Aceclofenac 100mg Tablets
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PRESERVEX™ 100MG TABLETS
(aceclofenac)
Your medicine is available using the name Preservex 100mg Tablets but will be referred to as Preservex throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
■ 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Preservex is and what it is used for
2. Before you take Preservex
3. How to take Preservex
4. Possible side effects
5. How to store Preservex
6. Further information
1. What Preservex is and what it is used for
Preservex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs have antiinflammatory and painkiller properties. The active ingredient of Preservex is aceclofenac.
Preservex works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins are released at the sites of injury, tissue damage and immune reactions. Prostaglandins play an important role in both the inflammatory response of the body and stimulating the re-absorption of bone in diseases.
Preservex is used to relieve pain and inflammation in patients suffering from:
■ arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
■ autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
■ arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).
2. Before you take Preservex
Do not take Preservex
■ if you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of Preservex.
■ if you are allergic (hypersensitive) to aspirin or any other 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 ulcer or intestinal bleeding.
■ if you have moderate to severe kidney disease.
■ if you have or have ever had a severe heart failure (heart
attack).
■ if you suffer from, or suspect that you have liver failure.
■ if you are pregnant (unless considered essential by your
doctor).
Preservex is not recommended for use in children.
Take special care with Preservex
Before you start taking Preservex, tell your doctor:
■ if you suffer from any other form of liver disease.
■ if you have any of the following gastro-intestinal disorders:
■ inflammatory bowel disease (ulcerative colitis)
■ chronic inflammatory bowel disease (Crohn's disease)
■ bleeding
■ vomiting of blood
■ if you have, or have ever had problems with the circulation of the blood to your brain.
■ if you suffer from asthma or any other breathing problems.
■ if you suffer from a blood disorder known as porphyria.
■ if you 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.
■ If you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration).
Medicines such as Preservex 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Please tell your doctor if you are taking:
■ medicines used to treat depression or manic depression (lithium)
■ medicines used to treat heart failure and irregular heart beats (cardiac glycosides)
■ medicines used to treat high blood pressure (antihypertensives)
■ quinolone antibiotics
■ drugs used to increase the rate of urine excretion (diuretics)
■ medicines that stop blood clotting (anticoagulants) such as warfarin, heparin
■ methotrexate which is used to treat cancer and autoimmune disorders
■ mifepristone which is used as an emergency contraceptive or to induce abortions
■ any steroids (oestrogens, androgens, or glucocorticoids)
■ medicines used to supress the immune system (cyclosporin or tacrolimus)
■ medicines used to treat HIV (zidovudine)
■ medicines used to lower blood sugar levels (antidiabetics)
■ any other NSAID drugs (aspirin, ibuprofen, naproxen)
Taking Preservex with food and drink
Preservex must be taken preferably with or after food.
Pregnancy and breast-feeding
You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.
Do not take Preservex if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy has not been estblished. It is not recommended for use in pregnancy unless considered essential by your doctor.
Preservex 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.
Consult your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you are taking Preservex and you experience dizziness, drowsiness, tiredness or any visual disturbances, you must not drive or use machinery.
3. How to take Preservex
Always take Preservex exactly as your doctor has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. You should check with your doctor or pharmacist if you are not sure.
The recommended dose in adults is 200mg (two Preservex tablets). One 100mg tablet should be taken in the morning and one in the evening.
Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets.
Do not exceed the stated daily dose.
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 Preservex for you, you will be given the lowest effective dose over the shortest duration.
If you take more Preservex than you should
If you accidentally take too many Preservex tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Preservex tablets came in, with you to the hospital so that they will know what you have taken.
POM
If you forget to take Preservex
If you miss a dose, do not worry, just take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Preservex
Do not stop taking Preservex unless your doctor advises you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Preservex can cause side effects, although not everybody gets them.
If you experience any of the following side effects, tell your doctor IMMEDIATELY:
■ medicines such as Preservex 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
■ swelling of the face
■ kidney failure
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
■ Pass blood in your faeces (stools/motions)
■ Pass black tarry stools
■ Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
■ Indigestion or heartburn
■ Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
If any of the below side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (occur in more than 1 in 100 patients but in less than 1 in 10 patients):
■ dizziness
■ nausea (feeling sick)
■ diarrhoea
■ increased liver enzymes in the blood
Uncommon (occur in more than 1 in 1,000 patients but in less than 1 in 100 patients):
■ wind (flatulence)
■ inflammation or irritation of the lining of the stomach (gastritis)
■ constipation
■ vomiting
■ mouth ulcers
■ itching
■ rash
■ inflammation of the skin (dermatitis)
■ raised circular red itchy, stinging or burning patches on the skin (hives)
■ increase in blood urea levels
■ increase in blood creatinine levels
Rare (occur in more than 1 in 10,000 patients but in less than 1 in 1,000 patients):
■ low levels of iron in the blood
■ hypersensitivity (allergic reaction)
■ visual disturbance
■ shortness of breath
Very Rare (occur in less than 1 in 10,000 patients):
■ low white blood cells levels
■ low platelets levels in the blood
■ abnormal breakdown of red blood cells (anemia)
■ high potassium levels in the blood
■ depression
■ strange dreams
■ inability to sleep
■ tingling, pricking or numbness of skin
■ uncontrollable shaking (tremor)
■ drowsiness
■ headaches
■ abnormal taste in the mouth
■ sensation of spinning when standing still
■ heart pounding or racing (palpitations)
■ hot flushes
■ difficulty breathing
■ high pitched noise when breathing
■ inflammation of the mouth
■ stomach ulcer
■ inflammation of the pancreas (pancreatitis)
■ inflammation of the liver (hepatitis)
■ yellowing of the skin (jaundice)
■ spontaneous bleeding into the skin (appears as a rash)
■ blisters
■ water retention and swelling
■ tiredness
■ leg cramps
■ increased blood alkaline phosphatase levels
■ weight gain
If any of the below side effects get serious, please tell your doctor or pharmacist.
Other side effects that have been reported with this type of drug (NSAIDs) are:
■ bone marrow failure
■ hallucinations
■ confusion
■ blurred, partial or complete loss of vision
■ painful movement of the eye
■ ringing in the ears
■ aggravated asthma
■ ulcers
■ perforation of either the stomach, large intestine or bowel wall
■ blistering and peeling of the top layer of skin
■ mild, itchy pink/redness of the skin
■ reddening or scaling of skin
■ skin irritation (eczema)
■ skin reaction to sunlight
■ inflammation of the kidneys
■ generally feeling unwell
■ aseptic meningitis
■ exacerbation of colitis and Crohn's disease
■ hypertension (high blood pressure)
■ cardiac failure
■ bone marrow depression
5. How to store Preservex
Keep out of the sight and reach of children.
The box is marked by a "use by date". Do not take the tablets after this date. The expiry date is stated on the outer carton.
The expiry date refers to the last day of that month.
It is recommended that you store Preservex in the original box.
Do not store above 30°C.
If your tablets appear to be discoloured or show any signs of deterioration, please return them to your pharmacist who will advise you.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist. Only keep the tablets if your doctor tells you to.
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. Further information
What Preservex contains
The active ingredient in Preservex is aceclofenac.
Each film-coated tablet contains 100mg of aceclofenac.
Preservex also contains the following inactive ingredients used to bind and coat the tablets, these are: microcrystalline cellulose, sodium croscarmellose polyvidone, glycerol palmitostearate, and the film coat, containing partially substituted hydroxypropyl methylcellulose, polyoxyethylene 40 stearate and titanium dioxide.
What Preservex looks like and contents of the pack
Preservex are white round film-coated tablets, 8mm in diameter, without any markings.
Preservex are available in blister strips of 20, 40 and 60 tablets.
Manufacturer
Preservex are manufactured by: Industrias Farmaceuticas Almirall Prodesfarma, S.L., Ctra. Nacional II, Km. 593, 08740 Sant Andreu de la Barca - Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0339
Leaflet revision date: 10.07.13
Preservex™ is a trademark of Almirall S.A.
ACECLOFENAC 100MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Aceclofenac 100mg Tablets but will be referred to as Aceclofenac throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
■ 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Aceclofenac is and what it is used for
2. Before you take Aceclofenac
3. How to take Aceclofenac
4. Possible side effects
5. How to store Aceclofenac
6. Further information
1. What Aceclofenac is and what it is used
for
Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs have antiinflammatory and painkiller properties. The active ingredient of Aceclofenac is aceclofenac.
Aceclofenac works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins are released at the sites of injury, tissue damage and immune reactions. Prostaglandins play an important role in both the inflammatory response of the body and stimulating the re-absorption of bone in diseases.
Aceclofenac is used to relieve pain and inflammation in patients suffering from:
■ arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
■ autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
■ arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).
2. Before you take Aceclofenac
Do not take Aceclofenac
■ if you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of Aceclofenac.
■ if you are allergic (hypersensitive) to aspirin or any other 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 ulcer or intestinal bleeding.
■ if you have moderate to severe kidney disease.
■ if you have or have ever had a severe heart failure (heart
attack).
■ if you suffer from, or suspect that you have liver failure.
■ if you are pregnant (unless considered essential by your
doctor).
Aceclofenac is not recommended for use in children.
Take special care with Aceclofenac
Before you start taking Aceclofenac, tell your doctor:
■ if you suffer from any other form of liver disease.
■ if you have any of the following gastro-intestinal disorders:
■ inflammatory bowel disease (ulcerative colitis)
■ chronic inflammatory bowel disease (Crohn's disease)
■ bleeding
■ vomiting of blood
■ if you have, or have ever had problems with the circulation of the blood to your brain.
■ if you suffer from asthma or any other breathing problems.
■ if you suffer from a blood disorder known as porphyria.
■ if you 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.
■ If you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration).
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Please tell your doctor if you are taking:
■ medicines used to treat depression or manic depression (lithium)
■ medicines used to treat heart failure and irregular heart beats (cardiac glycosides)
■ medicines used to treat high blood pressure (antihypertensives)
■ quinolone antibiotics
■ drugs used to increase the rate of urine excretion (diuretics)
■ medicines that stop blood clotting (anticoagulants) such as warfarin, heparin
■ methotrexate which is used to treat cancer and autoimmune disorders
■ mifepristone which is used as an emergency contraceptive or to induce abortions
■ any steroids (oestrogens, androgens, or glucocorticoids)
■ medicines used to supress the immune system (cyclosporin or tacrolimus)
■ medicines used to treat HIV (zidovudine)
■ medicines used to lower blood sugar levels (antidiabetics)
■ any other NSAID drugs (aspirin, ibuprofen, naproxen)
Taking Aceclofenac with food and drink
Aceclofenac must be taken preferably with or after food.
Pregnancy and breast-feeding
You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.
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 estblished. It is not recommended for use in pregnancy unless considered essential by your doctor.
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.
Consult your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you are taking Aceclofenac and you experience dizziness, drowsiness, tiredness or any visual disturbances, you must not drive or use machinery.
3. How to take Aceclofenac
Always take Aceclofenac exactly as your doctor has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. You should check with your doctor or pharmacist if you are not sure.
The recommended dose in adults is 200mg (two Aceclofenac tablets). One 100mg tablet should be taken in the morning and one in the evening.
Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets.
Do not exceed the stated daily dose.
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 over the shortest duration.
If you take more Aceclofenac than you should
If you accidentally take too many Aceclofenac tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Aceclofenac tablets came in, with you to the hospital so that they will know what you have taken.
POM
If you forget to take Aceclofenac
If you miss a dose, do not worry, just take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Aceclofenac
Do not stop taking Aceclofenac unless your doctor advises you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Aceclofenac can cause side effects, although not everybody gets them.
If you experience any of the following side effects, tell your doctor IMMEDIATELY:
■ 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
■ swelling of the face
■ kidney failure
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
■ Pass blood in your faeces (stools/motions)
■ Pass black tarry stools
■ Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
■ Indigestion or heartburn
■ Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
If any of the below side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (occur in more than 1 in 100 patients but in less than 1 in 10 patients):
■ dizziness
■ nausea (feeling sick)
■ diarrhoea
■ increased liver enzymes in the blood
Uncommon (occur in more than 1 in 1,000 patients but in less than 1 in 100 patients):
■ wind (flatulence)
■ inflammation or irritation of the lining of the stomach (gastritis)
■ constipation
■ vomiting
■ mouth ulcers
■ itching
■ rash
■ inflammation of the skin (dermatitis)
■ raised circular red itchy, stinging or burning patches on the skin (hives)
■ increase in blood urea levels
■ increase in blood creatinine levels
Rare (occur in more than 1 in 10,000 patients but in less than 1 in 1,000 patients):
■ low levels of iron in the blood
■ hypersensitivity (allergic reaction)
■ visual disturbance
■ shortness of breath
Very Rare (occur in less than 1 in 10,000 patients):
■ low white blood cells levels
■ low platelets levels in the blood
■ abnormal breakdown of red blood cells (anemia)
■ high potassium levels in the blood
■ depression
■ strange dreams
■ inability to sleep
■ tingling, pricking or numbness of skin
■ uncontrollable shaking (tremor)
■ drowsiness
■ headaches
■ abnormal taste in the mouth
■ sensation of spinning when standing still
■ heart pounding or racing (palpitations)
■ hot flushes
■ difficulty breathing
■ high pitched noise when breathing
■ inflammation of the mouth
■ stomach ulcer
■ inflammation of the pancreas (pancreatitis)
■ inflammation of the liver (hepatitis)
■ yellowing of the skin (jaundice)
■ spontaneous bleeding into the skin (appears as a rash)
■ blisters
■ water retention and swelling
■ tiredness
■ leg cramps
■ increased blood alkaline phosphatase levels
■ weight gain
If any of the below side effects get serious, please tell your doctor or pharmacist.
Other side effects that have been reported with this type of drug (NSAIDs) are:
■ bone marrow failure
■ hallucinations
■ confusion
■ blurred, partial or complete loss of vision
■ painful movement of the eye
■ ringing in the ears
■ aggravated asthma
■ ulcers
■ perforation of either the stomach, large intestine or bowel wall
■ blistering and peeling of the top layer of skin
■ mild, itchy pink/redness of the skin
■ reddening or scaling of skin
■ skin irritation (eczema)
■ skin reaction to sunlight
■ inflammation of the kidneys
■ generally feeling unwell
■ aseptic meningitis
■ exacerbation of colitis and Crohn's disease
■ hypertension (high blood pressure)
■ cardiac failure
■ bone marrow depression
5. How to store Aceclofenac
Keep out of the sight and reach of children.
The box is marked by a "use by date". Do not take the tablets after this date. The expiry date is stated on the outer carton.
The expiry date refers to the last day of that month.
It is recommended that you store Aceclofenac in the original box.
Do not store above 30°C.
If your tablets appear to be discoloured or show any signs of deterioration, please return them to your pharmacist who will advise you.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist. Only keep the tablets if your doctor tells you to.
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. Further information
What Aceclofenac contains
The active ingredient in Aceclofenac is aceclofenac.
Each film-coated tablet contains 100mg of aceclofenac.
Aceclofenac also contains the following inactive ingredients used to bind and coat the tablets, these are: microcrystalline cellulose, sodium croscarmellose polyvidone, glycerol palmitostearate, and the film coat, containing partially substituted hydroxypropyl methylcellulose, polyoxyethylene 40 stearate and titanium dioxide.
What Aceclofenac looks like and contents of the pack
Aceclofenac are white round film-coated tablets, 8mm in diameter, without any markings.
Aceclofenac are available in blister strips of 20, 40 and 60 tablets.
Manufacturer
Aceclofenac are manufactured by: Industrias Farmaceuticas Almirall Prodesfarma, S.L., Ctra. Nacional II, Km. 593, 08740 Sant Andreu de la Barca - Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0339
Leaflet revision date: 10.07.13
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