daily since higher doses do not
provide any further
analgesic effect.
_CHILDREN 12 YEARS OR UNDER: _
Not recommended.
_ELDERLY AND SPECIAL RISK GROUPS: _
NEW ZEALAND DATA SHEET
DHC Continus tabs
Jan 2024
Page 2 of 11
DHC CONTINUS® tablets should be administered initially at the lowest
dose possible in elderly or
debilitated
patients,
patients
with
impaired
renal
function,
impaired
hepatic
function,
or
hypothyroidism.
_METHOD OF ADMINISTRATION: _
DHC CONTINUS® tablets must be swallowed whole and not broken, chewed
or crushed.
4.3
CONTRAINDICATIONS
•
Known hypersensitivity to dihydrocodeine hydrogen tartate or to any of
the excipients (see
section 6.1)
•
Severe chronic obstructive lung disease
•
Severe _cor pulmo