User Information: Product Information

PHYSIONEAL 40 Glucose 1.36% p/v/ 13.6 mg/ml, Solution for Peritoneal Dialysis

PHYSIONEAL 40 Glucose 2.27% p/v/ 22.7 mg/ml, Solution for Peritoneal Dialysis

PHYSIONEAL 40 Glucose 3.86% p/v/ 38.6 mg/ml, Solution for Peritoneal Dialysis

Read this entire product information carefully before starting to use this medication, as 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 40 and how it is used

2. What you need to know before starting to use PHYSIONEAL 40

3. How to use PHYSIONEAL 40

4. Possible adverse effects

5. Storage of PHYSIONEAL 40

6. Contents of the package and additional information

PHYSIONEAL 40 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 40 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 40 may be prescribed if you have:

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

The PHYSIONEAL 40 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 40

• 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 surgically uncorrectable condition 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.

Warnings and precautions

Consult your doctor before starting to use PHYSIONEAL 40.

Be especially cautious:

• If you have severe conditions that affect the integrity of your abdominal wall or cavity. For example, in the case of hernia or chronic infection or inflammatory disease affecting 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. Contact your medical team urgently. Note the batch number of the peritoneal dialysis solution bags you are using and bring them along with the drained liquid bag 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. Your doctor may give you a broad-spectrum antibiotic until you know what infection you have.

A broad-spectrum antibiotic is effective against a wide range of bacteria.

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

• you have a severely low blood pressure
• you have a blood infection
• you have acute kidney 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, your medication doses used to regulate your blood sugar levels (e.g. insulin) should be regularly reviewed. Especially, your medication doses for diabetes should be adjusted when starting or changing peritoneal dialysis treatment.
• If you have an allergy to corn that may lead to hypersensitivity reactions, including severe reactions known as anaphylaxis. Stop administration immediately and drain the solution from your peritoneal cavity.
• If you have high levels of parathyroid hormone in your blood due to your renal disorder. The low levels of calcium in PHYSIONEAL 40 may worsen your hyperparathyroidism. Your doctor will monitor your parathyroid hormone levels in your blood.

Your doctor will monitor your blood parameters at regular intervals. Particularly, your electrolyte levels (e.g. bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids.

• If you have high levels of bicarbonate in your 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.
• An improper sequence of priming or clamping may cause air to be perfused into your peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• If you administer the solution without mixing, an immediate drainage (emptying) of the solution and use of a new mixed bag should be performed.
• Due to a condition known as encapsulating peritoneal sclerosis (EPS), 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, which may be associated with abdominal pain, abdominal distension, or vomiting. In rare cases, 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 PHYSIONEAL 40 with other medications

• Inform your doctor if you are using or have recently used other medications,

including those purchased without a prescription.

• If you use other medications, your doctor may need to increase your dose since peritoneal dialysis treatment increases the elimination of certain medications.
• Be cautious if you use heart medications called cardiac glycosides (e.g. digoxin), as 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, or think you may be pregnant, or plan to become pregnant, 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 40 should be administered into your peritoneal cavity. This cavity is located in the

abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs, such as the intestines or the liver.

Do not use by intravenous route.

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

If the bag is damaged, it should be discarded.

Quantity and frequency

Your doctor will indicate the suitable 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 the treatment with PHYSIONEAL 40

Do not interrupt peritoneal dialysis without your doctor's consent. Interruption of the treatment may have harmful consequences for your life.

Administration form

Before use,

• Mix the two chambers carefully by breaking the breakable seal that is between the two chambers. Wait until the upper chamber has emptied completely into the lower chamber. Mix the solution carefully, pressing with both hands on the walls of the lower chamber.
• • 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 for you to add directly to the PHYSIONEAL 40 bag. In this case, add the medication through the medication addition site located in the small chamber, before breaking the breakable seal that is between the two chambers. Use the product immediately after adding the medication. Consult your doctor if you are unsure.

If in 24 hours you use more PHYSIONEAL 40 bags than you should

If you are administered an excessive dose of PHYSIONEAL 40, you may experience:

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 medications, this medication 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:

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 prospectus.

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
• Increased bicarbonate levels (alkalosis).

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

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

Other side effects related to the peritoneal dialysis procedure:

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 prospectus. You can also report them directly through the Spanish System for FV of 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 medication.

Dispose of PHYSIONEAL 40 as instructed.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. 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 40

The mixed peritoneal dialysis solution contains the following active principles:

The other components are: water for injection preparations and carbon dioxide.

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

Appearance of the product and contents of the package

PHYSIONEAL 40 is an colourless, transparent and sterile peritoneal dialysis solution.

Only some sizes of packaging may be commercially available.

Marketing authorization holder

Vantive Health, S.L.

Industrial Sector 14

Camilo Pouet 2 Street

46394 Ribarroja del Turia (Valencia) Spain

Responsible for manufacturing

Vantive Manufacturing Limited

Moneen Road

Castlebar

County Mayo – Ireland

or

Bieffe Medital SpA

New Provincial Road

23034 Grosotto

Italy

Last revision date of this leaflet: November 2018

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Vantive and Physioneal are registered trademarks of Vantive Health Inc. or its subsidiaries