Canorof 25 mg Injection

CANOROF contains the active ingredient diclofenac sodium (75 mg/3 mL ampoule). Diclofenac sodium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. CANOROF is used as an intramuscular injection for:

• Treating inflammation of muscles, joints and tissues and pain associated with inflammation.

CANOROF should not be administered to you if:

• You are hypersensitive (allergic) to diclofenac sodium, aspirin, ibuprofen or any other NSAIDs or any of the other ingredients of CANOROF (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction.
• 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).
• You have had stomach or bowel problems after you have taken other NSAIDs.
• You have moderate or severe heart, kidney or liver failure.
• You are more than more or less 20 weeks pregnant.
• You are breastfeeding.
• You have porphyria.

Warnings and precautions

Tell your doctor or healthcare provider before being given CANOROF injection:

• You should receive the lowest dose of CANOROF for the shortest possible time, particularly if you are underweight or elderly.
• You should be aware that medicines such as diclofenac 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. Do not exceed the recommended dose or duration of treatment.
• Whilst you are taking these medicines your doctor may want to give you a check-up from time to time.
• 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, CANOROF 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 receiving CANOROF.
• CANOROF contains the preservative, sodium metabisulphite. This can sometimes cause allergic reactions and breathing difficulties.
• CANOROF should not be used in children.
• Patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported with CANOROF therapy.

Do not share medicines prescribed for you with any other person. Always use CANOROF exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults CANOROF is given by deep intra-muscular injection into the gluteal muscle in a dose of 75 mg once daily or, if required in severe conditions, 75 mg twice daily. CANOROF should not be given as an intravascular injection. The maximum total daily dose of CANOROF by any route is 150 mg. Your doctor will tell you how long your treatment with CANOROF will last. If you have the impression that the effect of CANOROF is too strong or too weak, tell your doctor or pharmacist. CANOROF will be given to you as an intramuscular injection. The directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissues at the injection site. After inserting the needle, the plunger should be pulled back to avoid inadvertent intra-arterial injection. You will not be expected to give yourself CANOROF. It will be given to you by a person who is qualified to do so.

If you receive more CANOROF than you should

Since a healthcare provider will administer CANOROF, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. General symptoms of nausea, vomiting, headache, drowsiness, blurred vision and dizziness have been reported. There have been isolated case reports of more serious toxicity, including seizures, hypotension, apnoea, coma, and renal failure, although usually after ingestion of substantial quantities. Treatment is entirely supportive. Gastric lavage and activated charcoal may be of benefit within 1 hour of ingestion. Forced diuresis, haemodialysis, or haemoperfusion are unlikely to be of any benefit, although haemodialysis may be required if oliguric renal failure develops. There is no specific antidote.

If you forget to use CANOROF

Since a healthcare provider will administer CANOROF, it is unlikely that the dose will be missed.

CANOROF can have side effects. Not all side effects reported for CANOROF are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CANOROF, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop using CANOROF and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• Rash or itching,
• Fainting,
• 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 bruising, painful red areas, peeling or blistering, wheezing or shortness of breath (bronchospasm),
• 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,
• You are bruising more easily than usual or have frequent sore throats or infections.

These are all serious side effects. You may need urgent medical attention. The side effects listed below have also been reported. Tell your doctor if you notice any of the following:

Frequent 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,
• Vision disturbed/blurred, diplopia (double vision).

Less frequent side effects:

• Stomach ulcers or bleeding (there have been very rare, reported cases resulting in death, particularly in the elderly),
• Disorientation, depression, insomnia (struggle to sleep), nightmare, irritability, psychotic disorder,
• Drowsiness, tiredness, paraesthesia (needles and pins), memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular haemorrhage,
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness) or hypertension (high blood pressure),
• Skin rash and itching,
• Fluid retention, symptoms of which include swollen ankles,
• Liver function disorders, including hepatitis and jaundice,
• Impaired hearing,
• Asthma or breathing problems,
• Haematuria (blood in urine), proteinuria (protein in urine) and renal function disorders,
• Impotence.

Side effects with frequency unknown:

• Injection site necrosis,
• Confusion, hallucinations, disturbances of sensation, malaise (feeling unwell),
• Optic neuritis (inflammation of the nerves of the eye causing pain/vision disturbances),
• Chest pain signalling acute coronary artery syndrome associated with allergic reaction also called Kounis syndrome,
• Ischaemic colitis (inflammatory bowel disease).

Do not be alarmed by this list - most people have an injection of CANOROF without any problems. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store below 25 °C. Protect from light. KEEP OUT OF REACH OF CHILDREN. Keep ampoules in the carton/polystyrene container until required for use. Store in original package. Do not use after the expiry date stated on the carton. Your doctor, pharmacist or healthcare professional knows how to store CANOROF. The doctor or nurse who is administering CANOROF to you, will make sure that the medicine is not used after the expiry date printed on the vial. They will also visually inspect the solution before giving it to you. Only clear solution without particles will be used. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).