Myprodol ® 10 mg/200 mg/250 mg Suspension

MYPRODOL ® SUSPENSION contains paracetamol, ibuprofen and codeine phosphate and belongs to a group of medicines called pain-killers or analgesics. It is used to for mild to moderate pain, caused by inflammation, with or without fever.

Do not take MYPRODOL ® SUSPENSION:

• if you are hypersensitive (allergic) to paracetamol, ibuprofen or codeine phosphate or any of the other ingredients of MYPRODOL ® SUSPENSION (listed in section 6),
• if you have liver or kidney problems,
• if you have heart problems or heart failure,
• if you have or have had a stomach ulcer or a history of bleeding into, or preformation of, the intestine especially after previous treatment with NSAIDs (non-steroidal anti-inflammatory medicines, such as ibuprofen) or MYPRODOL ® SUSPENSION.
• if you have breathing or lung problems (especially if you are turning blue due to low oxygen levels) and have an increased amount of mucus from your lungs,
• if you have had an operation involving the gallbladder,

Read all of this leaflet carefully before you start taking MYPRODOL ® SUSPENSION

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist, nurse or health care provider.
• MYPRODOL ® SUSPENSION has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

• if you are drinking alcohol in large quantities,

• if you have a head injury or have a condition where the pressure inside your skull has increased,

• if you currently have an asthma attack,

• if you have heart failure as a result of ongoing lung disease,

• if you are taking monoamine oxidase inhibitors (for the treatment of depression or anxiety) or if you have stopped treatment in the past 14 days,

• if you are using medicines known as blood thinners (coumarin anticoagulants),

• if you are sensitive (or allergic) to aspirin,

• if you have growths in your nose (nasal polyps) associated with aspirin induced breathing difficulty (bronchospasm),

• if you are in the third trimester of pregnancy (28 to 40 weeks),

• if you are breastfeeding your baby

• if your child is under 12 years old,

• For pain relief in children and adolescents (0-18 years of age) after removal of tonsils or adenoids due to obstructive sleep apnoea syndrome.

• 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 have severe diarrhoea associated with pseudomembranous colitis.

• if you have any bleeding disorders.

Do not share medicines prescribed for you with any other person. Always use MYPRODOL ® SUSPENSION exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not use more than the recommended dose below. The usual dose is:

Adults: Two to four medicine measures (10 to 20 ml) four hourly and not more than twenty-four medicine measures in twenty-four hours. You should use the lowest effective dose for the shortest possible duration of treatment. You should contact your doctor if no relief is obtained with the recommended dosages.

Shake the bottle before use.

If you take more MYPRODOL ® SUSPENSION than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Prompt medical attention is critical. Even if you do not show symptoms of an overdose, go immediately to your nearest hospital or Poison Centre. MYPRODOL ® SUSPENSION contains paracetamol and an overdose, can be fatal. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), or severe diarrhoea. In addition to these symptoms, headache, bleeding in the digestive tract, 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, changes in the blood clotting time, acute kidney failure, liver damage, respiratory depression, cold body feeling, and breathing problems have been reported.

If you forget to take MYPRODOL ® 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.

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

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

• Mouth ulcers, cold sores and ulcers or soreness of your tongue,
• skin lumps or hives (raised, red or white, itchy patches of skin),
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• allergic reactions which can include flu-like symptoms along with a skin rash or sunburn when you have been outside (even on a cloudy day), itching, painful red areas, peeling or blistering on your skin or inside your mouth, nose, vagina, or bottom, swollen mouth, face, lips, tongue or throat (also known as Stevens-Johnson's syndrome),
• fever, skin rash, swelling of the lymph nodes and/or swelling of the face (also known as DRESS),
• fainting.

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

• Shortness of breath, fatigue, weakness, swelling in your legs, ankles and feet,
• changes in the way your heart beats, for example, if you notice it is beating faster or not rhythmic, heart failure, chest pain, changes in blood pressure; symptoms include palpitations, dizziness, fainting, shortness of breath and chest discomfort,
• high blood pressure which may cause a serious headache,
• stomach ulcers, ruptures or tears in your gastrointestinal tract (that may cause severe pain) or blood in your stools,
• vomiting of blood,
• 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),
• yellowing of your skin or the whites of your eyes (jaundice),
• kidney failure or liver failure,
• 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:
• nausea (feeling sick),
• vomiting,
• diarrhoea,
• passing of wind,
• constipation,
• indigestion,
• abdominal pain,
• dizziness
• headache.

Less frequent side effects:

• abdominal pain including risk of inflammation of pancreas, which causes severe pain in the abdomen and back,
• 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 (miosis), 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,
• 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 of unknown frequency:

• MYPRODOL ® SUSPENSION, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness,
• increased sensitivity to sunlight (photosensitivity).
• Skin lumps or hives (raised, red or white, itchy patches of skin), burning and pain (FDE)

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. This includes any possible side effects not listed in this leaflet. 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 MYPRODOL ® SUSPENSION.

• Store all medicines out of reach of children.
• Store at or below 30 °C in well-closed containers.
• Protect from light.
• Do not use after the expiry date stated on the label / carton / bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).