Package Insert: Information for the User

CAPD/DPCA 3 Solution for Peritoneal Dialysis

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

CAPD/DPCA 3is used to clean the bloodthrough the peritoneum in patients with end-stage chronic kidney disease. This type of blood cleaning is known as peritoneal dialysis.

No use CAPD/DPCA 3

• if your blood potassium level is very low
• if your blood calcium level is very high
• if you have alactate metabolism disorder
• if you have afructose metabolism disorder(hereditary fructose intolerance)

• if the volume of fluids in your body is too low
• if you have low blood pressure

Generally, peritoneal dialysis treatment should not be initiated if you have:

• abdominal alterations such as

• injuries, or after a surgical operation
• severe burns
• important skin inflammatory reactions
• peritoneal inflammation
• non-healing suppurating wounds
• umbilical, inguinal, or diaphragmatic hernia
• abdominal or intestinal tumors

• intestinal inflammation
• intestinal obstruction
• lung disease, especially pneumonia
• bloodstream infection caused by bacteria
• very high levels of fat in the blood
• blood contamination by the accumulation of uremic toxins, whose elimination cannot be performed by cleaning the blood.
• severe malnutrition and weight loss, particularly if adequate protein-containing food consumption is not possible

Warnings and precautions

Consult your doctor immediately

• in case ofsevere loss of electrolytes (salts)caused byvomiting and/or diarrhea.
• in case ofperitoneal inflammation, recognizable by a cloudy peritoneal dialysis solution, abdominal pain, fever, malaise, or, in very rare cases, blood contamination.

Show your doctor the drainage solution bag.

• in case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication derived from peritoneal dialysis treatment that can lead to death.

Peritoneal dialysis may causeprotein lossandsoluble vitamin lossin water. It is recommended to follow an adequate diet or take nutritional supplements to avoid nutritional deficiencies.

Your doctor should regularly monitorelectrolyte balance (salts), blood cell count, renal function,your body weight, and nutritional status.

CAPD / DPCA 3 contains 42.5 g of glucose in 1000 ml of solution. Depending on the dosing instructions and the size of the container used, it is administered with each bag up to 106 g of glucose (CAPD: a 2500 mlstay•safebag) or up to 212.5 g of glucose (APD: a 5000 mlsleep•safebag). This should be taken into account in the treatment of patients with diabetes mellitus

Due to the high glucose concentration, CAPD 3 should be used with caution and under the supervision of your doctor.

Use of CAPD/DPCA 3 withother medications

Inform your doctor or pharmacist if you are using, haveutilized recentlyor may need to use any other medication.

Peritoneal dialysis may alter the effect of some medications, so your doctor may need to change the dose for some of them, especially the following:

• Cardiac failure medications, such as digoxin.

Your doctor will check your potassium level in the blood and, if necessary, take the necessary measures.

• Medications that affect calcium levels, such as those containing calcium or vitamin D.
• Medications that increase urine excretion, such asdiuretics.
• Oral medicationsthat decrease blood sugar levelsor insulin. Regularly monitor blood sugar levels.

Pregnancy and lactation

If you are pregnant or breastfeeding, consultyour doctor before using this medication.No adequate data is available on the use of CAPD/DPCA 3 in pregnant women or during lactation. If you are pregnant, do not use CAPD/DPCA 3unless your doctor considers it absolutely necessary.

The active principles of CAPD/DPCA 3 or their metabolites are unknown to be excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and using machines

The influence of CAPD/DPCA 3 on the ability to drive and use machines is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

Your doctor will determine the method, duration, and frequency of use, as well as the required volume of solution and the time of residence in the peritoneal cavity.

If you have tension in the abdominal region, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: The recommended dose is between 2000 – 3000 ml of solution four times a day depending on body weight and renal function.

After a residence time of 2 to 10 hours, the solution is drained.

• Children: The doctor will determine the required volume of dialysis solution depending on tolerance, age, and body surface area of the child.

The initial recommended dose is 600 – 800 ml/m2of body surface area four times a day (up to 1000 ml/m2at night).

Automated Peritoneal Dialysis (APD)

The exchange of bags is controlled automatically by a machine throughout the night. The CAPD/DPCA systemsleep•safeis used.

• Adults:The normal prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a cyclator time of 8 to 10 hours, and one or two exchanges during the day.

• Children:The volume per exchange should be 800-1000 ml/m2(up to 1400 ml/m2) of body surface area with 5-10 exchanges during the night.

Use CAPD/DPCA 3 only in the peritoneal cavity.

Use only CAPD/DPCA 3 if the solution is transparent and the container is not damaged.

Usage Instructions

Systemstay•safefor Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the bag with the solution to body temperature. This should be done using a special heating plate. A 2000 ml bag at an initial temperature of22ºCwill require 120 minutes of heating time. You can find more detailed information in the manual of your heater. To warm the solution, ovens should not be used due to the risk of local overheating. After warming the solution, the exchange of bags can be performed.

1. Check the solution bag (label, expiration date, transparency of the solution, integrity of the bag and overbag)?open the outer bag and the packaging of the disinfectant plug.
2. Wash your hands with an antimicrobial washing solution.
3. Place the DISC in the organizer (hang the bag with the solution by the upper hanger of the infusion support?unroll the "DISC-bag solution" line?place the DISC in the organizer?place the drainage bag in the lower hanger of the infusion support).
4. Place the catheter extension in one of the two inserts of the organizer.?Put the new disinfectant plug in the other free insert.
5. Disinfect your hands and remove the protective cap from the DISC.
6. Connect the catheter extension to the DISC.
7. Open theextension valve?position “?”?initiate the outflow.
8. After the completion of drainage:Purge?position “??”?purge the drainage bag with clean solution (approx. 5 seconds).
9. Outflow?position “?”???connect the bag with the solution to the catheter.
10. Security phase?position "????"?close the catheter extension by introducing the PIN.
11. Disconnection?removethe protective cap of the new disinfectant plug and screw it onto the old?unscrewthe catheter extension from the DISCand screw on the new disinfectant plug.
12. Close the DISC with the open end of the disinfectant plug (located in the right hole of the organizer).
13. Check the clarity and weightof the drained dialysate andif the liquid is clear, discard it.

Systemsleep•safefor Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the machine automatically warms the solution.

1. Preparation of the solution

• Check the solution bag (label, expiration date, transparency of the solution, integrity of the bag and overbag).
• Place the bag on a solid surface.
• Open the overbag.
• Wash your hands using an antimicrobial lotion.
• Check that the solution is transparent and that the bag has no leaks.

1. Unroll the tube of the bag.
2. Remove the protective cap
3. Place the connector in the free connection of the traysleep•safe
4. The bag is already prepared for use with thesleep•safeequipment.

The bags are for single use and any remaining solution without use must be discarded.

After proper training, CAPD/DPCA 3 can be used independently at home. Make sure you follow all the steps you learned during training and maintain the necessary hygiene conditions when exchanging bags.

Always check the turbidity of the drained dialysate. See section 2.

If you use more CAPD/DPCA 3 than you should

Any excess dialysis solution that has entered the peritoneal cavity can easily be drained into the drainage bag. If you use too many bags, please contact your doctor, as it may cause electrolyte and/or fluid imbalance.

If you forgot to use CAPD/DPCA 3

Try to reach the prescribed dialysis volume for each 24-hour period to avoid consequences that may put your life at risk. You should consult your doctor if you have any doubts.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

The following side effects may occur as a result of treatment:

Very common(may affect more than 1 in 10 people)

• Peritoneal inflammation, which is observed by cloudy dialysate drainage, abdominal pain, fever, malaise, or, in very rare cases, blood infection.

Show your doctor the bag containing the drainage solution.

• Skin inflammation at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, exudation, or scabs.
• Abdominal wall hernia.

Contact your doctor immediately if you experience any of these side effects.

Other side effects of treatment are as follows:

Common(may affect up to 1 in 10 people)

• Problems with the entry or exit of the dialysis solution drainage.
• Abdominal fullness or stretching sensation
• Shoulder pain

Uncommon(may affect up to 1 in 100 people)

• Diarrhea
• Constipation

Unknown frequency(the frequency cannot be estimated from available data)

• Respiratory difficulties due to diaphragm elevation
• Encapsulating peritoneal sclerosis, whose symptoms may be abdominal pain, abdominal distension, or vomiting

You may experience the following side effects when using CAPD/DPCA 3:

Very common(may affect more than 1 in 10 people)

• Potassium deficiency

Common(may affect up to 1 in 10 people)

• Elevated blood sugar levels
• Elevated blood lipid levels
• Weight gain
• Excessive calcium if calcium intake is too high

Uncommon(may affect up to 1 in 100 people)

• Low fluid volume, which can be recognized by rapid weight loss
• Dizziness
• Low blood pressure
• Fast pulse
• High fluid volume, which can be recognized by rapid weight gain
• Fluid accumulation in tissues and lungs
• Elevated blood pressure
• Respiratory difficulties

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 use this medication after the expiration date that appears on the bag and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not refrigerate or freeze.

The solution should be used immediately after the first opening.

Composition ofCAPD/DPCA 3

• The active principles in one liter of solution are:

These amounts of active substance are equivalent to:

1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 103.5 mmol/l chloride, 35 mmol/l (S)-lactate, and 235.8 mmol/l glucose.

• The other components of CAPD/DPCA 3 are water for injection, hydrochloric acid, and sodium hydroxide.

Appearance of the product and contents of the package

The solution is transparent and colorless to slightly yellowish.

The theoretical osmolality of the solution is 511 mosm/l, the pH is over 5.5.

CAPD/DPCA 3 is available in the following application systems and package sizes:

Only some package sizes may be commercially available.

Marketing Authorization Holder

Fresenius Medical Care Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H.

Germany

Responsible for manufacturing

Fresenius Medical Care Deutschland GmbH,

Frankfurter Straße 6-8,66606 St. Wendel

Germany

Local Representative

Fresenius Medical Care España S.A.,

C/ Ronda de Poniente, 8, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid),

Spain

Last review date of this leaflet: 09/2019

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