ACECLOFENAC 100MG FILM-COATED TABLETS
Active substance: ACECLOFENAC
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170 mm
ACECLOFENAC 100 mg FILM-COATED TABLETS
(aceclofenac)
Read all of this leaet carefully before you start taking this medicine. Keep this leaet. 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 eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Aceclofenac is and what it is used for. 2. Before you take Aceclofenac. 3. How to take Aceclofenac. 4. Possible side eects. 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-inammatory drugs, or NSAIDs. Aceclofenac is used to relieve pain and inammation that occur with: osteoarthritis rheumatoid arthritis ankylosing spondylitis. 2. BEFORE YOU TAKE ACECLOFENAC Do not take Aceclofenac if you are allergic (hypersensitive) to aceclofenac or any other ingredient in this medicine if you are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inammatory drugs (NSAIDs) e.g. aspirin, 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 diculty breathing, wheezing, abnormal pain and vomiting if you have a history of, suer 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 coee granules. if you have bleeding or bleeding disorders if you have moderate to severe kidney disease if you have or have ever had a severe heart failure (heart attack) if you suer from, or suspect that you have liver failure if you are pregnant (talk to your doctor). Take special care with Aceclofenac You should tell your doctor before taking this medicine if you: have any of the following gastro-intestinal disorders: * inammatory bowel disease (ulcerative colitis) * chronic inammatory bowel disease (Crohns 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. suer from asthma or any other breathing problem suer 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. suer from a blood clotting disorder suer 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 eective dose over the shortest duration) are currently suering 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
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, especially any of the following: medicines used to treat depression or manic depression (lithium, uoxetine, 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 - 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 (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) or steroids (e.g. oestrogens, androgens, or glucocorticoids) cyclosporin or tacrolimus (used to prevent organ or tissue rejection) medicine to treat an infection (quinolone antibiotics, e.g. ciprooxacin) medicines used to treat high blood pressure (antihypertensives) medicines used to treat HIV infection (zidovudine). These drugs may increase your risk of experiencing side eects. 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 dicult 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 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. 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. Driving and using machines Do not drive or operate dangerous machinery while you are being treated with non-steroidal anti-inammatory drugs if you suer from dizziness, drowsiness, tiredness or any visual disturbances. 3. HOW TO TAKE ACECLOFENAC Always take Aceclofenac exactly as your doctor has told you. You should 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. Adults and Elderly 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. Patients with liver problems Your doctor may want you to take only one tablet a day to begin with. Children Aceclofenac is not recommended for use in children. 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Like all medicines, Aceclofenac can cause side eects, 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: Heart failure - heart problems which can cause shortness of breath or ankle swelling (rare). Medicines such as Aceclofenac may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke (rare). Severe allergic reaction (anaphylactic shock ). Symptoms may include diculty breathing, wheezing, abnormal pain and vomiting (rare). Stomach ulcer, stomach bleeding or perforation of the stomach, large intestine or bowel wall (rare): Symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coee grounds), blood in the faeces (stools/motions) or passing black tarry stools. Itchy swollen skin, skin rash, fever, tightness of the chest and diculty with breathing (angioedema) (rare). Itchy skin, yellowing of the skin or whites of the eyes caused by liver problems (hepatitis very rare). Inammation of the pancreas which causes severe pain in abdomen and back (very rare). Kidney problems (very rare). Worsening of pre-existing conditions like: inammation of the intestine which causes abdominal pain or diarrhoea (colitis and Crohns disease) (very rare). Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens Johnson syndrome) (very rare). Severe blistering and peeling of the top layer of the skin (very rare). Reduced white or red blood cell count which can lead to fever, sore throat or swelling of the glands (bone marrow depression) (very rare). Depression (very rare). These side eects are rare or very rare but potentially serious and you may need medical attention. Common side eects (aecting fewer than 1 in 10 people): Dizziness. Indigestion, stomach pain. Feeling sick. Diarrhoea. Increased liver enzymes in the blood. Uncommon side eects (aecting fewer than 1 in 100 people): Constipation, wind. Being sick. Mouth ulcers. Itchy skin, rash. Increase in blood urea levels. Increase in blood creatinine levels. Inammation or irritation of the lining of the stomach (gastritis). Inammation of the skin (dermatitis). Raised circular red itchy, stinging or burning patches on the skin (hives). Rare side eects (aecting fewer than 1 in 1,000 people): Low red blood cell count, which may cause tiredness, shortness of breath or loss of appetite. Visual disturbance. Breathlessness or diculty breathing. Raised blood pressure. Very rare side eects (aecting fewer than 1 in 10,000 people): Reduced white blood cell count which can lead to fever, sore throat or swelling of the glands. Reduction in blood platelets which increases the risk of bleeding or bruising. Reduction in red blood cells which can make the skin pale or yellow and cause weakness or breathlessness. Abnormal breakdown of red blood cells (haemolytic anemia). High potassium levels in the blood. Increased blood alkaline phosphatase levels. Swelling of blood vessels (vasculitis). Hallucinations or confusion. Diculty sleeping or falling asleep. Unusual dreams. Uncontrollable shaking (tremor). Sleepiness. Headache. Disturbance or loss of taste. Inammation of the mouth. 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 ushes.
Wheezing, diculty in breathing. Water retention and swelling. Cramp in the legs. Tiredness. Weight increase. Taking Aceclofenac can aect the results of various blood tests you may have done. This eect is generally not serious and the results should return to normal when you stop taking Aceclofenac. Medicines such as Aceclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If any of the side eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE ACECLOFENAC Keep out of the reach and sight 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 30C. Store in original package. 6. FURTHER INFORMATION What Aceclofenac contains The active substance is aceclofenac. Each tablet contains 100 mg aceclofenac. The other ingredients are: microcrystalline cellulose, povidone, stearic acid, croscarmellose sodium and magnesium stearate. The coating also contains: titanium dioxide (E171), hypromellose (E464), macrogol 400 and polysorbate 80 (E433). What Aceclofenac looks like and contents of the pack Your medicine comes as a circular tablet, white or o-white in colour and marked 'G' on one side. Aceclofenac is available in blister packs comprising of 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. Polgono Merck 08100 Mollet del Valls (BARCELONA) SPAIN Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
600 mm
50051869
This leaet was last revised in: February 2013
50051869 10004857
ACECLOFENAC 100 mg FILM-COATED TABLETS
(aceclofenac)
Read all of this leaet carefully before you start taking this medicine. Keep this leaet. 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 eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Aceclofenac is and what it is used for. 2. Before you take Aceclofenac. 3. How to take Aceclofenac. 4. Possible side eects. 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-inammatory drugs, or NSAIDs. Aceclofenac is used to relieve pain and inammation that occur with: osteoarthritis rheumatoid arthritis ankylosing spondylitis. 2. BEFORE YOU TAKE ACECLOFENAC Do not take Aceclofenac if you are allergic (hypersensitive) to aceclofenac or any other ingredient in this medicine if you are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inammatory drugs (NSAIDs) e.g. aspirin, 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 diculty breathing, wheezing, abnormal pain and vomiting if you have a history of, suer 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 coee granules. if you have bleeding or bleeding disorders if you have moderate to severe kidney disease if you have or have ever had a severe heart failure (heart attack) if you suer from, or suspect that you have liver failure if you are pregnant (talk to your doctor). Take special care with Aceclofenac You should tell your doctor before taking this medicine if you: have any of the following gastro-intestinal disorders: * inammatory bowel disease (ulcerative colitis) * chronic inammatory bowel disease (Crohns 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. suer from asthma or any other breathing problem suer 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. suer from a blood clotting disorder suer 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 eective dose over the shortest duration) are currently suering 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
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, especially any of the following: medicines used to treat depression or manic depression (lithium, uoxetine, 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 - 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 (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) or steroids (e.g. oestrogens, androgens, or glucocorticoids) cyclosporin or tacrolimus (used to prevent organ or tissue rejection) medicine to treat an infection (quinolone antibiotics, e.g. ciprooxacin) medicines used to treat high blood pressure (antihypertensives) medicines used to treat HIV infection (zidovudine). These drugs may increase your risk of experiencing side eects. 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 dicult 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 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. 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. Driving and using machines Do not drive or operate dangerous machinery while you are being treated with non-steroidal anti-inammatory drugs if you suer from dizziness, drowsiness, tiredness or any visual disturbances. 3. HOW TO TAKE ACECLOFENAC Always take Aceclofenac exactly as your doctor has told you. You should 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. Adults and Elderly 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. Patients with liver problems Your doctor may want you to take only one tablet a day to begin with. Children Aceclofenac is not recommended for use in children. 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Like all medicines, Aceclofenac can cause side eects, 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: Heart failure - heart problems which can cause shortness of breath or ankle swelling (rare). Medicines such as Aceclofenac may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke (rare). Severe allergic reaction (anaphylactic shock ). Symptoms may include diculty breathing, wheezing, abnormal pain and vomiting (rare). Stomach ulcer, stomach bleeding or perforation of the stomach, large intestine or bowel wall (rare): Symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coee grounds), blood in the faeces (stools/motions) or passing black tarry stools. Itchy swollen skin, skin rash, fever, tightness of the chest and diculty with breathing (angioedema) (rare). Itchy skin, yellowing of the skin or whites of the eyes caused by liver problems (hepatitis very rare). Inammation of the pancreas which causes severe pain in abdomen and back (very rare). Kidney problems (very rare). Worsening of pre-existing conditions like: inammation of the intestine which causes abdominal pain or diarrhoea (colitis and Crohns disease) (very rare). Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens Johnson syndrome) (very rare). Severe blistering and peeling of the top layer of the skin (very rare). Reduced white or red blood cell count which can lead to fever, sore throat or swelling of the glands (bone marrow depression) (very rare). Depression (very rare). These side eects are rare or very rare but potentially serious and you may need medical attention. Common side eects (aecting fewer than 1 in 10 people): Dizziness. Indigestion, stomach pain. Feeling sick. Diarrhoea. Increased liver enzymes in the blood. Uncommon side eects (aecting fewer than 1 in 100 people): Constipation, wind. Being sick. Mouth ulcers. Itchy skin, rash. Increase in blood urea levels. Increase in blood creatinine levels. Inammation or irritation of the lining of the stomach (gastritis). Inammation of the skin (dermatitis). Raised circular red itchy, stinging or burning patches on the skin (hives). Rare side eects (aecting fewer than 1 in 1,000 people): Low red blood cell count, which may cause tiredness, shortness of breath or loss of appetite. Visual disturbance. Breathlessness or diculty breathing. Raised blood pressure. Very rare side eects (aecting fewer than 1 in 10,000 people): Reduced white blood cell count which can lead to fever, sore throat or swelling of the glands. Reduction in blood platelets which increases the risk of bleeding or bruising. Reduction in red blood cells which can make the skin pale or yellow and cause weakness or breathlessness. Abnormal breakdown of red blood cells (haemolytic anemia). High potassium levels in the blood. Increased blood alkaline phosphatase levels. Swelling of blood vessels (vasculitis). Hallucinations or confusion. Diculty sleeping or falling asleep. Unusual dreams. Uncontrollable shaking (tremor). Sleepiness. Headache. Disturbance or loss of taste. Inammation of the mouth. 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 ushes.
Wheezing, diculty in breathing. Water retention and swelling. Cramp in the legs. Tiredness. Weight increase. Taking Aceclofenac can aect the results of various blood tests you may have done. This eect is generally not serious and the results should return to normal when you stop taking Aceclofenac. Medicines such as Aceclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If any of the side eects gets serious, or if you notice any side eects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE ACECLOFENAC Keep out of the reach and sight 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 30C. Store in original package. 6. FURTHER INFORMATION What Aceclofenac contains The active substance is aceclofenac. Each tablet contains 100 mg aceclofenac. The other ingredients are: microcrystalline cellulose, povidone, stearic acid, croscarmellose sodium and magnesium stearate. The coating also contains: titanium dioxide (E171), hypromellose (E464), macrogol 400 and polysorbate 80 (E433). What Aceclofenac looks like and contents of the pack Your medicine comes as a circular tablet, white or o-white in colour and marked 'G' on one side. Aceclofenac is available in blister packs comprising of 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. Polgono Merck 08100 Mollet del Valls (BARCELONA) SPAIN Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
600 mm
50051869
This leaet was last revised in: February 2013
50051869 10004857
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
