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ECONAC SR 75MG TABLETS

Active substance(s): DICLOFENAC SODIUM

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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
1. WHAT ECONAC TABLET IS AND
WHAT IT IS USED FOR
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ECONAC TABLETS
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

Size : 160 x 270 (mm) Front Side

• 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.
3. HOW TO TAKE ECONAC TABLETS
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.
4. POSSIBLE SIDE EFFECTS
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.

Size : 160 x 270 (mm) Back Side

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
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
5. HOW TO STORE ECONAC TABLETS
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.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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