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ENSTAR XL 100MG TABLETS

Active substance(s): DICLOFENAC SODIUM

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Artwork No.

250517/4

Colours Used

Customer

Ennogen

Black

Description

Enstar XL Leaflet

Keyline

Market

UK

Language

English

Size

180 x 400 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

4

Date

06-10-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

Enstar XL 100mg 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.

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
PACKAGE LEAFLET: INFORMATION FOR THE USER
the skin
!
Disorientation, depression, sleeplessness, nightmare,
3. HOW TO TAKE ENSTAR XL 100MG TABLETS
irritability, psychotic disorder, nervousness, abnormal
sensation typically tingling or pricking, memory impairment,
Always take this medicine exactly as your doctor has told you.
(Diclofenac Sodium)
dysfunction of the sense of taste
Check with your doctor or pharmacist if you are not sure.
!
Visual disturbance, blurred vision, double vision
!
Ringing in the ears, impaired hearing
The
tablets
must
be
swallowed
whole
with
a
glass
of
water,
with
Read all of this leaflet carefully before you start taking this
Side effects may be minimised by using the lowest effective dose
!
Palpitations (awareness of your heartbeat), chest pain,
or after food. Do not crush or chew the tablet.
medicine because it contains important information for
for the shortest duration necessary.
abnormally low blood pressure (hypotension), abnormally
you.
high blood pressure (hypertension), inflammation of blood
The recommended dose is:
Keep this leaflet. You may need to read it again.
!
If you are having a medical examination, tell the doctor that you
vessels
Adults:
One
tablet
once
a
day.
!
If you have further questions, ask your doctor, pharmacist or
!
are taking Enstar XL 100mg Tablets as they reduce the signs of
!
Colitis (inflammation of the lining of the colon), constipation,
Elderly: As adult dose. The lowest effective dose should be
!
nurse.
infection, fever and inflammation which would otherwise be
mouth ulcers, inflammation of intestines (Crohn's disease)
taken
and
your
doctor
will
need
to
monitor
you
regularly.
If
This medicine has been prescribed for you only. Do not pass
!
noticed.
!
Inflammation of skin with blisters containing fluid, increase
you are elderly your doctor may prescribe a lower daily dose
it on to others. It may harm them, even if their signs of illness
in reactivity of the skin to sunlight, itching and bleeding of
and reduce the duration of treatment.
are the same as yours.
Medicines such as Enstar XL 100mg Tablets may be associated
skin, baldness, inflammation of small blood vessels
If you get any side effects, talk to your doctor, pharmacist or
!
with a small increased risk of heart attack (“myocardial
(Henoch-Schönlein purpura)
Use in children
nurse. This includes any possible side effects not listed in
infarction”) or stroke. Any risk is more likely with higher doses
!
Presence of blood in urine
Enstar
XL
100mg
Tablets
are
not
recommended
for
use
in
this leaflet. See section 4.
and prolonged treatment. Do not exceed the recommended
!
Tremor (Uncontrollable shaking)
children.
dose or duration of treatment.
!
Pneumonitis (inflammation of the lung)
What is in this leaflet:
!
Stomatitis including ulcerative stomatitis (inflammation and
If
you
take
more
Enstar
XL
100mg
Tablets
than
you
should
1. What Enstar XL 100mg Tablets are and what they are
If you have heart problems or have suffered from a previous
ulcers of the bowel), glossitis (inflammation of the tongue),
If
you
(or
someone
else)
take
too
many
of
these
tablets,
contact
used for
stroke or think that you may be at risk of these conditions (for
oesophageal (food pipe) disorder, large intestinal strictures
your
doctor
or
hospital
immediately
for
advice.
Bring
the
pack
2. What you need to know before you take Enstar XL
example, if you have high blood pressure, diabetes or high
(narrowing of the gut)
with any remaining tablets with you. Symptoms of overdose may
100mg Tablets
cholesterol or are a smoker) you should discuss your treatment
!
Erythema (redness of the skin), purpura (bleeding or
include but are not limited to headache, nausea and vomiting
3. How to take Enstar XL 100mg Tablets
with your doctor or pharmacist.
bruising under the skin)
(being sick), stomach pain, bloody diarrhoea, dizziness,
4. Possible side effects
!
Proteinuria (excess protein in the urine).
disorientation, excitation, drowsiness, tinnitus (perception of
5. How to store Enstar XL 100mg Tablets
Long term use with diclofenac is not recommended, however it is
noise or ringing in the ears), fainting, shortness of breath and
6. Contents of the pack and other information
advised to undergo routine blood tests if diclofenac is indicated
Not known (frequency cannot be estimated from the
convulsions (uncontrollable shaky movements).
for long term treatment.
available data):
1. WHAT ENSTAR XL 100MG TABLETS ARE AND WHAT
Confusional state
!
If you forget to take Enstar XL 100mg Tablets
THEY ARE USED FOR
Other medicines and Enstar XL 100mg Tablets
Hallucinations (seeing or hearing things that are not really
!
Do not take a double dose to make up for a forgotten dose.
Tell your doctor or pharmacist if you are taking, have recently
there)
Continue the treatment as advised by your doctor.
Enstar XL 100mg Tablets belong to a group of medicines called
taken or might take any other medicines.
Sensory disturbances
!
non-steroidal anti-inflammatory drugs (NSAIDs). Enstar XL
Inflammation of the nerves in the eye
!
If you stop taking Enstar XL 100mg Tablets
100mg Tablets are used to relieve symptoms caused by
Enstar XL 100mg Tablets may affect or be affected by the
Erectile dysfunction
!
Changes to dosage or stopping of treatment should only be as
osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
following medicines:
Feeling of discomfort.
!
directed by your doctor.
(rheumatism of the spine) such as swelling, stiffness or joint
Anticoagulant tablets (to prevent blood clots, e.g. warfarin)
!
pain. It does not cure arthritis and will help you only as long as
Medicines for the treatment of high blood pressure
!
Medicines such as Enstar XL 100mg Tablets may be associated
If you have any further questions on the use of this medicine, ask
you continue to take it.
(diuretics, beta-blockers and ACE inhibitors)
with a small increased risk of heart attack ("myocardial
your doctor, pharmacist or nurse.
Diuretics (to make you pass more water e.g. spironolactone,
!
infarction") or stroke.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
amiloride and triamterene)
4. POSSIBLE SIDE EFFECTS
ENSTAR XL 100MG TABLETS
Lithium (for depression)
!
Reporting of side effects
Medicines for the treatment of heart conditions (e.g.
!
If you get any side effects, talk to your doctor, pharmacist or
Like all medicines, this medicine can cause side effects,
Do not take Enstar XL 100mg Tablets if you:
digoxin)
nurse. This includes any possible side effects not listed in this
although not everyone gets them.
Are allergic to diclofenac sodium or any of the other
!
A corticosteroid (e.g. for asthma and various inflammatory
!
leaflet. You can also report side effects directly via the Yellow
ingredients of this medicine (listed in section 6)
conditions)
Card Scheme at: http://www.mhra.gov.uk/yellowcard or search
Some side effects can be serious. Stop taking Enstar XL
Have or previously have had a peptic ulcer bleeding or
!
Antibiotics such as quinolone (for an infection e.g.
!
for MHRA Yellow Card in the Google Play or Apple App Store.
100mg Tablets and tell your doctor straight away if you
perforation in your stomach or intestines
quinolones like ciprofloxacin, nalidixic acid, norfloxacin)
By reporting side effects you can help provide more information
notice any of the following side effects:
Have severe heart, kidney or liver failure or cerebrovascular
!
Any other NSAID (for painful or inflammatory conditions e.g.
!
on the safety of this medicine.
Mild cramping and tenderness of the abdomen, starting
!
bleeding (bleeding in your brain)
aspirin, ibuprofen, naproxen etc.)
shortly after the start of the treatment with Enstar XL 100mg
Are in your last three months of pregnancy
!
!
Mifepristone (used as emergency contraceptive or to induce
5. HOW TO STORE ENSTAR XL 100MG TABLETS
Tablets and followed by rectal bleeding or bloody diarrhoea
Have had stomach or bowel problems after taking other
!
abortion or labour)
usually within 24 hours of the onset of abdominal pain
NSAIDs
!
Ciclosporin or tacrolimus (used to suppress the body's
Keep this medicine out of the sight and reach of children.
(frequency not known, cannot be estimated from the
Show any signs of allergy (such as asthma, hay fever or skin
!
immune system e.g. following transplants or in diseases
available data)
rash) to aspirin, ibuprofen or other NSAIDs
such as psoriasis and rheumatoid arthritis)
Do not store above 25°C.
Any sign of bleeding in the stomach or intestine, for
!
Have established heart disease and/or cerebrovascular
!
!
Zidovudine (an anti-viral drug)
Do not use this medicine after the expiry date which is stated on
example, when emptying your bowels, blood in vomit or
disease e.g. if you have had a heart attack, stroke, mini!
Medicines of the class SSRIs (Selective Serotonin
the carton. The expiry date refers to the last day of that month.
black, tarry faeces
stroke (TIA) or blockages to blood vessels to the heart or
Reuptake Inhibitors) used to treat depression such as
Do not throw away any medicines via wastewater or household
Allergic reactions which can include skin rash, itching or
!
brain or an operation to clear or bypass blockages
fluoxetine or sertraline
waste. Ask your pharmacist how to throw away medicines you
hives on the skin, swelling of the face, lips, tongue or other
If you have or have had problems with your blood circulation
!
!
Medicines used to treat diabetes
no longer use. These measures will help protect the
parts of the body, shortness of breath, wheezing or trouble
(peripheral arterial disease).
!
Phenytoin (medicines to treat epilepsy)
environment.
breathing
!
Colestipol and cholestyramine (medicines to lower
Painful red areas, peeling or blistering
!
Tell your doctor or pharmacist if you are not sure if any of the
cholesterol level)
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Yellowing of your skin or the whites of your eyes,
!
conditions above apply to you.
!
CYP2C9 inhibitors: e.g. Sulfinapyrazone and voriconazole
inflammation of liver (hepatitis), liver disorder and liver
!
Methotrexate (used to treat cancer)
What Enstar XL 100mg Tablets contain
failure
Enstar XL 100mg Tablets are not recommended for children.
!
Anti-platelet drugs which affect the clotting of blood which
The active substance is Diclofenac Sodium 100mg.
!
An unexpected change in the amount of urine produced
!
may increase the risk of bleeding.
The other ingredients are lactose (see section 2, "Enstar XL
!
and/or its appearance, kidney failure
Warnings and precautions
100mg Tablets contain lactose"), magnesium stearate,
Flu-like symptoms with painful red or purplish rashes and
!
Talk to your doctor, pharmacist or nurse before taking Enstar XL
Pregnancy, breast-feeding and fertility
hydrogenated vegetable oil Type 1 (Sterotex), povidone
blisters on skin (Stevens-Johnson syndrome and toxic
100mg Tablets if you:
If you are pregnant or breast-feeding, think you may be pregnant
K30 and talc.
epidermal necrolysis)
Have had an ulcer or some other problem affecting your
!
or planning to have a baby, ask your doctor or pharmacist for
!
Meningitis (symptoms include stiff neck, headache, nausea,
stomach or intestines (ulcerative colitis, Crohn's disease)
advice before taking this medicine.
What Enstar XL 100mg Tablets look like and contents of the
vomiting, fever or disorientation, frequency very rare)
!
Have asthma or wheezing attacks (or if you have had
pack
!
Skin rash, which may form blisters and looks like small
asthma in the past)
Pregnancy
The modified release tablets are white to off white, circular,
targets (central dark spots surrounded by a paler area, with
!
Have any heart, liver or kidney problems
Do not take Enstar XL 100mg Tablets if you are pregnant (or
biconvex tablets with D4 embossed on one side.
a dark ring around the edge) (erythema multiforme,
!
Are elderly
think you may be) or breast-feeding unless your doctor has
frequency very rare)
!
Have low body weight
decided that it is in your best interests. If used, the lowest
Pack sizes:
!
Convulsions (sudden, violent movements of the body)
!
Have mixed connective tissue disorders and systemic lupus
effective dose should be used. You should NOT take these
a) Blister packs (Aluminium/Polyvinylchloride): 20, 21, 28, 30
!
Heart failure, heart attack
erythematosus - SLE (which results in joint pain, skin
tablets during the last three months of pregnancy as they may
tablets
!
Inflammation of the pancreas (pancreatitis, which
change and disorders of other organs)
affect the baby's circulation.
b) Polypropylene bottles with low-density polyethylene caps:
commonly causes abdominal pain)
!
Have a condition called porphyria
56, 100, 250 & 500 tablets
!
Stroke (cerebrovascular accident, frequency very rare).
!
Have recently undergone major surgery
Ask your doctor or pharmacist for advice before taking any
c) High-density polyethylene bottles with low-density
!
Are particularly prone to infections (diclofenac may
medicine.
polyethylene screw caps: 56, 100, 250 & 500 tablets.
If you notice that you are bruising more easily than usual or have
suppress the signs and symptoms of an infection)
(Not all pack sizes may be available)
frequent sore throats or infections, tell your doctor.
!
Have experienced stomach discomfort, had heartburn or
Breast-feeding
felt nauseous after taking aspirin or any other nonsteroidal
Diclofenac is known to pass into milk in small amounts and
Marketing Authorisation Holder and Manufacturer
Other side effects
anti-inflammatory drugs
hence should be avoided by nursing mothers.
Ennogen Pharma Limited,
Common (may affect up to 1 in 10 people):
!
Have a bleeding/blood disorder
Unit G4, Riverside Industrial Estate,
!
Headache, dizziness, spinning of head, feeling sick
!
Smoke
Fertility
Riverside Way, Dartford, DA1 5BS, UK.
(nausea), being sick (vomiting), diarrhoea, indigestion, pain
!
Have diabetes
Enstar XL 100mg Tablets may make it more difficult to become
in your stomach, wind, loss of appetite, raised liver enzymes
!
Have angina, blood clots, high blood pressure, raised
pregnant. You should inform your doctor if you are planning to
The Product Licence number is PL 40147/0033
and rash.
cholesterol or raised triglycerides
become pregnant or if you have problems becoming pregnant.
!
Have had a previous episode of vomiting blood or blood in
This leaflet was last revised in October 2017.
Rare (may affect up to 1 in 1000 people):
stools
Driving and using machines
!
Skin rashes (hives), drowsiness, asthma, difficulty in
!
Have experienced skin rash, itching, painful red areas,
If you feel dizzy, sleepy or experience visual disturbances when
breathing, gastritis (inflammation of the stomach),
peeling or blistering of the skin or any other allergic reaction
you start to use Enstar XL 100mg Tablets, do not drive or use
indigestion and stomach ache (signs of a gastrointestinal
within the first few days of treatment with diclofenac.
machines until the effect has worn off.
ulcer) and general swelling of the body.

Enstar XL 100mg Tablets

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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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