Prospect: information for the user

PHYSIONEAL 35 Glucose 1.36% p/v/ 13.6 mg/ml, Solution for peritoneal dialysis

PHYSIONEAL 35 Glucose 2.27% p/v/ 22.7 mg/ml, Solution for peritoneal dialysis

PHYSIONEAL 35 Glucose 3.86% p/v/ 38.6 mg/ml, Solution for peritoneal dialysis

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

1. What is PHYSIONEAL 35 and what it is used for

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 in blood acidity or alkalinity (pH) and electrolyte levels
• some types of medication overdose for which there are no other treatments available.

The 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 use 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 medicine (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.

Warnings and precautions

Consult your doctor before starting to use PHYSIONEAL 35.

Be especially careful:

• if you have severe problems that affect the integrity of your abdominal wall or cavity, for example, in 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. You should contact your medical team urgently. Note the batch number of the peritoneal dialysis solution bags you are using and take 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. Your doctor may give you an antibiotic that is effective against a wide range of bacteria until they know what infection you have. This type of antibiotic is called a broad-spectrum antibiotic.
• if you have high levels of lactate in your blood. You have an increased risk of lactic acidosis if:

• you have a very low blood pressure
• you have a blood infection
• you have acute kidney failure
• you have a congenital metabolic disorder
• you are taking metformin (a medicine 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 your blood sugar levels (e.g. insulin) should be reviewed regularly. Especially, you should adjust the dose of your diabetes medications when starting or changing peritoneal dialysis treatment.
• if you are under 18 years of age. Your doctor will evaluate the risk-benefit ratio of using this product.
• 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), 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, feeling of fullness in the 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 inadequate priming or clamping may cause the perfusion of air within the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• If you administer the solution without mixing it, an immediate drainage (emptying) of the solution should be performed and a new mixed bag should be used.
• Due to a condition called 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, which 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 risk-benefit ratio of using the product.

Use of PHYSIONEAL 35 with other medicines

• Inform your doctor if you are using or have recently used other medicines, even those purchased without a prescription.
• If you are using other medicines, your doctor may need to increase your dose as the peritoneal dialysis treatment increases the elimination of certain medicines.
• Be careful if you are using heart medications called cardiac glycosides (e.g. digoxin), you may:

• need potassium and calcium supplements
• develop arrhythmias (abnormal heart rhythms).
• Your doctor will perform a thorough check-up during treatment, especially of your potassium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Physioneal is not recommended during pregnancy or breastfeeding 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 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 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 the treatment with PHYSIONEAL 35

Do not interrupt peritoneal dialysis without your doctor's consent. Interrupting 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 35 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 35 bags than you should

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

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):

• 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):

• 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:

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is 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.
  • Store in the original packaging.
  • Formats corresponding to 2.0 l and 2.5 l bags:Do not store at a temperature below 4 °C.
• Formats corresponding to 1.5 l bags:Store between 4 °C and 30 °C.
• • Do not use this medication after the expiration date appearing on the outer packaging label and on the bag after the CAD abbreviation and the symbol?. The expiration date is the last day of the month indicated.

Dispose of PHYSIONEAL 35 as instructed.

Medications 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 35

The mixed peritoneal dialysis solution contains the following active principles:

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

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

Appearance of the product and contents of the package

PHYSIONEAL 35 is an incolored, transparent, and sterile peritoneal dialysis solution.

PHYSIONEAL 35 is packaged in a double-chamber PVC bag. The two chambers are separated by a permanent seal. Only mix PHYSIONEAL 35 when the solutions from the two chambers are fully mixed.

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder

Vantive Health, S.L.

Industrial Sector 14

Camilo Pouet 2

46394 Ribarroja del Turia (Valencia) Spain

Ó

Bieffe Medital SpA

New Provincial Road

23034 Grossotto

Italy

Review date of this leaflet: August 2017

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 affiliates