Pyrocaps 20 mg Capsules

PYROCAPS contains piroxicam which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Piroxicam contains properties for the management of pain, inflammation and fever.

PYROCAPS are used for the treatment of:

• Inflammatory disease of the joints (rheumatoid arthritis)
• wear and tear of joints (osteo-arthritis)
• progressive stiffening of the spine (ankylosing spondylitis)
• injuries or pain in the human musculoskeletal system, including the joints, ligaments, muscles, nerves, tendons, and the structures that support the limbs, neck and back. (acute musculoskeletal disorders)
• Arthritis caused by the formation of uric acid crystals in the joints. (Gout)

Do not take PYROCAPS:

• If you are hypersensitive (allergic) to piroxicam or any of the other ingredients of PYROCAPS (see section 6).
• are suffering from liver problems (hepatic dysfunction)
• if you have a history of stomach problems such as ulcers, Crohn’s disease, stomach cancers and inflammation/infections of the intestines.
• are suffering from internal bleeding of the stomach or intestines (gastro-intestinal haemorrhage)
• take aspirin and other non-steroidal anti-inflammatory medicines which cause symptoms of asthma, inflamed mucous membrane of the nose or raised red itchy areas of the skin.
• pregnant or breastfeeding
• under 12 years of age
• take anticoagulants (medicines that prevent blood clotting)
• if you had a previous serious allergic medicine reactions of any type, especially skin eruptions such as skin immune reaction (redness, rash), Steven-Johnson syndrome and toxic epidermal necrolysis.
• If you suffer from severe heart failure
• If you are pregnant and in the last trimester of your pregnancy
• If you are pregnant, do not use PYROCAPS at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause harm in your unborn baby.

Do not share medicines prescribed for you with any other person. Always take PYROCAPS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis: The usual daily dose is 20 mg (one capsule) given in a single dose. Long-term administration of doses higher than 30 mg carries an increased risk of gastrointestinal (stomach and intestines) side effects.

Acute musculoskeletal disorders: 40 mg (two capsules) initially for the first two days given in single or divided doses, thereafter, 20 mg (one capsule) for the remainder of the seven to fourteen day period.

Acute Gout: Therapy should be initiated by a single oral dose of 40 mg (two capsules) followed on the next four to six days by 40 mg (two capsules) given in a single or divided dosage. Pyrocaps® is not indicated for the long-term management of gout. Your doctor will tell you how long your treatment with PYROCAPS will last. Do not stop treatment early because you feel better. If you have the impression that the effect of PYROCAPS is too strong or too weak, tell your doctor or pharmacist.

If you take more PYROCAPS® CAPSULES than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Remember to take this leaflet and/or the package with you to show the doctor what you have taken.

If you forget to take PYROCAPS: If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose to make up for forgotten individual doses. You should contact your doctor on how to proceed.

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

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

• Extremely serious allergic skin reaction, rash, itching of the skin (Steven-Johnson Syndrome and toxic epidermal necrolysis)
• Stomach or intestinal ulcers with bleeding
• Prolonged bleeding time
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• Fixed drug eruptions (FDE) (may look like round or oval patches of redness and swelling of the skin), blistering (hives), itching. These are all very serious side effects. If you have them, you may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Swelling/fluid buildup especially in the ankles

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• ringing in the ears
• dizziness
• headache
• drowsiness
• blurred vision
• decreased red blood cell count

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effect you can help provide more information on the safety of PYROCAPS.

• Store all medicines out of reach of children.
• Store at or below 25 °C
• Store in the original package / container
• Protect from light
• Do not use after the expiry date stated on the label / carton / ampoule
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).