Parativ 1 g Solution

PARATIV 1 g is an analgesic (it relieves pain) and an antipyretic (it lowers fever). PARATIV 1 g is indicated for the short-term treatment of mild to moderate pain, especially following dental procedures and minor orthopaedic surgery, and for the short-term treatment of fever, when oral medicine is unsuitable. The 100 mL vial is restricted to adults, adolescents and children weighing more than 33 kg.

PARATIV 1 g should not be administered to you if:

• You are hypersensitive (allergic) to the paracetamol or to any of the other ingredients contained in PARATIV 1 g (listed in section 6)
• You are hypersensitive (allergic) to the propacetamol hydrochloride (another analgesic for infusion and a precursor of paracetamol)
• You suffer from severe liver disease.

Warnings and precautions

Dosages of PARATIV 1 g in excess of those recommended may cause severe liver damage. PARATIV 1 g can cause serious skin reactions, which can be fatal. Use of the medicine should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity (allergy). It is recommended to use a suitable oral analgesic (pain relieving medicine) treatment as soon as this is possible. PARATIV 1 g 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.

Take special care with PARATIV 1 g if:

• you suffer from liver or kidney disease, or from alcohol abuse or excessive alcohol intake (3 or more alcoholic drinks every day)
• you suffer from a condition that causes the breakdown of red blood cells, called Glucose 6 Phosphate Dehydrogenase deficiency
• you are taking other medicines containing paracetamol or propacetamol (including prescription and non-prescription medicines). Doses higher than the recommended dose entails risk for very serious liver damage
• in cases of nutritional problems (malnutrition) or dehydration
• you are pregnant or breastfeeding
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in patients receiving paracetamol. If you experience any signs of serious skin reactions such as swelling, itching, red severe rash, stop using PARATIV 1 g immediately and contact your doctor.
• you are taking or have recently taken medication, especially probenecid, salicylamide or enzyme-inducing substances. Inform your doctor before treatment if any of the above-mentioned conditions apply to you.

PARATIV 1 g contains mannitol. Mannitol may cause mild laxative effects.

DO NOT EXCEED THE RECOMMENDED DOSE. Do not share medicines prescribed for you with any other person. Carefully follow all instructions given to you by your doctor, nurse or pharmacist. You will not be expected to give yourself PARATIV 1 g. It will be given to you by a person who is qualified to do so. The solution for infusion will be injected directly into your vein (intravenous administration) over 15 minutes. Your doctor will prescribe the appropriate dose for you. The dose you are given is based on your weight and general condition. If you have the impression that the effect of PARATIV 1 g, solution for infusion is too strong or too weak, talk to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you are given more PARATIV 1 g than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Since a health care provider will administer PARATIV 1 g, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you forget to use PARATIV 1 g Since a health care provider will administer PARATIV 1 g, it is unlikely that the dose will be missed.

PARATIV 1 g can have side effects. Not all side effects reported for PARATIV 1 g are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PARATIV 1 g, please consult your health care provider for advice. If any of the following happens, stop using PARATIV 1 g and tell your doctor immediately:

• A serious skin reaction or allergic reaction; redness of the skin, flushing, itching and abnormally rapid beating of the heart. These are very rare but very serious side effects. If you have them, you may have had a serious reaction to PARATIV 1 g. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• Hypersensitivity (allergic) reaction.
• Kidney pain, kidney failure, white blood cells in urine.
• Increased levels of liver enzymes (hepatic transaminases), liver inflammation, pancreas inflammation.
• Low blood platelets (blood cells that help the blood clot when there are injuries to blood vessels) (thrombocytopenia).
• Decrease in number of white blood cells (type of blood cells that are part of your body’s immune system and help fight infection and other diseases) (Leukopenia and Neutropenia).
• Decrease in the number of red blood cells (anemia).
• Decrease in the number of red blood cells, white blood cells and platelets (pancytopenia).
• Drop in blood pressure (Hypotension).
• 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:
• Pain and burning sensation at injection site have been reported.
• Less frequent side effects:
• Malaise
• Side effects with frequency unknown:
• Erythema, flushing, pruritus and tachycardia have been reported.

The following adverse events have also been reported during postmarketing surveillance but the incidence rate (frequency) is not known. Low blood platelets, increased heart rate, nausea, vomiting, administration site reaction, liver inflammation (hepatitis), hepatic failure, increased liver enzymes, severe allergic reaction, severe swelling in the deep layers of skin, skin redness (erythema), flushing, itch (pruritus), rash, skin pustules, skin peeling and blistering (Toxic epidermal necrolysis, Stevens-Johnson syndrome, Fixed drug eruptions (FDE), Drug-induced hypersensitivity syndrome (DIHS).

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 or pharmacist. 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 PARATIV 1 g.

Store all medicines out of reach of children. Your doctor, pharmacist or healthcare professional knows how to store PARATIV 1 g. The doctor or nurse who is administering PARATIV 1 g to you, will make sure that the medicine is not used after the expiry date printed on the vial. They will also visually inspect the solution before giving it to you. Only clear solution without particles will be used. Store at or below 25 °C. Keep in original package.