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ACECLOFENAC 100MG FILM-COATED TABLETS

Active substance: ACECLOFENAC

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Aceclofenac 100 mg
Film-coated Tablets

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 or pharmacist.
• 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. This includes
any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet
1. What Aceclofenac is and what it is
used for
2. What you need to know before you
take Aceclofenac
3. How to take Aceclofenac
4. Possible side effects
5. How to store Aceclofenac
6. Contents of the pack and
other information

1. What Aceclofenac is and what it

is used for
Aceclofenac belongs to a group of
medicines called non-steroidal antiinflammatory drugs, or NSAIDs.
Aceclofenac is used to relieve pain and
inflammation that occur with:
• osteoarthritis
• rheumatoid arthritis
• ankylosing spondylitis.

2. What you need to know before

you take Aceclofenac

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Do not take Aceclofenac:
• if you are allergic to aceclofenac or any
of the other ingredients of this medicine
(listed in section 6)
• if you are allergic to aspirin (acetylsalicylic
acid) or any other non-steroidal antiinflammatory drugs (NSAIDs) such as
ibuprofen, naproxen or diclofenac
• if you have taken aspirin (acetylsalicylic
acid) or any other NSAIDs and
experienced one of the following:
* asthma attack (wheezing, chest
tightness, breathlessness)
* runny nose, itching and/or sneezing
(irritation of the nose)
* swelling of the face, lips, tongue or
throat (angioedema) leading to
difficulty breathing
* raised red circular patchy rash on the
skin which may have been itchy, stung or
had a burning sensation, known as hives
• if you have a history of, suffer from, or
suspect that you have a stomach or
intestinal ulcer or bleeding especially if it
is related to previous NSAIDs treatment.
Signs of stomach bleeding include
passing tarry stools, vomiting blood or
particles that look like coffee granules
• if you have bleeding or bleeding disorders
• if you have established heart disease and
/ or cerebrovascular disease e.g. if you
have had a heart attack, stroke, ministoke (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 you suffer from severe liver failure or
severe kidney failure
• if you are more than 6 months pregnant
(in your last trimester).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Aceclofenac if you:
• have any of the following
gastrointestinal disorders:
* inflammatory bowel disease
(ulcerative colitis)
* chronic inflammatory bowel disease
(Crohn’s disease)
Signs of these illnesses include
heartburn, indigestion, feeling sick
(nausea) or being sick (vomiting),
bloating, diarrhoea or constipation.
• are a smoker
• have diabetes
• have angina, blood clots, high blood
pressure, raised cholesterol or
raised triglycerides
• suffer from asthma or any other
breathing problems
• suffer from any form of liver or kidney
disease, your doctor will monitor you
closely and give you the lowest possible
dose to treat your symptoms
• suffer from a blood clotting disorder
• suffer from a blood disorder known as
porphyria or any other blood disorder
• have recently undergone major surgery
• are elderly (your doctor will prescribe
you the lowest effective dose for the
shortest period of time)
• have systemic lupus erythematosus (SLE)
or other problems with the skin as you
may be more likely to develop a form of
meningitis that cannot be passed on to
other people
• are currently suffering from chicken pox
or shingles.

• are less than 6 months pregnant (first or
second trimester), planning to become
pregnant or if you have problems
becoming pregnant.

During treatment
In the first month of treatment you are
at a higher risk of having serious skin
reactions. Stop taking aceclofenac if you
get a skin rash, mouth lesions (damage to
the skin or gums) or any other signs of an
allergic reaction (see section 4 ‘Possible
side effects’).
If you are receiving long-term treatment
with Aceclofenac, especially at high
doses, your doctor may wish to monitor
your progress with some blood tests.
Medicines such as Aceclofenac may be
associated with an increased risk of heart
attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and
prolonged treatment.
Side effects may be minimised by using
the lowest effective dose for the shortest
duration necessary. Do not exceed the
recommended dose or duration of treatment.

Other medicines and Aceclofenac
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription,
especially any of the following:
• medicines used to treat depression or
manic depression (lithium,
fluoxetine, citalopram)
• medicines used to treat heart failure and
irregular heart beats (cardiac glycosides
e.g. digoxin)
• medicines used to increase the rate
of urine excretion (diuretics or ‘water
tablets’ e.g. furosemide)
• medicines that stop blood clotting
(anticoagulants e.g. warfarin, heparin)
• medicines used to lower blood sugar
levels (antidiabetic drugs e.g. metformin)
• methotrexate which is used to treat
cancer and autoimmune disorders
• mifepristone which is used as an
emergency contraceptive or to
induce abortions
• any other NSAIDs (e.g. aspirin
(acetylsalicylic acid), ibuprofen,
naproxen, diclofenac)
• medicines to reduce inflammation
(corticosteroids e.g. prednisolone,
hydrocortisone)
• medicines used to prevent organ or tissue
rejection (ciclosporin or tacrolimus)
• medicines used to treat an infection
(quinolone antibiotics, e.g. ciprofloxacin)
• medicines used to treat high blood
pressure (antihypertensives)
• zidovudine, a medicine used to treat
HIV infection.
These drugs may increase your risk of
experiencing side effects.

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.
Pregnancy
Do not take Aceclofenac if you are
pregnant or think you are pregnant. The
safety of this medicine for use during
pregnancy has not been established. It is
not recommended for use in pregnancy
unless considered essential by your doctor.
Aceclofenac must not be used during the
last three months of pregnancy.
Breast-feeding
Aceclofenac should not be used if you
are breast-feeding. It is not known if this
medicine passes into breast milk. It is not
recommended for use during breastfeeding unless considered essential by
your doctor.
Fertility
NSAIDs 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
Do not drive or operate dangerous
machinery if you suffer from dizziness,
drowsiness, a spinning sensation (vertigo),
tiredness or any visual disturbances while
you are being treated with non-steroidal
anti-inflammatory drugs.

3. How to take Aceclofenac
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
The tablets should be swallowed whole
with a glass of water. Aceclofenac can be
taken with or after food. Do not crush or
chew the tablets.

Use in adults
The maximum recommended dose is
200 mg daily, one tablet in the morning
and one tablet in the evening.
Use in elderly
If you are elderly, you are more likely to
experience serious side effects (listed in
section 4 ‘Possible side effects’). If your
doctor prescribes Aceclofenac for you,
you will be given the lowest effective
dose for the shortest period of time.

595328

Date: 02 Jul 2015
Description Aceclofenac 100mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 595328

SAP No. N/A

Superceded Affiliate Item Code 503151
TrackWise PR No. 595328
MA No. 04569/1198

Vendor Job No. 249347
Proof No. 6
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

TBC
21121222222

Package leaflet: Information for the patient

No. of colours
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Time: 12:48
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Dimensions 170 x 600mm

Min Text Size used 11 pt

Patients with liver problems
Your doctor may want you to take only
one tablet a day to begin with.

• Inflammation of the skin (dermatitis).
• Raised circular red itchy, stinging or
burning patches on the skin (hives).

Use in children and adolescents
Aceclofenac is not recommended for use
in children and adolescents.

Rare (may affect up to 1 in 1,000 people):
• Low red blood cell count which can be
seen in a blood test.
• Other problems with your sight.
• Breathlessness or difficulty breathing.
• Raised blood pressure.

If you take more Aceclofenac than
you should
Contact your doctor or nearest hospital
emergency department immediately.
Take the container and any remaining
tablets with you. You may have a
headache, feel sick (nausea), be sick
(vomit), have stomach pain, bleeding or
other problems with your gut, diarrhoea,
reduced consciousness, feel disorientated,
excited, drowsy, dizzy, ringing in the ears
(tinnitus), low blood pressure, slower
breathing, fainting, occasional fits, severe
kidney failure or liver damage.
If you forget to take Aceclofenac
Do not take a double dose to make up for
a forgotten dose. Take your dose as soon
as you remember. If it is nearly time for
your next dose, do not take the missed
dose and carry on as normal.
If you stop taking Aceclofenac
You should not stop your treatment
before speaking to your doctor.
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
STOP taking your medicine and contact
a doctor or visit your nearest hospital
emergency department immediately
if you experience any of the following
side effects:

Rare (may affect up to 1 in 1,000 people):
• Heart failure or heart problems which
can cause shortness of breath or
ankle swelling.
• Severe allergic reaction (anaphylactic
shock). Symptoms may include difficulty
breathing, wheezing, abnormal pain
and vomiting.
• Stomach ulcer, stomach bleeding
or perforation of the stomach, large
intestine or bowel wall. Symptoms could
include severe abdominal pain, vomiting
blood (or liquid with what looks like
coffee grounds), blood in the faeces
(stools/motions) or passing black
tarry stools.
• Itchy swollen skin, skin rash, fever,
tightness of the chest and difficulty with
breathing (angioedema).
Very rare (may affect up to 1 in
10,000 people):
• Itchy skin, yellowing of the skin or whites
of the eyes caused by liver
problems (hepatitis).
• Inflammation of the pancreas which
causes severe pain in abdomen and back.
• Kidney problems such as producing little
or no urine, urinating more often or less
often, lower back pain or have blood in
your urine.
• Serious skin condition with severe
blisters and bleeding in the lips, eyes,
mouth, nose and genitals (Stevens
Johnson syndrome).
• Severe blistering and peeling of the top
layer of the skin.
• Reduced white or red blood cell count
which can lead to fever, sore throat or
swelling of the glands (bone
marrow depression).
• Abnormal breakdown of red blood cells
causing tiredness, shortness of breath or
loss of appetite with a yellowing of the
skin or whites of the eyes.
Not known (cannot be estimated from
the available data):
• Medicines such as aceclofenac may be
associated with a small increased risk of
heart attack (“myocardial infarction”), a
decrease in blood flow to the heart or
stroke.
• Stiff neck, extreme sensitivity to bright
light with fever, headache, feeling sick or
being sick. These may be signs you
have meningitis.
• Sudden dimming, blurring or loss
of vision.
• Hallucinations or confusion.
If any of the following side effects gets
serious, or if you notice any side effects
not listed in this leaflet, tell your doctor
or pharmacist:

Common (may affect up to 1 in
10 people):
• Dizziness.
• Indigestion, stomach pain.
• Feeling sick.
• Diarrhoea.
• Increased liver enzymes in the blood.
Uncommon (may affect up to 1 in
100 people):
• Constipation, wind.
• Being sick.
• Mouth ulcers.
• Itchy skin, rash.
• Increase in blood urea levels.
• Increase in blood creatinine levels.
• Inflammation or irritation of the lining of
the stomach (gastritis).

Very rare (may affect up to 1 in
10,000 people):
• Reduction in blood platelets which
increases the risk of bleeding or bruising.
• High potassium levels in the blood.
• Depression.
• Increased blood alkaline
phosphatase levels.
• Swelling of blood vessels (vasculitis).
• Difficulty sleeping or falling asleep.
• Unusual dreams.
• Uncontrollable shaking (tremor).
• Sleepiness.
• Headache.
• Disturbance or loss of taste.
• Inflammation of the mouth.
• Worsening of pre-existing conditions
like inflammation of the intestine which
causes abdominal pain or diarrhoea
(colitis and Crohn’s disease).
• Ringing in the ears (tinnitus).
• Tingling, pricking or numbness of skin.
• Unusual bleeding or bruising under the
skin (purpura).
• Feeling of spinning (vertigo).
• Irregular and/or forceful heart
beat (palpitations).
• Flushing or hot flushes.
• Wheezing, difficulty breathing, high
pitched noise when breathing.
• Water retention and swelling.
• Cramp in the legs.
• Tiredness.
• Weight increase.
Not known (cannot be estimated from
the available data):
• Generally feeling unwell.
• Sensitivity of skin to light.
Taking Aceclofenac can affect the results
of various blood tests you may have done.
This effect is generally not serious and the
results should return to normal when you
stop taking Aceclofenac.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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 Aceclofenac
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 the last day
of that month.
Do not store above 30ºC. Store in the
original package.
Do not throw away any medicines 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.  ontents of the pack and
C
other information
What Aceclofenac contains
The active substance is aceclofenac. Each
tablet contains 100 mg aceclofenac.
The other ingredients are: cellulose
microcrystalline, povidone, stearic acid,
croscarmellose sodium and magnesium
stearate. The film-coating also contains:
titanium dioxide, hypromellose, macrogol
and polysorbate 80 (E433).

What Aceclofenac looks like and
contents of the pack
Aceclofenac film-coated tablets are round
white or off-white with two sides that
curve out marked “G” on one side.
Aceclofenac is available in blister packs
containing 10, 20, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Merck S.L.
Polígono Merck
08100 Mollet del Vallés (Barcelona) Spain
McDermott Laboratories t/a Gerard
Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland
Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary.
This leaflet was last revised
in 07/2015

Date: 02 Jul 2015
Description Aceclofenac 100mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 595328

SAP No. N/A

Superceded Affiliate Item Code 503151
TrackWise PR No. 595328
MA No. 04569/1198

Vendor Job No. 249347
Proof No. 6
Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

595328

Time: 12:48
Page Count

1

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 11 pt

Dimensions 170 x 600mm

Min Text Size used 11 pt

Expand view ⇕

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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