METHADONE INJECTION BP 10MG/ML 1ML 2ML 5ML AND 10ML

PATIENT INFORMATION LEAFLET Diclofenac Sodium 75mg in 3ml Injection This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is administered. The leaflet contains a summary but not all of the information about Diclofenac Sodium Injection. If you require any further information, or if you are unsure about anything, ask your doctor or pharmacist. ABOUT YOUR MEDICINE The active ingredient is Diclofenac Sodium. Each ampoule contains 75mg of Diclofenac Sodium in 3ml of solution. The solution is sterile and is colourless or almost colourless. Inactive ingredients: Sodium Metabisulphite (E223), Propylene Glycol, Benzyl Alcohol, Sodium Hydroxide and Water for Injections. Pack Sizes: 5 x 3ml or 10 x 3 ml ampoules. Type of Medicine Diclofenac Sodium belongs to a group of medicines called non-steroidal anti-inflammatory drug (NSAIDs). These drugs have pain-relieving properties and reduce inflammation and lower the body temperature when it is raised. Holder of Product Licence: Mercury Pharma International Ltd., 4045, Kingswood Road, City

West Business Park, Co Dublin, Ireland.
Product Licence Number: PL 02848/0181 Manufacturer: B. Braun Melsungen AG, Mistelweg 2/6, Berlin 47, D12357, Germany. USES Diclofenac Sodium Injection may be used when there is an increase in severity of rheumatoid arthritis or osteoarthritis. It may also be used for acute back pain, acute gout, pain after surgery or following injury, fracture pain, or colicky pain from the kidney area. BEFORE YOU RECEIVE YOUR MEDICINE 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 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 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 if you have had stomach or bowel problems after taking other NSAIDs If you are taking medicines known as SSRIs used to treat depression.

Before taking your medicine, tell your doctor if you suffer from stomach or bowel disorders, including ulcerative colitis or Crohn s disease you have kidney, liver or heart problems, or you are elderly you have persistent disease affecting joints, skin and other body system (Lupus) you suffer from disease which affect the brain function and lead to conditions like abdominal pain vomiting, muscle weakness etc. (porphyria) . you have ever had high blood pressure . you have had or are about to have major surgery . you suffer from any blood or bleeding disorder Diclofenac sodium injection contains the preservative sodium metabisulphite. This can sometimes cause allergic reactions and breathing difficulties. Then, Diclofenac sodium injection might not be the right medicine for you. 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. 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. Taking 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) Ciclosporin 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) Medicines to treat diabetes Oral steroids (an anti-inflammatory drug) Zidovudine (treatment of HIV infection) steroids Phenytoin (medicines to treat epilepsy) Colestipol and cholestyramine(medicines to lower cholesterol level) CYP2C9 inhibitors: e.g Sulfinapyrazone and voriconazole Other NSAIDs (for painful or inflammatory conditions) including cox2 inhibitors Medicines known as SSRIs used to treat depression, such as paroxetine or fluoxetine Medicines used to treat heart conditions or high blood pressure for example beta-blockers or ACE inhibitors. 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 sodium 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 sodium 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. Elderly: The elderly have increased frequency of adverse reactions to NSAIDs especially gastrointestinal 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. This injection contains less that 1 mmol (23 mg) sodium per 3ml i.e. essentially sodium-free. Diclofenac Sodium Injection is not recommended for use in children. What if you have had too much Diclofenac sodium Injection? If you think you have been given too much Diclofenac sodium Injection tell your doctor or nurse straight away. HOW YOUR MEDICINE IS ADMINISTERED Adults: Diclofenac Sodium injection 75mg in 3ml is given by deep injection into the large muscle of the buttock. The usual dose is one ampoule once daily. One ampoule twice daily may be required in severe cases, the second dose being injected into the buttock muscle on the other side. The injection should not be given for more than 2 days. For colicky pain from the kidney area the dose is one ampoule injected into the buttock muscle and this dose may be repeated after 30 minutes if necessary. The injection should not be given into a vein and the total dose in one day should not exceed 150mg (two ampoules). Your doctor may decide on smaller doses if you are elderly and frail, or if you have a low body weight. AFTER YOU RECEIVE YOUR MEDICINE Diclofenac sodium Injection is suitable for most people, but, like all medicines, they can sometimes cause 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 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 (bronchospasm) Swollen, face, lips, hands or fingers 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. If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

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 sodium 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 sodium 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. Elderly: The elderly have increased frequency of adverse reactions to NSAIDs especially gastrointestinal 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. This injection contains less that 1 mmol (23 mg) sodium per 3ml i.e. essentially sodium-free. Diclofenac Sodium Injection is not recommended for use in children. What if you have had too much Diclofenac sodium Injection? If you think you have been given too much Diclofenac sodium Injection tell your doctor or nurse straight away. HOW YOUR MEDICINE IS ADMINISTERED Adults: Diclofenac Sodium injection 75mg in 3ml is given by deep injection into the large muscle of the buttock. The usual dose is one ampoule once daily. One ampoule twice daily may be required in severe cases, the second dose being injected into the buttock muscle on the other side. The injection should not be given for more than 2 days. For colicky pain from the kidney area the dose is one ampoule injected into the buttock muscle and this dose may be repeated after 30 minutes if necessary. The injection should not be given into a vein and the total dose in one day should not exceed 150mg (two ampoules). Your doctor may decide on smaller doses if you are elderly and frail, or if you have a low body weight. AFTER YOU RECEIVE YOUR MEDICINE Diclofenac sodium Injection is suitable for most people, but, like all medicines, they can sometimes cause 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 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 (bronchospasm) Swollen, face, lips, hands or fingers 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. 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 (feeling sick), vomiting (being sick), 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, Rare (affects less than 1 in 1000) Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly) Blood in vomit or black, tarry faeces Shock (symptoms of which include weak and rapid pulse, confusion, weakness or low blood pressure) Gastritis (inflammation, irritation or swelling of the stomach lining) Diarrhoea with blood in it or bleeding from the back passage Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness) Fluid retention, symptoms of which include swollen ankles Liver function disorders, including hepatitis and jaundice. Asthma including shortness of breath Injection site necrosis (dead skin and tissue around the injection site) 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, malaise (weakness), disorientation and loss of memory, fits, disturbances in sensation Meningitis (fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light). Constipation, diarrhoea, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon). Worsening of ulcerative colitis (ulcers in the colon) or Crohn's disease which is characterized by abdominal pain, diarrhea, bloody stools or fever. Severe upper abdominal pain Oesophageal disorder characterized by difficulty in swallowing, back pain. Narrowing of the bowel (which leads to intestinal obstruction). Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, blood disorders (including anaemia). 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 Lyell s 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 purple discolorations 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, inflammation of the nerves in the eye.

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. STORING THIS MEDICINE Do not use after expiry date shown on the label. Do not store above 25 C. Keep the container in the outer carton in order to protect from light. Keep out of the reach and sight of children. If only part used, discard the remaining solution.

Marketing authorization holder Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Date of last revision: March 2012