Ibugesic Plus 200 mg/250 mg Capsules

IBUGESIC PLUS contains paracetamol, which has analgesic (pain relieving) and antipyretic (reduces fever) effects, and ibuprofen, which has analgesic, antipyretic and anti-inflammatory activities. IBUGESIC PLUS is used in the treatment of mild to moderate pain of inflammatory origin or non-inflammatory origin with or without fever.

Do not take IBUGESIC PLUS:

• If you are hypersensitive (allergic) to the ibuprofen or paracetamol or to any of the inactive ingredients of IBUGESIC PLUS (listed in section 6).
• If you have a history of gastrointestinal perforation, ulceration or bleeding related to previous nonsteroidal anti-inflammatory medicines (NSAIDs) therapy, including IBUGESIC PLUS.
• If you have a history of recurring or an active stomach ulcer/haemorrhage/perforation (two or more confirmed cases of gastrointestinal ulceration or bleeding).
• If you have previously had hypersensitivity reactions (e.g. asthma, running nose, swelling or a rash) after having taken aspirin or other anti-inflammatory medication.
• If you have a bleeding disorder.
• If you have heart failure.
• If you have liver failure or kidney failure.
• If you are pregnant due to risk of kidney dysfunction in the unborn babies.
• If you are breastfeeding your baby.
• If you have uncontrolled asthma or breathing difficulties.
• If you have nasal polyps due to aspirin-induced asthma.
• If you are taking certain blood thinning medication.

Warnings and precautions

Take special care with IBUGESIC PLUS: IBUGESIC PLUS should not be used with other nonsteroidal anti-inflammatory medicines (NSAIDs), including cyclooxygenase-2 selective inhibitors. IBUGESIC PLUS should not be used with other products containing paracetamol, due to the risk of severe liver damage as a result of paracetamol overdose (see “If you take more IBUGESIC PLUS than you should”). Paracetamol overdose could lead to death.

Do not share medicines prescribed for you with any other person. Always take IBUGESIC PLUS exactly as described in this leaflet or your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. DO NOT EXCEED THE RECOMMENDED DOSE. If you have the impression that the effect of IBUGESIC PLUS is too strong or too weak, talk to your doctor or pharmacist. IBUGESIC PLUS is for oral administration and short term use only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see “Take special care with IBUGESIC PLUS”). IBUGESIC PLUS should not be used by children under 12 years of age. Adults and children over 12 years: 2 capsules every 4 hours when necessary. Do not take more than 6 capsules (1200 mg ibuprofen and 1500 mg paracetamol) in 24 hours. Consult your doctor immediately:

• If you are taking IBUGESIC PLUS for pain and the pain continues for longer than 7 days.
• If you are taking IBUGESIC PLUS for fever and the fever continues for longer than 3 days.
• If your condition deteriorates.
• If new symptoms develop.

In adolescents (age range: 12 years to < 18 years): If in adolescents IBUGESIC PLUS is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

IBUGESIC PLUS can have side effects. Not all side effects reported for IBUGESIC PLUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking IBUGESIC PLUS, please consult your healthcare professional for advice. If any of the following happens, stop taking IBUGESIC PLUS and tell your doctor immediately or go casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• rash or itching
• fainting
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to IBUGESIC PLUS. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the following:

• Oedema (swelling of your body and limbs)
• Heart failure or heart attack
• Abnormal heart beat
• Increased heart rate
• High or low blood pressure
• Stroke
• Aseptic meningitis (inflammation of the linings of the brain with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation)
• Blood disorders, which may affect red blood cells, white blood cells or blood platelets
• Kidney damage or failure (e.g. causing increased or decreased urination, swelling of the legs)
• Gastrointestinal bleeding, ulcers and perforation
• Gastrointestinal ulcers
• Exacerbation of colitis (inflammation of the intestines) and Crohn’s disease (inflammation of the gastrointestinal tract)
• Inflammation of the stomach lining (gastritis), oesophagus (the tube from the throat entering the stomach) or pancreas
• Stomach pain
• Black, tarry stools
• Vomiting blood
• Liver damage or failure
• Increased liver enzymes
• Abnormal liver function test results
• Skin rash or itching, which may include redness, hives (red itchy bumps), blisters, pustules or peeling of the skin (toxic epidermal necrolysis) and bleeding in the lips, eyes, mouth, nose and genitals (toxic epidermal necrolysis or Stevens-Johnson Syndrome).
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells)
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
• Depression or psychotic (mental) reactions.

These are all serious side effects and you may need urgent medical attention.

Keep well closed and store at or below 25 °C. Protect from light. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Do not use the capsules after the expiry date printed on the blisters and containers. Decomposed products may be toxic. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).