Mybulen 200 mg/10 mg/250 mg/10 ml Suspension

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

Do not take MYBULEN SUSPENSION:

• if you are hypersensitive (allergic) to ibuprofen, paracetamol, codeine phosphate or any of the other ingredients of MYBULEN SUSPENSION (listed in section 6).
• if you have had a history of stomach (gastrointestinal) perforation, ulceration and 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 had operations on your biliary tract (for example your liver, gall bladder or bile ducts).
• if you have an active or a history of recurrent stomach (gastrointestinal) ulcers, bleeding or perforations.
• if you have any bleeding disorders.
• if you have liver or kidney problems.
• 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 heart failure or heart disease secondary to chronic lung disease.
• if you have had allergic reactions such as runny nose, itchy skin, rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other medicines for pain and inflammation (NSAIDs) (if you are sensitive to aspirin or NSAIDs).
• if you currently have an asthma attack, have uncontrolled asthma, difficulty breathing or breathing problems (bronchospasm).
• if you have nasal polyps associated with aspirin-induced bronchospasm.
• 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 regularly drink large quantities of alcohol.
• if you have respiratory depression, a head injury or a condition where the pressure inside your skull has increased.
• if you have a newborn baby, as MYBULEN SUSPENSION contains sodium benzoate, which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• if you have severe diarrhoea associated with pseudomembranous colitis.
• if you are pregnant, do not use NSAIDs, including MYBULEN SUSPENSION, 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.

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

The usual dose of MYBULEN SUSPENSION is:

Consult your healthcare provider if no relief is obtained with the recommended dosage. Use the lowest effective dose for the shortest possible duration of treatment.

DO NOT EXCEED THE RECOMMENDED DOSE. Prolonged use of MYBULEN SUSPENSION may lead to dependency and addiction. If you have the impression that the effect of MYBULEN SUSPENSION is too strong or too weak, talk to your doctor or pharmacist.

If you take more MYBULEN SUSPENSION than you should MYBULEN SUSPENSION 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, exacerbation of asthma in asthmatics may occur. 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 SUSPENSION take your missed dose as soon as you remember, if within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking MYBULEN SUSPENSION 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 SUSPENSION. 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),
• stomach (peptic) ulceration, perforation or any sign of bleeding in the stomach or intestine (gastrointestinal bleeding), such as, black tarry stools, when emptying your bowels (melaena), or vomiting blood (haematemesis) which may be fatal,
• yellowing of your skin or the whites of your eyes (jaundice),
• 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, changes in blood pressure, irregular heartbeat, or abnormal heart rhythm; symptoms include palpitations, dizziness, fainting, shortness of breath and chest discomfort,
• severe fall in blood pressure,
• breathing disorders such as slow, ineffective or difficulty breathing which may cause wheezing or coughing, asthma attacks,
• 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, headache,
• indigestion, diarrhoea, nausea, vomiting, abdominal cramps and pain, wind, constipation.

Less frequent side effects:

• Inflammation of the mucous members in the nose, which may cause a stuffy or runny nose (rhinitis),
• confusional state, nervousness, sleeplessness, excess sleepiness, depression, restlessness, anxiety, changes in mood, drowsiness, spinning (vertigo),
• tingling of the hands and feet,
• blurred vision, decreased pupil size (myosis), inflammation of the optic nerve, and other ocular (eye) reactions,
• ringing in the ears,
• bloating, dry mouth, decreased appetite,
• mouth ulcers and inflammation,
• abnormalities of liver function tests, inflammation of the liver,
• impairment of kidney function, fluid retention, 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),
• 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.

Side effects with an unknown frequency:

• Increased sensitivity to sunlight (photosensitivity),
• 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 SUSPENSION.

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 label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).