Voltarol 75mg/3ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

25mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5010678461008

Patient Information leaflet

VOLTAROL
® AMPOULES
(DICLOFENAC SODIUM)
PATIENT INFORMATION LEAFLET
WHAT YOU NEED TO KNOW ABOUT VOLTAROL AMPOULES
Your doctor has decided that you need this medicine to help treat your
condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IT CONTAINS IMPORTANT
INFORMATION. Keep the leaflet in a safe place because you may want to
read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone
else. It may not be the
right medicine for them even if their symptoms seem to be the same as
yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Voltarol Ampoules are, and what they are used for
2.
Things to consider before you start to take Voltarol Ampoules
3.
How to take Voltarol Ampoules
4.
Possible side effects
5.
How to store Voltarol Ampoules
6.
Further information
1.
WHAT VOLTAROL AMPOULES ARE, AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in Voltarol Ampoules, is one
of a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce
pain and
inflammation.
The intramuscular injection is used to treat a number of painful
conditions including:

'Flare-ups' of joint or back pain

Attacks of gout

Pain caused by kidney stones

Pain caused by injuries.
Voltarol Ampoules can either be given as an injection into the muscle,
or as a slow infusion
into a vein. The intravenous infusion is used in hospitals to prevent
or treat pain following an
operation.
Voltarol Ampoules are not suitable for children.
2.
THINGS TO CONSIDER BEFORE YOU HAVE VOLTAROL INJECTION
SOME PEOPLE MUST NOT HAVE THIS INJECTION. TALK TO YOUR DOCTOR IF:

you think you may be allergic to diclofenac sodium, sodium
metabisulphite, aspirin,
ibuprofen or any other NSAID, or to any of the other ingredients of
Vol

Summary of Product characteristics

OBJECT 1
VOLTAROL AMPOULES
Summary of Product Characteristics Updated 07-Apr-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Voltarol
®
Ampoules
2. Qualitative and quantitative composition
The active ingredient is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate) (diclofenac
sodium).
Each 3ml ampoule contains 75mg diclofenac sodium Ph.Eur.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in ampoules.
4. Clinical particulars
4.1 Therapeutic indications
_Ampoules for im use_:
The ampoules are effective in acute forms of pain, including renal
colic, exacerbations of osteo- and
rheumatoid arthritis, acute back pain, acute gout, acute trauma and
fractures, and post-operative pain.
_Ampoules used in 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 minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4 Special warnings and
precautions for use).
ADULTS
Voltarol ampoules (given im or iv) should not be given for more than
two days; if necessary, treatment
can be continued with Voltarol tablets or suppositories.
Intramuscular injection: The following directions for intramuscular
injection must be adhered to in order
to avoid damage to a nerve or other tissue at the injection site.
One ampoule once (or in severe cases twice) daily intramuscularly by
deep intragluteal injection into the
upper outer quadrant. If two injections daily are required it is
advised that the alternative buttock be used
for the second injection. Alternatively, one ampoule of 75mg can be
combined with other dosage forms of
Voltarol (tablets or suppositories) up to the maximum daily dosage of
150mg.
Renal colic: One 75mg ampoule intramuscularly. A further ampoule may
be administered after 30
minutes if necessary. The recommended maximum daily dose of Voltarol
is 150mg.
_Intravenous Infusion_: Immedia