ROFENAC ampoules: management of mild to moderate pain

What ROFENAC Ampoules are? and what they are used for?

Diclofenac sodium, the active ingredient in ROFENAC 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:

  1. ‘Flare-ups’ of joint or back pain .
  2. Attacks of gout.
  3. Pain caused by kidney stones and biliary colic.
  4. Pain caused by injuries. 

ROFENAC 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. ROFENAC Ampoules are not suitable for children less than 13 years old.

روفيناك حقن rofenac ampoule
روفيناك حقن rofenac ampoule

Facts about ROFENAC ampoules

  • ROFENAC is an NSAID indicated for use in adults for the management of mild to moderate pain. 
  • Avoid use ROFENAC after 30 weeks gestation because this may affect the baby’s circulation.  
  • Nursing Mothers: Use Diclofenac( ROFENAC) with caution as diclofenac may be present/ secreted in human milk.
  • The usual adult dose is one or two ampoules (75 to 150 mg) each day for one or two days.
  • Your doctor may also prescribe another drug to protect the stomach to be taken at the same time with ROFENAC, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
  • Your doctor will prescribe the lowest dose of ROFENAC for the shortest possible time, particularly if you are underweight or elderly.
  • Before taking ROFENAC, tell your doctor if you have kidney or liver problems.

How to take ROFENAC Ampoules ?

Your doctor will decide when and how to treat you with ROFENAC 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. If you think you have been given too much ROFENAC tell your doctor or nurse straight away. 

Common side effects

  • 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. 

Things to consider before you start to take ROFENAC Ampoules 

Some people MUST NOT have this injection. Talk to your doctor if: 

  1. 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 ROFENAC 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, chest pain, runny nose, skin rash or any other allergic type reaction.
  2. 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).
  3. you have had stomach or bowel problems after you have taken other NSAIDs.
  4. you have heart, kidney or liver failure.
  5.  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.
  6. if you have or have had problems with your blood circulation (peripheral arterial disease).
  7. you are more than six months pregnant.

You should also ask yourself these questions before having a ROFENAC Injection or Infusion, if the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because ROFENAC Ampoules might not be the right medicine for you. 

  • 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, abnormally high levels of fat in your blood (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 smoke? 
  • Do you have Lupus (SLE) or any similar condition?
  • Could you be suffering from dehydration? 
  • Have you suffered any heavy loss of blood recently? 

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:

  1. Medicines to treat diabetes.
  2. Anticoagulants (blood thinning tablets like warfarin).
  3. Diuretics (water tablets).
  4. Lithium (used to treat some mental problems).
  5. Methotrexate (for some inflammatory diseases and some cancers).
  6. Cyclosporine and tacrolimus (used to treat some inflammatory diseases and after transplants).
  7. Trimethoprim (a medicine used to prevent or treat urinary tract infections).
  8. Quinolone antibiotics (for infections).
  9. Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen.
  10. Mifepristone (a medicine used to terminate pregnancy).
  11. Cardiac glycosides (for example digoxin), used to treat heart problems.
  12. Medicines known as SSRIs used to treat depression.
  13. Oral steroids (an anti-inflammatory drug).
  14. Medicines used to treat heart conditions or high blood pressure, for example beta-blockers or ACE inhibitors. 
  15. Voriconazole (a medicine used to treat fungal infections). 
  16. Phenytoin (a medicine used to treat seizures) .
  17. 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.


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 ROFENAC Injection during the last 3 months of pregnancy as it may affect the baby’s circulation.  

Are you trying for a baby? Having ROFENAC 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. 

Will there be any problems with driving or using machinery?

Very occasionally people have reported that ROFENAC 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 ROFENAC 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 ROFENAC. The risk is higher if you are taking high doses for a long time.  If at any time while taking ROFENAC you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.  
  • 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, ROFENAC 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 ROFENAC.  ROFENAC Ampoules contain the preservative, sodium metabisulphite. This can sometimes cause allergic reactions and breathing difficulties.
  • ROFENAC Ampoules should not be used in children. 
  • Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking ROFENAC Ampoules, as ROFENAC Ampoules can sometimes worsen wound healing in your gut after surgery.
For Arabic Information
ROFENAC ampoules.. Arabic Information

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