Diclofenac 75 mg/3 ml Injection

DICLOFENAC INJECTION UNIMED belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

DICLOFENAC INJECTION UNIMED is used as an intramuscular injection to relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles, and tendons including:

• Rheumatoid arthritis, osteoarthritis, (pain, stiffness and swelling of the joints especially in the hands, hips and knees), ankylosing spondylitis (form of spinal arthritis) and spondylarthritis.
• Painful musculoskeletal conditions such as backache, sprains and strains, soft tissue sports injuries, dislocations and fractures.
• Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis.
• Attacks of gout.
• Painful post-operative and post-traumatic inflammation and swelling.
• Pain associated with dental surgery.
• Menstrual pain.

DICLOFENAC INJECTION UNIMED should not be administered to you:

• if you have stomach ulcers,
• if you are hypersensitive (allergic) to diclofenac sodium, sodium metabisulphite, or any of the other ingredients of DICLOFENAC INJECTION UNIMED (listed in section 6),
• if you are hypersensitive (allergic) to aspirin, ibuprofen or any other NSAIDs,
• if you have asthma and have previously experienced an asthma attack, runny nose or skin rash when taking aspirin or other NSAIDs,
• if you have now, or have ever had stomach or intestinal perforation, 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 stomach or bowel problems after you have taken other NSAIDs,
• if you have heart failure, established heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke 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 have inherited a disorder of the red blood pigment haemoglobin (porphyria),
• if you have kidney or liver failure,
• if you are pregnant, do not use NSAIDs at 20 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby,
• if you are breastfeeding your baby,
• if the patient is a child.

Warnings and precautions

Tell your doctor or healthcare provider before being given DICLOFENAC INJECTION UNIMED:

• You should receive the lowest effective dose of DICLOFENAC INJECTION UNIMED for the shortest duration possible time to reduce the risk of developing side effects.
• If you are taking DICLOFENAC INJECTION UNIMED for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harm to the kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Do not share medicines prescribed for you with any other person. Always use DICLOFENAC INJECTION UNIMED exactly as directed in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use the lowest effective dose for the shortest possible duration of treatment. The usual dose is:

Adults

The dosage is generally one DICLOFENAC INJECTION UNIMED ampoule daily. DICLOFENAC INJECTION UNIMED should not be mixed with other injection solutions. By way of exception, in severe cases, two injections separated by an interval of a few hours can be given per day (one into each buttock). DICLOFENAC INJECTION UNIMED should not be given for more than two days. Your doctor will tell you how long your treatment with DICLOFENAC INJECTION UNIMED will last. If you have the impression that the effect of DICLOFENAC INJECTION UNIMED is too strong or too weak, tell your doctor or pharmacist.

DICLOFENAC INJECTION UNIMED 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 tissue at the injection site. After inserting the needle the plunger should be pulled back to avoid inadvertent intra-arterial injection. DICLOFENAC INJECTION UNIMED is not intended for the intravenous route of administration. DICLOFENAC INJECTION UNIMED is given by deep intragluteal injection into the upper outer quadrant. You will not be expected to give yourself DICLOFENAC INJECTION UNIMED. It will be given to you by a person who is qualified to do so.

Children

DICLOFENAC INJECTION UNIMED is not suitable for use in children.

If you receive more DICLOFENAC INJECTION UNIMED than you should Since a healthcare provider will administer DICLOFENAC INJECTION UNIMED, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

DICLOFENAC INJECTION UNIMED can have side effects. Not all side effects reported for DICLOFENAC INJECTION UNIMED are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DICLOFENAC INJECTION UNIMED, please consult your healthcare provider for advice.

If any of the following happens, stop using DICLOFENAC INJECTION UNIMED 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,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). These are all very serious side effects. If you have them, you may have had a serious reaction to DICLOFENAC INJECTION UNIMED. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sudden and crushing chest pain (signs of myocardial infarction or heart attack),
• heart disorders or breathlessness, difficulty breathing when lying down, or swelling of the feet or legs (signs of heart failure), especially if you have been using a higher dose (150 mg per day) for a long period of time,
• fast or irregular heartbeat (palpitations),
• sudden weakness or numbness in the face, arm or leg especially on one side of the body, sudden loss or disturbance of vision, sudden difficulty in speaking or ability to understand speech, sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke,
• high blood pressure (hypertension), low blood pressure, symptoms of which may include faintness, giddiness or light headedness (hypotension),
• lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease),
• inflammation of the pancreas (pancreatitis),
• stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick) as you may be experiencing ischemic colitis,
• diarrhoea with blood in it or bleeding from the back passage (haemorrhagic diarrhoea),
• any sign of ulcers or bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit (haematemesis) or black, tarry faeces (melaena),
• kidney disorders including kidney failure, kidney pain or inflammation of the kidneys,
• liver disorders including liver failure or inflammation of the liver,
• presence of blood or protein in the urine,
• an unexpected change in the amount of urine produced and/or its appearance,
• yellowing of your skin or the whites of your eyes (jaundice),
• wheezing or shortness of breath (bronchospasm),
• breathlessness, coughing and a tightness across the chest (asthma),
• inflammation of the lung (pneumonitis),
• inflammation of blood vessels (vasculitis),
• inflammation of the lining of the brain with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (meningitis),
• mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with DICLOFENAC INJECTION UNIMED and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain,
• if you notice that you are bruising more easily than usual or have frequent sore throats or infections,
• convulsions (fitting),
• injection site reactions including injection site pain, redness, swelling, hard lump, sores and bruising. This can progress to blackening and death of the skin and underlying tissues surrounding the injection site, that heal with scarring, also known as Nicolau syndrome.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• stomach pain, heartburn, nausea, vomiting, diarrhoea, constipation, indigestion, wind, loss of appetite,
• inflammation, irritation or swelling of the stomach lining (gastritis),
• mouth ulcers with swelling and redness inside the mouth or individual painful sores,
• skin rash and spots,
• headache, dizziness,
• a feeling of whirling or spinning (vertigo),
• raised levels of liver enzymes in the blood,
• anorexia (eating disorder),
• discomfort of the limbs,
• injection site reactions, symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity.
• Less frequent side effects:
• tiredness, excess sleepiness (somnolence),
• fluid retention, symptoms of which include swollen ankles (oedema),
• visual disturbances such as blurred or double vision,
• hearing disorders, tinnitus (ringing in the ears),
• sleeplessness, nightmares, depression, anxiety, irritability, mental disorders,
• disorientation, loss of memory, fits, tremor,
• tingling or numbness in the fingers,
• taste changes,
• inflammation of the tongue (glossitis), inflammation of the inside of the mouth or lips (stomatitis),
• blood disorders (including anaemia),
• photosensitivity (increased sensitivity to sunlight),
• hair loss,
• loss of male sexual ability (impotence),
• tissue damage at the injection site.

Side effects with an unknown frequency:

• inflammation of the nerves in the eye (optic neuritis), other ocular reactions,
• drowsiness, nervousness, agitation,
• confusion, hallucinations, malaise (general feeling of discomfort)

DICLOFENAC INJECTION UNIMED, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DICLOFENAC INJECTION UNIMED.

• Store at or below 25 ° C. Protect from light.
• Do not freeze.
• Store all medicines out of reach of children.
• Store in the original package.
• Do not use after the expiry date stated on the label.
• Do not use DICLOFENAC INJECTION UNIMED if you notice any foreign particles in the solution.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).