Product Details

What you need to know before you take Arthrotec
Do not take Arthrotec If you:
• currently have an ulcer or perforation (hole) in your stomach or intestines
• currently suffer from bleeding in your stomach, intestines or brain
• are pregnant, or trying to become pregnant, because it may cause a miscarriage. Women who have not reached the menopause should use reliable contraception while they are taking Arthrotec
• are a woman of childbearing age and you are not using an effective contraceptive method to avoid becoming pregnant (see section on ‘Pregnancy’ for further information)
• think you may be allergic to diclofenac sodium, aspirin (acetylsalicylic acid), ibuprofen or any other NSAIDs, misoprostol or another prostaglandin medicine, or any of the other ingredients of Arthrotec (see section 6). Signs of a hypersensitivity reaction include a skin rash, swelling or itchiness of the skin, swelling of the face and mouth (angioedema), severe nasal congestion, asthma (breathing problems), chest pain, wheezing or any other allergic type reaction.
• are undergoing or you have just had coronary artery bypass graft (CABG) surgery
• have severe kidney or liver failure
• have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• have or have had problems with your blood circulation (peripheral arterial disease)
Warnings and precautions
Talk to your doctor or pharmacist before taking Arthrotec If you:
• have other health problems such as a disease of the liver or kidneys. Do not take Arthrotec if you have severe kidney or liver failure
• previously had an ulcer or bleeding in your stomach or intestines. Do not take Arthrotec if you currently have an ulcer or bleeding in your stomach or intestines
• bleed or bruise easily
• have inflammation of the intestines (ulcerative colitis or Crohn’s disease)
• have, or have ever had asthma or an allergic disease
• have an infection, as Arthrotec may mask a fever or other signs of infection
• are dehydrated
• are over the age of 65 as your doctor will want to monitor you regularly
• are pregnant or plan to become pregnant (see section on “Pregnancy”). Due to the risk to the foetus,
your treatment with Arthrotec must be discontinued immediately
• are a woman of childbearing age (see also section on “Pregnancy”). It is important to use effective
contraception while you are taking this medicine
• recently had or you are going to have a surgery of the stomach or intestinal tract before receiving/taking/using Arthrotec, as Arthrotec can sometimes worsen wound healing in your gut after surgery
NSAID medicines such as Arthrotec can cause bleeding or ulceration. If this occurs, treatment should be stopped. Use of Arthrotec with another NSAID other than aspirin (e.g. ibuprofen) may also increase frequency of ulcers or bleeding in your stomach or intestines.
Arthrotec may cause serious side effects, especially stomach and intestinal complications, if you are using a corticosteroid (e.g. prednisone), an oral anticoagulant, or a Selective Serotonin Re-uptake Inhibitor (e.g. sertraline) or if you drink alcohol.
Make sure your doctor knows, before you are given Arthrotec If you:
• smoke
• have diabetes
• have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
Medicines such as Arthrotec 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.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
As with other NSAIDs (e.g. ibuprofen) Arthrotec may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.

If you have heart, liver or kidney problems, your doctor will want to monitor you regularly.
Other medicines and Arthrotec
Some medicines can affect the way other medicines work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
• Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)
• Medicines used to treat osteoarthritis or rheumatoid arthritis known as cyclo-oxygenase-2 (COX2) inhibitors
• Diuretics (used to treat excess fluid in the body)
• Ciclosporin or tacrolimus (used for immune system suppression e.g. after transplants)
• Lithium (used to treat some types of depression)
• Digoxin (a medicine for an irregular heart beat and/or heart failure)
• Warfarin or other oral anticoagulants (blood-thinning agents that reduce blood clotting, e.g. aspirin)
• Medicines used to treat anxiety and depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs)
• Medicines used to control your blood sugar (oral hypoglycaemics for diabetes)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• Steroid medications (e.g. corticosteroids, which are often used as anti-inflammatory medicines)
• Medicines for high blood pressure (anti-hypertensives)
• Magnesium containing antacids (used to treat heartburn, indigestion)
• Quinolone antibiotics (used to treat some infections)
• Ketoconazole, fluconazole, miconazole and voriconazole (used to treat some fungal infections)
• Amiodarone (used to treat an abnormal heart beat)
• Sulfinpyrazole (used to treat gout)
• If you have taken a medicine called mifepristone (used to terminate pregnancy) within the last 12 days. Arthrotec should not be taken within 8-12 days of taking mifepristone
Pregnancy, breast-feeding and fertility
Pregnancy
Do not take Arthrotec if you are pregnant, think you may be pregnant or trying to become pregnant.
You should tell your doctor if you are planning to become pregnant. Due to the possible risk of damage to the foetus, you must make sure you are not pregnant before starting treatment. Women who have not reached menopause must use reliable contraception while they are taking Arthrotec.
Your doctor will make you aware of the risks if you do become pregnant while taking Arthrotec as it may cause a miscarriage, premature birth, abnormal formation of the foetus (birth defects). You should NEVER take this medicine if you are pregnant, as it can also have severe consequences on your child, especially on the heart, lungs and/or kidneys, including death. If you have received
treatment with this medicine during pregnancy, talk with your doctor. If you decide to continue with the pregnancy, careful ultrasound scan monitoring of the pregnancy, with special attention to the limbs and head must be carried out.
Breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine if you are breast-feeding. Do not use Arthrotec while you are breast-feeding.
Driving and using machines
If you feel dizzy or drowsy after taking Arthrotec, do not drive and do not use any tools or machines until these effects have worn off