Arthrotec

• Used to treat rheumatoid arthritis and osteoarthritis
• Painkiller with stomach coater
• Tablet for oral use
• Not to be used while pregnant or breastfeeding

ARTHROTEC contains two active ingredients:

• diclofenac, an antiinflammatory painkiller (NSAID), and
• misoprostol, which helps protect your stomach.

Diclofenac reduces pain and inflammation, for instance in the joints. This medicine is used to treat conditions such as rheumatoid arthritis (a condition in which the joints become inflamed) and osteoarthritis (joint disease caused by chronic wear of cartilage).

Although NSAIDs relieve the pain, they can reduce the amount of natural protective substances called prostaglandins in the stomach lining. This means that NSAIDs can lead to stomach upsets or stomach ulcers. ARTHROTEC also contains misoprostol which is very similar to these prostaglandins and helps protect your stomach.

ARTHROTEC tablets should be taken with food. The tablets should not be chewed but swallowed whole with some water.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The recommended dose in adults is:

• Arthrotec 50: one tablet two or three times a day.
• Arthrotec 75: one tablet twice a day.

ARTHROTEC is for adults only, it is not for use in children (under 18 years).

Alcohol/driving

This medicine does not interact with alcohol.

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.

If you use too much/forget to use/stop using ARTHROTEC

If you take too many tablets contact your doctor, pharmacist or hospital as soon as possible, and take your medicine with you.

If you forget to take a tablet, take it as soon as you remember. Do not use a double dose to make up for a forgotten one.

Do not stop using ARTHROTEC without talking to your doctor.

ARTHROTEC is not suitable for everyone. Do not use this medicine if:

• You think you may be allergic to diclofenac sodium, or any other NSAIDs, misoprostol or another prostaglandin medicine, or any of the other ingredients in ARTHROTEC (see section 'What ARTHROTEC contains').
• You currently have an ulcer or perforation (hole) in your stomach or intestines.
• You currently suffer from bleeding in your stomach, intestines or brain.
• You are undergoing or you have just had coronary artery bypass graft (CABG) surgery.
• You have severe kidney or liver failure.
• You have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, ministroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages (bypass surgery).
• You have, or have had, problems with your blood circulation (peripheral arterial disease).
• You 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.

When should this medicine be used with caution?

Make sure your doctor knows if:

• You smoke.
• You have diabetes mellitus.
• You have chest tightness or pain (angina), blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Talk to your doctor before using 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.
• You 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.
• You bleed or bruise easily.
• You have inflammation of the intestines (ulcerative colitis or Crohn’s disease).
• You have, or have ever had, asthma or an allergic disease.
• You have an infection, as ARTHROTEC may mask a fever or other signs of infection.
• You are dehydrated.
• You are over the age of 65 as your doctor will want to monitor you regularly.

See the package leaflet for more warnings associated with the use of ARTHROTEC.

Pregnancy and breastfeeding

Do not use ARTHROTEC if you are pregnant or want to become pregnant. Women who have not reached the menopause should use reliable contraception while they are taking ARTHROTEC.

Do not use ARTHROTEC if you are breastfeeding.

Other medicines and ARTHROTEC

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. ARTHROTEC is known to interact with the following medicines:

• Aspirin (acetylsalicylic acid) or other NSAIDs (e.g., ibuprofen).
• Medicines used to treat osteoarthritis or rheumatoid arthritis known as cyclooxygenase-2 (COX2) inhibitors.
• Diuretics (water pills).
• Ciclosporin or tacrolimus.
• Lithium.
• Digoxin.
• Warfarin or other oral anticoagulants (bloodthinning agents that reduce blood clotting).
• Certain medicines used to treat anxiety and depression known as Selective Serotonin Re‑uptake Inhibitors (SSRIs).
• Certain medicines used to control your blood sugar (oral hypoglycaemics for diabetes).
• Methotrexate.
• Steroid medications (e.g., corticosteroids).
• Medicines for high blood pressure.
• Magnesium containing antacids.
• Quinolone antibiotics.
• Ketoconazole.
• If you have taken a medicine called mifepristone (used to terminate pregnancy) within the last 12 days. ARTHROTEC should not be taken within 812 days of taking mifepristone.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Stop taking ARTHROTEC and get emergency medical help immediately if you have serious side effects, such as a stomach or intestinal ulcer, an allergic reaction or a decrease in a type of white blood cell (see the package leaflet for a list of symptoms).

Other side effects that are known to be associated with ARTHROTEC include:

Very common (may affect more than 1 in 10 people):

• Abdominal pain, diarrhoea, nausea, indigestion. See the package leaflet for more information.

Common (may affect 1 to 10 in every 100 people):

• Skin irritation and itching.
• Vomiting, wind, constipation, burping, gastritis (indigestion, stomach pain, vomiting).
• Ulcers in the stomach or intestines.
• Headache, dizziness.
• Difficulty sleeping.
• Changes in blood tests relating to the liver.

Uncommon (may affect 1 to 100 in every 1,000 people):

• Swelling of the mouth.
• Abnormal or unexpected bleeding from the vagina, menstrual disturbances.
• Reduction in the number of blood platelets (increased chance of bleeding or bruising).
• Purpura (purple spots on the skin).
• Hives (raised itchy rash).

For a complete list of possible side effects, see the package leaflet. Consult a doctor if the side effects are persistent, also if you experience side effects that are not listed on the package leaflet.

The active substances are diclofenac sodium and misoprostol. One ARTHROTEC tablet contains 50 mg or 75 mg diclofenac sodium and 0.2 mg misoprostol.

Read the package leaflet before use. The official package leaflet of ARTHROTEC is available for download here.