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Active substance(s): DICLOFENAC SODIUM

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Package leaflet: Information for the patient
Diclofenac 75 mg / 3 ml Solution for Injection
Diclofenac Sodium
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 or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
The name of your medicine is Diclofenac 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 is provided as a solution for injection, containing 75 mg Diclofenac sodium in 3 ml,
to be given by intramuscularly ( into a muscle) or intravenously (into a vein) as an infusion.
Diclofenac Injection is indicated for the treatment of painful conditions, such as kidney stone pain,
osteoarthritis (degeneration of joints) and rheumatoid arthritis (inflammation of joints), back pain, gout
(formation of crystals in joints), injuries and fractures in children aged over 12 years, adults and older
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 Sodium or any of the other ingredients of this medicine (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
• 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 or nurse before you are given Diclofenac Sodium:
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
• 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.
• 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 antiinflammatory 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.
Elderly people
Elderly 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 serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as aspirin.

Other medicines and Diclofenac Injection
Tell your doctor or nurse 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 days)
• 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
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 or nurse 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
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 machines:
Diclofenac Injection may make you feel drowsy or dizzy, or cause headaches or problems with vision. If
you are affected, do not drive or operate machinery.3

Diclofenac Injection contains less than 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 or nurse.
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:
• 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
• 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
• 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)”.

The following side effects have also been reported:
Common (may affect up to 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

Rare (may affect up to 1 in 1,000 people)

Asthma including shortness of breath
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)
Hypotension (low blood pressure, symptoms of which may include faintness, giddiness
or light Headedness)
Fluid retention, symptoms of which include swollen ankles

Very rare (may affect up to 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
Disturbances in sensation
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, with scaling (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

Disturbances of sensation
Optic neuritis (inflammation of the nerves in the eye)
Malaise (General feelings of being unwell, weakness)
Tissue damage at the injection site.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse, this includes any possible side effects not listed in
this leaflet. 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.
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month. Once opened, any unused liquid should be discarded.
· 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

6 .Contents of the pack and other information
What Diclofenac Injection contains
- The active substance is Diclofenac sodium. Each ampoule contains 75 mg Diclofenac sodium in 3 ml
injectable solution
- The other ingredients are mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite, sodium
hydroxide, water for injection.

What Diclofenac Injection looks like and contents of the pack
Diclofenac Injection is available in 3 ml Type I glass ampoules packaged in a carton
There are 10 ampoules per carton.
Marketing Authorisation Holder
Mercury Pharmaceuticals Limited
Capital House
85 King William Street
PL 12762/0092
Astrapin Pharma
Gewerbestrasse 1 and 13
This leaflet was last revised in December 2016.

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