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Active substance(s): DICLOFENAC SODIUM

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Package Leaflet: Information for the Patient
Diclofenac Sodium 75mg / 3ml Solution for Injection
Read all of this leaflet carefully before you are given 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, nurse 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, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Diclofenac Sodium 75mg / 3ml Solution for Injection. It will
be referred to as Diclofenac Injection for ease hereafter.
What is in this leaflet:
1. What Diclofenac Injection is and what it is used for
2. What you need to know before you are given Diclofenac Injection
3. How you are given Diclofenac Injection
4. Possible side effects
5. How to store Diclofenac Injection
6. Contents of the pack and other information
1. What Diclofenac Injection is and what it is used for
Diclofenac Injection contains the active substance Diclofenac sodium which belongs to a
group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).
Diclofenac Injection may be used when there is an increase in severity of rheumatoid arthritis
or osteoarthritis. It may also be used for acute back pain, acute gout, pain after surgery or
following injury, fracture pain, or colicky pain from the kidney area.
2. What you need to know before you are given Diclofenac Injection
You should not be given Diclofenac Injection
• if you are allergic to Diclofenac Injection or any of the other ingredients of Diclofenac
Injection (listed in section 6)
• if 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 stools or black, tarry stools)
• if you have had any allergic reaction to ibuprofen, aspirin, or other NSAIDs (including
difficulty in breathing, runny nose, swelling of the face or throat, or rash)
• if you have asthma
• if you have kidney or liver problems.
• if you are dehydrated or have recently lost a lot of blood
• if you have severe heart failure
• if you have a condition where you don’t stop bleeding normally (such as haemophilia)
• if you have had a stroke
• if you are taking other non steroidal anti-inflammatory drugs
• if you are taking anticoagulant drugs (medicines for preventing blood clots, such as

heparin and warfarin)
• if you are more than 6 months pregnant
• if you are taking medicines known as SSRIs used to treat depression.
• if you have been told by your doctor that you have an intolerance to some sugars
• if you have had stomach or bowel problems after you have taken other NSAIDs.
• 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 or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you are breast-feeding
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Diclofenac Injection:
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised
• If you have heart problems, previous stroke or think that you might be at risk of these
conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a
smoker) you should discuss your treatment with your doctor or pharmacist.
• If you suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s
disease, inflammation of the colon.
• If you have a history of any of the following: stomach or bowel ulcers, vomiting of blood
or black, tarry faeces and Gastro-intestinal ulcers
• 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, Diclofenac 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 Diclofenac.
• If you have heart, kidney or liver problems, or having medicines to increase urine volume
such as diuretics, your doctor may monitor your kidney function.
• If you have kidney, liver or heart problems.
• If you are pregnant.
• If you have a history of high blood pressure and/or heart failure.
• If you suffer from or have previously suffered from asthma.
• If you suffer from systemic lupus erythematous or mixed connective tissue disorders.
• If you are an older patient.
• If you have had or are about to have major surgery.
• If you suffer from any blood or bleeding disorder.
Diclofenac Injection is not recommended for use in children.
Older people
Older people have increased frequency of adverse reactions to NSAIDs especially
gastrointestinal bleeding and perforation which may be fatal. Caution should be advised in
patients receiving concomitant medications which could increase the risk of ulceration or
bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotoninreuptake inhibitors (SSRIs) or anti-platelet agents such as aspirin.

Other medicines and Diclofenac Injection
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other
medicines. This includes any herbal products or medicines bought without a prescription.
• Digoxin (used to treat heart problems)
• Lithium (used to treat mental illness)
• Antibiotics called quinolones (such as ciprofloxacin)
• Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
• Methotrexate (used for some inflammatory diseases and cancers)
• Drugs that can increase your risk of bleeding, sometimes given if you have heart problems,
such as dipyridamole or clopidogrel
• Diuretics (water tablets)
• Medicines to treat high blood pressure
• Mifepristone, used to terminate pregnancy (including if you have taken it within the last 12
• Medicines to treat diabetes
• Oral steroids (an anti-inflammatory drug)
• Steroids
• Zidovudine (treatment of HIV infection)
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine (medicines to lower cholesterol level)
• CYP2C9 inhibitors: e.g. Sulfinpyrazone and voriconazole
• Other NSAIDs (for painful or inflammatory conditions) including COX2 inhibitors
• Medicines known as SSRIs used to treat depression, such as paroxetine or fluoxetine
• Medicines used to treat heart conditions or high blood pressure for example beta-blockers or
ACE inhibitors.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.
Diclofenac Injection should only be used during pregnancy when your doctor decides the
benefits to you are greater than any possible risk to the unborn baby.
Do not take Diclofenac Injection during the last 3 months of pregnancy as it may affect your
baby’s circulation and kidneys.
Do not take Diclofenac Injection during breast-feeding as Diclofenac passes into the breast
milk in small amounts.
Taking Diclofenac Injection 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 machinery
Diclofenac Injection may make you feel drowsy or dizzy, or cause problems with vision. If
you are affected, do not drive or operate machinery.

Diclofenac Injection contains less that 1 mmol (23 mg) sodium per 3ml i.e. essentially
sodium free.
Diclofenac Injection contains sodium metabisulphite which can cause severe allergic
reactions, especially in patients with a history of asthma or other allergies.
3. How you are given Diclofenac Injection
Diclofenac Injection can be given by deep injection into the large muscle of the buttock. The
usual dose is one ampoule once daily. One ampoule twice daily may be required in severe
cases, the second dose being injected into the buttock muscle on the other side.
The injection should not be given for more than 2 days. For colicky pain from the kidney area
the dose is one ampoule injected into the buttock muscle and this dose may be repeated after
30 minutes if necessary.
The total dose in one day should not exceed 150mg (two ampoules).
Your doctor may decide on smaller doses if you are:
• an older person
• frail
• or you have a low body weight
If you are given more Diclofenac Injection than you should
If you think you have been given too much Diclofenac Injection tell your doctor or nurse
straight away.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines this medicine can cause side-effects although not everybody gets them.
Some side effects can be serious and you should tell your doctor immediately if you notice
the following:
• Mild cramping and tenderness of the abdomen, starting shortly after the start of the
treatment with Diclofenac Injection and followed by rectal bleeding or bloody diarrhoea
usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be
estimated from the available data)
• 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 are bruising more easily than usual or have frequent sore throats or infections

The following side effects have also been reported:
Common (affects less than 1 in 10 people)

Stomach pain
Nausea (feeling sick)
Vomiting (being sick)
Loss of appetite
Skin rash or spots
Raised levels of liver enzymes in the blood.
Injection site reactions, symptoms include redness, swelling, change in the skin colour
or texture
Fluid retention, symptoms of which include swollen ankles

Rare (affects less than 1 in 1,000 people)

Asthma including shortness of breath
Diarrhoea with blood in it or bleeding from the back passage
Blood in vomit or black, tarry faeces
Liver function disorders, including hepatitis and jaundice
Stomach ulcers or bleeding (there have been very rare reported cases resulting in
death, particularly in older patients)
Gastritis (inflammation, irritation or swelling of the stomach lining)
Somnolence (sleepiness)
Urticaria (raised, itchy rash)
Shock (symptoms of which include weak and rapid pulse, confusion, weakness or low
blood pressure)

Very rare (affects less than 1 in 10,000 people)

Hearing loss or impairment
Tinnitus (ringing in the ears)
Blurred or double vision
Visual disturbance
Formation of pus (abscess) at the injection site
Tingling or numbness in the skin (Paraesthesia)
Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and
other skin rashes (erythema multiforme, photosensitivity reaction)
Taste changes
Memory impairment


Insomnia (sleeplessness)
Irritability (mood changes)
Psychotic disorder (mental disorders)
Fits (convulsions)
Hair loss
Blistering of skin
Recurring skin rashes
Swelling of skin (including angioneurotic oedema with face oedema)
Inflammation of skin (Eczema)
Red or purple discolorations on the skin (Exfoliative dermatitis)
Severe upper abdominal pain
Lower gut disorders (including inflammation of the colon)
Narrowing of the bowel (which leads to intestinal obstruction)
Worsening of ulcerative colitis (ulcers in the colon) or Crohn's disease which is
characterized by abdominal pain
Mouth ulcers
Inflammation of the tongue
Inflammation of the inside of the mouth or lips
Oesophageal disorder characterized by difficulty in swallowing
Hypertension (high blood pressure)
Hypotension (low blood pressure)
Aseptic meningitis (fever, nausea, vomiting, headache, stiff neck and extreme
sensitivity to bright light)
Inflammation of blood vessels (vasculitis)
Kidney or liver disorders
Presence of blood or protein in the urine
Death of kidney cell and inflammation of the kidney
An unexpected change in the amount of urine produced and/or its appearance which
may be made worse by exposure to sunlight
Inflammation of the pancreas
Increased risk of heart attack or stroke
Chest pain
Heart disorders, including congestive heart failure
Blood disorders (including anaemia).
Palpitations (fast or irregular heart beat)
Inflammation of the lung (pneumonitis)
Back pain

Not known: frequency cannot be estimated from the available data

Injection site necrosis (dead skin and tissue around the injection site)
Disturbances of sensation


Optic neuritis (inflammation of the nerves in the eye)
Malaise (General feelings of being unwell, weakness)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. Side effects may be minimised by using the lowest effective
dose for the shortest duration necessary.
You can also report side effects directly via By reporting side
effects you can help provide more information on the safety of this medicine.
5. How to store Diclofenac Injection

Keep this medicine out of the sight and reach of children.
Keep the container in the outer carton in order to protect from light.
Do not store above 25°C.
Do not use after the expiry date shown on the carton. Once opened, any unused liquid
should be discarded. The expiry date refers to the last day of that month.
· Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment
6. Contents of the pack and other information
What Diclofenac Injection contains
The active substance is Diclofenac sodium. Each ampoule contains 75mg of Diclofenac
Sodium in 3ml of solution. The solution is sterile and is colourless or almost colourless.
The other ingredients of the each ampoule are Sodium Metabisulphite (E223), Propylene
Glycol, Benzyl Alcohol, Sodium Hydroxide and Water for Injections.
What Diclofenac Injection looks like and contents of the pack
The ampoules are available in 3ml strengths in clear glass ampoules and are packed in
cardboard cartons containing 5 or 10 ampoules.
Marketing authorization holder
Mercury Pharma International Ltd.,
4045, Kingswood Road,
City West Business Park,
Co Dublin, Ireland.
PL 02848/0181
B. Braun Melsungen AG,
2/6, Berlin 47,

For any information about this medicine, please contact the local representative of the
Marketing Authorisation Holder:
MercuryPharm Ltd,
4045, Kingswood Road,
City West Business Park,
Co Dublin,
This leaflet was last revised in August 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.