Diclo SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diclofenac sodium 100mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Diclofenac sodium 100 mg

Dosage:

100 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Diclofenac sodium 100mg Excipient: Dextrates Hyetellose Hypromellose Iron oxide red Iron oxide yellow Macrogol 3350 Magnesium stearate Microcrystalline cellulose Titanium dioxide

Units in package:

Blister pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)

Therapeutic indications:

Diclofenac is used for the relief of moderate pain and inflammation in: - Rheumatic disorders: e.g. ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis including juvenile rheumatoid arthritis, painful syndromes of the vertebral column, nonarticular rheumatism. - Painful post-operative inflammation and swelling (including dental and orthopaedic procedures). - Painful or inflammatory gynaecological conditions e.g. primary dysmenorrhoea. - In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Diclofenac provides symptomatic relief but has not been shown to halt or reverse the underlying disease process. Fever alone is not an indication.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 90 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 500 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 1000 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 500 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, white PP lift n peel cap - 1000 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle, blue PP lift n peel cap - 1000 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1993-06-25

Patient Information leaflet

APO-AZITHROMYCIN TABLETS
1
APO-DICLO SR TABLETS
_Contains the active ingredient diclofenac sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Apo-Diclo SR. 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 taking Apo-Diclo SR
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 YOUR
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Diclofenac SR is used for the
treatment of:
•
Inflammatory and
degenerative forms of
rheumatism: rheumatoid
arthritis, ankylosing
spondylitis, osteoarthritis
and spondylarthritis, painful
syndromes of the vertebral
column, nonarticular
rheumatism.
•
Post-traumatic and post-
operative pain,
inflammation, and swelling,
e.g. following dental or
orthopaedic surgery.
•
Painful and/or inflammatory
conditions in gynaecology,
e.g. primary dysmenorrhoea
or adnexitis.
Diclofenac SR belongs to a family of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs).
These medicines can relieve the
symptoms of pain and inflammation,
but they will not cure your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DICLOFENAC HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
This medicine is not addictive.
_USE IN CHILDREN _
This is not recommended for use in
children, as there is not enough
information on its use in this age
group.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DICLOFENAC IF YOU ARE
ALLERGIC TO:
•
diclofenac
•
other medicines containing
diclofenac
•
aspirin/acetylsalicyclic acid
•
any other NSAID medicine
•
any of the ingredients listed
at the end of this leaflet.
Many medicines used to treat
headac

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-DICLO SR
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 16
1. PRODUCT NAME
Apo-Diclo SR 75mg modified release tablet
Apo-Diclo SR 100mg modified release tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg diclofenac sodium and typically weigh 195 to
207mg.
Each tablet contains 100mg diclofenac sodium and typically weigh 258
to 277mg.
Excipient with known effect
Apo-Diclo SR is gluten and lactose free.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
APO-DICLO SR 75mg tablet are light pink, triangular biconvex,
bevelled-edge, film coated
tablet. Engraved “APO” over “75” on one side, other side
plain.
APO-DICLO SR 100 mg tablets are pink, round biconvex, bevelled-edge,
film-coated
tablet. Engraved “APO” over “100” on one side, other side
plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of:
• Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing
spondylitis, osteoarthritis and spondylarthritis, painful syndromes of
the vertebral column,
nonarticular rheumatism.
• Post-traumatic and post-operative pain, inflammation, and
swelling, e.g. following dental
or orthopaedic surgery.
• Painful and/or inflammatory conditions in gynaecology, e.g.
primary dysmenorrhoea or
adnexitis.
4.2 DOSE AND METHOD OF ADMINISTRATION
This product is not able to deliver all approved dose regimens.
Diclofenac slow release tablet should only be prescribed when the
benefits are considered
to outweigh the potential risks. After assessing the risk/benefit
ratio in each individual
patient, the lowest effective dose for the shortest possible duration
should be used. Adverse
effects may be minimized by using the lowest effective dose for the
shortest duration
necessary to control symptoms (see section 4.4 Special Warnings and
Precautions for use).
APO-DICLO SR
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 16
The t