Skip to Content

ENSTAR SR 75MG TABLETS

Active substance(s): DICLOFENAC SODIUM

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Artwork No.

240517/6

Colours Used

Customer

Ennogen

Black

Description

Enstar SR Leaflet

Keyline

Market

UK

Language

English

Size

160 x 430 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

5

Date

06-10-17

Software

Coreldraw 12

Packaging Development

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enstar SR 75mg Tablets
(Diclofenac Sodium)

Quality Assurance (QA)

Quality Control (QC)

Production

Driving and using machines
If you feel dizzy, sleepy or experience visual
disturbances when you start to use Enstar SR
75mg Tablets, do not drive or use machines until
the effect has worn off.
Enstar SR 75mg Tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars contact your doctor
before taking this medicine.

Rare (may affect up to 1 in 1000
people):
Skin rashes (hives), drowsiness,
!
asthma, difficulty in breathing, gastritis
(inflammation of the stomach),
stomach ache (a sign of
gastrointestinal ulcer) and general
swelling of the body.

Very rare (may affect up to 1 in 10,000
people):
Read all of this leaflet carefully before you start
other allergic reaction within the first few days
3. HOW TO TAKE ENSTAR SR 75MG
Deficiency of red cells or of haemoglobin in the
!
taking this medicine because it contains
of treatment with diclofenac.
TABLETS
blood
important information for you.
Fluid retention in body and face characterised
!
!
Keep this leaflet. You may need to read it
Side effects may be minimised by using the lowest
Always take this medicine exactly as your doctor or
by swelling of the skin
again.
effective dose for the shortest duration necessary.
pharmacist has told you. Check with your doctor or
Disorientation, depression, sleeplessness,
!
!
If you have further questions, ask your doctor,
pharmacist if you are not sure.
nightmare, irritability, psychotic disorder,
pharmacist or nurse.
If you are having a medical examination, tell the
nervousness, abnormal sensation typically
!
This medicine has been prescribed for you
doctor that you are taking Enstar SR 75mg Tablets
The tablets must be swallowed whole with a glass
tingling or pricking, memory impairment,
only. Do not pass it on to others. It may harm
as they reduce the signs of infection, fever and
of water, with or after food. Do not crush or chew
dysfunction of the sense of taste
them, even if their signs of illness are the same
inflammation which would otherwise be noticed.
the tablet.
!
Visual disturbance, blurred vision, double vision
as yours.
!
Ringing in the ears, impaired hearing
!
If you get any side effects, talk to your doctor,
Medicines such as Enstar SR 75mg Tablets may
The recommended dose is:
!
Palpitations (awareness of your heartbeat),
pharmacist or nurse. This includes any possible
be associated with a small increased risk of heart
Adults: One tablet once or twice a day.
!
chest pain, abnormally low blood pressure
side effects not listed in this leaflet. See section
attack (“myocardial infarction”) or stroke. Any risk is
Elderly: As adult dose. The lowest effective
!
(hypotension), abnormally high blood pressure
4.
more likely with higher doses and prolonged
dose should be taken and your doctor will need
(hypertension), inflammation of blood vessels
treatment. Do not exceed the recommended dose
to monitor you regularly. If you are elderly your
!
Colitis (inflammation of the lining of the colon),
What is in this leaflet:
or duration of treatment.
doctor may prescribe a lower daily dose and
constipation, mouth ulcers, inflammation of
1. What Enstar SR 75mg Tablets are and what
reduce the duration of treatment.
intestines (Crohn's disease)
they are used for
If you have heart problems or have suffered from a
!
Inflammation of skin with blisters containing
2. What you need to know before you take
previous stroke or think that you may be at risk of
Use in children
fluid, increase in reactivity of the skin to
Enstar SR 75mg Tablets
these conditions (for example, if you have high
Enstar SR 75mg Tablets are not recommended for
sunlight, itching and bleeding of skin, baldness,
3. How to take Enstar SR 75mg Tablets
blood pressure, diabetes or high cholesterol or are
use in children.
inflammation of small blood vessels (Henoch4. Possible side effects
a smoker) you should discuss your treatment with
Schönlein purpura)
5. How to store Enstar SR 75mg Tablets
your doctor or pharmacist.
If you take more Enstar SR 75mg Tablets than
!
Presence of blood in urine
6. Contents of the pack and other information
you should
!
Inflammation of the walls of the lung
Long term use with diclofenac is not
If you (or someone else) take too many of these
(pneumonitis)
1. WHAT ENSTAR SR 75MG TABLETS ARE
recommended, however it is advised to undergo
tablets, contact your doctor or hospital immediately
!
Tremor (uncontrollable shaking)
AND WHAT THEY ARE USED FOR
routine blood tests if diclofenac is indicated for long
for advice. Bring the pack with any remaining
!
Stomatitis including ulcerative stomatitis
term treatment.
tablets with you. Symptoms of overdose may
(inflammation and ulcers of the bowel), glossitis
Enstar SR 75mg Tablets belong to a group of
include but are not limited to headache, nausea
(inflammation of the tongue), oesophageal
medicines called non-steroidal anti-inflammatory
Other medicines and Enstar SR 75mg Tablets
and vomiting (being sick), stomach pain, bloody
(food pipe) disorder, large intestinal strictures
drugs (NSAIDs). Enstar SR 75mg Tablets are used
Tell your doctor or pharmacist if you are taking,
diarrhoea, dizziness, disorientation, excitation,
(narrowing of the gut)
to relieve symptoms caused by osteoarthritis,
have recently taken or might take any other
drowsiness, tinnitus (perception of noise or ringing
!
Erythema (redness of the skin), purpura
rheumatoid arthritis and ankylosing spondylitis
medicines.
in the ears), fainting, shortness of breath and
(bleeding or bruising under the skin)
(rheumatism of the spine) such as swelling,
convulsions (uncontrollable shaky movements).
!
Proteinuria (excess protein in the urine).
stiffness or joint pain. It does not cure arthritis and
Enstar SR 75mg Tablets may affect or be
will help you only as long as you continue to take it.
affected by the following medicines:
If you forget to take Enstar SR 75mg Tablets
Not known (frequency cannot be estimated
!
Anticoagulant tablets (to prevent blood clots,
Do not take a double dose to make up for a
from the available data):
2. WHAT YOU NEED TO KNOW BEFORE YOU
e.g. warfarin)
forgotten dose. Continue the treatment as advised
!
Erectile dysfunction
TAKE ENSTAR SR 75MG TABLETS
!
Antihypertensives (for the treatment of high
by your doctor. Do not take more than two tablets
!
Feeling of discomfort.
blood pressure e.g. diuretics, beta-blockers and
in 24 hours.
Do not take Enstar SR 75mg Tablets if:
ACE inhibitors)
Reporting of side effects
!
You are allergic to diclofenac sodium or any of
!
Diuretics (to make you pass more water e.g.
If you stop taking Enstar SR 75mg Tablets
If you get any side effects, talk to your doctor,
the other ingredients of this medicine (listed in
spironolactone, amiloride and triamterene)
Changes to dosage or stopping of treatment
pharmacist or nurse. This includes any possible
section 6)
!
Lithium (for depression)
should only be as directed by your doctor.
side effects not listed in this leaflet. You can also
!
You have a history of bleeding from the
!
Medicines for the treatment of heart conditions
report side effects directly via the Yellow Card
stomach or bowels when taking NSAIDs
(e.g. digoxin)
If you have any further questions on the use of this
Scheme at: http://www.mhra.gov.uk/yellowcard or
previously
!
Corticosteroids (e.g. for asthma and various
medicine, ask your doctor, pharmacist or nurse.
search for MHRA Yellow Card in the Google Play
!
You have suffered severe heart, kidney or liver
inflammatory conditions)
or Apple App Store.
failure or cerebrovascular bleeding (bleeding in
!
Antibiotics (for an infection e.g. quinolones like
4. POSSIBLE SIDE EFFECTS
By reporting side effects you can help provide
your brain)
ciprofloxacin, nalidixic acid, norfloxacin)
more information on the safety of this medicine.
!
You are in your last three months of pregnancy
!
Any other NSAID (for painful or inflammatory
Like all medicines, this medicine can cause side
!
You have established heart disease and/or
conditions e.g. aspirin, ibuprofen, naproxen
effects, although not everyone gets them.
5. HOW TO STORE ENSTAR SR 75MG
cerebrovascular disease e.g. if you have had a
etc.)
TABLETS
heart attack, stroke, mini-stroke (TIA) or
!
Medicines for the treatment of diabetes (such
Some side effects can be serious. Stop taking
blockages to blood vessels to the heart or brain
as chlorpropamide and tolbutamide)
Enstar SR 75mg Tablets and tell your doctor
Keep this medicine out of the sight and reach
or an operation to clear or bypass blockages
!
Mifepristone (used to terminate pregnancies or
straight away if you notice any of the following
of children.
!
You have or have had problems with your blood
as emergency contraceptive)
side effects:
circulation (peripheral arterial disease)
!
Methotrexate which can be used to treat certain
Mild cramping and tenderness of the abdomen,
!
Do not store above 25°C.
!
You show any signs of allergy (such as asthma,
tumours and other diseases including psoriasis
starting shortly after the start of the treatment
Do not use this medicine after the expiry date
hay fever or skin rash) to aspirin, ibuprofen or
and rheumatoid arthritis
with Enstar SR 75mg Tablets and followed by
which is stated on the carton. The expiry date
other NSAIDs (such as naproxen,
!
Cyclosporine or tacrolimus which can be used
rectal bleeding or bloody diarrhoea usually
refers to the last day of that month.
indomethacin, mefenamic acid etc)
to suppress the body's immune system (e.g.
within 24 hours of the onset of abdominal pain
Do not throw away any medicines via wastewater
!
You have or previously have had a peptic ulcer
following transplants or in diseases such as
(frequency not known, cannot be estimated
or household waste. Ask your pharmacist how to
bleeding or perforation in your stomach or
psoriasis and rheumatoid arthritis)
from the available data)
throw away medicines you no longer use. These
intestine.
!
Zidovudine (an anti-viral drug)
Any sign of bleeding in the stomach or
!
measures will help protect the environment.
!
Phenytoin (medicines to treat epilepsy)
intestine, for example, when emptying your
Tell your doctor or pharmacist if you are not sure if
!
Colestipol and cholestyramine (medicines to
bowels, blood in vomit or black, tarry faeces
6. CONTENTS OF THE PACK AND OTHER
any of the conditions above apply to you.
lower cholesterol level)
Allergic reactions which can include skin rash,
!
INFORMATION
!
Medicines of the class SSRIs (Selective
itching or hives on the skin, swelling of the face,
Enstar SR 75mg Tablets are not recommended for
Serotonin Reuptake Inhibitors) used to treat
lips, tongue or other parts of the body,
What Enstar SR 75mg Tablets contain
children.
depression such as fluoxetine or sertraline
shortness of breath, wheezing or trouble
!
The active substance is diclofenac sodium.
!
CYP2C9 inhibitors: e.g. Sulfinapyrazone and
breathing
Each tablet contains 75mg diclofenac sodium.
Warnings and precautions
voriconazole
Painful red areas, peeling or blistering
!
!
The other ingredients are lactose monohydrate
Talk to your doctor, pharmacist or nurse before
!
Anti-platelet drugs which affect the clotting of
Yellowing of your skin or the whites of your
!
(see section 2, "Enstar SR 75mg Tablets
taking Enstar SR 75mg Tablets:
blood which may increase the risk of bleeding.
eyes, inflammation of liver (hepatitis), liver
contain lactose"), magnesium stearate,
!
If you have had an ulcer or some other problem
disorder and liver failure
methylhydroxypropyl-cellulose, microcrystalline
affecting your stomach or intestines
Pregnancy, breast-feeding and fertility
An unexpected change in the amount of urine
!
cellulose, povidone, talc, iron oxide red (E172).
!
If you have asthma or wheezing attacks (or if
If you are pregnant or breast-feeding, think you
produced and/or its appearance, kidney failure
you have had asthma in the past)
may be pregnant or planning to have a baby, ask
If you notice that you are bruising more easily
!
What Enstar SR 75mg Tablets look like and
!
If you have any heart, liver or kidney problems
your doctor or pharmacist for advice before taking
than usual or have frequent sore throats or
contents of the pack
!
If you are elderly
this medicine.
infections, tell your doctor
The sustained release tablets are light pink, round,
!
If you are taking other NSAIDs (for painful or
Flu-like symptoms with painful red or purplish
!
biconvex tablets with D3 embossed on one side.
inflammatory conditions) including COX-2
Pregnancy
rashes and blisters on skin (Stevens-Johnson
Pack sizes:
inhibitors
Do not take Enstar SR 75mg Tablets if you are
syndrome and toxic epidermal necrolysis)
a) Al/Al blister: Pack sizes: 10, 20, 28, 30, 50, 56,
!
If you suffer from any stomach or bowel
pregnant (or think you may be) or breast-feeding
Meningitis (symptoms include stiff neck,
!
60, 90, 100 tablets
disorders including ulcerative colitis or Crohn's
unless your doctor has decided that it is in your
headache, nausea, vomiting, fever or
b) PP-container with PE lids: Pack sizes: 28, 56,
disease
best interests. If used, the lowest effective dose
disorientation)
100 tablets
!
If you are taking diuretics (water pills)
should be used. You should NOT take these
Skin rash, which may form blisters and looks
!
c) HDPE-container with PE lids: Pack sizes: 28,
!
If you have substantial fluid loss (e.g. before or
tablets during the last three months of pregnancy
like small targets (central dark spots
56, 100 tablets
after major surgery)
as they may affect the baby's circulation.
surrounded by a paler area, with a dark ring
d) Al/PVDC blister: Pack sizes: 10, 20, 28, 30, 50,
!
If your blood does not clot correctly
around the edge) (erythema multiforme,
56, 60, 90, 100 tablets
(haemostasis)
Ask your doctor or pharmacist for advice before
frequency very rare)
(Not all pack sizes may be available)
!
If you have mixed connective tissue disorders
taking any medicine.
!
Convulsions (sudden, violent movements of the
and systemic lupus erythematosus SLE (which
body)
Marketing Authorisation Holder & Manufacturer
results in joint pain, skin change and disorders
Breast-feeding
!
Heart failure, heart attack
Ennogen Pharma Limited,
of other organs)
Diclofenac is known to pass into milk in small
!
Inflammation of the pancreas (pancreatitis,
Unit G4, Riverside Industrial Estate,
!
If you have a condition called porphyria
amounts and hence should be avoided by nursing
which commonly causes abdominal pain)
Riverside Way, Dartford, DA1 5BS, UK.
!
If you smoke
mothers.
!
Stroke (cerebrovascular accident, frequency
!
If you have diabetes
very rare).
The Product Licence number is PL
!
If you have angina, blood clots, high blood
Fertility
40147/0032
pressure, raised cholesterol or raised
Enstar SR 75mg Tablets may make it more difficult
Other side effects
triglycerides
to become pregnant. You should inform your doctor
Common (may affect up to 1 in 10 people):
This leaflet was last revised in October 2017.
!
If you had a previous episode of vomiting blood
if you are planning to become pregnant or if you
!
Headache, dizziness, spinning of head, feeling
or blood in stools
have problems becoming pregnant.
sick (nausea), being sick (vomiting), diarrhoea,
!
If you experience skin rash, itching, painful red
indigestion, pain in your stomach, wind, loss of
areas, peeling or blistering of the skin or any
appetite, raised liver enzymes and rash.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide