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ENSTAR XL 100MG TABLETS

Active substance(s): DICLOFENAC SODIUM

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Artwork No.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

060812/1

Colours Used

Customer

Ennogen

Black

Description

Enstar XL Leaflet

Keyline

Market

UK

Language

English

Size

180 x 320 mm

Min. Font Size

8 pt

Page No.

1 of 2

Version No.

14

Date

16-04-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enstar XL 100mg 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 further questions, please ask your doctor
or 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, or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Enstar XL 100mg Tablets are and what they
are used for
2. What you need to know before you take Enstar
XL 100mg Tablets
3. How to take Enstar XL 100mg Tablets
4. Possible side effects
5. How to store Enstar XL 100mg Tablets
6. Contents of the pack and other information
1. WHAT ENSTAR XL 100MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Enstar XL 100mg Tablets belong to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
Enstar XL 100mg Tablets are used to relieve symptoms
caused by osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis (rheumatism of the spine) such as
swelling, stiffness or joint pain. It does not cure arthritis
and will help you only as long as you continue to take it.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ENSTAR XL 100MG TABLETS
Do not take Enstar XL 100mg Tablets if you:
! Are allergic (hypersensitive) to diclofenac sodium or
any of the other ingredients in Enstar XL 100mg
Tablets (see Section 6)
! Suffer from asthma, hives or a runny nose caused
by an allergy to salicylates (e.g. aspirin) or other
NSAIDs such as ibuprofen
! Have severe liver, kidney or heart failure
! Are in the last three months of pregnancy
! Have or have ever had, a stomach (gastric) or
intestinal (peptic) ulcer, or bleeding in the digestive
tract (this can include blood in vomit, bleeding when
emptying the bowels, fresh blood in the faeces or
black tarry stools)
! Have had stomach or bowel problems after you have
taken other NSAIDs
! Are currently taking other NSAIDs or COX (cyclooxygenase) 2- inhibitors
! 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 have or have had problems with your blood
circulation (peripheral arterial disease).
If any of these apply to you, you should not be given
Enstar XL 100mg Tablets. Tell your doctor immediately.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before taking
Enstar XL 100mg Tablets if you:
! Have reduced kidney or liver function
! Have recently had or you need to have surgery
! Are elderly, as your doctor may wish to minimise
treatment duration and to see you more often while
you are taking Enstar XL 100mg Tablets
! Are taking other medicines like corticosteroids or
certain drugs for depression called selective
serotonin reuptake inhibitors (SSRIs), or
acetylsalicylic acid to prevent blood clotting, your
doctor may prescribe you in addition to the Enstar XL
100mg Tablets a medicine for protecting your
stomach and intestines
! Have ever had asthma
! Have or had a history of gastrointestinal disorders
(inflammation of the stomach or intestines) that
predispose to bleeding disorders such as ulcerative
colitis, Crohn's disease, gastrointestinal cancers,
diverticulitis (inflammed or infected pouches/pockets
of the colon)

!
!
!
!

!

Suffer from any blood or bleeding disorders. Your
doctor may ask you to go for regular check-ups while
you are taking these tablets
Suffer from liver porphyria (disorder of the red blood
pigment)
Suffer from SLE (systemic lupus erythema) or other
connective tissue disorders
Have heart problems, have previously had a
stroke or think that you might be at risk of these
conditions (for example if you have high blood
pressure, diabetes, high cholesterol or are a smoker)
you should discuss your treatment with your doctor or
pharmacist
Are trying to get pregnant (see section Pregnancy,
breastfeeding and fertility).

Make sure your doctor knows, before you are given
diclofenac
! If you smoke
! If you have diabetes
! If you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides.
Medicines such as Enstar XL 100mg Tablets may be
associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke. Any risk is more likely
with high doses and prolonged treatment. Do not exceed
the recommended dose or duration of treatment.
Because it is an anti-inflammatory medicine, Enstar XL
100mg Tablets may reduce the symptoms of infection, for
example, headache and a high temperature. If you feel
unwell and need to see a doctor, remember to tell him/her
that you are taking Enstar XL 100mg Tablets.
If you have a history of stomach problems while you are
taking NSAIDs, particularly if you are elderly, you must
tell your doctor straight away if you notice any unusual
symptoms.
Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
Other medicines and Enstar XL 100mg Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Especially if you are taking:
! Any other NSAIDs or COX-2 (cyclo-oxygenase-2)
inhibitor, e.g. aspirin or ibuprofen
! Corticosteroids (e.g hydrocortisone) given to treat
a variety of conditions such as allergies and hormone
imbalances
! Anticoagulants such as warfarin to prevent blood
clots
! Lithium and serotonin re-uptake inhibitors
(SSRIs) e.g fluoxetine used to treat depression
! Diuretics (water tablets) - the effect may be
decreased. Potassium-sparing diuretics may increase
the blood levels of potassium
! ACE-inhibitors e.g captopril (medicines used to
treat high blood pressure) - the blood pressure
lowering effect may be reduced
! Ciclosporin or tacrolimus (medicines used to
prevent rejection after an organ transplant) - may
harm kidney function
! Quinolones e.g ciprofloxacin (antibiotics used to
treat infections) - as they may cause fits
! Medicines to treat diabetes e.g metformin - a dose
adjustment of these medicines may be necessary as
your blood sugar may drop too low
! Cytotoxic medicines e.g. methotrexate (to treat
cancers) - should not be taken less than 24 hours
before or after Enstar XL 100mg Tablets as an
increase in the blood levels of this medicine may
occur
! Mifepristone (used to induce abortion) effect of
mifepristone may be reduced by NSAIDs
! Cardiac glycosides such as digoxin (used for some
heart conditions) as this may worsen heart failure
! Trimethoprim used to treat infections
! Phenytoin used to treat seizures
! Colestipol and cholestyramine used to treat high
cholesterol
! Voriconazole used to treat fungal infections.
Laboratory tests
Regular liver and kidney function tests and monitoring of
blood counts are necessary during long-term treatment.

Artwork No.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

060812/1

Colours Used

Customer

Ennogen

Black

Description

Enstar XL Leaflet

Keyline

Market

UK

Language

English

Size

180 x 320 mm

Min. Font Size

8 pt

Page No.

2 of 2

Version No.

14

Date

16-04-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking
any medicine.
Fertility
Enstar XL 100mg 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.
Pregnancy and breastfeeding
You should not take Enstar XL 100mg Tablets during the
first 6 months of pregnancy unless directed by your
doctor and must not take Enstar XL 100mg Tablets during
the last 3 months of pregnancy as damage to the baby
and reduced labour may occur.
You should only use Enstar XL 100mg Tablets whilst
breastfeeding if advised by your doctor.
Driving and using machines
Some patients may experience side effects such as
dizziness, drowsiness, feeling tired or sleepy and visual
disturbances which may affect their ability to drive or
operate machinery. Make sure you are not affected
before driving or operating machinery.
Enstar XL 100mg Tablets contain lactose and sodium
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.
Each tablet contains 8mg of sodium, this should be taken
into account if you are on a salt restricted diet.
3. HOW TO TAKE ENSTAR XL 100MG TABLETS
Always take Enstar XL 100mg Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Enstar XL 100mg Tablets must not be taken long-term,
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.
The usual dose is:
! Adults: One tablet once a day.
! Elderly: As adult dose. The lowest effective dose
should be taken and your doctor will need to monitor
you regularly. If you are elderly your doctor may
prescribe a lower daily dose and reduce the duration
of treatment.
! Children: Not recommended.
If you take more Enstar XL 100mg Tablets than you
should
Contact your doctor, local hospital casualty department or
pharmacist if you have taken more Enstar XL 100mg
Tablets than stated in this leaflet or more than what your
doctor has prescribed (and you feel unwell).
Symptoms of overdose may be gastrointestinal disorders,
feeling or being sick, diarrhoea, kidney failure, fits,
headache, disorientation, excitement, coma, drowsiness,
dizziness, ringing in the ears, fainting and liver damage.
If you forget to take Enstar XL 100mg Tablets
Do not take a double dose to make up for a forgotten
dose. Continue the treatment as advised by your doctor.
If you stop taking Enstar XL 100mg Tablets
Changes to dosage or stopping of treatment should only
be as directed by your doctor.

Quality Control (QC)

Production

STOP TAKING the medicine and tell your doctor if you
experience:
! Indigestion or heartburn
! Abdominal pain (pains in your stomach) or other
abdominal stomach symptoms.
Medicines such as Enstar XL 100mg Tablets may be
associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke.
The most common side effects are :! Indigestion, heartburn, stomach pain or cramps,
feeling or being sick, diarrhoea, flatulence, loss of
appetite, constipation, mouth ulcers, worsening of
ulcerative colitis or Crohn's disease, inflammation of
the pancreas or tongue
! Skin rash, itching, skin eruptions, eczema.
Other less common side effects are:! Hair loss, sensitivity to light
! Changes in kidney function, blood or protein in the
urine
! Changes in liver function causing yellowing of your
skin or the whites of the eyes or increased liver
enzyme levels in the body, blood disorders including
anaemia
! Palpitation, chest pain, high blood pressure, heart
failure
! Headache, dizziness, 'spinning' sensation,
drowsiness or tiredness, disturbances of sensation,
'pins and needles', memory disturbance,
disorientation, disturbance of vision, sleeplessness,
impaired hearing, ringing in the ears, irritability,
convulsions, depression, anxiety, nightmares,
confusion, hallucinations, tremor, psychotic reactions
or taste alteration disorders, impotence, low blood
pressure (symptoms may include feeling faint and
lightheadedness), inflammation of the blood vessels
(vasculitis), inflammation of the lungs (pneumonitis),
stomach ulcers or bleeding.
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 ENSTAR XL 100MG TABLETS
Keep all medicines out of the sight and reach of
children.
Do not store above 25°C.
Do not use Enstar XL 100mg Tablets after the expiry date
which is stated on the carton. The expiry date refers to
the last day of that month.
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 Enstar XL 100mg Tablets contain
! The active substance (the ingredient that makes the
tablet work) is Diclofenac Sodium 100mg.
! The other ingredients are lactose, magnesium
stearate, hydrogenated vegetable oil Type 1
(Sterotex), povidone K30 and talc.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience any of the following side effects with
Enstar XL 100mg Tablets at any time during your
treatment, STOP TAKING your tablets and seek
immediate medical help:
! Passing blood in your faeces (stools / motions)
! Passing black tarry stools
! Vomiting any blood or dark particles that look like
coffee grounds
! An allergic reaction such as itching, swelling of the
face, lips, tongue, mouth and throat, which may
cause shortness of breath or difficulty swallowing
! A form of meningitis (aseptic) causing a
combination of symptoms such as headache, fever,
stiff neck, tiredness, feeling or being sick and
disorientation
! A severe, painful skin disorder with blisters and
peeling skin. You may also have flu-like symptoms
such as fever and sore throat - Stevens-Johnson
Syndrome
! A severe rash with reddening, peeling and swelling
skin that looks like burns- Lyell's syndrome
! Round red patches on the skin - Erythema
multiforme.

What Enstar XL 100mg Tablets look like and contents
of the pack
The modified release tablets are white to off white,
circular, biconvex tablets with D4 embossed on one side.
Pack sizes:
a) Blister packs (Aluminium/Polyvinylchloride): 20, 21,
28, 30 tablets
b) Polypropylene bottles with low-density polyethylene
caps: 56, 100, 250 & 500 tablets
c) High-density polyethylene bottles with low-density
polyethylene screw caps: 56, 100, 250 & 500 tablets.
(Not all pack sizes may be available)
Marketing Authorisation Holder and Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
The Product Licence number is PL 40147/0033
This leaflet was last revised in April 2014.

L0028/1

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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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