Diclofenac sodium, the active ingredient in Voltic™ 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.
Voltic™ 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.
Voltic™ Ampoules are not suitable for children.

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 Voltic Ampoules.
(These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include
swelling of the face and mouth (angioedema), breathing problems, runny nose, skin
rash or any other allergic type reaction.
• you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or
bleeding in the digestive tract (this can include blood in vomit, bleeding when
emptying bowels, fresh blood in faeces or black, tarry faeces).
• you have had stomach or bowel problems after you have taken other NSAIDs.
• you have moderate or severe heart, kidney or liver failure.
• if you have established heart disease and/or cerebrovascular disease e.g. if you have
had a heart attack, stroke, mini-stroke TIA) or blockages to blood vessels to the heart
or brain or an operation to clear bypass blockages.
• if you have or have had problems with your blood circulation (peripheral arterial
disease)
• you are more than six months pregnant.
You should also ask yourself these questions before having a Voltic™ Injection or
Infusion:
• Do you suffer from any bowel disorders including ulcerative colitis or Crohn's
disease?
• Do you have kidney or liver problems, or are you elderly?
• Do you suffer from any blood or bleeding disorder?
• Do you have a condition called porphyria?
• Have you ever had asthma?
• Are you breastfeeding?
• Do you have angina, blood clots, high blood pressure, raised cholesterol or raised
triglycerides?
• Do you have heart problems, or have you had a stroke, or do you think you might be
at risk of these conditions (for example, if you have high blood pressure, diabetes or
high cholesterol or are a smoker)?
• Do you have diabetes?
• Do you have Lupus (SLE) or any similar condition?
• Could you be suffering from dehydration?
• Have you suffered any heavy loss of blood recently?

If the answer to any of these questions is YES, discuss your treatment with your
doctor or pharmacist because Voltic™ Ampoules might not be the right medicine for
you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or pharmacist if
you are taking any of the following:
• Medicines to treat diabetes.
• Anticoagulants (blood thinning tablets like warfarin).
• Diuretics (water tablets).
• Lithium (used to treat some mental problems).
• Methotrexate (for some inflammatory diseases and some cancers).
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after
transplants).
• Trimethoprim (a medicine used to prevent or treat urinary tract infections).
• Quinolone antibiotics (for infections).
• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or
ibuprofen.
• Mifepristone (a medicine used to terminate pregnancy).
• Cardiac glycosides (for example digoxin), used to treat heart problems.
• Medicines known as SSRIs used to treat depression.
• Oral steroids (an anti-inflammatory drug).
• Medicines used to treat heart conditions or high blood pressure, for example betablockers
or ACE inhibitors.
• Voriconazole (a medicine used to treat fungal infections).
• Phenytoin (a medicine used to treat seizures).
• Colestipol/cholestyramine (used to lower cholesterol).
Always tell your doctor or pharmacist about all the medicines you are taking. This
means medicines you have bought yourself as well as medicines on prescription from
your doctor.
Pregnancy
• Are you pregnant or planning to become pregnant? Although not common,
abnormalities have been reported in babies whose mothers have taken NSAIDs during
pregnancy. You should not have a Voltic™ Injection during the last 3 months of
pregnancy as it may affect the baby’s circulation.
• Are you trying for a baby? Having Voltic™ Injections may make it more difficult to
conceive. You should talk to your doctor if you are planning to become pregnant, or if
you have problems getting pregnant.
Driving and using machines
Very occasionally people have reported that Voltic™ Ampoules have made them feel
dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are
affected in this way, you should not drive or operate machinery.
Other special warnings
• You should take the lowest dose of Voltic™ for the shortest possible time, particularly
if you are underweight or elderly.
• There is a small increased risk of heart attack or stroke when you are taking any
medicine like Voltic™. The risk is higher if you are taking high doses for a long time.
Always follow the doctor’s instructions on how much and how long to take it for.
• Whilst you are taking these medicines your doctor may want to give you a check-up
from time to time.
• If you have a history of stomach problems when you are taking NSAIDs,
particularly if you are elderly, you must tell your doctor straight away if you notice
any unusual symptoms.
• Because it is an anti-inflammatory medicine, Voltic™ may reduce the symptoms of
infection, for example, headache and high temperature. If you feel unwell and need to
see a doctor, remember to tell him or her that you are taking Voltic™.
• Voltic™ Ampoules contain the preservative, sodium metabisulphite. This can
sometimes cause allergic reactions and breathing difficulties.
• Voltic™ Ampoules should not be used in children.

Your doctor will decide when and how to treat you with Voltic™ Ampoules. You will
either be given an intravenous infusion (a drip into a vein) or an intramuscular
injection (an injection into a muscle). The intramuscular injection is usually injected
into the buttocks.
The usual dose is:
Adults
One or two Ampoules (75 to 150 mg) each day for one or two days.
Elderly
Your doctor may give you a dose that is lower than the usual adult dose if you are
elderly.
Children
Not suitable for children.
A doctor, nurse or pharmacist will prepare the injection for you. If you have had an
operation and are in hospital, the ampoule contents may be diluted and put into a drip
bag before being given to you. A nurse or doctor will usually then give you the
injection or infusion. You would not usually have to give the injection to yourself.
The doctor may also prescribe another drug to protect the stomach to be taken at the
same time, particularly if you have had stomach problems before, or if you are elderly,
or taking certain other drugs as well.

What if you have had too much Voltic™? (Overdose)
If you think you have been given too much Voltic™ tell your doctor or nurse straight
away.

Voltic™ Ampoules are suitable for most people, but, like all medicines, they can
sometimes cause side effects. Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
Some side effects can be serious
Tell the doctor straight away if you notice:
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being
sick)
• Any sign of bleeding in the stomach or intestine, for example, when emptying your
bowels, blood in vomit or black, tarry faeces
• Allergic reactions which can include skin rash, itching, bruising, painful red areas,
peeling or blistering
• Wheezing or shortness of breath (bronchospasm)
• Swollen, face, lips, hands or fingers
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• An unexpected change in the amount of urine produced and/or its appearance.
If you notice that you are bruising more easily than usual or have frequent sore throats
or infections, tell your doctor.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100 patients):
Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of
appetite, headache, dizziness, vertigo, skin rash or spots, raised levels of liver enzymes
in the blood.
Injection site reactions, symptoms include redness, swelling, change in the skin colour,
inflammation, pain, and hypersensitivity.
Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000
patients): Stomach ulcers or bleeding (there have been very rare reported cases
resulting in death, particularly in the elderly), gastritis (inflammation, irritation or
welling of the stomach lining).
Vomiting blood.
Diarrhoea with blood in it or bleeding from the back passage.
Black, tarry faeces or stools.
Drowsiness, tiredness.
Hypotension (low blood pressure, symptoms of which may include faintness,
giddiness or light headedness).
Skin rash and itching.
Fluid retention, symptoms of which include swollen ankles.
Liver function disorders, including hepatitis and jaundice.
Injection site necrosis (dead skin and tissue around the injection site).
Very rare side effects (These may affect less than 1 in every 10,000 patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual disturbances such as blurred or
double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness,
nightmares, mood changes, depression, anxiety, mental disorders, disorientation and
loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff
neck, disturbances in sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of
the mouth or lips, taste changes, lower gut disorders (including inflammation of the
colon, or worsening of colitis or Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of blood vessels (vasculitis),
inflammation of the lung (pneumonitis), heart disorders, including congestive heart
failure or heart attack, blood disorders (including anaemia).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or protein in
the urine.
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome Lyell’s syndrome and other
skin rashes which may be made worse by exposure to sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling, inflammation of the lining
of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise
(general feeling of discomfort), inflammation of the nerves in the eye.
Do not be alarmed by this list - most people have an injection of VolticTM without
any problems.
If any of the symptoms become troublesome, or if you notice anything else not
mentioned here, please go and see your doctor. He/she may want to give you a
different medicine.

• Keep out of the reach and sight of children.
• Do not store above 30 ºC. Protect from light and heat.
• Do not use this medicine after the expiry date which is stated on the label and carton.
• Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the
environment.