User Information: Product Information

PHYSIONEAL 35 Glucose 1.36% p/v/ 13.6 mg/ml CLEAR-FLEX, Solution for Peritoneal Dialysis

PHYSIONEAL 35 Glucose 2.27% p/v/ 22.7 mg/ml CLEAR-FLEX, Solution for Peritoneal Dialysis

PHYSIONEAL 35 Glucose 3.86% p/v/ 38.6 mg/ml CLEAR-FLEX, Peritoneal Dialysis Solution

Read this entire product information carefully before starting to use this medication, because it contains important information for you..

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this product information. See section 4.

1.What is PHYSIONEAL 35 and how it is used

2.What you need to know before starting to use PHYSIONEAL 35

3.How to use PHYSIONEAL 35

4.Possible adverse effects

5.Storage of PHYSIONEAL 35

6.Contents of the package and additional information

PHYSIONEAL 35 is a peritoneal dialysis solution.It removes water and waste products from the blood. Additionally, it corrects abnormal levels of the different components of the blood.

PHYSIONEAL 35 contains different concentrations of glucose (1.36%, 2.27% or 3.86%). The higher the glucose concentration in the solution, the more water will be removed from the blood.

PHYSIONEAL 35 may be prescribed if you have:

• temporary or permanent kidney insufficiency
• severe water retention
• severe alterations of blood acidity or alkalinity (pH) and electrolyte levels
• some types of medication overdose for which there are no other treatments available.

PHYSIONEAL 35 solution has a pH similar to that of the blood. For this reason, it may be particularly useful if you experience discomfort or pain caused during the administration of other more acidic peritoneal dialysis solutions.

Your doctor should supervise the administration of this product if it is the first time you use it.

Do not use PHYSIONEAL 35

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• if you have any irreversible surgical problem that affects your abdominal wall or cavity or an irreversible alteration that increases the risk of abdominal infections.

• if you have documented loss of peritoneal function due to severe peritoneal scarring.

The treatment with PHYSIONEAL 35 in its CLEAR FLEX container is sometimes not recommended:

• for children who require filling volumes of 1600 ml.

Warnings and precautions

Before using it, you must:

• First, mix the contents of the two chambers by opening the long seal;

• Second, open the short seal (Safety Moon).
• If the unmixed solution is infused (the long seal between the two chambers has not been opened), you may experience abdominal pain. Drain the solution immediately, use a new mixed bag, and inform your doctor right away.

• If the unmixed solution is not drained, the levels of salts or other chemical substances may increase in the blood. This can cause adverse effects such as confusion, drowsiness, and irregular heart rhythm.

Inform your doctor before using PHYSIONEAL 35.

Be especially careful:

• if you have severe problems that affect the integrity of your abdominal wall or cavity. For example, in the case of hernia or chronic infection or inflammatory disease that affects the intestines.
• if you have an aortic graft.
• if you have severe breathing difficulties.
• if you experience abdominal pain, elevated body temperature, or notice that the drainage liquid is cloudy or contains particles. This may be a sign of peritonitis (inflamed peritoneum) or infection. You must contact your medical team urgently. Note the batch number of the peritoneal dialysis solution bags you are using and bring the bag with the drained liquid to your medical team. Your medical team will decide whether to interrupt treatment or initiate corrective treatment. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most suitable for you.

• if you have high levels of lactate in the blood. You have an increased risk of lactic acidosis if:

• you have a significant drop in blood pressure
• you have a bloodstream infection
• you have acute renal failure
• you have a congenital metabolic disorder
• you are taking metformin (a medication used to treat diabetes)
• you are taking medications to treat HIV, especially certain medications called NRTIs.

• if you have diabetes and use this solution, the dose of your medications used to regulate blood sugar levels (e.g., insulin) should be reviewed regularly. Especially, the dose of your diabetes medications should be adjusted when starting or changing peritoneal dialysis treatment.
• if you have an allergy to corn that may cause hypersensitivity reactions, including severe allergic reactions known as anaphylaxis.Stop infusion immediately and drain the solution from the peritoneal cavity.
• You, probably in conjunction with your doctor, will keep a record of your fluid balance and body weight. Your doctor will monitor your blood parameters at regular intervals. Particularly, electrolytes (e.g., bicarbonate, potassium, magnesium, calcium, and phosphate) and parathyroid hormone and lipids.
• if you have high levels of bicarbonate in the blood.
• Do not use more solution than prescribed by your doctor. Symptoms of excessive administration include abdominal distension, heavy stomach, and difficulty breathing.
• Your doctor will regularly check your potassium levels. If they drop too low, your doctor may administer potassium chloride to compensate.
• A sequence of improper priming or clamping may cause the infusion of air into the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• Due to a condition known as encapsulating peritoneal sclerosis (EPS), which is a known and rare complication of peritoneal dialysis therapy, you, probably in conjunction with your doctor, should be aware of this possible complication. EPS causes:
• inflammation of the abdomen (stomach)
• thickening of the intestines that may be associated with abdominal pain, abdominal distension, or vomiting.EPS can be fatal.

Children

If you are under 18 years of age, your doctor will evaluate the benefit-risk ratio of using the product.

Use of other medications and PHYSIONEAL 35

• Inform your doctor if you are using, have used recently, or may need to use any other medication.
• If you are using other medications, your doctor may need to increase your dose since peritoneal dialysis treatment increases the elimination of certain medications.

• Be careful if you are using heart medications called cardiac glycosides (e.g., digoxin), you may need:
• potassium and calcium supplements
• develop arrhythmias.
• Your doctor will perform a thorough check during treatment, especially of your potassium levels.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor before using this medication. Physioneal is not recommended during pregnancy or lactation unless your doctor advises you to do so.

Driving and operating machinery

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

PHYSIONEAL 35 must be administered in your peritoneal cavity. This cavity is located in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs, such as the intestines or the liver.intestines or the liver.

Do not use by intravenous route.

Follow exactly the administration instructions of this medication indicated by your specialized dialysis peritoneal team doctor.In case of doubt, consult them again.

If the bag is damaged, it must be discarded.

Quantity and frequency

Your doctor will indicate the appropriate glucose concentration as well as the number of bags you should use each day.

Use in children and adolescents

If you are under 18 years of age, your doctor will carefully evaluate the prescription of this medication.

If you interrupt treatment with PHYSIONEAL 35

Do not interrupt peritoneal dialysiswithout your doctor's consent.Interrupting treatment may have harmful consequences for your life.

Administration form

Before use,

• Warm the bag to 37°C. Use the warming plate specifically designed for this purpose. Never submerge the bag in water to warm it. Do not use a microwave oven to warm the bag.
• You must use an aseptic technique during the entire administration of the solution, as you have been taught.
• Before performing an exchange, make sure to wash your hands and the area where you will perform the exchange.
• Before opening the overbag, check that it is the correct solution, the expiration date, and the amount (volume). Lift the bag to check for leaks (excess liquid in the overbag). Do not use the bag if you find that it has leaks.

• After removing the overbag, check if there are signs of leaks in the container by pressing firmly on the bag. Check that none of the long and short seals are open. Discard the bag if any of the seals are open, even partially. Do not use the bag if you detect any leaks.
• Check that the solution is transparent. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, check that all connections are secure.
• Mix the two chambers carefully by breaking the long seal first and then the short seal (Safety Moon).

• Consult your doctor if you have any questions or doubts about this product or its use.
• Use each bag only once.Discard the remaining solution that you do not use.
• The solution must be administered within 24 hours after mixing.

After use, check that the drainage liquid is not cloudy.

Compatibility with other medications

Your doctor may prescribe other injectable medications to add directly to the PHYSIONEAL 35 bag. In this case, add the medication through the medication addition site located in the large chamber, before opening the long seal. Disinfect the medication addition site immediately before proceeding with the injection.Use the product immediately after adding the medication. Consult your doctor if you are unsure.

If in 24 hours you use more PHYSIONEAL 35 bags than you should

If you are administered an excessive dose of PHYSIONEAL 35, you may experience:

• abdominal distension
• heaviness in the stomach and/or
• difficulty breathing.

Immediately contact your doctor.They will inform you of what to do.

If you have any other doubts about the use of this product, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following situations, contact your doctor or peritoneal dialysis unit immediately:

• Hypertension (blood pressure above normal levels).
• Swelling of the ankles or legs, puffy eyes, difficulty breathing, or chest pain (hypervolemia).
• Abdominal pain.

• Chills (flu-like symptoms), fever,

• Peritonitis (inflamed peritoneum)

All of these are serious side effects. You may need urgent medical attention.

If you notice any side effect, report it to your doctor or peritoneal dialysis unit. This includes any side effect not listed in this leaflet.

Frequent (may affect up to 1 in 10 people):

• Modification of your blood parameters:

• Increased calcium levels (hypercalcemia)
• Decreased potassium levels (hypokalemia) that may cause muscle weakness,muscle cramps, or heart rhythm disturbances.

• Weakness, fatigue.
• Fluid retention (edema).
• Weight gain.

Rare (may affect up to 1 in 100 people):

• Decreased fluid removal during dialysis.
• Dizziness, fainting, or headache.
• Cloudy solution extracted from the peritoneum, stomach pain.
• Peritoneal hemorrhage, pus, swelling, or pain around the catheter exit site and catheter blockage.
• Nausea, loss of appetite, indigestion, flatulence (gas), thirst, and dry mouth.
• Abdominal distension or inflammation, shoulder pain, abdominal hernia (bulge in the groin).

• Modification of your blood parameters:

• Lactic acidosis
• Increased carbon dioxide levels
• Increased glucose levels (hyperglycemia)
• Increased white blood cell count (eosinophilia).

• Difficulty sleeping.
• Low blood pressure (hypotension).
• Cough.
• Muscle or bone pain.
• Facial or throat inflammation.
• Skin rash.

Other side effects related to the peritoneal dialysis procedure:

• Infection around the catheter exit site, catheter blockage.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for the Notification of Adverse Reactions to Medicinal Products for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature below 4 °C.

Do not use this medication after the expiration date. The expiration date is indicated on the outer packaging label and on the bag after the abbreviation CAD and the symbol?.The expiration date is the last day of the month indicated.

Dispose of PHYSIONEAL 35 as instructed.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

This leaflet does not contain all the information about this medicine.If you have any questions or are unsure about anything, ask your doctor.

Composition of PHYSIONEAL 35

The peritoneal dialysis solutionmixedcontains the following active ingredients:

The other components are:water for injection, sodium hydroxide, and hydrochloric acid.

The composition in mmol/l of themixedsolution is:

Appearance of the medicine and contents of the pack

PHYSIONEAL 35 is a colourless, transparent, and sterile peritoneal dialysis solution.

PHYSIONEAL 35 is packaged in a PVC-free plastic bag with two chambers.The two chambers are separated by non-permanent seals. You should only infuse PHYSIONEAL 35 when the solutions in the two chambers are fully mixed. Only then should you open the short seal (Safety Moon).

Each bag is wrapped in a pouch and supplied in a cardboard box.

Only some sizes of packaging may be commercially available.

For further information about this medicine, please contact the local representative of the marketing authorisation holder:

Marketing authorisation holder

Vantive Health, S.L.

Industrial Sector 14

Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia)

Spain

Responsible for manufacturing

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Netherlands, Hungary, Ireland, Iceland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden:PHYSIONEAL 35 CLEAR-FLEX

Italy: FIXIONEAL35

Last update of this leaflet: April 2022

Further information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

Vantive, Physioneal, and Clear-Flex are registered trademarks of Vantive Health Inc. or its subsidiaries