Physioneal 40 G/1,36 %/13,6 mg

PHYSIONEAL 40 GLUCOSE is used whenever peritoneal dialysis is employed as well as in patients in whom solutions based on lactate buffer only, with a low pH, cause abdominal inflow pain or discomfort. For patients with renal failure peritoneal dialysis is used to remove toxic substances produced by nitrogen metabolism and which are normally excreted by the kidneys, and for aiding the regulation of fluid and electrolyte as well as acid base balances.

Do not use PHYSIONEAL 40 GLUCOSE:

• If you are hypersensitive (allergic) to PHYSIONEAL 40 GLUCOSE or to any of the ingredients of PHYSIONEAL 40 GLUCOSE listed in section 6;
• If you have a surgically uncorrectable problem affecting your stomach wall or cavity or uncorrectable problem that increases risk of stomach infections;
• If you have documented loss of peritoneal (The membrane that lines the walls of the abdomen and the pelvis) function due to severe peritoneal scarring.

Warnings and precautions

Take special care with PHYSIONEAL 40 GLUCOSE:

• If you have serious problems affecting your abdominal (stomach) wall or cavity. For example, if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines;
• If you have an aortic graft placement;
• If you have severe breathing difficulties;
• If you are treated with cardiac glycosides (a chemical that has effects on the heart, stomach, intestines, nervous system) your doctor will monitor your serum potassium levels;
• You – possibly together with your doctor – should keep a record of your fluid balance and of your body weight. Your doctor will monitor your blood at regular intervals. Particularly salts (e.g. Bicarbonate, potassium, magnesium, calcium and phosphate), parathyroid hormone and lipids;
• Your doctor will check your potassium levels regularly. If it falls too low, they may give you some potassium chloride to compensate.

Do not share medicines prescribed for you with any other person.

• PHYSIONEAL 40 GLUCOSE is to be administered into your peritoneal cavity;
• This is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver;
• It is for single use only;
• It is not for intravenous use;

Use aseptic technique throughout the administration of the solution as you have been trained;

In case of damage the container should be discarded;

Always use this medicine exactly as instructed by the medical team specialised in peritoneal dialysis.

How much and how often

Your doctor will prescribe the appropriate glucose strength and the number of bags you must use every day. Your doctor will tell you how long your treatment with PHYSIONEAL 40 GLUCOSE will last. If you have the impression that the effect of PHYSIONEAL 40 GLUCOSE is too strong or too weak, tell your doctor or pharmacist.

Method of administration

• Use aseptic technique throughout the administration of the solution as you have been trained;
• Warm the bag to body temperature (37 °C). Use only dry heat (for example, heating pad, warming plate). Never immerse in water. Never use a microwave oven to warm the bag;
• After removal of the overpouch, Mix the two chambers thoroughly by breaking the interchamber frangible pin;
• Wait until the upper chamber has completely drained into the lower chamber. Mix gently by pushing with both hands on the lower chamber walls;
• The solution must be infused within 24 hours after mixing;
• Do not use the bag if the solution is cloudy or contains particles, shows evidence of leakage between chambers or to the exterior, or if seals are not intact;
• Ensure all connections are secure before beginning the exchange;

After use, check that the drained fluid is not cloudy. If you take more PHYSIONEAL 40 GLUCOSE than you should consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

PHYSIONEAL 40 GLUCOSE can have side effects. Not all side effects reported for PHYSIONEAL 40 GLUCOSE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this PHYSIONEAL 40 GLUCOSE, please consult your healthcare provider for advice.

Undesirable effects of peritoneal dialysis include procedure and solution related problems. If any of the following happens, stop taking / using PHYSIONEAL 40 GLUCOSE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Abdominal pain
• Bleeding
• Peritonitis (which is followed by abdominal pain, cloudy effluent and sometimes fever)
• Infection around the catheter (signs of inflammation: redness and secretion)
• Catheter blockage
• Shoulder pain
• Hernia of the abdominal cavity (groin lump)

These are all serious side effects. If you have them, you may have had a serious reaction to PHYSIONEAL 40 GLUCOSE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Oedema (fluid retention)
• Asthenia (weakness)
• Fluid retention
• Hypertension (abnormally high blood pressure)
• Weight increased

Less frequent side effects:

• Peritoneal membrane failure
• Dyspepsia (indigestion)
• Flatulence (passing wind)
• Nausea
• Weakness
• Tiredness
• Chills
• Facial oedema (facial swelling)
• Hernia
• Malaise (feeling of discomfort)
• Thirst
• Musculoskeletal pain
• Headache
• Fainting
• Dizziness.
• Respiratory symptoms associated with pulmonary oedema (lung swelling and fluid in the lungs)
• Dyspnoea (shortness of breath)
• Cough
• Electrolyte disturbances (e.g. hypokalaemia, hypocalcaemia)
• Metabolic alkalosis (disturbance of the body's acid/base balance)
• Hypervolaemia (fluid overload)
• Anorexia (lack or loss of appetite for food)
• Dehydration (too much water lost)
• Hyperglycaemia (high blood sugar)
• Lactic acidosis (too much acid in the body)
• Insomnia (sleeplessness)
• Hypotension (low blood pressure)
• Encapsulating peritoneal sclerosis (symptoms of EPS are: inflammation in your abdomen (stomach), thickening of intestines that may be associated with abdominal pain, abdominal distension or vomiting. EPS can be fatal) and cloudy peritoneal effluent (cloudy peritoneum liquid waste)
• Pyrexia (fever)
• Eosinophilia (a higher than normal level of a certain type of white blood cell)
• Angioedema (swelling of the area beneath the skin)
• Rash
• PCO2 (partial pressure of carbon dioxide) increased

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 PHYSIONEAL 40 GLUCOSE. For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected].

PHYSIONEAL 40 GLUCOSE has a shelf life of 24 months. Store at or below 25 °C. Do not freeze. After reconstitution, use within 24 hours. Discard any unused solution. KEEP OUT OF REACH OF CHILDREN. Store in the original package.