ACECLOFENAC 100MG FILM-COATED TABLETS

Active substance: ACECLOFENAC

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Package leaflet: Information for the patient

Aceclofenac 100 mg
film‑coated tablets‌
(aceclofenac)

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
anti‑inflammatory 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
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 or any other
non‑steroidal anti‑inflammatory drugs
(NSAIDs) such as ibuprofen, naproxen
or diclofenac
• if you have taken aspirin or any other
NSAIDs and experienced one of
the following:
* asthma attack
* runny nose, itching and/or sneezing
(irritation of the nose)
* raised red circular patchy rash on the
skin which may have been itchy, stung
or had a burning sensation
* severe allergic reaction (anaphylactic
shock). Symptoms include difficulty
breathing, wheezing, abnormal pain
and vomiting
• if you have a history of, suffer from, or
suspect that you have a stomach or
intestinal ulcer or bleeding 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 severe kidney disease
• if you have or have ever had severe heart
failure or heart attack
• if you suffer from, or suspect that you
have liver failure
• if you are pregnant (talk to your doctor).
Warnings and precautions
Talk to your doctor before taking this
medicine if you:
• have any of the following
gastrointestinal disorders:
• inflammatory bowel disease
(ulcerative colitis)
• chronic inflammatory bowel disease
(Crohn's disease)
• have heart problems, previous 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
• 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 or have ever had problems with the
circulation of the blood to your brain
• have recently undergone major surgery
• are elderly (your doctor will prescribe
you the lowest effective dose over the
shortest duration)
• are currently suffering from chicken pox
or shingles.
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 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.

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, ibuprofen,
naproxen, diclofenac)
• any steroids (e.g. oestrogens, androgens,
or glucocorticoids)
• 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)
• medicines used to treat HIV infection
(zidovudine).
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 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
breast‑feeding unless considered
essential by your doctor.
Fertility
NSAIDs may make it more difficult to
become pregnant.
Driving and using machines
Do not drive or operate dangerous
machinery while you are being treated
with non‑steroidal anti‑inflammatory
drugs if you suffer from dizziness,
drowsiness, tiredness or any
visual disturbances.
3. How to take Aceclofenac
Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Adults
The maximum recommended dose is
200 mg daily, one tablet in the morning
and one tablet in the evening. Do not
crush or chew the tablets.
Older people
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 over the shortest duration.
Patients with liver problems
Your doctor may want you to take only
one tablet a day to begin with.
Use in children
Aceclofenac is not recommended for use
in children.
Method of administration
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.
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.
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 you doctor.
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.
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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.
• Medicines such as Aceclofenac may be
associated with a small increased risk
of heart attack ('myocardial infarction')
or stroke.
• 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.
• Rare 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).

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, 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 Aceclofenac
Keep this medicine out of the sight and
reach of children.
Do not use Aceclofenac after the expiry
date, which is stated on the carton.
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. Contents of the pack and
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 (E171), hypromellose
(E464), macrogol 400 and polysorbate 80
(E433).
What Aceclofenac looks like and
contents of the pack
Aceclofenac are round white or off‑white
film‑coated tablets marked 'G' on
one side.

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:

Aceclofenac is available in blister packs
containing of 10, 20, 30 and 60 tablets.

Common (may affect up to
1 in 10 people):
• Dizziness.
• Indigestion, stomach pain.
• Feeling sick.
• Diarrhoea.
• Increased liver enzymes in the blood.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

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).
• Inflammation of the skin (dermatitis).
• Raised circular red itchy, stinging or
burning patches on the skin (hives).
Rare (may affect up to
1 in 1,000 people):
• Low red blood cell count, which may
cause tiredness, shortness of breath or
loss of appetite.
• Visual disturbance, including blurred,
partial or complete loss of vision.
• Breathlessness or difficulty breathing.
• Raised blood pressure.
• Hallucinations or confusion.
• Generally feeling unwell.
Very rare (may affect up to
1 in 10,000 people):
• Reduction in blood platelets which
increases the risk of bleeding or bruising.
• Abnormal breakdown of red blood cells
(haemolytic anaemia).
• 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.
• Sensitivity of skin to light.
• Unusual bleeding or bruising under the
skin (purpura).
• Skin irritation (eczema).
• Feeling of spinning when standing still
(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 all pack sizes may be marketed.

Manufacturer
Merck S.L.
Polígono Merck
08100 Mollet del Vallés (BARCELONA)
SPAIN.
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 07/2013

This leaflet was last revised
in 07/2013

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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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