Tiperabex 4 g/0,5 g Solution

TIPERABEX 4 g/0,5 g belongs to a group of medicines called antibacterials for systemic use and is a combination of penicillin and tazobactam (a beta-lactamase inhibitor). Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. When given together, more types of bacteria are killed.

TIPERABEX 4 g/0,5 g is used to treat bacterial infections of the chest, abdomen, skin, uterus and blood. It may be given together with another medicine called an aminoglycoside in patients who have very low levels of white blood cells and are therefore not able to fight infections.

TIPERABEX 4 g/0,5 g should not be administered to you:

• if you are hypersensitive (allergic) to piperacillin / tazobactam or to any of the other ingredients of TIPERABEX 4 g/0,5 g (listed in section 6),
• if you have a history of allergic reactions to any of the penicillins and/or cephalosporins or ß-lactamase inhibitors.

Warnings and precautions

Special care should be taken with TIPERABEX 4 g/0,5 g:

• if you have previously had an allergic reaction to penicillins, other beta-lactam medicines such as cephalosporin, monobactam or carbapenem, because you are more likely to be allergic to TIPERABEX 4 g/0,5 g. It may cause serious and occasionally fatal allergic reactions.
• TIPERABEX 4 g/0,5 g may cause severe skin reactions. Tell your doctor if you develop a skin rash.
• if you develop a fever, stomach pains, rash and yellowing of the skin and eyes, as you may have developed a condition where your immune system does not work properly.
• If you experience severe and continuous diarrhoea. Tell your doctor immediately and do not take any medicine to stop the diarrhoea.
• if you experience excessive or unexplained bleeding or bruising.
• if you experience seizures.
• if you have any kidney problems.

Children

TIPERABEX 4 g/0,5 g should not be given to children 0 - 2 years old because safety has not been established. TIPERABEX 4 g/0,5 g should only be given to children under the age of 12 if they experience a decrease in neutrophils (a specific type of white blood cell; a main defender of bacteria) and are more prone to infection.

Other medicines and TIPERABEX 4 g/0,5 g

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) If you are taking any of the following medicines, please inform your doctor before taking TIPERABEX 4 g/0,5 g:

• Medicine that helps prevent blood clots (blood thinners) as the blood clotting function may be affected and you may require more frequent blood tests.
• An antibiotic that is an aminoglycoside (a class of antibiotics such as tobramycin and gentamicin) as TIPERABEX 4 g/0,5 g may weaken the effects of these antibiotics if you have kidney problems.
• Methotrexate (a medicine that slows down your body's immune system and helps reduce inflammation) as piperacillin may reduce the rate at which methotrexate is removed from your body.
• Muscle relaxants such as vecuronium because piperacillin may prolong its effects.
• Probenecid (a medicine that is used in the treatment of chronic gout or gouty arthritis; these conditions are caused by too much uric acid in the blood) because it prolongs the amount of time that both piperacillin and tazobactam stay in your system.
• Vancomycin (an antibiotic) because being given both TIPERABEX 4 g/0,5 g and vancomycin could lead to kidney injury.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. Safety in pregnancy and breastfeeding has not been established.

Driving and using machines

It is not always possible to predict to what extent TIPERABEX 4 g/0,5 g may interfere with your daily activities. You should ensure that they do not engage in the above activities until you are aware of the measure to which TIPERABEX 4 g/0,5 g affects you.

TIPERABEX 4 g/0,5 g contains sodium Each vial of TIPERABEX 4 g/0,5 g contains 9,39 mmol (216 mg) of sodium. You should take this into consideration if you are on a controlled sodium diet.

You will not be expected to give yourself TIPERABEX 4 g/0,5 g. It will be given to you by a person who is qualified to do so. Your doctor will decide on the dose that you require and for how long your treatment will last. TIPERABEX 4 g/0,5 g will be given to you as an infusion into your vein. The infusion will take about 30 minutes to complete.

If you are given more TIPERABEX 4 g/0,5 g than you should

Since a health care provider will administer TIPERABEX 4 g/0,5 g, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take TIPERABEX 4 g/0,5 g

Since a health care provider will administer TIPERABEX 4 g/0,5 g, it is unlikely that the dose will be missed.

TIPERABEX 4 g/0,5 g can have side effects. Not all side effects reported for TIPERABEX 4 g/0,5 g are included in this leaflet. Should your general health worsen or if you experience any untoward effects while [ taking ] receiving TIPERABEX 4 g/0,5 g, please consult your health care provider for advice.

If any of the following happens, tell your doctor to stop TIPERABEX 4 g/0,5 g immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TIPERABEX 4 g/0,5 g. 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:

• several severe skin reactions: blisters (bullous dermatitis), a painful, red skin with peeling, a measles-like rash that gradually becomes more generalised and red, or a rapid appearance of pinhead-sized pustules on a red skin.
• severe watery diarrhoea which may also be bloody.
• signs of recurrent infections such as fever or sore throat.
• less urine than is normal for you, swelling of feet and ankles, nausea, vomiting, tiredness or shortness of breath – these may indicate a kidney problem.
• yellowing of the skin and eyes, dark urine and tiredness which may be symptoms of liver problems.

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),
• abdominal cramps or stomach pains,
• headache,
• dizziness,
• tiredness,
• light-headedness,
• yeast infections (a thick, white, clumpy vaginal discharge),
• decreased number of blood platelets with symptoms such as bruising easily and nose bleeds,
• low number of red blood cells in your blood with symptoms such as tiredness, lack of energy shortness of breath, irregular or fast heartbeat,
• sleeplessness,
• constipation,
• digestion problems such as heartburn or indigestion,
• Laboratory test results may show: Increase in blood liver enzymes, decrease in blood protein, abnormal kidney blood test, deficiency in blood clotting factors,

Less frequent side effects

• dry cough,
• inflammation of oral mucosa (the inside of your mouth becomes red, shiny, swollen, raw and painful),
• muscle cramps,
• flatulence or wind,
• excessive or unexplained bruising or bleeding,
• nose bleeds,
• decrease in number of granulocytes, may include symptoms like lesions of the throat and other mucous membranes, gastrointestinal tract, and of the skin,
• decrease in the number of all types of blood cells with symptoms such as fatigue, weakness, bleeding problems, frequent infections, rapid heart rate, shortness of breath, headache and marrow hypoplasia (a bone marrow disorder),
• seizures,
• low blood pressure,
• inflammation of a vein at the site of injection,
• pain in joints, or stiffness; difficulty in moving,
• muscle aching or cramping, muscle pain or stiffness; difficulty in moving,
• chills,
• loss of appetite,
• Laboratory test results may show: Low blood potassium, lower blood glucose, increased prothrombin time (test to measure how long it takes blood to clot), increased bilirubin (high levels of bilirubin may cause jaundice (a yellowing of the skin and eyes)).

Side-effects with unknown frequency

• Various blood disorders (low levels of red blood cells, white blood cells and platelets, too many eosinophils (eosinophilia); these disorders are determined by laboratory tests). Tell your doctor if you are pale and tired.
• A dry, unproductive cough, wheezing and a slight fever caused by a type of white blood cell building up in your lungs and blood (eosinophilic pneumonia).
• Prolonged bleeding times.
• Laboratory tests may show liver function problems.

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 TIPERABEX 4 g/0,5 g.

Store all medicines out of reach of children. Store the vial in the original container, at or below 25 °C. Reconstituted and diluted solutions: TIPERABEX 4 g/0,5 g is for single use only; any unused solution must be disposed of in accordance with local requirement. When prepared as directed, chemical and physical in-use stability of reconstituted and diluted solutions of TIPERABEX 4 g/0,5 g were demonstrated for 24 hours when stored at or below 25 °C or for 48 hours when stored in the refrigerator at 2 to 8 °C.

The expiry date is stated on the label and carton. Your healthcare professional will make sure that TIPERABEX 4 g/0,5 g is not past its expiry date before administering the product. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).