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Diclofenac Injection

Diclofenac Injection 75mg/3ml

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.

Diclofenac Injection1. 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.

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, 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 have 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

Take special care with Diclofenac Injection

• Do you suffer from stomach or bowel disorders, including ulcerative colitis orCrohn’s 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.

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)

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 orfluoxetine

• 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)

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.

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:

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.

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

Like all medicines, Diclofenac Injection can have side effects.

Some side effects can be serious. Tell the doctor straight away if you notice:

• Stomach pain, indigestion, heartburn or vomiting

• Any sign of bleeding in the stomach or intestine, for example, bleeding 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, swelling of face, lips, hands or fingers

• Jaundice (yellowing of your skin or the whites of your eyes)

•  Persistent sore throat or high temperature, bruising more easily than usual or frequent infections

• An unexpected change in the amount of urine produced or its appearance

The side effects listed below have been reported:

Stomach ulcers, bleeding from stomach & intestine. Being sick or feeling sick, diarrhoea, flatulence, constipation, indigestion, stomach pain, black stools, vomiting of blood, mouth ulcers, inflammation of stomach and bowel, inflammation of the pancreas.

Kidney and liver disorders.

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

Problems with eyesight, headache, tingling in arms or legs, difficulty in sleeping, vertigo, dizziness, stiff neck, fever, depression, confusion, hallucination, ringing noise in the ears, tiredness and drowsiness.

Fluid retention, symptoms of which include swollen ankles.

Medicines such as Diclofenac injection may be associated with a small increased risk of heart attack or stroke.

Do not be alarmed by this list – most people have Diclofenac injection 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.

5. STORING DICLOFENAC INJECTION

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

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

Use by date:

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

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