Econac Injection 75mg/3ml
Package Leaflet: Information for the Patient Econac 75 mg / 3 ml Solution for Injection Diclofenac Sodium
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Econac 75 mg / 3 ml Solution for Injection. It will be referred to as Econac Injection for ease hereafter.
What is in this leaflet:
1. What Econac Injection is and what it is used for
2. What you need to know before you are given Econac Injection
3. How you are given Econac Injection
4. Possible side effects
5. How to store Econac Injection
6. Contents of the pack and other information
1. What Econac Injection is and what it is used for
Econac Injection contains the active substance Diclofenac sodium which belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).
Econac Injection is used in adults for the treatment of painful conditions, such as kidney stone pain, osteo and rheumatoid arthritis, back pain, gout, injuries and fractures. It is also used to prevent or treat pain following an operation.
2. What you need to know before you are given Econac Injection You should not be given Econac Injection
• if you are allergic to Econac Injection or any of the other ingredients of Econac Injection (listed in section 6)
• if 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 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
heparin and
• if you are taking anticoagulant drugs (medicines for preventing blood clots, such as warfarin)
• if you are more than 6 months pregnant
• if you are taking medicines known as SSRIs used to treat depression.
• if you have been told by your doctor that you have an intolerance to some sugars
• if you have had stomach or bowel problems after you have taken other NSAIDs.
heart operation to
• if you have established heart disease and /or cerebrovascular disease e.g. if you have had a attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you are breast-feeding
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Econac Injection:
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
• 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 or pharmacist.
• If you suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s disease, inflammation of the colon.
• If you have a history of any of the following: stomach or bowel ulcers, vomiting of blood or black, tarry faeces and Gastro-intestinal ulcers
• 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 antiinflammatory 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, your doctor may monitor your kidney function.
• If you have kidney, liver or heart problems.
• If you are pregnant.
• If you have a history of high blood pressure and/or heart failure.
• If you suffer from or have previously suffered from asthma.
• If you suffer from systemic lupus erythematous or mixed connective tissue disorders.
• If you are an older patient.
• If you have had or are about to have major surgery.
• If you suffer from any blood or bleeding disorder.
Children
Econac Injection is not recommended for use in children.
Older people
Older people 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.
Other medicines and Econac Injection
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought without a prescription.
• 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
• 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)
• Steroids
• Zidovudine (treatment of HIV infection)
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine(medicines to lower cholesterol level)
• CYP2C9 inhibitors: e.g. Sulfinpyrazone 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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Econac Injection should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.
Do not take Econac Injection during the last 3 months of pregnancy as it may affect your baby’s circulation and kidneys.
Breast-feeding
Do not take Econac Injection during breast-feeding as Diclofenac passes into the breast milk in small amounts.
Fertility
Taking Econac Injection 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.
Driving and using machinery
Econac Injection may make you feel drowsy or dizzy. If so, do not drive or operate any tools or machines until these effects have worn off.
Econac Injection contains less than 1 mmol (23 mg) sodium per 3ml i.e. essentially-free.
Econac Injection contains sodium metabisulphite which can cause severe allergic reactions, especially in patients with a history of asthma or other allergies.
3. How you are given Econac Injection
Econac Injection can be 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 total dose in one day should not exceed 150mg (two ampoules).
Your doctor may decide on smaller doses if you are:
• an older person
• frail
• or you have a low body weight
If you are given more Econac Injection than you should
If you think you have been given too much Econac Injection tell your doctor or nurse straight away.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines this medicine can cause side-effects although not everybody gets them.
Some side effects can be serious and you should tell your doctor immediately if you notice the following:
• Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Econac Injection and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data)
• 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 are bruising more easily than usual or have frequent sore throats or infections
The following side effects have also been reported:
Common (affects less than 1 in 10 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 or texture
• Fluid retention, symptoms of which include swollen ankles
Rare (affects less than 1 in 1,000 people)
• Asthma including shortness of breath
• Diarrhoea with blood in it or bleeding from the back passage
• Blood in vomit or black, tarry faeces
• Liver function disorders, including hepatitis and jaundice
• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in older patients)
• Gastritis (inflammation, irritation or swelling of the stomach lining)
• Somnolence (sleepiness)
• Urticaria (raised, itchy rash)
• Shock (symptoms of which include weak and rapid pulse, confusion, weakness or low blood pressure)
Very rare (affects less than 1 in 10,000 people)
• Hearing loss or impairment
• Tinnitus (ringing in the ears)
• Blurred or double vision
• Visual disturbance
• Formation of pus (abscess) at the injection site
• Tingling or numbness in the skin (Paraesthesia)
• Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes (erythema multiforme, photosensitivity reaction)
• Taste changes
• Tremor
• Disorientation
• Memory impairment
• Depression
• Insomnia (sleeplessness)
• Nightmares
• Irritability (mood changes)
• Anxiety
• Psychotic disorder (mental disorders)
• Fits (convulsions)
• Constipation
• Hair loss
■ Blistering of skin
■ Recurring skin rashes
■ Swelling of skin (including angioneurotic oedema with face oedema)
■ Itching
■ Inflammation of skin (Eczema)
■ Red or purple discolorations on the skin (Exfoliative dermatitis)
■ Severe upper abdominal pain
■ Lower gut disorders (including inflammation of the colon)
■ Narrowing of the bowel (which leads to intestinal obstruction)
■ Worsening of ulcerative colitis (ulcers in the colon) or Crohn's disease which is characterized by abdominal pain
■ Mouth ulcers
■ Inflammation of the tongue
■ Inflammation of the inside of the mouth or lips
■ Oesophageal disorder characterized by difficulty in swallowing
■ Hypertension (high blood pressure)
■ Hypotension (low blood pressure)
■ Aseptic meningitis (fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light)
■ Inflammation of blood vessels (vasculitis)
■ 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 which may be made worse by exposure to sunlight
■ Inflammation of the pancreas
■ Increased risk of heart attack or stroke
■ Chest pain
■ Heart disorders, including congestive heart failure
■ Blood disorders (including anaemia).
■ Palpitations (fast or irregular heart beat)
■ Inflammation of the lung (pneumonitis)
■ Fever
■ Back pain
Not known: frequency cannot be estimated from the available data
■ Injection site necrosis (dead skin and tissue around the injection site)
■ Confusion
■ Hallucinations
■ Disturbances of sensation
■ Impotence
■ Optic neuritis (inflammation of the nerves in the eye)
■ Malaise (General feelings of being unwell, weakness)
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Econac Injection
Keep this medicine out of the sight and reach of children.
Keep the container in the outer carton in order to protect from light.
Do not store above 25°C.
Do not use after the expiry date shown on the carton. Once opened, any unused liquid should be discarded. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Econac Injection contains
The active substance is Diclofenac sodium. Each ampoule contains 75mg of Diclofenac Sodium in 3ml of solution. The solution is sterile and is colourless to slightly yellow.
The other ingredients of the each ampoule are mannitol (E421), propylene glycol, benzyl alcohol, sodium metabisulphite (E223), sodium hydroxide and water for injection.
What Econac Injection looks like and contents of the pack
The ampoules are available in 3ml strengths in clear glass ampoules and are packed in cardboard cartons containing 10 ampoules.
Marketing authorization holder
Mercury Pharma Group Ltd,
Capital House,
85 King William Street,
London
EC4N 7BL, UK PL 10972/0070
Manufacturer
Hameln Pharmaceuticals Langesfled 13,
31789 Hameln,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Mercury Pharma Group Ltd,
Capital House,
85 King William Street,
London
EC4N 7BL, UK