Nurofen Express 342 mg/200 mg Tablets

The active ingredient is ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature.

NUROFEN EXPRESS is indicated for the short-term relief of headache and back pain of musculo-skeletal origin, feverishness, muscular aches and pain, menstrual pain, dental pain and for the relief of pain associated with migraine.

Do not take NUROFEN EXPRESS if:

• You are hypersensitive (allergic) to ibuprofen or any of the other ingredients of NUROFEN EXPRESS (listed in section 6).
• You have or have had stomach ulcer, perforation or bleeding related to previous NSAIDs.
• You have had a worsening of asthma, skin rash, itchy runny nose or hives after taking ibuprofen, aspirin or similar medicines.
• You are pregnant or breastfeeding.
• You are suffering from heart failure.
• You have severe kidney or liver problems.
• You are under 12 years old.

Warnings and precautions

Take special care with NUROFEN EXPRESS:

• If you have or have had high blood pressure.
• If you are elderly, as you are more likely to experience the side effects listed in this leaflet.
• If you have a history of gastrointestinal bleeding or perforation (PUBs).
• If you have kidney or bowel problems.
• If you have asthma or other allergies.
• If you are taking medicines for treating blood clotting conditions (coumarin anticoagulants).
• If you have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders).

Treatment with NUROFEN EXPRESS may lead to the following problems. If any of the following happens, discontinue treatment and consult your doctor:

• Drug reaction with eosinophilia and systemic symptoms (DRESS): life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abnormal heartbeat.
• Severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis: these are indicated by fever and body aches, painful/reddish rash on the skin, mouth, throat and/or genitals followed by blistering.
• Fertility problems in women: NUROFEN EXPRESS may cause impairment of female fertility but this is reversible upon withdrawal of treatment.

Do not share medicines prescribed for you with any other person. Always take NUROFEN EXPRESS 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.

The usual dose is:

Adults and children over 12 years: Initial dose 2 tablets taken with water, then if necessary, 1 or 2 tablets every four hours. Do not exceed 6 tablets in any 24 hours. Do not give to children under 12 years.

If symptoms persist for more than 7 days or worsen or if new symptoms occur, consult your doctor. Use the lowest effective dose for the shortest duration of treatment.

If you take more NUROFEN EXPRESS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take NUROFEN EXPRESS

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

NUROFEN EXPRESS can have side effects. Not all side effects reported for NUROFEN EXPRESS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NUROFEN EXPRESS, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• Signs of intestinal bleeding such as bright red faeces, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• Signs of serious allergic reaction such as difficulty breathing or unexplained wheezing, dizziness or faster heartbeat, swelling of mouth, throat and face or limbs.
• Asthma or worsening of your asthma.
• DRESS syndrome: life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abnormal heartbeat.
• Severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis: these are indicated by fever and body aches, painful/reddish rash on the skin, mouth, throat and/or genitals followed by blistering.
• Severe low blood pressure (can be indicated by fainting or loss of consciousness).

These are all very serious side effects. If you have them, you may have had a serious reaction to NUROFEN EXPRESS. 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:

• Less frequent side effects:
• Blood disorders, this can make you prone to opportunistic illnesses, bruising easily and being prone to bleeding. First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
• Aseptic meningitis (inflammation of the brain): signs include stiff neck, headache, nausea, vomiting, fever or disorientation.
• High blood pressure.
• Vomiting blood.
• Painful ulcers in the stomach and mouth.
• Bleeding in the gut.
• Liver disease (may be indicated by tummy pain and yellowing of the eyes and skin).

Side effects with unknown frequencies:

• Heart disease: may be indicated by chest pain, fatigue, leg swelling and/or shortness of breath.
• Kidney disease: signs may include reduced urine output, nausea and swelling of feet/legs and ankles.

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

• Less frequent side effects:
• Skin rash.
• Abdominal pain, nausea, diarrhoea (runny tummy), flatulence, indigestion, constipation, vomiting, black or tarry stools.
• Various skin rashes.
• Pain.

Side effects with unknown frequencies:

• Photosensitivity reactions.

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NUROFEN EXPRESS.

Store all medicines out of the reach of children. Store at or below 30 °C in a dry place, protected from light. Store in the original package. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage (systems e.g. toilets).