Mybulen 200 mg/10 mg/350 mg Film-Coated Tablets

MYBULEN contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. MYBULEN also contains ibuprofen. Ibuprofen, a non-steroidal anti-inflammatory medicine (NSAID), also acts to reduce swelling (inflammation). MYBULEN also contains paracetamol. Paracetamol, an analgesic, acts to relieve pain. MYBULEN is indicated for the relief of mild to moderate pain of inflammatory origin with or without fever for a maximum period of 5 days.

Do not take MYBULEN:

• if you are hypersensitive (allergic) to ibuprofen, paracetamol, codeine phosphate or any of the other ingredients of MYBULEN (listed in section 6).
• if you have had a history of stomach (gastrointestinal) perforation, ulceration or bleeding in the stomach or small intestine (duodenum) (PUBs) related to previous use of medicines for pain and inflammation such as non-steroidal anti-inflammatory medicines (NSAIDs).
• if you have an active or a history of recurrent stomach (gastrointestinal) ulcers, bleeding or perforations.
• if you have liver or kidney problems.
• if you are hypersensitive to aspirin or other non-steroidal anti-inflammatory medicines. This is because of the possibility of cross-sensitivity due to structural relationships, which exists among non-steroidal anti-inflammatory medicines (NSAIDs); acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
• if you have heart failure or heart disease secondary to chronic lung disease.
• if you have or have had cardiovascular diseases (you may have had chest pain, or tightness, or discomfort, shortness of breath; or pain, numbness, weakness or coldness in your legs or arms, if the blood vessels in those parts of your body are narrowed; or you might have had a blood clot).
• if you have respiratory depression, acute asthma, uncontrolled asthma, difficulty breathing or breathing problems, head injuries or increased pressure inside the skull.
• if you regularly drink large quantities of alcohol (acute alcoholism).
• if you have had operations on your biliary tract (for example your liver, gall bladder or bile ducts).
• if you are taking a medicine classified as a monoamine oxidase inhibitor (MAOI), or within 14 days of stopping such treatment.
• if you are taking coumarin anticoagulants (blood-thinning tablets).
• if you have nasal polyps associated with aspirin-induced bronchospasm.
• if you are pregnant, do not use NSAIDs, including MYBULEN at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby.
• if you are breastfeeding your baby, as the safety in breastfeeding has not been established.

Warnings and precautions

Take special care with MYBULEN: MYBULEN contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Always take MYBULEN exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure. Do not share medicines prescribed for you with any other person.

Adults (over the age of 12 years) The usual dose of MYBULEN is one to two tablets every six hours if necessary. Do not take more than 6 tablets in a 24 hour period. Consult your healthcare provider if you require further treatment after 5 days. If you have the impression that the effect of MYBULEN is too strong or too weak, talk to your doctor or pharmacist. MYBULEN is not recommended for children 12 years of age and younger. Use the lowest effective dose for the shortest possible duration of treatment. Exceeding the prescribed dose, together with prolonged and continuous use of MYBULEN, may lead to dependency and addiction. DO NOT EXCEED THE RECOMMENDED DOSAGE.

If you take more MYBULEN than you should MYBULEN contains paracetamol, which may be fatal in overdose. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Immediate medical attention is critical. Even if you do not show symptoms of an overdose, go immediately to your nearest hospital or poison centre. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), or severe diarrhoea. In addition to these symptoms, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, shaky eye movement and exacerbation of asthma in asthmatics. At high doses, drowsiness, excitation, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness and dizziness, blood in urine, low blood pressure, hyperkalaemia, metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold body feeling, and breathing problems have been reported.

If you forget to take MYBULEN Take your missed dose as soon as you remember, if within a few hours after missing a dose. If you only remember about the missed dose the following day, do not take a double dose to make up for forgotten individual doses.

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

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Drug-induced hypersensitivity syndrome (DIHS), Acute Generalised Exanthematous Pustulosis (AGEP), or Fixed Drug Eruption (FDE). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYBULEN. 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:

• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick), or vomiting (being sick) as you may be experiencing inflammation in your bowel, colon (colitis), or digestive tract (Crohn’s disease), or complications of the large bowel (perforation or fistula),
• stomach (peptic) ulceration, perforation or any sign of bleeding in the stomach or intestine (gastrointestinal haemorrhage), such as, black, tarry stools when emptying your bowels (melaena) or vomiting blood (haematemesis), which may be fatal,
• yellowing of skin or the whites of your eyes (jaundice).
• an unexpected change in the amount of urine passed, its frequency and/or its appearance,
• kidney failure or liver failure,
• kidney disease which affects the ability of the kidney to remove acids properly from your blood into your urine (renal tubular acidosis). This may also cause you to feel lightheaded or have weakness of your muscles,
• very low levels of sodium in your blood,
• heart failure, chest pain, low blood pressure, irregular heartbeat, or abnormal heart rhythm; symptoms include palpitations, dizziness, fainting, shortness of breath and chest discomfort,
• severe fall in blood pressure or life-threatening shock,
• breathing disorders such as slow, ineffective or difficulty breathing which may cause wheezing or coughing, asthma attacks,
• inflammatory lung disorder with symptoms of coughing and rapid, shallow breathing which may develop even with moderate exercise (alveolitis),
• sudden filling of your lungs with water, resulting in difficulty to breathe, high blood pressure, water retention and weight gain,
• brain injury or increasing pressure inside your skull,
• aseptic meningitis with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation. 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:

• Dizziness,
• heartburn, indigestion, stomach cramps and pain, nausea, constipation, diarrhoea, vomiting and wind.

Less frequent side effects:

• Inflammation of the mucous members in the nose, which may cause a stuffy or runny nose (rhinitis),
• mouth ulcers and inflammation,
• feeling tired and weak,
• blood disorders such as decrease in white blood cells, decrease in red blood cells. The first symptoms may include fever, sore throat, surface mouth ulcers, flu-like symptoms, severe tiredness, nasal and skin bleeding or unexplained bruising,
• confusional state, nervousness, sleeplessness, depression, restlessness, anxiety, changes in mood, hallucination, drowsiness, headache,
• a feeling of intense excitement and happiness,
• spinning (vertigo), agitation, irritability,
• blurred vision, small pupil of the eye (miosis), other ocular (eye) reactions,
• ringing in the ears,
• bloating, dry mouth, decreased appetite,
• abnormalities of liver function tests, inflammation of the liver,
• impairment of kidney function, kidney pain,
• inflammation of the pancreas with symptoms of nausea, vomiting and stomach pain,
• sweating, facial flushing, difficulties in passing urine, ureteric or biliary spasm,
• drop in body temperature (hypothermia),
• increased sensitivity to sunlight (photosensitivity),
• butterfly-shaped rash on the face (lupus erythematosus syndrome),
• hair loss,
• increase of blood urea nitrogen, serum transaminases and alkaline phosphatase, which will be shown by laboratory tests,
• decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease of serum calcium and increase in serum uric acid values, which will be shown by laboratory tests.

Side effects with an unknown frequency:

• Tingling of the hands and feet,
• fluid retention
• hearing problems,
• general feeling of being unwell,
• inflammation of the optic (eye) nerve which may cause eye problems,
• headache, nausea, vomiting, confusion, dizziness, feeling weak or tired, loss of appetite and increased heartbeat due to high acid levels in the body (metabolic acidosis or pyroglutamic aciduria).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of MYBULEN.

Store all medicines out of reach of children. Store at or below 25 °C, in a well closed container. Protect from light. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).