Rheugesic 20 mg Dispersible Tablets

RHEUGESIC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and also possesses analgesic and antipyretic properties. This means it will help to relieve pain and reduce swelling affecting the joints. RHEUGESIC is used for:

• For the emergency treatment of acute gout attacks.
• For the treatment of post-traumatic conditions.

Do not take RHEUGESIC:

• if you have a history of stomach or intestinal ulcer, bleeding or perforation
• if you are sensitive to aspirin or hypersensitive (allergic) to piroxicam (active ingredient in this medicine)
• If you are pregnant or breastfeeding your baby (see “PREGNANCY AND LACTATION”).
• If you have porphyria
• If you are under the age of 12 years

Warnings and precautions

Take special care with RHEUGESIC:

• If you suffer from severe heart failure
• If you have liver or renal failure
• If you are taking anticoagulants such as warfarin to prevent blood clots.
• If you experience blurred vision or diminished vision or changes in colour vision.

Other medicines and RHEUGESIC

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

RHEUGESIC with food and drink

Take RHEUGESIC with food or soon after eating.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking RHEUGESIC. RHEUGESIC should not be taken while you are pregnant or breastfeeding your baby. Do not take RHEUGESIC around 20 weeks or later in pregnancy as it may cause kidney problems in your unborn baby, which may lead to low levels of amniotic fluid that surrounds the baby. This fluid provides a protective cushion and helps the unborn baby's lungs and muscles develop. Complications can occur with low levels of this fluid.

Driving and using machines

It is not always possible to predict to what extent RHEUGESIC may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which RHEUGESIC affects them.

Important information about some of the ingredients of RHEUGESIC. RHEUGESIC contains lactose. Patients with a rare hereditary condition of lactose or galactose intolerance should not take RHEUGESIC.

Do not share medicines prescribed for you with any other person. Always take RHEUGESIC exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

Post-traumatic conditions

Take 20 mg (one tablet) daily for a maximum treatment period of 5 days.

Acute gout

Take 20 mg (one tablet) daily for a maximum treatment period of 5 days. RHEUGESIC (piroxicam) is not indicated for the long-term management of gout. RHEUGESIC Dispersible Tablets form a rapid dispersion in water and may either be taken whole with fluid or dispersed in a minimum of 50 mL water and then swallowed.

If you take more RHEUGESIC than you should

If you take more RHEUGESIC than you should, you may experience an increase in side effects (see Possible side effects). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take RHEUGESIC

Do not take a double dose to make up for forgotten individual doses.

RHEUGESIC can have side effects. Not all side effects reported for RHEUGESIC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RHEUGESIC, please consult your healthcare provider for advice. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• asthma or worsening of asthma, shortness of breath or trouble breathing
• fever, rash
• any sign of bleeding in the stomach or intestines
• blurred vision or changes in vision
• anaemia (low red blood cells)
• liver problems, kidney problems

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• Abdominal discomfort, nausea, vomiting, abdominal pain
• Headache, dizziness, nervousness, tinnitus (ringing in ears), depression, drowsiness and insomnia.

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. 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. Side effects may also be reported directly to Cipla Medpro (Pty) Ltd: [email protected]. By reporting side effects, you can help provide more information on the safety of RHEUGESIC.

Store all medicines out of reach of children. Store below 25 °C in a dry place. Protect from light. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.