Parafengen IV Solution

PARAFENGEN IV contains paracetamol 1000 mg and ibuprofen 300 mg per 100 mL vial. Paracetamol is used to treat pain and it reduces fever. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain. PARAFENGEN IV is used for the relief of mild to moderate pain and the reduction of fever in adults, where an intravenous route of administration is considered clinically necessary.

PARAFENGEN IV should not be administered to you:

• If you are hypersensitive (allergic) to paracetamol or ibuprofen or any of the other ingredients of PARAFENGEN IV (listed in section 6).
• If you regularly drink large quantities of alcohol.
• If you have severe heart disease or heart failure, renal (kidney) failure severe impaired kidney function or hepatic (liver) failure or liver diseases severe impaired liver function.
• If you vomited blood or material that looks like ground coffee, have (or have previously) bled from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea.
• If you have a peptic ulcer (sore on the lining of the stomach or small intestine), a recent history of one, or have had peptic ulcers before.
• If you have any bleeding.
• If you have asthma, urticaria (itchy, raised, red or skin-coloured swellings) or allergic-type reactions after taking aspirin, or other NSAIDs.
• If you had or need to have coronary artery bypass graft (CABG) surgery.
• If you have spinal cord injuries.
• If you are pregnant, planning to become pregnant or are breastfeeding your baby.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you suffer from kidney disease.
• If you have a genetic abnormality that results in an inadequate amount of glucose-6-phosphate dehydrogenase (G6PD) enzyme in the blood. As a result, paracetamol may trigger the red blood cells to be broken down, resulting in anaemia.
• If you have high blood pressure or heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery.
• If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
• If you suffer from anorexia, malnutrition or dehydration.
• If you have a history of gastrointestinal diseases, e.g., peptic ulcers, ulcerative colitis (inflammation and sores in your digestive tract), Crohn’s disease (inflammation of your digestive track), hiatus hernia (stomach pushing through an opening in the diaphragm), gastro-esophageal reflux disease (stomach acid flows back into the tube connecting your mouth and stomach).
• If you suffer from any skin reactions such as Stevens-Johnson syndrome, skin rash or mucosal lesions.
• If you suffer from liver disease.
• If you have blurred vision.

Children and adolescents

This product is not recommended for children under 18 years.

Other medicines and PARAFENGEN IV

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are taking any of the following:

• Other NSAIDs, including aspirin or products containing paracetamol
• Probenecid (used to treat gout)
• Medicines that can have an effect on the liver, e.g., anticoagulants (blood thinning products like aspirin and warfarin), barbiturates (sleeping tablets), isoniazid (tuberculosis medicine), rifampicin (antibiotic), zidovudine (HIV medicine), and chronic alcohol use
• Phenytoin (used for seizures)
• Chloramphenicol (antibiotic)
• Corticosteroids (used to treat many conditions, such as inflamed areas of the body, allergic reactions, itching, e.g., prednisone, cortisone)
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression, e.g., fluoxetine, citalopram, sertraline, paroxetine and escitalopram)
• Medicines that reduce high blood pressure, e.g., ACE-inhibitors such as captopril, beta-blockers (atenolol medicines), angiotensin-II receptor antagonists (losartan)
• Diuretics (water tablets, e.g., furosemide and thiazide)
• Lithium (used to treat some types of depression)
• Methotrexate (used to treat arthritis and some types of cancer)
• Ciclosporin or tacrolimus (immunosuppressive medicine used after organ transplant)
• Busulfan (used for treatment of cancer)
• Diflunisal (used for pain)
• Herbal extracts, like ginkgo biloba
• Quinolone antibiotics (ofloxacin, norfloxacin, ciprofloxacin, moxifloxacin)

Do not share medicines prescribed for you with any other person. PARAFENGEN IV will be given to you by a person who is qualified to do so. The usual dose is one vial (100 ml) PARAFENGEN IV administered as a 15-minute infusion drip every 6 hours, as necessary. The total daily dose of 4 vials that is 4 000 mg (4 g) paracetamol should not be exceeded.

If you are given more PARAFENGEN IV than you should receive Since a health care provider will administer PARAFENGEN IV, he/ she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. In case of an overdose, symptoms generally appear within 24 hours and include nausea, vomiting, stomach pain, convulsions and you might even become unconscious. If you think you might have been given an overdose, tell a doctor or health care provider immediately due to the risk of irreversible liver damage.

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

If any of the following happens, tell your doctor immediately as these can be serious:

• Liver damage: nausea, vomiting, loss of appetite, pale colour of the skin, stomach pain.
• Anaphylactic reaction (sudden allergic reaction) including skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath or trouble breathing.
• Serious skin reactions, including widespread redness and scaling of the skin, rash on the body where each mark resembles a bullseye, Stevens-Johnson syndrome a rare, serious disorder of your skin and mucous membranes. Often, it begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters.
• Perforation or gastrointestinal bleeding (vomiting blood or material that looks like coffee ground, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhea. These are all very serious side effects, and you need urgent medical attention. If these effects are not treated, they could be fatal.

Tell your doctor if you notice any of the following:

• Frequent Dizziness, headache, sleepiness
• Abdominal pain, diarrhoea, indigestion (dyspepsia), nausea, stomach discomfort, vomiting
• Rash, itching
• Pain at injection site, burning sensation, inflammation in the vein used for the infusion
• Decreased appetite

Frequency unknown:

• Swelling, fluid retention, hypertension and heart problems (cardiac failure)
• Bleeding or bruising more easily than normal, reddish or purplish blotches under the skin, severe skin reactions such as Stevens Johnson syndrome and toxic epidermal necrolysis
• Excessive sweating, purple-coloured spots on the skin, skin becomes very sensitive to the sun

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PARAFENGEN IV.

Store all medicines out of reach of children.

• Store at or below 25 ºC, protect from light.
• Do not refrigerate or freeze.
• 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).
• Do not use PARAFENGEN IV if you notice particles in the solution or the solution changes colour (it should be a clear colourless solution).