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ENSTAR SR 75MG TABLETS

Active substance(s): DICLOFENAC SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Enstar SR 75mg Tablets
(Diclofenac Sodium)

Read all of this leaflet carefully before you start
!
Do you have Lupus (SLE) or any similar
taking this medicine because it contains
condition?
important information for you.
!
Do you have an intolerance to some sugars
Keep this leaflet. You may need to read it
!
such as lactose? (These tablets contain
again.
lactose).
If you have further questions, please ask your
!
doctor or pharmacist or nurse.
Other medicines and Enstar SR 75mg Tablets
This medicine has been prescibed for you only.
!
Tell your doctor or pharmacist if you are taking,
Do not pass it on to others. It may harm them,
have recently taken or might take any other
even if their signs of illness are the same as
medicines. Especially if you are taking:
yours.
Medicines to treat diabetes
!
!
If you get any side effects, talk to your doctor,
!
Anticoagulants (blood thinning tablets like
or pharmacist or nurse. This includes any side
warfarin)
effects not listed in this leaflet. See section 4.
!
Diuretics (water tablets)
!
Lithium (used to treat some mental problems)
What is in this leaflet:
!
Methotrexate (for some inflammatory diseases
1. What Enstar SR 75mg Tablets are and what
and some cancers)
they are used for
!
Ciclosporin and tacrolimus (used to treat some
2. What you need to know before you take
inflammatory diseases and after transplants)
Enstar SR 75mg Tablets
!
Trimethoprim (a medicine used to prevent or
3. How to take Enstar SR 75mg Tablets
treat urinary tract infections)
4. Possible side effects
!
Quinolone antibiotics (for infections)
5. How to store Enstar SR 75mg Tablets
!
Any other NSAID or COX-2 (cyclo-oxgenase-2)
6. Contents of the pack and other information
inhibitor, for example aspirin or ibuprofen
!
Mifepristone (a medicine used to terminate
1. WHAT ENSTAR SR 75MG TABLETS ARE
pregnancy)
AND WHAT THEY ARE USED FOR
!
Cardiac glycosides (for example digoxin), used
to treat heart problems
Enstar SR 75mg Tablets belong to a group of
!
Medicines known as SSRIs used to treat
medicines called non-steroidal anti-inflammatory
depression
drugs (NSAIDs). Enstar SR 75mg Tablets are used
!
Oral steroids (an anti-inflammatory drug)
to relieve symptoms caused by osteoarthritis,
!
Medicines used to treat heart conditions or high
rheumatoid arthritis and ankylosing spondylitis
blood pressure, for example beta blockers or
(rheumatism of the spine) such as swelling,
ACE inhibitors
stiffness or joint pain. It does not cure arthritis and
!
Voriconazole (a medicine used to treat fungal
will help you only as long as you continue to take it.
infections)
!
Phenytoin (a medicine used to treat seizures)
2. WHAT YOU NEED TO KNOW BEFORE YOU
!
Colestipol/cholestyramine (used to lower
TAKE ENSTAR SR 75MG TABLETS
cholesterol)
!
Zidovudine (a medicine used in the treatment of
Do not take Enstar SR 75mg Tablets if:
HIV).
!
You think you may be allergic to diclofenac
sodium, aspirin, ibuprofen or any other NSAID,
Laboratory tests
or to any of the other ingredients of Enstar SR
Regular liver and kidney function tests and
75mg Tablets. (These are listed at the end of
monitoring of blood counts are necessary during
the leaflet.) Signs of a hypersensitivity reaction
long-term treatment.
include swelling of the face and mouth
(angioedema), breathing problems, runny nose,
Pregnancy and breast-feeding
skin rash or any other allergic type reaction
Ask your doctor or pharmacist for advice before
!
You have now, or have ever had, a stomach
taking any medicine.
(gastric) or duodenal (peptic) ulcer, or bleeding
Enstar SR 75mg Tablets may make it more difficult
in the digestive tract (this can include blood in
to become pregnant. You should inform your
vomit, bleeding when emptying bowels, fresh
doctor if you are planning to become pregnant or if
blood in faeces or black, tarry faeces)
you have problems becoming pregnant.
!
You have had stomach or bowel problems after
you have taken other NSAIDs
You should not take Enstar SR 75mg Tablets
!
You have severe heart, kidney or liver failure
during the first 6 months of pregnancy unless
!
You are more than six months pregnant
directed by your doctor and must not take Enstar
!
You have established heart disease and/or
SR 75mg Tablets during the last 3 months of
cerebrovascular disease e.g. if you have had a
pregnancy as damage to the baby and reduced
heart attack, stroke, mini-stroke (TIA) or
labour may occur.
blockages to blood vessels to the heart or brain
You should only use Enstar SR 75mg Tablets
or an operation to clear or bypass blockages
whilst breast-feeding if advised by your doctor.
!
You have or have had problems with your blood
circulation (peripheral arterial disease).
Other special warnings
!
You should take the lowest dose of Enstar SR
Make sure your doctor knows, before you are
75mg Tablets for the shortest possible time,
given diclofenac
particularly if you are underweight or elderly
!
If you smoke
!
There is a small increased risk of heart attack
!
If you have diabetes
or stroke when you are taking any medicine like
!
If you have angina, blood clots, high blood
Enstar SR 75mg Tablets. The risk is higher if
pressure, raised cholesterol or raised
you are taking high doses for a long time.
triglycerides.
Always follow the doctor's instructions on how
much to take and how long to take it for
Side effects may be minimised by using the lowest
!
Whilst you are taking these medicines your
effective dose for the shortest duration necessary.
doctor may want to give you a check-up from
time to time
Take special care with Enstar SR 75mg Tablets
!
If you have a history of stomach problems
If you answer YES to any of the questions
when you are taking NSAIDs, particularly if you
below, you should talk to your doctor before
are elderly, you must tell your doctor straight
taking Enstar SR 75mg Tablets:
away if you notice any unusual symptoms
!
Do you suffer from any stomach or bowel
!
Because it is an anti-inflammatory medicine,
disorders including ulcerative colitis or Crohn's
Enstar SR 75mg Tablets may reduce the
disease?
symptoms of infection, for example, headache
!
Do you have kidney or liver problems, or are
and high temperature. If you feel unwell and
you elderly?
need to see a doctor, remember to tell him or
!
Do you have a condition called porphyria?
her that you are taking Enstar SR 75mg
!
Do you suffer from any blood or bleeding
Tablets.
disorder? If you do, your doctor may ask you to
go for regular check-ups while you are taking
Driving and using machines
these tablets
Some patients may feel dizzy while taking this
!
Have you ever had asthma?
medicine. Do not drive or operate machinery if you
!
Are you breast-feeding?
are affected.
!
Do you have heart problems, or have you had a
stroke, or do you think you might be at risk of
Enstar SR 75mg Tablets contain lactose
these conditions (for example, if you have high
If you have been told by your doctor that you have
blood pressure, diabetes or high cholesterol or
an intolerance to some sugars, contact your doctor
are a smoker)?
before taking this medicine.

3. HOW TO TAKE ENSTAR SR 75MG
TABLETS
Always take Enstar SR 75mg Tablets exactly as
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Enstar SR 75mg Tablets must not be taken longterm, blood tests should be carried out if taken for
more than a few days.
The tablets must be swallowed whole with a glass
of water, with or after food. Do not crush or chew
the tablet.

Very rare side effects (These may
affect less than 1 in every 10,000
patients):
Effects on the nervous system:
Tingling or numbness in the fingers,
tremor, blurred or double vision, hearing
loss or impairment, tinnitus (ringing in the
ears), sleeplessness, nightmares, mood
changes, depression, anxiety, mental
disorders, disorientation and loss of
memory, fits, headaches together with a dislike of
bright lights, fever and a stiff neck, disturbances in
sensation.

The usual dose is:
Effects on the stomach and digestive system:
Adults: One tablet once or twice a day.
!
Constipation, inflammation of the tongue, mouth
Elderly: As adult dose. The lowest effective
!
ulcers, inflammation of the inside of the mouth or
dose should be taken and your doctor will need
lips, taste changes, lower gut disorders (including
to monitor you regularly. If you are elderly your
inflammation of the colon or worsening of
doctor may prescribe a lower daily dose and
ulcerative colitis or Crohn's disease).
reduce the duration of treatment.
Children: not recommended.
!
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest
If you take more Enstar SR 75mg Tablets than
pain, hypertension (high blood pressure),
you should
inflammation of blood vessels (vasculitis),
If you, or anyone else, accidentally takes too much,
inflammation of the lung (pneumonitis), heart
tell your doctor or your nearest hospital casualty
disorders, including congestive heart failure or
department. Take your medicine pack with you so
heart attack, blood disorders (including anaemia).
that people can see what you have taken.
Symptoms of overdose may be gastrointestinal
Effects on the liver or kidneys:
disorders, feeling or being sick, diarrhoea, kidney
Kidney or severe liver disorders including liver
failure, fits, headache, disorientation, excitement,
failure, presence of blood or protein in the urine.
coma, drowsiness, dizziness, ringing in the ears,
fainting and liver damage.
Effects on skin or hair:
Serious skin rashes including Stevens-Johnson
If you forget to take Enstar SR 75mg Tablets
syndrome, Lyell's syndrome and other skin rashes
Do not take a double dose to make up for a
which may be made worse by exposure to
forgotten dose. Continue the treatment as advised
sunlight.
by your doctor.Do not take more than two tablets in
Hair loss.
24 hours.
If you stop taking Enstar SR 75mg Tablets
Changes to dosage or stopping of treatment
should only be as directed by your doctor.
4. POSSIBLE SIDE EFFECTS

Other side effects that have also been reported
include:
Inflammation of the pancreas, impotence. Facial
swelling, inflammation of the lining of the brain
(meningitis), stroke, throat disorders.

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
Stop taking Enstar SR 75mg Tablets and tell
report side effects directly via the Yellow Card
your doctor straight away if you notice:
Scheme at: http://www.mhra.gov.uk/yellowcard
!
Stomach pain, indigestion, heartburn, wind,
By reporting side effects you can help provide
nausea (feeling sick) or vomiting (being sick)
more information on the safety of this medicine.
!
Any sign of bleeding in the stomach or
intestine, for example, when emptying your
5. HOW TO STORE ENSTAR SR 75MG
bowels, blood in vomit or black, tarry faeces
TABLETS
!
Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling or
Keep all medicines out of the sight and reach of
blistering
children.
!
Wheezing or shortness of breath
Do not store above 25°C.
(bronchospasm)
Do not use Enstar SR 75mg Tablets after the
!
Swollen face, lips, hands or fingers
expiry date which is stated on the carton. The
!
Yellowing of your skin or the whites of your
expiry date refers to the last day of that month.
eyes
!
Persistent sore throat or high temperature
Medicines should not be disposed of via
!
An unexpected change in the amount of urine
wastewater or household waste. Ask your
produced and/or its appearance
pharmacist how to dispose of medicines no longer
If you notice that you are bruising more easily than
required. These measures will help to protect the
usual or have frequent sore throats or infections,
environment.
tell your doctor.
Like all medicines, this medicine may cause you
some problems, although not everybody gets them

6. CONTENTS OF THE PACK AND OTHER
The side effects listed below have also been
INFORMATION
reported.
Common side effects (These may affect
What Enstar SR 75mg Tablets contain
between 1 and 10 in every 100 patients):
Each tablet contains 75mg diclofenac sodium.
!
!
Stomach pain, heartburn, nausea, vomiting,
The other ingredients are lactose monohydrate,
!
diarrhoea, indigestion, wind, loss of appetite
magnesium stearate, methylhydroxypropyl!
Headache, dizziness, vertigo
cellulose, microcrystalline cellulose, povidone,
!
Skin rash or spots
talc, iron oxide red (E172).
!
Raised levels of liver enzymes in the blood.

What Enstar SR 75mg Tablets look like and
Rare side effects (These may affect between 1
contents of the pack
in every 1000 to 1 in every 10,000 patients):
The sustained release tablets are light pink, round,
!
Stomach ulcers or bleeding (there have been
biconvex tablets with D3 embossed on one side.
very rare reported cases resulting in death,
Pack sizes:
particularly in the elderly)
a) Al/Al blister: Pack sizes: 10, 20, 28, 30, 50, 56,
!
Gastritis (inflammation, irritation or swelling of
60, 90, 100 tablets
the stomach lining)
b) PP-container with PE lids: Pack sizes: 28, 56,
!
Vomiting blood
100 tablets
!
Diarrhoea with blood in it or bleeding from the
c) HDPE-container with PE lids: Pack sizes: 28,
back passage
56, 100 tablets
!
Black, tarry faeces or stools
d) Al/PVDC blister: Pack sizes: 10, 20, 28, 30, 50,
!
Drowsiness, tiredness
56, 60, 90, 100 tablets
!
Hypotension (low blood pressure, symptoms of
(Not all pack sizes may be available)
which may include faintness, giddiness or light
headedness)
Marketing Authorisation Holder &
!
Skin rash and itching
Manufacturer
!
Fluid retention, symptoms of which include
Ennogen Pharma Limited
swollen ankles
Unit G4, Riverside Industrial Estate,
!
Liver function disorders, including hepatitis and
Riverside Way, Dartford, DA1 5BS, UK.
jaundice.
The Product Licence number is PL 40147/0032
This leaflet was last revised: May 2015.

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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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