Rheugesic 5 mg Gel

RHEUGESIC GEL 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 GEL is used for:

• The symptomatic treatment of musculoskeletal and joint disorders, such as osteoarthritis of superficial joints, peri-arthritis, tendinitis, soft tissue disorders and acute musculoskeletal injuries.

Do not use RHEUGESIC GEL:

• If you are hypersensitive (allergic) to piroxicam or any of the other ingredients in RHEUGESIC GEL (listed in section 6).
• If you are allergic to aspirin or other anti-inflammatory medicines.
• If you have porphyria.
• If you are under the age of 12 years.
• If you are pregnant or breastfeeding your baby (see section 2).

Warnings and precautions

Take special care with RHEUGESIC GEL:

• Life-threatening skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of RHEUGESIC GEL, appearing initially as reddish target-like spots or circular patches often with central blisters on the body. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and red swollen eyes (see section 4).
• These potentially life-threatening skin reactions are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• The highest risk of occurrence of serious skin reactions is within the first week of treatment.
• If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of RHEUGESIC GEL, you must not be re-started on treatment with RHEUGESIC GEL at any time.
• Cases of fixed drug eruption (FDE) have been reported with piroxicam, as contained in RHEUGESIC GEL. Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams (medicines from the same group as RHEUGESIC GEL). Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesion or any other sign of hypersensitivity (allergy).
• Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses (skin defect) or infection.
• Inform your doctor if you suffer from kidney disease as RHEUGESIC GEL may affect your kidneys.

Other medicines and RHEUGESIC GEL

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). RHEUGESIC GEL is not known to interact with any other medicines.

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 using RHEUGESIC GEL.

Pregnancy

RHEUGESIC GEL should not be used while you are pregnant (see section 2). Do not use RHEUGESIC GEL 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.

Breastfeeding

RHEUGESIC GEL should not be used while you are breastfeeding your baby (see section 2). Piroxicam, as contained in RHEUGESIC GEL, is passed into breast milk and may also inhibit lactation (ability to produce milk).

Fertility

RHEUGESIC GEL may cause reversible infertility in some women. In women who have difficulties conceiving (falling pregnant) or who are undergoing investigation of infertility, withdrawal of RHEUGESIC GEL should be considered.

Driving and using machines

It is not always possible to predict to what extent RHEUGESIC GEL 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 GEL affects them.

RHEUGESIC GEL contains:

• Benzyl alcohol which may cause mild local irritation.
• Chlorocresol which may cause allergic reactions.
• Propylene glycol which may cause skin irritation. Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.

Do not share medicines prescribed for you with any other person. Always use RHEUGESIC GEL 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: Apply 3 cm of gel to the affected area, three to four times daily. Treatment should be reviewed after 2 weeks. Use the lowest effective dose for the shortest possible duration of treatment.

If you use more RHEUGESIC GEL than you should

If you use more RHEUGESIC GEL than you should, you may experience an increase in side effects (see section 4). 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 use RHEUGESIC GEL

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

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

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

• Hypersensitivity reaction (allergic reaction) which includes swelling of the hands and feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Severe skin peeling and blistering (toxic epidermal necrolysis).
• Stevens-Johnson syndrome (severe skin reaction causing painful rash that spreads and blisters).

Tell your doctor if you notice any of the following:

Less frequent side effects:

• Nausea.
• Dyspepsia (indigestion).
• Abdominal pain.
• Gastritis (inflammation of the lining of the stomach).
• Nephrotic syndrome (a kidney disorder that causes the body to excrete too much protein in the urine).
• Interstitial nephritis (inflammation of an area of the kidney).

Side effects with unknown frequency:

• Bronchospasm (wheezing or coughing).
• Dyspnoea (shortness of breath).
• Fixed drug eruption (skin rash, mucosal lesions or any other sign of allergy).
• Skin rash.
• Erythema (reddening of the skin).
• Pruritus (itching of the skin).
• Phototoxic reactions (increased sensitivity of the skin to sunlight).
• Contact dermatitis (itchy rash caused by direct contact with RHEUGESIC GEL).
• Eczema (dry, itchy, inflamed skin).
• Pemphigus vulgaris (problem with the immune system causing blisters in the mouth and on the skin).
• Mild to moderate local irritation.

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.: at [email protected] or telephone 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of RHEUGESIC GEL.

Store at or below 25 °C in a dry place. Keep tube well closed. Store all medicines out of reach of children.

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.