What is it used for?

• Reducing pain and inflammation in rheumatoid arthritis, osteoarthritis and a form of arthritis that affects the joints in the spine called ankylosing spondylitis.

How does it work?

• Vitafen (Aceclofenac) 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 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.

How do I take it?

• The usual dose of aceclofenac for adults is one 100mg tablet taken twice a day, morning and evening.
• The tablets should be swallowed whole with a drink. They should preferably be taken with or after food.
• Try to space your doses evenly. If you forget to take a dose at your usual time take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the forgotten dose and take the next dose as usual. Do not take a double dose to make up for a missed dose.

Key Point

• 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.

Use with caution in

• Elderly people.
• People with a history of disorders affecting the stomach or intestines.
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• Kidney disease.
• Liver disease.
• High blood pressure (hypertension).
• People with raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
• Diabetes.
• Smokers.
• People with blood clotting problems or taking anticoagulant medicines.
• People with a history of asthma.
• People with a 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).
• People with an active peptic ulcer, perforation (hole) or bleeding in the gut.
• People who have had recurrent peptic ulcers or bleeding from the gut (two or more episodes).
• People who have previously experienced bleeding or perforation of the gut as a result of taking an NSAID.
• Heart failure.
• People with heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
• People with disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
• People with poor blood circulation in the arteries of the legs or feet (peripheral arterial disease).
• Severe liver failure.
• Severe kidney failure.
• Third trimester of pregnancy.
• Hereditary blood disorders called porphyrias.
• This medicine is not recommended for children and adolescents under 18 years of age.

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

• 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 further medical advice from your doctor.
• The safety of this medicine for use during breastfeeding has not been established. 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.

Side effects

• Dizziness.
• Disturbances of the gut such as diarrhoea, nausea, indigestion or abdominal pain.
• Alteration in results of liver function tests.
• 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.
• 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).
• Ulceration or bleeding in the gut. See the warning section above.
• Dark coloured, tarry stools, due to the presence of blood altered by the intestinal juices (melaena).
• Heart failure.

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?

Aceclofenac should not be used in combination with painkilling doses of aspirin or any other NSAID taken by mouth, eg ibuprofen, diclofenac, naproxen 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 in the gut if aceclofenac is taken with corticosteroids such as prednisolone.

There may be an increased risk of bleeding if aceclofenac is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin, dabigatran, apixaban, rivaroxaban, heparin
• anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole, prasugrel
• erlotinib
• iloprost
• selective serotonin re-uptake inhibitors (SSRIs) antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.

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
• aliskiren
• 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.

References:

https://www.netdoctor.co.uk/medicines/aches-pains/a7390/preservex-aceclofenac/

https://www.medicines.org.uk/emc/product/4240/smpc

https://phoenixlabs.ie/vitafen-2/

http://phoenixlabs.ie/wp-content/uploads/2018/05/Vitafen-Press-Release-2-1.pdf

http://www.ncpe.ie/drugs/aceclofenac-vitafen/

https://patient.info/medicine/aceclofenac-tablets-for-pain-and-inflammation-preservex