---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（2010113000432024.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文醋氯芬酸处方资料（仅供参考）

药物名称：醋氯芬酸

药物别名：Airtal、Biofenac、Falcol、Gerbin、preservex

英文名称：Aceclofenac

说明：肠溶片剂和肠溶胶囊，100mg/片(粒)。

功用作用：缓解风湿性关节炎、类风湿性关节炎、骨关节炎和强直性脊椎炎引起的炎症和疼痛。意外创伤或手术后疼痛。也用于其它疾病引起的疼痛和发热。

用法用量：口服，一日2次，每次100mg。

注意事项：禁忌症：胃溃疡或十二指肠溃疡，胃出血、妊娠、对非甾体抗炎药过敏者。
(1)不良反应发生率低，而且不严重。
(2)不良反应包括消化不良，恶心、腹泻、腹痛。
(3)罕见(发生率小于0.1%)疲倦、头痛、头晕和皮疹。

Preservex (aceclofenac)
How does it work?
Preservex tablets contain the active ingredient aceclofenac, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. Aceclofenac is also available without a brand name, ie as the generic medicine.

Aceclofenac works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins.

Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Aceclofenac blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.

Aceclofenac is used to relieve inflammation and related pain in arthritic conditions.

The tablets should preferably be taken with food to help avoid irritating the stomach.

What is it used for?
Reducing pain and inflammation in arthritis, osteoarthritis and ankylosing spondylitis.

Warning!
This medicine should be taken with or after food.
This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.
Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see below). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.
Non-steroidal anti-inflammatory drugs such as this one may be associated with a small increase in the risk of experiencing a heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have ever had a 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.
Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
If you have cirrhosis of the liver, heart failure or kidney disease, you are on a low sodium diet, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

Use with caution in
Elderly people.
History of disorders affecting the stomach or intestines.
Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
Kidney disease.
Liver disease.
Heart failure.
High blood pressure (hypertension).
Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
Diabetes.
Smokers.
People with blood clotting problems or taking anticoagulant medicines.
History of asthma.
History of allergies.
Diseases affecting connective tissue, eg systemic lupus erythematosus.

Not to be used in
People in whom aspirin or other NSAIDs, eg diclofenac, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
Active peptic ulcer or bleeding in the gut, or a history of this.
Severe heart failure.
Liver failure.
Kidney failure.
Third trimester of pregnancy.
Hereditary blood disorders called porphyrias.
This medicine is not recommended for children.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be taken in the third trimester of pregnancy because it may delay labour, increase the length of labour and cause complications in the newborn baby. It is not recommended for use in the first and second trimesters of pregnancy unless considered essential by your doctor. Some evidence suggests that NSAIDs such as this one should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.

The medicine passes into breast milk in small amounts. At normal doses it is unlikely to harm the nursing infant, however the manufacturer recommends that this medicine should be avoided where possible by women who are breastfeeding. It is important to seek medical advice from your doctor before taking this medicine if you are breastfeeding.

Label warnings
Take this medication with or after food.

Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)
Dizziness.
Disturbances of the gut such as diarrhoea, nausea, indigestion or abdominal pain.
Alteration in results of liver function tests.

Uncommon (affect between 1 in 100 and 1 in 1000 people)
Wind (flatulence).
Constipation.
Vomiting.
Mouth ulcers.
Inflammation of the stomach (gastritis).
Skin reactions, such as itching, rash and dermatitis.
Increased creatinine and urea in the blood.

Rare (affect between 1 in 1000 and 1 in 10,000 people)
Decrease in the number of red blood cells in the blood (anaemia).
Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock.
Visual disturbances.
Shortness of breath (dyspnoea).
Dark coloured, tarry stools, due to the presence of blood altered by the intestinal juices (melaena).
Swelling of the face, due to fluid retention.

Very rare (affect less than 1 in 10,000 people)
Difficulty sleeping (insomnia).
Abnormal dreams.
Depression.
Pins and needles (paraesthesia).
Tremor.
Abnormal taste.
Awareness of your heartbeat (palpitations).
Flushing.
Spinning sensation (vertigo).
Headache.
Fatigue.
Ulceration or bleeding in the gut.
Inflammation of the lining of the mouth (stomatitis).
Inflammation of the pancreas (pancreatitis).
Excessive fluid retention in the body tissues, resulting in swelling (oedema).
Kidney, liver or blood disorders.
Severe skin reactions.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Aceclofenac should not be used in combination with painkilling doses of aspirin or any other NSAID taken by mouth, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of cyclo-oxgenase 2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding from the gut if aceclofenac is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding from the gut if aceclofenac is taken with the following medicines:
anti-blood-clotting (anticoagulant) medicines, such as warfarin or heparin
anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
dabigatran
erlotinib
selective serotonin re-uptake inhibitors (SSRIs) antidepressants, eg fluoxetine, paroxetine, citalopram
venlafaxine.

Aceclofenac may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking aceclofenac with an anticoagulant medicine should be closely monitored by their doctor.

There may be an increased risk of side effects on the kidneys if aceclofenac is used with any of the following medicines:
ACE inhibitors, eg enalapril
angiotensin II receptor antagonists, eg losartan
ciclosporin
diuretics, eg furosemide
tacrolimus.

Aceclofenac may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following:
ACE inhibitors such as captopril
angiotensin II receptor antagonists, eg losartan
beta-blockers such as propranolol
diuretics such as furosemide.

Aceclofenac may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People using aceclofenac with any of these should be closely monitored by their doctor:
digoxin
lithium
methotrexate.

If this medicine is used in combination with quinolone antibiotics, such as ciprofloxacin or norfloxacin there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Other medicines containing the same active ingredient
Aceclofenac tablets are also available without a brand name, ie as the generic medicine.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（2010113000432024.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------