Patient Information Leaflet

ACECLOFENAC EG 100 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What ACECLOFENAC EG is and what it is used for
What you need to know before taking ACECLOFENAC EG
How to take ACECLOFENAC EG
Possible side effects
How to store ACECLOFENAC EG
Contents of the pack and other information

1. What ACECLOFENAC EG is and what it is used for

ACECLOFENAC EG contains the active substance aceclofenac. It belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
ACECLOFENAC EG is used to relieve pain and inflammation in patients with:
arthritis of the joints (osteoarthritis). This commonly occurs in patients over
50 years of age and causes loss of cartilage and bone tissue near the joint;
autoimmune disease causing chronic inflammation of the joints (rheumatoid
arthritis);
arthritis of the spine that may lead to fusion of the vertebrae (ankylosing
spondylitis).

2. What you should know before taking ACECLOFENAC EG

Do not take ACECLOFENAC EG:
if you are allergic (hypersensitive) to aceclofenac or to any of the other ingredients of
ACECLOFENAC EG (listed in section 6);
if you are allergic (hypersensitive) to aspirin or any other NSAID (such as ibuprofen, naproxen, or
diclofenac);
if after taking aspirin or other NSAIDs you have experienced any of the following
conditions:
o asthma attack,
o runny nose, itching and/or sneezing (nasal irritation),
o skin rash characterized by red, circular bumps, possibly associated with
itching, stinging, or a burning sensation,
o severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing,
shortness of breath, unusual pain, and vomiting;
if you have had, currently suffer from, or suspect you have a stomach ulcer or intestinal
bleeding;
if you suffer from severe kidney disease;
if you suffer from or suspect liver failure;
if you are pregnant or breastfeeding (unless your doctor considers it essential);
if you are experiencing active bleeding or have a tendency to bleed;
if you suffer from established heart and/or cerebrovascular disease, e.g. if you have had a
heart attack, stroke, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or if you have undergone surgery to remove or prevent such blockages;
if you have or have had circulation problems (peripheral arterial disease).
The use of ACECLOFENAC EG is not recommended in children.

Warnings and precautions
Talk to your doctor before taking ACECLOFENAC EG:
if you suffer from any other kidney or liver disease;
if you suffer from any of the following gastrointestinal disorders, including:
o inflammatory bowel disease (ulcerative colitis),
o chronic inflammatory bowel disease (Crohn's disease),
o ulceration, bleeding, or perforation,
o blood disorders;
if you suffer from asthma or any other respiratory problems;
if you suffer from a blood disorder known as porphyria;
in case of chickenpox, the use of this medicine should be avoided due to the occurrence of rare but serious skin infections associated with its use;
if you have recently undergone major surgery;
if you are elderly (your doctor will prescribe the lowest effective dose for the shortest duration of treatment).

Hypersensitivity reactions may occur, and very rarely, severe allergic reactions (see section 4 Possible side effects).
The risk is higher during the first month of treatment. Treatment with ACECLOFENAC EG must be discontinued at the first sign of skin rash, mucosal lesions, or any sign of hypersensitivity.
Medicines such as ACECLOFENAC EG may be associated with an increased risk of heart attack ("myocardial infarction").
Make sure to inform your doctor of the following before being administered aceclofenac:

if you smoke;
if you have diabetes;
if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Side effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Higher doses and prolonged treatment increase the likelihood of any risk.
Do not exceed the recommended dose or duration of treatment.

Other medicines and ACECLOFENAC EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor if you are taking:
medicines for the treatment of depression (selective serotonin reuptake inhibitors) or manic depression (lithium);
medicines used to treat heart failure and irregular heartbeat (cardiac glycosides);
medicines used to treat high blood pressure (antihypertensives);
quinolone antibiotics;
medicines used to increase the rate of urine excretion (diuretics);
medicines that prevent blood clotting (anticoagulants), such as warfarin, heparin;
methotrexate, used for the treatment of cancer and autoimmune diseases;
mifepristone, used to terminate pregnancy;
any steroids (estrogens, androgens, or glucocorticoids);
medicines used to suppress the immune system (cyclosporine or tacrolimus);
medicines for the treatment of HIV (zidovudine);
medicines used to reduce blood sugar levels (antidiabetics);
any other NSAIDs (aspirin, ibuprofen, naproxen), including COX-2 inhibitors.

ACECLOFENAC EG with food and drink
ACECLOFENAC EG should preferably be taken during or after meals.

Pregnancy, breastfeeding, and fertility
Inform your doctor if you are planning a pregnancy or have difficulty conceiving. NSAIDs may make it more difficult to conceive.
Do not take ACECLOFENAC EG if you are pregnant or suspect you are pregnant. The safety of using this medicine during pregnancy has not been established. Its use during pregnancy is not recommended unless your doctor considers it essential.
ACECLOFENAC EG should not be taken during breastfeeding. It is not known whether this medicine passes into breast milk. Its use during breastfeeding is not recommended unless your doctor considers it essential.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
If you are taking ACECLOFENAC EG and experience dizziness, drowsiness, fatigue, or any visual disturbances, do not drive or operate machinery.

3. How to take ACECLOFENAC EG

Take ACECLOFENAC EG exactly as prescribed by your doctor. You will be prescribed the lowest effective dose for the shortest duration necessary to reduce the risk of unwanted effects. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults is 200 mg (2 tablets). One 100 mg tablet should be taken in the morning and one in the evening.
The tablets should be swallowed whole with plenty of water and may be taken during or after a meal. Do not break or chew the tablets.
Do not exceed the prescribed daily dose.

Elderly
If you are elderly, you may be at increased risk of experiencing serious side effects (listed in section 4, 'Possible side effects').
Your doctor will prescribe ACECLOFENAC EG at the lowest effective dose for the shortest possible duration of treatment.

If you take more ACECLOFENAC EG than you should
If you accidentally take too many ACECLOFENAC EG tablets, contact your doctor immediately or go to the nearest Emergency Department. Take this leaflet or the package with you.

ACECLOFENAC EG so that doctors know what you have taken.

If you forget to take ACECLOFENAC EG
If you miss a dose, do not worry. Simply take the next dose at your usual time.
Do not take a double dose to make up for the missed tablet.

If you stop taking ACECLOFENAC EG
Do not stop taking ACECLOFENAC EG unless your doctor decides it is necessary.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ACECLOFENAC EG may cause side effects, although not everybody gets them.
STOP TAKING the medicine and consult a doctor IMMEDIATELY if you experience any of the following side effects:
severe allergic reaction (anaphylactic shock). Symptoms may develop rapidly and can be life-threatening if not treated immediately. Symptoms may include fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat;
severe skin rashes such as Stevens-Johnson Syndrome and toxic epidermal necrolysis. These effects are potentially life-threatening and develop rapidly, manifesting as large blisters and skin peeling. The rash may also appear in the mouth, throat, or eyes. Fever, headache, and joint pain usually occur at the same time;
meningitis: symptoms include high fever, headache, vomiting, red blotchy rash, neck stiffness, sensitivity and intolerance to light;
blood in the stools (faeces/evacuations);
black, tarry stools. Vomiting blood or dark particles resembling coffee grounds;
medicines such as ACECLOFENAC EG may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke;
kidney failure.

STOP TAKING the medicine and consult your doctor if you experience:
indigestion or stomach burning;
abdominal pain (stomach ache) or other unusual stomach symptoms;
blood disorders such as reduced production of blood cells, abnormal destruction of red blood cells (a condition known as haemolytic anaemia), low iron levels in the blood, low white blood cell count, low platelet count, increased potassium levels in the blood with possible irritation of blood vessels and resulting inflammation known as vasculitis. These disorders may cause extreme tiredness, shortness of breath, joint pain, and a tendency to develop repeated infections and bruising.

If any of the side effects listed below worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Common (may affect more than 1 in 100 people but less than 1 in 10):
dizziness;
nausea (feeling unwell);
diarrhoea;
increased liver enzymes in the blood.

Uncommon (may affect more than 1 in 1,000 people but less than 1 in 100):
gas (flatulence);
inflammation or irritation of the stomach lining (gastritis);
constipation;
vomiting;
mouth ulcers;
itching;
rash;
skin inflammation (dermatitis);
circular red bumps on the skin associated with itching, stinging pain, or burning sensation (urticaria);
increased levels of urea in the blood;
increased levels of creatinine in the blood.

Rare (may affect more than 1 in 10,000 people but less than 1 in 1,000):
low iron levels in the blood;
hypersensitivity (allergic reaction);
vision disorders;
heart failure;
hypertension;
shortness of breath;
gastrointestinal bleeding;
gastrointestinal ulceration.

Very rare (may affect less than 1 in 10,000 people):
depression;
abnormal dreams;
inability to sleep;
tingling, pricking, or numbing sensation of the skin;
uncontrollable trembling (tremors);
drowsiness;
headache;
abnormal taste in the mouth;
sensation of spinning while stationary;
ringing in the ears (tinnitus);
pounding or rapid heartbeat (palpitations);
hot flushes;
difficulty breathing;
high-pitched sound during breathing;
inflammation of the mouth;
perforation of the stomach, large intestine, or intestinal wall;
exacerbation of colitis or Crohn’s disease;
inflammation of the pancreas (pancreatitis);
inflammation of the liver (hepatitis);
yellowing of the skin (jaundice);
spontaneous subcutaneous bleeding (appearing as a skin rash);
blisters;
fluid retention and swelling;
tiredness;
leg cramps;
increased levels of alkaline phosphatase in the blood;
weight gain.

Other side effects reported with this type of medicine (NSAIDs) include:
hallucinations;
confusion;
blurred vision, partial or total blindness;
painful eye movement;
worsening of asthma;
skin reaction to sunlight;
kidney inflammation;
general feeling of malaise.

In very rare cases, severe skin infections associated with chickenpox may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACECLOFENAC EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACECLOFENAC EG contains
The active substance is aceclofenac. Each tablet contains 100 mg of aceclofenac.
The other components are: microcrystalline cellulose (E460i), sodium croscarmellose, copovidone,
talc (E553b), anhydrous colloidal silica, glycerol distearate.
The coating contains: HPMC 2910/hypromellose microcrystalline cellulose, titanium dioxide (E171),
polyoxyl 40 (Macrogol) stearate.

Description of the appearance of ACECLOFENAC EG and package contents
ACECLOFENAC EG is available as white, round, biconvex film-coated tablets.
They are packaged in aluminium/aluminium blister packs containing 20, 30, 40, 60, 90, 100 or 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
Laboratoires BTT, Z.I. de Krafft, 67150 Erstein, France
Rivopharm SA, Manno 6928, Switzerland

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Aceclofenac EG 100 mg filmomhulde tabletten
France: ACECLOFENAC EG LABO 100 mg, comprimé pelliculé
Italy: ACECLOFENAC EG 100 mg compresse rivestite con film
Luxembourg: Aceclofenac EG 100 mg comprimés pellliculés
United Kingdom: Aceclofenac Rivopharm 100 mg film-coated tablets
Spain: Aceclofenaco STADA 100 mg comprimidos recubiertos con película EFG