Econac Sr 75mg Tablets
MercuryPharma
Package leaflet: Information for the patient
Econac® SR 75mg Tablets
(Diclofenac Sodium)
Read all of this leaflet carefully before you start
taking 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, pharmacist or nurse.
- 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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet.(See section 4).
The name of your medicine is Econac® SR 75mg Tablets.
It will be referred to as Econac Tablets for ease here after.
What is in this leaflet:
1. What Econac Tablet is and what it is used for
2. What you need to know before you take Econac Tablets
3. How to take Econac Tablets
4. Possible side effects
5. How to store Econac Tablets
6. Contents of the pack and other information
Econac Tablets contain diclofenac and belong to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs). These medicines reduce pain and inflammation and bring down a high temperature.
Econac Tablets are used to treat a number of painful conditions affecting the joints and muscle sprains, fractures, dislocation, back pain, dental and other minor surgeries. Econac Tablets are specially formulated to release diclofenac slowly, over a long period of time.
Do not take Econac Tablets:
• If you know that you are allergic to Diclofenac Sodium or any of the other ingredients in these tablets (listed in section 6)
• If you have or previously have had a peptic ulcer in your stomach or intestines
• If 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
• If 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)
• If you have or have had problems with your blood circulation (peripheral arterial disease)
• If you have suffered severe heart, kidney or liver failure or cerebrovascular bleeding (bleeding in your brain)
• If you have a history of bleeding from the stomach or bowels when taking NSAIDs previously
• If you are in your last three months of pregnancy.
Tell your doctor or pharmacist if you are not sure if any of
the conditions above apply to you.
Econac Tablets are not recommended for children.
Warnings & Precautions:
Talk to your doctor, pharmacist or nurse before taking
Econac tablets
• If you have had an ulcer or some other problem affecting your stomach, or intestines
• If you have asthma or wheezing attacks (or if you have had asthma in the past)
• If you have any heart, liver or kidney problems
• If you are elderly
• If you are taking other NSAIDs (for painful or inflammatory conditions) including Cox2 inhibitors
• If you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease
• If you are taking diuretics (water pills)
• If you have substantial fluid loss (e.g before or after major surgery)
• If your blood does not clot correctly (haemostasis)
• If you have mixed connective tissue disorders and systemic lupus erythematosus - SLE (which results in joint pain, skin change and disorders of other organs)
• If you have a condition called porphyria
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• If you had a previous episode of vomiting blood or blood in stools
• If you experience skin rash, itching, painful red areas, peeling or blistering of the skin or any other allergic reaction within the first few days of treatment with diclofenac
• If you are planning to be pregnant or planning on becoming pregnant.
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 Tablets as they reduce the signs of infection, fever and inflammation which would otherwise be noticed. Medicines such as Econac 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 exceed the 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 high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Long term use with diclofenac is not recommended, however it is advised to undergo routine blood tests if diclofenac is indicated for long term treatment.
Other medicines and Econac Tablets:
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines. Econac 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 e.g. diuretics, beta-blockers and ACE inhibitors)
• Diuretics (to make you pass more water e.g. spironolactone, amiloride and triamterene)
• 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)
• Zidovudine (an anti-viral drug)
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine(medicines to lower cholesterol level)
• Medicines of the class SSRIs (Selective Serotonin Reuptake Inhibitors) used to treat depression such as fluoxetine or sertaline
• CYP2C9 inhibitors: e.g. Sulfinapyrazone and voriconazole. Anti-platelet drugs which affect the clotting of blood which may increase the risk of bleeding
Pregnancy, breast feeding and fertility:
Pregnancy:
Do not take Econac 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-Feeding:
Diclofenac is known to pass into milk into small amounts and hence should be avoided by nursing mothers.
Fertility:
Econac Tablets 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.
Driving and using machines:
If you feel dizzy, sleepy or experience visual disturbances when you start to use Econac Tablets, do not drive or use machines until the effect has worn off.
Econac Tablets contains lactose monohydrate:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Econac Tablets should be taken with or after food. The tablets should be swallowed whole with a glass of water. The recommended dose is:
Adults: The usual dose is one tablet once or twice daily. As a general principle, the smallest effective dose should be used.
Elderly patients: 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 Tablets are not recommended for use in children.
If you take more Econac Tablets than you should
If you (or someone else) take 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 Econac 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 a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Rare (may affect up to1 in 1000 people):
• allergic reactions, skin rashes, sleeplessness, asthma, difficulty in breathing, Gastritis, indigestion, stomach ache, inflammation of liver (hepatitis), jaundice and liver disorder general swelling of the body.
Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood platelets (increase chance of bleeding or bruising)
• deficiency of red cells or of haemoglobin in the blood
• deficiency of granulocytes in the blood, causing increased chances of infection
• fluid retention in body and face characterised by swelling of the skin
• disorientation, depression, sleeplessness, nightmare, irritability, psychotic disorder, nervousness, abnormal sensation typically tingling or pricking, memory impairment, convulsions (sudden, violent movements of the body), dysfunction of the sense of taste, hallucinations (seeing or hearing things that are not really there), sensory disturbance
• visual disturbance, blurred vision, double vision
• ringing in the ears, impaired hearing
• palpitations (awareness of your heartbeat), chest pain, heart failure, heart attack, abnormally low blood pressure (hypotension), abnormally high blood pressure (hypertension), inflammation of blood vessels
• colitis (inflammation of the lining of the colon), constipation, mouth ulcers, inflammation of intestines (Crohn's disease), inflammation of pancreas and liver j failure
• inflammation of skin with blisters containing fluid, flulike symptoms with painful red or purplish rashes and blisters on skin (Stevens-Johnson syndrome), increase in reactivity of the skin to sunlight, itching and bleeding of skin, baldness, inflammation of small blood vessels (Henoch-Schonlein purpura)
• kidney failure and presence of blood in urine.
Not known (frequency cannot be estimated from the available data):
• confusional state, Hallucinations (seeing or hearing things that are not really there), sensory disturbances, Inflammation of the nerves in the eye, feeling of discomfort and erectile dysfunction.
Reporting of side effects
If you get any side effects, talk to your doctor pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this 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.
Other side effects
Common (may affect up to 1 in 10 people):
• headache, dizziness, spinning of head, feeling sick (nausea), being sick (vomiting), diarrhea, indigestion, pain in your stomach, wind, loss of appetite, raised liver enzymes and rash.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the Carton after ‘Exp.' The Expiry date refers to last day of that month. Do not store above 25°C. Keep in original container/package in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Econac Tablets contains
Econac Tablets are prolonged release tablets. Each tablet contains 75mg of the active substance, Diclofenac Sodium. The other ingredients are lactose monohydrate, magnesium stearate, povidone K 30, talc, hypromellose and microcrystalline cellulose. Iron oxide red (E172).
What Econac Tablets look like and contents of the pack Econac Tablets are light pink, round convex tablets embossed with “D” 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 March 2015
Econac is a registered trade mark of Mercury Pharma Group Ltd
100180/LF/066/06