Physioneal 40 Glucose 3.86% w/v / 38.6 mg/ml Clear-Flex, Solution for peritoneal dialysis.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What PHYSIONEAL 40 is and what it is used for
2. What you need to know before you use PHYSIONEAL 40
3. How to use PHYSIONEAL 40
4. Possible side effects
5. How to store PHYSIONEAL 40
6. Contents of the pack and other information

• If you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6)
• If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.
• If you have documented loss of peritoneal function due to severe peritoneal scarring.

Sometimes treatment with PHYSIONEAL 40 in the CLEAR-FLEX container is not recommended:

• Children requiring fill volumes less than 1600 ml.

Before use, you must:

• Firstly mix the content of the two chambers by opening the long seal;
• Secondly open the short SafetyMoon seal.
• If you infuse unmixed solution (the long-seal between the two chambers is not opened), you may experience abdominal pain. Drain the solution immediately, use a newly mixed bag and inform your doctor straight away.
• If you do not drain the unmixed solution your blood levels of salts and other chemicals will increase. This will cause undesirable effects such as confusion, drowsiness and irregular heart beat.

Talk to your doctor before using PHYSIONEAL 40.

Take special care:

• If you have serious problems affecting your abdominal 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 experience abdominal pain, increased body temperature or notice cloudiness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number of the peritoneal dialysis solution bags you were using and bring them along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, they may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
• If you have a high level of lactate in your blood. You are at increased risk of lactic acidosis if:
  • you have profoundly low blood pressure
  • you have a blood-infection
  • You have acute kidney failure
  • you have an inherited metabolic disease
  • you are taking metformin (a medicine used to treat diabetes)
  • you are taking medicines to treat HIV, especially medicines called NRTIs.
• If you have diabetes and use this solution, the dose of your drugs which regulate the blood sugar level (e.g. insulin) should be evaluated on a regular basis. Especially when the peritoneal dialysis treatment is started, or changed, the dose of your diabetes drugs may need to be adjusted.
• If you have an allergy to corn (maize) which may result in hypersensitivity reactions, including a serious allergic reaction called anaphylaxis. Stop the infusion immediately and drain the solution from the peritoneal cavity.
• If you have a high level of parathyroid hormone in your blood due to your kidney disease. The low level of calcium in PHYSIONEAL 40 could worsen hyperparathyroidism. Your doctor will monitor levels of parathyroid hormone in your blood.
• 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 parameters at regular intervals. Particularly salts (e.g. hydrogen carbonate, potassium, magnesium, calcium and phosphate), parathyroid hormone and lipids.
• If you have a high level of hydrogen carbonate in your blood.
• Not to use more solution than your doctor has prescribed. Symptoms of overinfusion include abdominal distension, feeling of fullness and shortness of breath.
• Your doctor will check your potassium level regularly. If it falls too low they may give you some potassium chloride to compensate.
• Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.
• Because a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy.
  You – possibly together with your doctor – should be aware of this possible complication. EPS causes:
  • inflammation in your abdomen (belly)
  • Thickening of intestines that may be associated with abdominal pain, abdominal distension or vomiting. EPS can be fatal.

Children

Your doctor will assess the risk against the benefit of using this product if you are under 18 years old.

• Tell your doctor if you are taking, have recently taken or might take any other medicines.
• If you use other medicines, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines.
• Take care if you use heart medicines known as cardiac glycosides (eg. digoxin). You may:
  • need potassium and calcium supplements
  • develop an irregular heartbeat (an arrhythmia)
  • your doctor will monitor you closely during treatment, especially your potassium level.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Physioneal is not recommended during pregnancy or while breast-feeding unless your doctor advises differently

This treatment may cause weakness, blurred vision or dizziness. Do not drive or operate machines if you are affected.

Your doctor will prescribe the appropriate glucose strength and the number of bags you must use every day.

If you are below 18 years old, your doctor will assess carefully the prescription of this medicine.

Do not stop peritoneal dialysis without the agreement of your doctor. If you stop the treatment, it may have life-threatening consequences.

Before use,

• Warm the bag to 37°C. Use the warming plate specially designed for this purpose. Never immerse in water. Never use a microwave oven to warm the bag.
• Use aseptic technique throughout the administration of the solution as you have been trained.
• Prior to beginning an exchange, ensure you clean your hands and the area where your exchange will be performed.
• Prior to opening the overpouch, check for the correct solution type, expiration date, and amount (volume). Lift the dialysate bag to check for any leaks (excess fluid in the overpouch). Do not use the bag if leaks are discovered.
• After removing the overpouch, inspect the container for signs of leakage by pressing firmly on the bag. Check that the long and short seals are not opened at any point. If one of the seals is opened, even partially, discard the bag. Do not use the bag if any leak is detected.
• Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
  Ensure all connections are secure before beginning the exchange.
• Mix the two chambers thoroughly, by opening the long seal first and then the short SafetyMoon seal.
• Ask your doctor if you have questions or concerns about this product or how to use it.
• Use each bag only once. Discard any unused remaining solution.
• The solution must be infused within 24 hours after mixing.
  After use, check that the drained fluid is not cloudy.

Your doctor may prescribe you other injectable drugs to be added directly into the PHYSIONEAL 40 bag. In that situation, add the drug through the medication site located on the large chamber before opening the long-seal. Disinfect the medication site immediately before injection. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.

If you infuse too much PHYSIONEAL 40 you may get:

• abdominal distension
• a feeling of fullness and/or
• a shortness of breath.

Contact your doctor immediately. They will advise you what to do.

• Hypertension (blood pressure that is higher than usual),
• Swollen ankles or legs, puffy eyes, shortness of breath or chest pain (hypervolaemia),
• Abdominal pain,
• Chills (shivering/flu-like symptoms), fever,
• Inflamed peritoneum (peritonitis).

These are all serious side effects. You may need urgent medical attention.

If you get any side effects talk to your doctor or your peritoneal dialysis centre. This includes any side effects not listed in this leaflet.

Common (may affect up to 1 in 10 people)

• Modification of your blood tests:
  • increase of calcium (hypercalcaemia)
  • decrease of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm
  • increase of hydrogen carbonate (alkalosis).
• Weakness, fatigue
• Fluid retention (oedema)
• Weight increase

Uncommon (may affect up to 1 in 100 people)

• Decrease in fluid removal on dialysis
• Fainting, dizziness or headache
• Cloudy solution drained from the peritoneum, stomach-ache
• Peritoneal bleeding, pus, swelling or pain around the exit site of your catheter, catheter blockage.
• Nausea, loss of appetite, indigestion, flatulence (passing wind), thirst, dry mouth
• Distension or inflammation of your abdomen, shoulder pain, hernia of the abdominal cavity (groin lump).
• Modification of your blood tests:
  • lactic acidosis
  • increased level of carbon dioxide
  • increase in sugar (hyperglycaemia)
  • increase in white blood cells (eosinophilia)
• Difficulty in sleeping
• Low blood pressure (hypotension)
• Cough
• Aching in muscles or bones
• Swelling of the face or throat
• Rash.

Other side effects related to the peritoneal procedure

• Infection around the exit site of your catheter, catheter blockage.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system.

Malta

Republic of Ireland

UK

By reporting side effects you can help provide more information on the safety of this medicine.

The active substances in the mixed peritoneal dialysis solution are:

Physioneal 40 1.36%

Glucose monohydrate 15.0 g/l

equivalent to Glucose anhydrous 13.6 g/l

Sodium chloride 5.38 g/l

Calcium chloride dihydrate 0.184 g/l

Magnesium chloride hexahydrate 0.051 g/l

Sodium hydrogen carbonate 2.10 g/l

Sodium (S)-lactate solution

equivalent to sodium (S)-lactate 1.68 g/l

Physioneal 40 2.27%

Glucose monohydrate 25.0 g/l

equivalent to Glucose anhydrous 22.7 g/l

Sodium chloride 5.38 g/l

Calcium chloride dihydrate 0.184 g/l

Magnesium chloride hexahydrate 0.051 g/l

Sodium hydrogen carbonate 2.10 g/l

Sodium (S)-lactate solution

equivalent to sodium (S)-lactate 1.68 g/l

Physioneal 40 3.86%

Glucose monohydrate 42.5 g/l

equivalent to Glucose anhydrous 38.6 g/l

Sodium chloride 5.38 g/l

Calcium chloride dihydrate 0.184 g/l

Magnesium chloride hexahydrate 0.051 g/l

Sodium hydrogen carbonate 2.10 g/l

Sodium (S)-lactate solution

equivalent to sodium (S)-lactate 1.68 g/l

The other ingredients are Water for Injections, sodium hydroxide, hydrochloric acid.

The composition in mmol/l in the mixed solution is:

Physioneal 40 1.36%

Glucose anhydrous 75.5 mmol/l

Sodium 132 mmol/l

Calcium 1.25 mmol/l

Magnesium 0.25 mmol/l

Chlorides 95 mmol/l

Hydrogen bicarbonate 25 mmol/l

Lactate 15 mmol/l

Physioneal 40 2.27%

Glucose anhydrous 126 mmol/l

Sodium 132 mmol/l

Calcium 1.25 mmol/l

Magnesium 0.25 mmol/l

Chlorides 95 mmol/l

Hydrogen bicarbonate 25 mmol/l

Lactate 15 mmol/l

Physioneal 40 3.86%

Glucose anhydrous 214 mmol/l

Sodium 132 mmol/l

Calcium 1.25 mmol/l

Magnesium 0.25 mmol/l

Chlorides 95 mmol/l

Hydrogen bicarbonate 25 mmol/l

Lactate 15 mmol/l

• PHYSIONEAL 40 is a clear, colourless, sterile solution for peritoneal dialysis.
• PHYSIONEAL 40 is packed in a non-PVC bag with two chambers. The two chambers are separated by non-permanent seals.
  You must only infuse PHYSIONEAL 40 once the solutions of the two chambers are fully mixed. Only then should you open the short SafetyMoon seal.
• Each bag is over-wrapped in an overpouch and supplied in a carton box.

Pack sizes:

5x1500 L Single bag (APD) with luer connector

6x1500 L Single bag (APD) with luer connector

5x1500 L Twin bag (CAPD) with luer connector

6x1500 L Twin bag (CAPD) with luer connector

4x2000 L Single bag (APD) with luer connector

5x2000 L Single bag (APD) with luer connector

4x2000 L Twin bag (CAPD) with luer connector

5x2000 L Twin bag (CAPD) with luer connector

3x2500 L Single bag (APD) with luer connector

4x2500 L Single bag (APD) with luer connector

3x2500 L Twin bag (CAPD) with luer connector

4x2500 L Twin bag (CAPD) with luer connector

3x3000 L Tingle bag (APD) with luer connector

3x3000 L Twin bag (CAPD) with luer connector

2x4500 L Single bag (APD) with luer connector

2x5000 L Single bag (APD) with luer connector

2x5000 L Single bag (APD) with luer connector and Homechoice APD set luer

Not all configurations may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: PHYSIONEAL 40 CLEAR-FLEX

Italy: FIXIONEAL 40