CAPD/DPCA 4 SOLUTION FOR PERITONEAL DIALYSIS

Introduction

Package Leaflet: Information for the User

CAPD/DPCA 4 Solution for Peritoneal Dialysis

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is CAPD/DPCA 4 and what is it used for

CAPD/DPCA 4 is used to clean the bloodthrough the peritoneum in patients with end-stage chronic kidney failure. This type of blood cleaning is known as peritoneal dialysis.

2. What you need to know before you use CAPD/DPCA 4

Do not use CAPD/DPCA 4

• if your blood potassium level is too low
• if your blood calcium level is too high
• if you have a disorder of lactate metabolism
• if you have a disorder of fructose metabolism (hereditary fructose intolerance)

In general, peritoneal dialysis treatment should not be started if you have:

• abdominal wall abnormalities such as

• wounds, or after surgery
• severe burns
• significant skin inflammatory reactions
• peritonitis
• unclosed suppurating wounds
• umbilical, inguinal or diaphragmatic hernia
• tumors in the abdomen or intestine

• intestinal inflammation
• intestinal obstruction
• lung disease, especially pneumonia
• generalized blood infection caused by bacteria
• very high levels of fat in the blood
• contamination due to the accumulation of uremic toxins in the blood that cannot be removed by cleaning the blood.
• severe malnutrition and weight loss, especially if it is not possible to consume adequate amounts of protein-containing foods.

Warnings and precautions

Consult your doctor immediately

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

Show your doctor the bag containing the dialysate.

• in case of severe abdominal pain, abdominal distension or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that can be life-threatening.

Peritoneal dialysis may cause loss of proteinsand water-soluble vitamins. It is recommended to follow an adequate diet or take nutritional supplements to avoid deficient nutritional states.

Your doctor should regularly check the balance of electrolytes (salts), blood cell count, kidney function, your body weight, and nutritional status.

CAPD/DPCA 4 contains 22.73 g of glucose in 1000 ml of solution. Depending on the dosing instructions and the size of the bag used, up to 57 g of glucose (CAPD: one 2500 ml stay•safebag) or up to 114 g of glucose (APD: one 5000 ml sleep•safebag) are administered with each bag. This should be taken into account in the treatment of patients with diabetes mellitus.

Due to the high glucose concentration, CAPD 4 should be used with caution and under the supervision of your doctor.

Using CAPD/DPCA 4 withother medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Peritoneal dialysis may alter the effect of some medicines, so it may be necessary for your doctor to change the dose for some of them, especially the following:

• Medicines for heart failure, such as digitoxin.

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

• Medicines that affect calcium levels, such as those containing calcium or vitamin D.
• Medicines that increase urine excretion, such as diuretics.
• Medicinesgiven orally that lower blood sugar levelsor insulin. Blood sugar levels should be regularly checked.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. There are no adequate data on the use of CAPD/DPCA 4 in pregnant or breastfeeding women. If you are pregnant, you should not use CAPD/DPCA 4 unless your doctor considers it absolutely necessary.

It is not known whether the active substances of CAPD/DPCA 4 or their metabolites are excreted in breast milk. Breastfeeding is not recommended for mothers undergoing peritoneal dialysis.

Driving and using machines

CAPD/DPCA 4 has no or negligible influence on the ability to drive and use machines.

3. How to use CAPD/DPCA 4

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the method, duration, and frequency of use, as well as the required volume of solution and the dwell time 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 kidney function.

After a dwell time of between 2 and 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 recommended initial dose is 600 - 800 ml/m2 of body surface area four times a day (up to 1000 ml/m2 at night).

Automated Peritoneal Dialysis (APD)

The exchange of bags is automatically controlled by a machine overnight. For this, the sleep•safesystem of CAPD/DPCA is used.

• Adults: the normal prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges overnight and a cycling 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 overnight.

Use CAPD/DPCA 4 only in the peritoneal cavity.

Use only CAPD/DPCA 4 if the solution is clear and the bag is not damaged.

Instructions for use

stay•safeSystem for 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 of 22°C will need about 120 minutes of warming time. You can obtain more detailed information in the manual of your heater. Microwaves should not be used to warm the solution due to the risk of local overheating. After warming the solution, the bag exchange can be carried out.

1. Check the solution bag (label, expiration date, transparency of the solution, integrity of the bag and overbag) ? open the outer bag and the wrapping of the disinfectant cap.
2. Wash your hands with an antimicrobial washing solution.
3. Place the DISC in the organizer (hang the solution bag from the upper hook of the infusion stand ? unroll the "DISC-solution bag" line ? place the DISC in the organizer ? place the drain bag on the lower hook of the infusion stand).
4. Place the catheter extension in one of the two inserts of the organizer. ? Put the new disinfectant cap on 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 the extension valve ? position “?” ? start the outflow
8. After completion of drainage: Purge ? position “??” ? purge the drain bag with clean solution (approx. 5 seconds).
9. Inflow ? position “???” ? connect the solution bag to the catheter.
10. Safety phase ? position "????" ? close the catheter extension by inserting the PIN.
11. Disconnection ? remove the protective cap from the new disinfectant cap and screw it onto the old one ? unscrew the catheter extension from the DISC and screw it onto the new disinfectant cap.
12. Close the DISC with the open end of the disinfectant cap (located in the hole on the right side of the organizer).
13. Check the clarity and weight of the drained dialysate and if the liquid is clear, discard it.

sleep•safeSystem for Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the device automatically heats 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 washing solution.
• Check that the solution is clear and that the bag has no leaks.

1. Unroll the tube of the bag.
2. Remove the protective cap
3. Place the connector on the free connection of the sleep•safetray
4. The bag is now ready for use with the sleep•safeequipment

The bags are for single use and any unused solution should be discarded.

After proper training, CAPD/DPCA 4 can be used independently at home. Make sure you follow all the steps you have learned during training and maintain adequate hygiene conditions when exchanging bags.

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

If you use more CAPD/DPCA 4 than you should

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

If you forget to use CAPD/DPCA 4

Try to reach the prescribed dialysate volume for each 24-hour period to avoid life-threatening consequences. You should consult your doctor if you have any doubts.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience the following side effects as a result of treatment:

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

• peritonitis, which is observed by a cloudy drained dialysate, abdominal pain, fever, malaise or, in very rare cases, blood infection.

Show your doctor the bag containing the dialysate.

• skin inflammation at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, discharge, or crusts.
• hernia in the abdominal wall.

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

Other side effects of treatment are the following:

common(may affect up to 1 in 10 people)

• problems with the entry or exit of the dialysis solution.
• feeling of stretching or fullness of the abdomen
• shoulder pain

uncommon(may affect up to 1 in 100 people)

• diarrhea
• constipation

frequency not known(frequency cannot be estimated from the available data)

• breathing difficulties due to elevation of the diaphragm

• encapsulating peritoneal sclerosis, whose symptoms could be abdominal pain, abdominal distension, or vomiting

You may experience the following side effects when using CAPD/DPCA 4:

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

• potassium deficiency

common(may affect up to 1 in 10 people)

• high blood sugar levels
• high blood fat levels
• weight gain
• excess calcium if calcium intake is too high

uncommon(may affect up to 1 in 100 people)

• low body fluid level, which can be recognized by rapid weight loss
• dizziness
• low blood pressure
• rapid pulse
• high body fluid level, which can be recognized by rapid weight gain
• fluid in the tissues and lungs
• high blood pressure
• breathing difficulties

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CAPD/DPCA 4

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

Do not use this medicine after the expiry date which is stated on the bag and on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Do not refrigerate or freeze.

The solution should be used immediately after the first opening.

6. Contents of the pack and other information

Composition of CAPD/DPCA 4

• The active substances 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 126.1 mmol/l glucose.

• The other components of CAPD/DPCA 4 are water for injections, hydrochloric acid, and sodium hydroxide.

Appearance and packaging of the product

The solution is clear and colorless to slightly yellowish.

The theoretical osmolarity of the solution is 401 mosm/l, the pH is above 5.5.

CAPD/DPCA 4 is available in the following application systems and pack sizes:

Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Medical Care Deutschland GmbH

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

Germany

Manufacturer

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, planta baja, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid),

Spain

Date of last revision of this leaflet: 09/2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.