Econac Sr 75mg Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What are Econac SR 75mg Tablets and what they are used for
2. Before you take Econac SR 75mg Tablets
3. How to take Econac SR 75mg Tablets
4. Possible side effects
5. How to store Econac SR 75mg Tablets
6. Further information
Econac SR 75mg Tablets contain diclofenac and belong to a group of medicines called non-steroid antiinflammatory drugs (NSAIDs). These medicines reduce pain and inflammation, and bring down a high temperature.
Econac SR 75mg Tablets are used to treat a number of painful conditions affecting the joints and muscles, fractures, dislocation, back pain, dental and other minor surgeries.
Econac SR 75mg Tablets are specially formulated to release diclofenac slowly, over a long period of time.
DO NOT take Econac SR 75mg Tablets if:
• You know that you are allergic to Diclofenac Sodium or any of the other ingredients in these tablets (listed at the end of this leaflet)
• You have or previously have had a peptic ulcer in your stomach, or intestines
• 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 or bypass blockages
• You show any signs of allergy (such as asthma, hay fever or skin rash) to aspirin, ibuprofen or other NSAIDs (such as naproxen, ibuprofen, indomethacin, mefenamic acid, etc)
• You have or have had problems with your blood circulation (peripheral arterial disease)
• You have suffered severe heart, kidney or liver failure or cerebrovascular bleeding (bleeding in your brain)
• You have a history of bleeding from the stomach or bowels when taking NSAIDs previously
• You are in your last three months of pregnancy.
Take special care with Econac SR 75mg Tablets and
check with your doctor or pharmacist before taking
your medicine if:
• You have had an ulcer or some other problem affecting your stomach, or intestines
• You have asthma or wheezing attacks (or if you have had asthma in the past)
• You have any heart, liver or kidney problems
• You are elderly
• You are taking other NSAIDs (for painful or inflammatory conditions) including Cox2 inhibitors
• You suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease
• You are taking diuretics (water pills)
• You have substantial fluid loss (e.g before or after major surgery)
• Your blood does not clot correctly (haemostasis)
• You have mixed connective tissue disorders and systemic lupus erythematosus - SLE (which results in joint pain, skin change and disorders of other organs).
• You smoke
• You have diabetes
• You have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
If you are having a medical examination, tell the doctor that you are taking Econac SR 75mg Tablets as they reduce the signs of fever and inflammation which would otherwise be noticed.
Medicines such as Econac SR 75mg Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with higher doses and prolonged treatment. Do not exceedthe recommended dose or duration of treatment. If you have heart problems or have suffered from a previous stroke or think that you may be at risk of these conditions (for example, if you have nigh blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist. Taking other medicines:
Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.
Econac SR 75mg Tablets may affect or be affected by the following medicines:
• Anticoagulant tablets (to prevent blood clots, e.g. warfarin)
• Antihypertensives (for the treatment of high blood pressure)
• Diuretics (to make you pass more water)
• Lithium (for depression)
• Medicines for the treatment of heart conditions (e.g. digoxin)
• Corticosteroids (e.g. for asthma and various inflammatory conditions)
• Antibiotics (for an infection, e.g. quinolones like ciprofloxacin, nalidixic acid, norfloxacin)
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin, ibuprofen, naproxen, etc.)
• Medicines for the treatment of diabetes (such as chlorpropamide and tolbutamide)
• Mifepristone (used to terminate pregnancies or as emergency contraceptive)
• Methotrexate which can be used to treat certain tumours and other diseases including psoriasis and rheumatoid arthritis
• Cyclosporine or tacrolimus which can be used to suppress the body’s immune system e.g. following transplants or in diseases such as psoriasis and rheumatoid arthritis)
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine(medicines to lower cholesterol level)
• Medicines to treat depression such as fluoxetine or sertaline (for depression)
• CYP2C9 inhibitors: e.g. Sulfinapyrazone and voriconazole.
Pregnancy and breast feeding:
Do not take Econac SR 75mg Tablets if you are pregnant (or think you may be), or breast feeding unless your doctor has decided that it is in your best interests.
If used, the lowest effective dose should be used. You should NOT take these tablets during the last three months of pregnancy as they may affect the baby’s circulation.
If you are pregnant or planning to become pregnant, or are breast feeding, please tell your doctor or pharmacist before taking Econac SR 75mg Tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
If you feel dizzy, sleepy or experience visual disturbances when you start to use Econac SR 75mg Tablets, do not drive or use machines until the effect has worn off. Important information about some of the ingredients of Econac SR 75mg Tablets:
This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• You should take the lowest dose of Econac 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 Econac. The risk is higher if you are taking high doses for a long time. Always follow the doctors instructions on how much to take and how long to take it for.
• 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, Econac Tablets may reduce the symptoms of infection, for example, headache and nigh temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Econac Tablets.
Make sure you take your tablets exactly as directed by your doctor. The instructions will be written on the label. You should check with your doctor or pharmacist if you are not sure.
Econac SR 75mg Tablets should be taken with or after food.
The tablets should be swallowed whole with a glass of water.
Adults: The usual dose is one tablet once or twice daily. As a general principle, the smallest effective dose should be used.
Elderly: If you are elderly, your doctor may want to reduce the usual adult dose and check that the medicine is suiting you, especially during the first four weeks of treatment. Make sure to follow your doctor’s instructions carefully and to keep your appointments.
Children: Econac SR 75mg Tablets are not recommended for use in children.
If you take more Econac SR 75mg Tablets than you should:
If you (or someone else) takes too many of these tablets, contact your doctor, or hospital immediately for advice. Bring the pack with any remaining tablets with you.
If you forget to take your Econac SR 75mg Tablets:
If you miss a dose, leave it out and take the next dose whenever it is due. After that, just carry on as before. Do not take double the dose.
If you have any further questions about these tablets, ask your doctor or pharmacist.
• Asthma including shortness of breath.
Very rare (affects less than 1 user in
10,000):
Tingling or numbness in the skin, tremor, blurreaor double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, disturbances in sensation.
Anxiety (sweating, trembling, feeling nervous or anxious, fast heart beat).
Meningitis (fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light).
Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon).
Worsening of Crohn's disease which is characterized by abdominal pain, diarrhea, bloody stools or fever. 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), congestive heart failure, blood disorders (including anaemia, bleeding or bruising more easily than normal).
Angioneurotic oedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing).
Kidney or liver disorders, presence of blood or protein in the urine.
• 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.
Inflammation of the pancreas.
Increased risk of heart attack (“myocardial infarction”) or stroke.
Other side effects:
Impotence.
Do not be alarmed by this list - most people take Econac Tablets 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.
Like all medicines Econac can cause side effects,
although not everybody gets them.
Some side effects can be serious.
Stop taking Econac SR 75mg Tablets and tell your
doctor straight away if you notice any of the side effects:
• 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, or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• Painful red areas, peeling or blistering
• 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.
Common (affects more than 1 in 100 people):
• 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
• Itching or burning in back passage.
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
• Drowsiness, tiredness
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
• Skin rash and itching
• Fluid retention, symptoms of which include swollen ankles
• Liver function disorders, including hepatitis and jaundice
What Econac SR 75mg Tablets contain
Econac SR 75mg Tablets are prolonged release tablets, j Each tablet contains 75mg of the active substance, Diclofenac Sodium.
The other ingredients are lactose monohydrate, magnesium stearate, povidone K30, talc, hypromellose ■ ana microcrystalline cellulose.
What Econac SR 75mg Tablets look like and contents of the pack:
Econac SR 75mg Tablets are light pink, round convex tablets embossed with “A” on one side. They are packed ! in either aluminium blister packs (10, 20, 28, 30, 50, 56, !
60, 90, 100 tablets) or containers with plastic lids (28, 56, \ 100 tablets). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Mercury Pharmaceuticals Ltd., No.1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK This leaflet was last revised in September 2014.
Econac is a registered trade mark of Mercury Pharma Group Ltd
100180/LF/4)