Econac Xl 100mg Tablets
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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 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 or pharmacist. This includes any possible side effects not listed in this leaflet.
The name of your medicine is Econac XL 10Omg Tablets. It will be referred to as Econac Tablets for ease here after. What is in this leaflet:
1. What Econac Tablets are and what they are 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 such as arthritis and muscles, fractures, dislocation, back pain, dental and other minor surgeries. Econac Tablets are specially formulated to release diclofenac slowly, over several hours.
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)
• You have or previously have had a peptic ulcer bleeding or perforation in your stomach, or intestines
• You have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, ministroke (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
• You have severe heart, kidney or liver failure or cerebrovascular bleeding (bleeding in your brain)
• You have or have had problems with your blood circulation (peripheral arterial disease)
• You have had stomach or bowel problems after taking other NSAIDs
• You are in your last three months of pregnancy.
Take special care with Econac 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 (ulcerative colitis, Crohn’s disease)
• 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 have low body weight
• You have mixed connective tissue disorders and systemic lupus erythematosus -SLE (which results in joint pain, skin change and disorders of other organs)
• You have a condition called porphyria
• You have recently undergone major surgery
• You are particularly prone to infections (diclofenac may suppress the signs and symptoms of an infection)
• You have experienced stomach discomfort, had heartburn or felt nauseous after taking aspirin or any other nonsteroidal anti-inflammatory drugs
• You have a bleeding/blood disorder
• 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 Tablets as they reduce the signs of 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 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.
Other medicines and Econac Tablets:
Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.
Econac Tablets may affect or be affected by the following medicines:
• Anticoagulant tablets (to prevent blood clots, e.g. warfarin)
• Medicines for the treatment of high blood pressure
• 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)
• A corticosteroid (e.g. for asthma and various inflammatory conditions)
• Antibiotics such as quinolone (for an infection)
• Any other NSAID (for painful or inflammatory conditions e.g. aspirin)
• Mifepristone (used as an emergency contraceptive, or to induce abortion or labour)
• Ciclosporin or Tacrolimus (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)
• Medicines to treat depression such as fluoxetine or sertaline (for depression)
• Medicines used to treat diabetes
• Phenytoin (medicines to treat epilepsy)
• Colestipol and cholestyramine(medicines to lower cholesterol level)
• CYP2C9 inhibitors:e.g Sulfinapyrazone and voriconazole
• Methotrexate (used to treat cancer).
Pregnancy, breast feeding and fertility:
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.
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.
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 Tablets, do not drive or use machines until the effect has worn off.
Important information about some of the ingredients of Econac Tablets:
This medicine also 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.
Special Warnings and Precaution:
• You should take the lowest dose of Econac for the shortest possible time, particularly if you are underweight or elderly
"Tfierels a smaTincreasecTrisR oTTfeart 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 doctor’s 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 high 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 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 each day.
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. Be 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) 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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Econac 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.
STOP TAKING the medicine and tell your doctor if you experience any of the side effects:
Common (affects more than 1 in 100 people): Indigestion, heart burn, abdominal pain (pain in your stomach) or other abdominal (stomach) symptoms, nausea (feeling sick), vomiting (being sick), diarrhoea, wind, loss of appetite Skin rash or spots
Raised levels of liver enzymes in the blood Itching or burning in back passage Headache, dizziness, vertigo (dizziness).
Rare (affects less than 1 in 1000):
Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in tine 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
HuiS"retention,"symptoms orwHfcFi'incTude swollen ankles
• Liver function disorders, including hepatitis and jaundice
• Asthma including shortness of breath.
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, mental disorders, confusion, hallucinations, malaise (weakness), 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, nausea, vomiting, diarrhoea, inflammation of the tongue, mouth ulcers, 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.
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) 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 or stroke.
Other side effects:
Impotence
Inflammation of the nerves in the eye.
Do not be alarmed by this list - most people take Econac Tablets without any problems.
If any of the symptoms become trouble some, 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.
Medicines such as Econac may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
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.
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.
What Econac Tablets contain:
Econac Tablets are prolonged release tablets. Each tablet contains 100mg of the active substance, Diclofenac Sodium. The other ingredients are lactose monohydrate, magnesium stearate, hydrogenated vegetable oil Type I, povidone K 30, talc. What Econac Tablets look like and contents of the pack: Econac Tablets are white circular, biconvex, tablets engraved with “DSR” on one side. Each tablet contains 100mg diclofenac sodium. They are packed in either aluminium blister packs (20, 21,28, 30 tablets), tubes with plastic caps (56, 100, 250, 500 tablets) or plastic bottles with screw caps (56, 100, 250, 500 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
100170/LF/4