Ibucine 200 mg/400 mg Tablets

IBUCINE 200 mg: Each sugar coated tablet contains 200 mg ibuprofen. 206,7 mg sugar (lactose monohydrate & sucrose) IBUCINE 400 mg: Each film - coated tablet contains 400 mg ibuprofen. 320,4 mg sugar (lactose monohydrate & sucrose)

IBUCINE is used for the treatment of mild to moderate pain of inflammatory origin and fever, including:

• Soft tissue injuries such as sprains and strains
• headache
• back pain of musculo - skeletal origin
• fever
• muscular aches and pain
• menstrual pain
• toothache
• pain associated with migraine
• earache

Do not use IBUCINE Tablets:

• If you ……
• Are allergic to ibuprofen or any of the other ingredients in IBUCINE.
• Have experienced asthma, skin rash or any allergic - type reaction after taking aspirin, ibuprofen or any other non - steroidal anti - inflammatory drug.
• Have a history of perforation or bleeding from the stomach or bowel related to previous use of a medicine belonging to a class of medicines called non - steroidal antiinflammatory NSAID’s.
• Have or had a history of peptic ulceration, ulcerative colitis or Crohn’s disease.
• Have heart failure.
• Have renal failure.

Do not use IBUCINE during the third trimester of pregnancy, labour and delivery.

Take special care with IBUCINE:

• Speak to your doctor or pharmacist if you are allergic to ibuprofen or to any other substances such as other medicines, colourants, preservatives or foods.
• Speak to your doctor or pharmacist about all other medicines that you are taking. This includes other prescription medicines, medicines bought without a prescription, and herbal medicines. Taking any other medicine together with IBUCINE may cause undesirable interactions.
• Speak to your doctor if you have any other medical problems such as asthma, high blood pressure, heart failure, a stomach ulcer, bleeding from the stomach or bowel or any other gastric complaint.
• If your body cannot tolerate milk and dairy products (lactose intolerant). IBUCINE contains lactose monohydrate and should not be given to patients with rare hereditary problems or history of galactose intolerance, lapp lactose deficiency or glucose - galactose malabsorption.
• If you have a history of high blood pressure and/or heart failure.
• If you have a history of peptic ulcers and other stomach or bowel disease.
• If you experience any unusual abdominal symptoms (especially bleeding from the stomach or bowel) during treatment with IBUCINE.
• If you are an elderly person: The elderly have an increased frequency of adverse reactions to NSAIDs including IBUCINE, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal. Serious skin reactions, some of them fatal, have been reported in association with the use of nonsteroidal anti - inflammatory medicines such as IBUCINE. IBUCINE should be discontinued at the first appearance of skin rash, skin lesion or any other sign of hypersensitivity.

Always take IBUCINE exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of IBUCINE is too strong or too weak, talk to your doctor or pharmacist.

Usual dose of IBUCINE: The lowest effective dose should be used and for the shortest possible duration.

Adults: The recommended dose is 1200 mg daily in divided doses (1 to 2 tablets every four hours) for the relief of:

1. Mild to moderate pain of
• Soft tissue injuries such as sprains and strains
• Toothache
• Back pain of musculo - skeletal origin
• Earache
• Headache
• Pain associated with migraine
• Muscular ache and pains
• fever
• Period pain

Children: Not to be given to children under 12 years of age.

If you take more IBUCINE than you should: The most common symptoms of overdosage are pain in the upper middle part of the abdomen and nausea. Other symptoms include vomiting, dizziness, convulsion, loss of consciousness and depression of the central nervous system and respiratory system. If recently taken, gastric lavage will remove any unabsorbed IBUCINE. Treatment is symptomatic and supportive. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

If you forget to take IBUCINE: If you miss a dose of IBUCINE, take it as soon as you remember unless it is almost time for your next dose. If it is, do not take the missed dose at all. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR FORGOTTEN INDIVIDUAL DOSES.

IBUCINE can have side effects. If any of the following happens, stop taking IBUCINE and tell your doctor immediately or go to the casualty department at your nearest hospital:

Gastrointestinal system disorders: The most common side effects of IBUCINE include indigestion, nausea, vomiting, constipation, diarrhoea, abdominal pain, flatulence, black stools, vomiting of blood, bleeding from the stomach or bowel, headache, dizziness and rash.

Less frequent: abdominal discomfort or pain, nausea, vomiting, gastro - intestinal ulcers, sometimes with bleeding.

Immune disorders: Less frequent: Aseptic meningitis (non - infectious inflammation of the membranes covering the brain), angioedema (type of swelling that affects deeper layers in your skin, often around your eyes and lips), anaphylaxis (a severe, potentially life - threatening allergic reaction to something you're allergic to). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to IBUCINE. 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:

Nervous system disorder: Frequent: Dizziness, nervousness, tinnitus (ringing sound in the ear), drowsiness, insomnia.

Psychiatric disorder: Frequent: Depression.

Eye disorders: Visual impairment, changes in visual colour perception, toxic amblyopia (lazy eye syndrome).

Renal and Urinary disorders: Less frequent: Acute renal failure, cystitis (inflammation of the bladder), haematuria (blood in urine), interstitial nephritis (swelling of the kidney), nephrotic syndrome (kidney disorder that causes your body to excrete too much protein in your urine).

Hepatobiliary syndrome: Less frequent: Hepatotoxicity (liver damage), abnormalities in liver function tests.

Blood and lymphatic system disorders: Less frequent: low blood cell count (Anaemia, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis).

Hypersensitivity disorders: Less frequent: Fever, rashes, exacerbation of asthma and bronchospasm.

Cardiovascular disorders: Frequency unknown: Oedema (swelling), hypertension and cardiac failure.

Skin and subcutaneous tissue disorders: Frequency unknown: Bullous reactions (sensitivity of the skin to the sun, blistering and swelling), including Stevens - Johnson syndrome and toxic epidermal necrolysis. These are all serious side effects. You may need urgent medical attention.

Not all side effects reported for IBUCINE are included in this leaflet. Should your general health worsen while taking IBUCINE, please consult your doctor, pharmacist or other health care professional for advice.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/publications/index/8

Keep all medicines out of the reach and sight of children. Store at or below 25°C. Return any unused or expired medicines to your pharmacist for safe disposal.