FLAMUGO contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). FLAMUGO is used to reduce inflammation and pain.
1. WHAT FLAMUGO IS AND WHAT IT IS USED FOR:
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLAMUGO:
Do not use FLAMUGO:
- if you are hypersensitive (allergic) to diclofenac, aspirin, other non-steroidal anti-inflammatory medicines or any of the other ingredients of FLAMUGO (listed in section 6)
- if you have previously developed breathing problems (asthma, bronchospasm), skin reactions (hives), runny nose, or swelling of the face or tongue after taking/using diclofenac or acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen)
- in the third trimester of pregnancy (see Pregnancy)
- if you have porphyria (a group of disorders that can cause nerve or skin problems).
Warnings and precautions:
Take special care with FLAMUGO: Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. FLAMUGO should only be applied to the skin and should not be taken by mouth. FLAMUGO should not come into contact with eyes. Stop the treatment if a skin rash develops after applying FLAMUGO. Do not use FLAMUGO under airtight occlusive dressings (i.e. a dressing that does not allow air or moisture in). It may be used with a non-occlusive dressing (i.e. a dressing that allows the wound to breathe). Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice. Due to an increased possibility of side effects, take care if you are using any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen. Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight. If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel. Do not smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with FLAMUGO burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Children and adolescents: FLAMUGO is contraindicated in children under 12 years.
3. HOW TO USE FLAMUGO:
Do not share medicines prescribed for you with any other person. Always use FLAMUGO exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure. FLAMUGO is used 3 to 4 times daily. Depending on the size of the affected site to be treated, a cherry or walnut-sized quantity, corresponding to 2 to 4 g of gel is required.
How to apply:
FLAMUGO is for use on the skin only. Apply the gel to the affected parts of the body thinly and rub gently into the skin. After application you should wash your hands, unless they are the site being treated.
Duration of treatment:
The duration of use depends on the symptoms and the underlying disease. If symptoms worsen or do not improve after 7 days, a doctor should be consulted. It is recommended that treatment be reviewed after 2 weeks.
If you use more FLAMUGO than you should: An overdose is unlikely to happen if you use more FLAMUGO than you should, because the absorption into the blood stream is low when used on the skin. If the recommended dose is significantly exceeded when used on the skin, the gel should be removed and washed off with water. If you accidentally swallow FLAMUGO, contact your doctor or pharmacist who will decide on the appropriate measures. If neither is available, contact the nearest hospital or poison centre. If you forget to use FLAMUGO: Apply it as soon as you remember. Do not use a double dose to make up for a forgotten application. If you have any further questions on the use of FLAMUGO, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS:
FLAMUGO can have side effects. Not all side effects reported for FLAMUGO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using FLAMUGO, please consult your healthcare provider for advice. If you experience any of the following signs of allergy, stop using FLAMUGO and tell your doctor immediately or go to the casualty department at your nearest hospital:
- skin rash with blisters; hives
- wheezing, shortness of breath or feeling of tightness in the chest (asthma)
- swelling of the face, lips, tongue or throat.
These are all very serious side effects. If you have them, you may have had a serious reaction to FLAMUGO. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
Frequent side effects:
- skin rash; itching; reddening; eczema; dermatitis (inflammation of the skin) including contact dermatitis.
Less frequent side effects:
- skin peeling, discolouration of skin
- pustular rash (pus filled pimples), sensitivity to light with appearance of skin reactions after exposition to sunlight.
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, pharmacist or nurse. You can also report side effects to SAHPRA via the Adverse drug reaction and quality problem reporting form, found online under SAHPRA’s publications: https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/. By reporting side effects, you can help provide more information on the safety of FLAMUGO.
5. HOW TO STORE FLAMUGO:
Store all medicines out of reach of children. Do not store above 25 °C. Store in the original tube in order to protect from light. Do not use after the expiry date stated on the carton and label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).