Amdocin 25 mg Capsules

AMDOCIN belongs to a group of medicines called non-steroidal anti-inflammatory medicines or NSAIDs. These work by reducing the body’s ability to produce inflammation, which may cause pain and discomfort. AMDOCIN reduces fever, pain and inflammation. Your doctor has prescribed AMDOCIN for you because you are suffering from one of the following:

• Rheumatoid arthritis (disease mainly of the joints).
• Osteoarthritis (disease of the joints).
• Ankylosing spondylitis (a form of arthritis which mainly affects the back).
• Muscle and bone disorders (musculoskeletal disorders), such as tendonitis, inflammation of the joints, sprains and strains.
• Pain and swelling in gout (a form of arthritis in which crystals build up in the joints).
• Fever in Hodgkin’s disease (a type of cancer).
• Fever (AMDOCIN is used in addition to the primary treatment for a short duration to assist in reducing the fever).
• Pain, inflammation and swelling following orthopaedic surgery or nonsurgical procedures (associated with repositioning bones after dislocation or fracture).
• Pain, inflammation and swelling following dental surgical procedures.
• Period pain.
• Low back pain.
• A disease where the cartilage that serves as a cushion in the joints of the hips deteriorates (degenerative joint disease of the hip).
• Fever, the reduction of symptoms in some conditions which may produce fever (febrile conditions).

Do not take AMDOCIN if you:

• are hypersensitive (allergic) to indomethacin or any of the other ingredients of AMDOCIN (listed in section 6),
• have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had episodes of peptic ulcers, stomach bleeding or perforation and bleeding related to previous use of NSAIDs,
• are taking a medicine called triamterene for swelling and high blood pressure,
• are taking a medication called diflunisal for pain, swelling, stiffness or joint pain,
• have polyps in your nose (teardrop-shaped, non-cancerous growths) due to swelling of the area under the skin,
• have had a history of asthma attacks, hives, or inflammation of the inside of the nose after taking aspirin or other NSAIDs, including AMDOCIN,
• have a history of sensitivity (allergy) that causes swelling of the face and mouth (angioedema) after taking NSAIDs, including AMDOCIN and/or aspirin,
• have heart failure or heart disease and/or cerebrovascular disease, e.g., if you have had a heart attack, stroke, 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),
• have a bleeding disorder,
• have inflammation of the stomach and/or intestines (gastritis, regional enteritis, ulcerative colitis),
• have kidney and/or liver failure,
• are pregnant, do not take NSAIDs such as AMDOCIN, at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby,
• are breastfeeding your baby.

Safety of AMDOCIN in children has not been established.

Warnings and precautions

AMDOCIN may lead to serious heart problems (cardiovascular events), stomach or intestinal problems (gastrointestinal events), or skin reactions (cutaneous reactions) which may lead to death. Take special care with AMDOCIN if:

Do not share medicines prescribed for you with any other person. Always take AMDOCIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use the lowest effective dose for the shortest possible duration of treatment. The usual dose of AMDOCIN is 25 mg two to three times per day taken with food. Do not take more than 200 mg of AMDOCIN per day. Your doctor will tell you how long your treatment with AMDOCIN will last. Do not stop treatment early because your doctor will monitor your recovery and advise you when to stop treatment. If you have the impression that the effect of AMDOCIN is too strong or too weak, tell your doctor or pharmacist.

AMDOCIN can have side effects. Not all side effects reported for AMDOCIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AMDOCIN, please consult your healthcare provider for advice.

If any of the following happens, stop taking AMDOCIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering and/or peeling of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS).
• eruption of lesions on the skin known as erythema multiforme,
• fever, flu-like symptoms, a painful red rash, may include purplish spots that spreads and blisters follow where the top part of the skin dies and peels off known as toxic epidermal necrolysis (TEN), or Drug Rash with Eosinophilia and System Symptoms (DRESS).

These are all very serious side effects. If you have them, you may have had a serious reaction to AMDOCIN. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).