K-Fenak 1,16 % Gel

K-FENAK GEL belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and provides a local anti-inflammatory and analgesic effect in inflammatory reactions. This means it will help to relieve pain and reduce swelling affecting the joints.

K-FENAK GEL is used for:

• the symptomatic relief of localised, traumatic inflammation and pain.

Do not use K-FENAK GEL:

• if you are allergic to diclofenac, acetylsalicylic acid (aspirin) and other non-steroidal anti-inflammatory drugs such as ibuprofen, as well as to isopropyl alcohol or propylene glycol, or any of the other ingredients of K-FENAK GEL (listed in section 6).
• if you are allergic to aspirin or other anti-inflammatory drugs (NSAIDs), which may arise as asthma, rhinitis, angio-oedema or urticaria.
• if you have porphyria.
• if you are a child.
• if you are pregnant or breastfeeding your baby (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Take special care with K-FENAK GEL:

• when applying on large areas of skin and over a prolonged period of time, unless under medical advice.
• if you are using any other medicines containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen.
• if you have liver and kidney problems.
• if local irritation develops.
• temporary skin discolouration or staining of clothing may occur if K-FENAK GEL is not rubbed in completely.
• do not apply the gel to skin that has a rash, eczema, cuts or an open wound. K-FENAK GEL should only be applied to skin surfaces that are intact.
• K-FENAK GEL should only be applied to the skin and should not be taken by mouth.
• if you have asthma and have experienced asthma attacks, hives or runny nose when taking acetylsalicylic acid (aspirin) or other painkillers such as naproxen, or ibuprofen.
• if you are sunbathing or using sun lamps as your skin may be more sensitive to sunlight.
• K-FENAK GEL can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
• if you currently, or previously suffered from a stomach or duodenal ulcer tell your doctor or pharmacist before using K-FENAK GEL.
• Risk of renal impairment and low potassium levels are associated with non-steroidal anti-inflammatory medicine (NSAID) usage.
• if you are pregnant or breastfeeding your baby (see “Do not use K-FENAK GEL”).

Other medicines and K-FENAK GEL

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Ask your doctor or pharmacist for advice before you use K-FENAK GEL if you are also taking lithium (used for mood disorders), or acetylsalicylic acid (aspirin).

Do not share medicines prescribed for you with any other person.

Always use K-FENAK 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.

Depending on the size of the painful site to be treated, apply 2 g to 4 g K-FENAK GEL three to four times daily to the skin and rub in gently. After application, your hands should be washed, unless they are the site being treated. The duration of treatment will be determined by the initial indication and the relief obtained. Treatment should be reviewed after two weeks. Use the lowest effective dose for the shortest possible duration of treatment.

Children: Not recommended.

If you use more K-FENAK GEL than you should

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 K-FENAK GEL

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

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

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

• hypersensitivity (allergic) reaction manifested by cutaneous rash (skin eruption with redness), shortness of breath, and difficulty of swallowing.
• wheezing, shortness of breath or feeling of tightness in the chest (bronchospasm, or asthma).
• blistering skin rash (erythema multiforme), or hives (urticaria). These are all very serious side effects. If you have them, you may have had a serious reaction to K-FENAK GEL. 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:

• yellowing of the skin and eyes (jaundice), dark urine, pale stool and tiredness which may be symptoms of liver problems (hepatitis). 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:

• skin rash, or dry, scaly patches on the skin (eczema).
• reddening of the skin (erythema), skin inflammation (dermatitis), or itching (pruritis).

Less frequent side effects:

• pimple forming skin rash.
• bruising of the skin, unusual bleeding, pinpoint red spots on the skin, bleeding from the gums, pale skin, shortness of breath upon exertion, unusual tiredness or weakness, fever and chills, as these symptoms may be due to abnormal blood cell and platelet counts.
• swelling of the legs, ankles or feet (peripheral oedema).
• nausea, stomach pain, bloody or tarry stools, or vomiting blood or a substance that looks like coffee grounds, as these may be symptoms of a stomach ulcer or bleeding.
• skin rash in areas exposed to the sun.
• decreased urine or foamy urine, swelling of the ankles or feet, shortness of breath and loss of appetite, as these may be symptoms of kidney problems or kidney failure.

Side effects with unknown frequency:

• headache, or slight dizziness.
• stomach pain, eructation (burping or belching), nausea, diarrhoea.
• skin irritation, peeling or flaky skin (desquamation), skin discolouration.

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 K-FENAK GEL.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store in a well closed container, protected from moisture.

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.