Diclac 25 mg/ml Solution for Injection 3 ml Ampoule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Rowex Ltd

ATC code:

M01AB; M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances; diclofenac

Authorization status:

Marketed

Authorization date:

1992-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLAC 25MG/ML SOLUTION FOR INJECTION 3ML AMPOULE
DICLOFENAC SODIUM
WHAT IS IN THIS LEAFLET
1.
What Diclac is and what it is used for
2.
What you need to know before you take Diclac
3.
How to take Diclac
4.
Possible side effects
5.
How to store Diclac
6.
Contents of the pack and other information.
1
WHAT DICLAC IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in Diclac Solution for
Injection, is one of a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs reduce pain and
inflammation.
Diclac Injection can either be given as an injection into the muscle,
or as a slow infusion into a vein.
The intramuscular injection is used to treat a number of painful
conditions including:
•
acute back pain
•
attacks of gout
•
pain caused by gallstones or kidney stones
•
pain due to osteo- and rheumatoid arthritis
•
pain caused by injuries, acute trauma and fractures
•
pain following surgery.
The intravenous infusion is used in hospital to prevent or treat pain
following an operation.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLAC
•
SOME PEOPLE MUST NOT USE DICLAC. TALK TO YOUR DOCTOR IF:
•
you think you may be allergic to diclofenac sodium, aspirin, ibuprofen
or any other NSAIDs, or to
any of the other ingredients of Diclac. (These are listed at the end
of the leaflet). Signs of a
hypersensitivity reaction include swelling of the face and mouth
(angioedema), breathing
problems, chest pain, runny nose, skin rash or any other allergic type
reaction.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes an

Summary of Product characteristics

Health Products Regulatory Authority
07 December 2022
CRN00D6H1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac 25 mg/ml Solution for Injection 3 ml Ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3ml ampoule contains 75 mg Diclofenac Sodium (25 mg/ml)
EXCIPIENTS WITH KNOWN EFFECT:
Each 3 ml ampoule contains 120 mg of benzyl alcohol (40 mg/ml) and 600
mg propylene glycol (200 mg/ ml).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INTRAMUSCULAR INJECTION:
Treatment of
• exacerbation of inflammatory and degenerative forms of rheumatism:
rheumatoid arthritis,
osteoarthritis
• renal colic and biliary colic
• acute attacks of gout
• acute trauma and fractures
• post traumatic and post-operative pain, inflammation and swelling.
INTRAVENOUS INFUSION:
• For treatment or prevention of post-operative pain in the hospital
setting
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable 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 special precautions for
use). Diclac ampoules should not be given for more
than 2 days, if necessary treatment can be continued with tablets or
suppositories.
ROUTE OF ADMINISTRATION:
FOR INTRAVENOUS INFUSION OR INTRAMUSCULAR USE ONLY INTRAVENOUS USE:
Diclac should not be administered by intravenous bolus injection
Immediately before starting an intravenous infusion,
diclofenac solution for injection must be diluted. For Instruction on
dilution of the product before administration, see section
6.6.
Two alternative dosage regimens of diclofenac solution for injection
are recommended.
For the treatment of moderate to severe post-operative pain, 75 mg
should be infused continuously over a period of 30
minutes to 2 hours. If necessary, treatment may be repeated after 4-6
hours, but the dose should not ex