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PATIENT INFORMATION LEAFLET

Diclofenac Injection 75mg/3ml

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING

THIS MEDICINE.

Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to

others. It may harm them even if their symptoms are the same as yours.

In this leaflet:

1. What Diclofenac Injection is and what it is used for.

2. Before you have Diclofenac Injection.

3. How to have Diclofenac Injection.

4. Possible side effects.

5. Storing Diclofenac Injection.

Diclofenac Injection is provided as an injection solution, containing 75 mg Diclofenac

sodium in 3ml, to be given by intramuscularly (into a muscle) or intravenously (into a vein)

as an infusion.

The active substance is Diclofenac sodium.

Other ingredients are mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite,

sodium hydroxide, water for injection.

Note: Sodium metabisulphite can cause severe allergic reactions, especially in patients with a

history of asthma or other allergies.

Marketing authorisation holder:

Mercury Pharmaceuticals Ltd,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Manufacturer:

Astrapin Pharma. Gewerbestrasse 1 and 13, 55546, Pfaffen-Schwabenheim, Germany.

1. WHAT DICLOFENAC INJECTION IS AND WHAT IT IS USED FOR

Diclofenac Injection is provided as an injection solution, containing 75 mg Diclofenac

sodium in 3 ml, to be given by intramuscularly ( into a muscle) or intravenously (into a vein)

as an infusion Each ampoule contains 75mg diclofenac sodium. The ampoules are packaged in a carton,

and 10 ampoules are in each carton.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are prescribed for

adults and the elderly for 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.

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2. BEFORE YOU HAVE DICLOFENAC INJECTION.

You must NOT have Diclofenac Injection:

if you are allergic to Diclofenac or any of the contents of this medicine (listed above)

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, freshblood 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 dont 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 are breastfeeding

Take special care with Diclofenac Injection

Do you suffer from stomach or bowel disorders, including ulcerative colitis or Crohns

disease?

Do you have kidney, liver or heart problems, or are you elderly?

Do you have lupus (SLE) or any similar condition?

Do you suffer from a condition called porphyria?

If the answer to any of these questions is YES, discuss your treatment with your doctor or

pharmacist because Diclofenac injection might not be the right medicine for you.

Medicines such as Diclofenac Injection may be associated with a small increased risk of heart

attack

("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged

treatment. 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 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 or you are elderly, your doctor may monitor your kidney function.

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Diclofenac injection should not be used in children.

Taking/using other medicines

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are

taking any of the following:

Digoxin (used to treat heart problems) Medicines to treat diabetes

Oral steroids (an anti-inflammatory drug)

Lithium (used to treat mental illness)

Antibiotics called quinolones (such as ciprofloxacin)

Cyclosporin 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

Some medicines for depression, such as paroxetine or fluoxetine

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)

Steroids

Zidovudine (treatment of HIV infection)

Phenytoin (medicines to treat epilepsy

Colestipol and cholestyramine(medicines to lower cholesterol level)

CYP2C9 inhibitors: e.g Sulfinapyrazone and voriconazole

Other NSAIDs or cox2 inhibitors, for example aspirin or ibuprofen

Please consult your doctor or pharmacist if you are taking any other medicines or food

supplements, including those which you are taking without prescription, in case these interact

with diclofenac.

Pregnancy

Diclofenac may make it more difficult to become pregnant. You should inform your doctor

if you are planning to become pregnant or if you have problems becoming pregnant.

If you are pregnant, or think you may be pregnant, you must not receive Diclofenac

Injection unless your doctor advises it. However, diclofenac must never be given in the last

three months of pregnancy.

Breast-feeding

If you are breast-feeding you must not receive Diclofenac Injection.

Driving and using machinery

Diclofenac may make you feel drowsy or dizzy, or cause problems with vision. If you are

affected, do not drive or operate machinery.

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Elderly

The elderly have increased frequency of adverse reactions to NSAIDs especially gastro

intestinal 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.

3. HOW TO TAKE DICLOFENAC INJECTION.

Your doctor will decide when and how to treat you with Diclofenac Injection. 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:

AdultsOne 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.

If you have more Diclofenac Injection than you should:

If you think you have been given too much, tell your doctor or nurse straight away.

4. POSSIBLE SIDE EFFECTS

Diclofenac Injection is suitable for most people, but, like all medicines, they can sometimescause side effects.

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 you bowels,

blood in vomit or black, tarry faeces

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Allergic reactions which can include skin rash, itching, hives on the skin, , wheezing,

shortness of breath (bronchospasm), or trouble breathing, swelling of the face, lips, tongue,

or other parts of the body

Painful red areas, bruising, peeling or blistering

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. Pain or formation of pus (abscess) at the injection site

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 been reported. Some side effects can be serious Tell the

doctor straight away if you notice any of these side effects.

common (affects more than 1 in 100 people):

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.pain,induration at the injection site.

Stomach ulcers or bleeding (there have been very rare reported cases resulting in death,

particularly in the elderly)Gastritis (inflammation, irritation or swelling of the stomach lining)

Blood in vomit or black or tarry faeces.

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.

Asthma including shortness of breath

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

Tingling or numbness in the skin, tremor, blurred or double vision, hearing loss or

impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes,

depression, anxiety, mental disorders, confusion, hallucinations, generally feeling unwell ,

disorientation and loss of memory, fits, headaches together with a dislike of bright lights,

fever and a stiff neck, disturbances in sensation.

Constipation, diarrhoea, inflammation of the tongue, mouth ulcers, taste changes, lower gut

disorders (including inflammation of the colon). severe upper abdominal pain.

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure),

inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis),

congestive heart failure, blood disorders (including anaemia).

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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

Serious skin rashes including Stevens-Johnson syndrome and Lyells syndrome and other

skin rashes which may be made worse by exposure to sunlight.

Hair loss. blistering of skin ,recurring skin rashes, swelling of skin, itching. red or purplediscolorations on the skin. Formation of pus (abscess) at the injection site.Inflammation of the pancreas, inflammation of the protective covering of the brain

increased risk of heart attack or stroke.

Other side effects: Impotence

Do not be alarmed by this list - most people have an injection of Diclofenac 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.

5. STORING DICLOFENAC INJECTION

Keep Diclofenac Injection and all medicines out of the reach and sight of children.

Do not store above 25C. Keep the container in the outer carton.

Use by date:

Do not use Diclofenac Injection after the expiry/use before date on the carton.

Further Information:

This leaflet only gives a brief outline of some of the more important points about Diclofenac

Injection. If you want to know more about these injections or their effects, or you have

questions which you want to ask, please ask your doctor or pharmacist.

This leaflet was last revised in March 2012

PL: 12762/0092