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ECONAC SR 75MG TABLETS

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM / DICLOFENAC SODIUM

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DUMMY
92640

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 are allergic to Diclofenac Sodium or any of the
other ingredients of this medicine (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, 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 and 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 COX-2 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.
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
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

Version No:
Product Name:

100180/LF/066/07

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Econac SR 75mg
Tablets
28 Tablets
Leaflet
100180
UK
Intas
6
10/01/2017
PAT
PR 4990

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

160 x 270mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

10/01/2017
8 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

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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 population: 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.
Use in 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.
Symptoms of overdose may include but are not limited to
headache, nausea and vomiting (being sick), stomach
pain, bloody diarrhoea, dizziness, disorientation,
excitation, drowsiness, tinnitus (perception of noise or
ringing in the ears), fainting, shortness of breath and
convulsions (uncontrollable shaky movements).
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, 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:
• Mild cramping and tenderness of the abdomen, starting
shortly after the start of the treatment with Econac
tablets 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
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,
inflammation of liver (hepatitis), jaundice and liver disorder
• 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

• Flu-like symptoms with painful red or
purplish rashes and blisters on skin
(Stevens-Johnson syndrome)
• Meningitis (symptoms include stiff neck,
headache, nausea, vomiting, fever or
disorientation).
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.
Rare (may affect up to 1 in 1000 people):
• skin rashes (hives), drowsiness, asthma, difficulty in
breathing, gastritis, indigestion, stomach ache, general
swelling of the body.
Very rare (may affect up to 1 in 10,000 people):
• deficiency of red cells or of haemoglobin in the blood
• 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, 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,
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
• stroke (cerebrovascular accident)
• inflammation of the walls of the lung (pneumonitis).
Not known (frequency cannot be estimated from the
available data):
• erectile dysfunction
• feeling of discomfort.
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. Do not throw
away any medicine 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 Tablets contain
- The active substance is Diclofenac Sodium. Each tablet
contains 75mg of the Diclofenac Sodium.
- The other ingredients are lactose monohydrate,
magnesium stearate, povidone K 30, talc, hypromellose,
microcrystalline cellulose and 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 January 2017
Econac is a registered trade mark of Mercury Pharma
Group Ltd
100180/LF/066/07

DUMMY
92640

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 contain 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.

Version No:
Product Name:

100180/LF/066/07

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Econac SR 75mg
Tablets
28 Tablets
Leaflet
100180
UK
Intas
6
10/01/2017
PAT
PR 4990

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

160 x 270mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

10/01/2017
8 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

Expand Transcript

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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