POLITHERA (ICODEXTRIN 7.5%) SOLUTION FOR PERITONEAL DIALYSIS

2. What you need to know before you use Polithera

Your doctor should supervise you the first time you use this medicine.

Do not use Polithera

• if you are allergic to icodextrin, starch derivatives (e.g. cornstarch) or any of the other components of this medicine (listed in section 6)
• if you do not tolerate maltose or isomaltose (sugar derived from starch)
• if you have any glycogen storage disease
• if you have severe lactic acidosis (too much acid in the blood)
• if you have any problem that cannot be corrected by surgery that affects your abdominal wall or cavity or an incurable condition that increases the risk of abdominal infections
• if you have a documented loss of peritoneal function due to severe peritoneal scarring.

Warnings and precautions

Talk to your doctor before you start using Polithera

• if you are an elderly patient. There is a risk of dehydration
• if you are diabetic and use this solution for the first time. You may need to adjust your insulin dose
• if you need to control your blood glucose level (for example, if you are diabetic). Your doctor will tell you which test method to use (see "Other forms of interactions").
• if you have a high risk of severe lactic acidosis (too much acid in the blood). You have a high risk of lactic acidosis if:
• • you have very low blood pressure
  • you have a blood infection
  • you have severe acute kidney failure
  • you have a hereditary metabolic disease
  • you are taking metformin (a medicine used to treat diabetes)
  • you are taking medicines to treat HIV, especially ones called NRTI
• if you feel abdominal pain or notice that the drainage fluid is cloudy, has lumps or particles.

This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and take it with the drained fluid bag to the medical team. The medical team will decide whether to interrupt treatment or start 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 that is effective against a wide range of different bacteria until they know what infection you have.

• during peritoneal dialysis, your body may lose proteins, amino acids, and vitamins. Your doctor will determine if you need to replace these losses
• if you have problems that affect the integrity of the abdominal wall or cavity. For example, in case of hernia or a chronic or inflammatory disease that affects the intestines
• if you have had an aortic graft
• if you have severe lung disease, such as emphysema
• if you have breathing difficulties
• if you have disorders that prevent normal nutrition
• if you have low potassium levels

You should also be aware that:

• a disorder called encapsulating peritoneal sclerosis (EPS) is a known and rare complication of peritoneal dialysis therapy. You, probably together with your doctor, should be aware of this possible complication. EPS causes:
• • abdominal inflammation (belly)
  • the growth of layers of fibrous tissue that cover and join the organs, which will affect their normal movement. In rare cases, it has been fatal
• you, probably together with your doctor, will keep a record of your fluid balance and body weight. Your doctor will check your blood parameters at regular intervals
• your doctor will regularly check your potassium levels. If the levels drop too low, you may be given potassium chloride to compensate.

In some cases, treatment with this medicine is not recommended, for example, if:

• you have acute kidney failure.

Children and Adolescents

The safety and efficacy of Polithera in children under 18 years of age have not been established.

Other medicines and Polithera

Tell your doctor if you are taking, have recently taken or might take any other medicines.

• if you are taking other medicines, your doctor may need to increase the dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines.
• be careful if you use heart medicines called cardiac glycosides (e.g. digoxin). Your heart medicine may not be as effective or its toxicity may be increased. You may:
• • need potassium and calcium supplements
  • develop heart rhythm disorders (arrhythmia)

Your doctor will closely monitor you during treatment, especially your potassium levels.

Other forms of interactions

Polithera interferes with the determination of blood glucose with certain test kits. If you need to perform blood glucose tests, make sure to use a method that is specific for glucose. Your doctor will advise you on which kit to use.

Using an unsuitable kit can cause false readings of high blood glucose levels, which can lead to the administration of more insulin than necessary. This can cause low blood glucose levels (hypoglycemia), which can lead to loss of consciousness, coma, brain damage, or death. Additionally, false readings of high blood glucose levels can mask real hypoglycemia and allow it to remain untreated with similar consequences.

False readings of high blood glucose levels can occur up to two weeks after stopping treatment with Polithera. In case of hospitalization, you should inform the doctors about this possible interaction, who should carefully review the product information of the test kit to ensure the use of a glucose-specific kit.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery. Polithera should only be administered to pregnant women after careful evaluation.

At therapeutic doses, no effects of Polithera on newborns/breastfed infants are expected. However, breast-feeding is not recommended while the patient requires peritoneal dialysis.

Driving and using machines

This treatment can cause fatigue, weakness, blurred vision, or dizziness. Do not drive or use machinery if you experience any of these effects.

3. How to use Polithera

Follow the instructions for administration of this medicine exactly as told by your doctor. Ask your doctor if you are not sure.

Polithera is indicated as an exchange to be performed once a day during the long dwell period (6 to 16 hours) in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) regimen for the treatment of end-stage renal failure.

Polithera should be administered in your peritoneal cavity. This cavity is found in the abdomen (belly) situated between the skin and the peritoneum. The peritoneum is the membrane that surrounds the internal organs, such as the intestines and liver.

Follow the instructions for administration of this medicine exactly as told by your doctor specialized in peritoneal dialysis. If in doubt, ask your doctor.

The recommended dose is

• One bag per day during the longest dwell period, such as:
• • at night in Continuous Ambulatory Peritoneal Dialysis (CAPD) regimen
  • during the day in Automated Peritoneal Dialysis (APD) regimen.
• The solution should be infused over a period of 10-20 minutes.
• The dwell time with Polithera is between 6 to 12 hours in CAPD regimen and between 14 to 16 hours in APD regimen.

Method of administration

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.
• 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 the exchange will be performed.
• Before opening the overbag, check that the type of solution, quantity (volume), and expiration date are correct. Lift the dialysate bag to check for leaks (excess liquid in the overbag). Do not use the bag if it has leaks.
• Once the overbag is removed, inspect the container to ensure it does not show signs of leaks, by pressing firmly on the bag. Do not use the bag if it has leaks.
• Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, check that all connections are secure.
• Consult your doctor if you have any questions or doubts about this product or its use.
• Use each bag only once. Discard any unused solution.
• After use, check that the drainage fluid is not cloudy.
• This solution should not be used for intravenous infusion.

Compatibility with other medicines

Your doctor may prescribe other injectable medicines to be added directly to the Polithera bag. In this case, add the medicine through the medication addition site located at the bottom of the bag. Use the product immediately after adding the medicine. Consult your doctor if you are not sure.

If you use more than one bag of Polithera in 24 hours

If you use too much Polithera, you may experience abdominal distension, a feeling of fullness, and/or difficulty breathing.

Contact your doctor immediately. The doctor will tell you what to do.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you stop treatment with Polithera

Do not interrupt or stop treatment without your doctor's consent. Stopping treatment can have potentially fatal consequences.

Consult your doctor or nurse if you have any questions about the use of this medicine.

4. Possible side effects

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

If you experience side effects, talk to your doctor or dialysis center, even if it is possible side effects not listed in this leaflet

If you experience any of the following side effects, contact your doctor or dialysis center immediately

• Hypertension.
• Swelling of the ankles or legs, puffy eyes, difficulty breathing, or chest pain (hypervolemia).
• Hypersensitivity (allergic reaction), which can include swelling of the face, throat, or eyelids (angioedema).
• Abdominal pain.
• Chills (feeling of cold/flu-like symptoms).

These can be signs of serious side effects. You may need urgent medical attention.

Frequent: may affect up to 1 in 10 patients treated with Polithera:

• Redness and peeling of the skin, rash, itching.
• Feeling of dizziness or thirst (dehydration).
• Decreased blood volume (hypovolemia).
• Abnormal laboratory test results.
• Weakness, headache, fatigue.
• Swollen ankles or legs.
• Low blood pressure (hypotension).
• Ringing in the ears (tinnitus).

Other side effects related to the peritoneal dialysis procedure or common to all peritoneal dialysis solutions:

• Cloudy solution extracted from the peritoneum, stomach pain.
• Peritoneal bleeding, pus, swelling, pain, or infection around the catheter exit site, catheter blockage, injury, interaction with the catheter.
• Fainting, cold sweat, hunger, confusion, possibly loss of consciousness, and convulsions due to low blood sugar levels (hypoglycemia). In some cases, it can evolve into serious side effects. Consult your doctor.
• Shock or coma caused by low blood sugar levels.
• Frequent urination, thirst, fatigue due to high blood sugar levels (hyperglycemia). In some cases, it can evolve into serious side effects. Consult your doctor.
• Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhea, flatulence, stomach or intestinal disorders such as intestinal obstruction, stomach ulcer, abdominal pain, or indigestion.
• Abdominal inflammation, abdominal cavity hernia (causes a lump in the groin area).
• Changes in blood parameters.
• Abnormal liver function tests.
• Weight gain or loss.
• Pain, fever, general malaise.
• Cardiac disorders, rapid heartbeat, difficulty breathing, or chest pain.
• Anemia (reduction of red blood cells, which can cause pale skin and produce weakness or difficulty breathing); increased or decreased white blood cell count; decreased platelet count, which increases the risk of bleeding or bruising.
• Feeling of numbness, tingling, or burning.
• Involuntary movements (hyperkinesia).
• Blurred vision.
• Loss of taste.
• Fluid in the lungs (pulmonary edema), shortness of breath, difficulty breathing, or wheezing, cough, hiccups.
• Kidney pain.
• Nail disorders.
• Skin disorders such as hives (urticaria), psoriasis, skin ulcers, eczema, dry skin, skin color changes, blisters, allergic or contact dermatitis, and skin rashes and itching.
• Skin rashes can be red, itchy spots covered with bumps or with rashes or peeling. The following three types of serious skin reactions can occur:
• Toxic epidermal necrolysis. This causes:
• • a red skin rash over most of the body
  • peeling of the outer layer of the skin.
• Stevens-Johnson syndrome. An allergic reaction on the skin that causes spots, hives, or purple-colored areas with blisters. It can also affect the mouth, eyes, and other mucous membranes.
• Vasculitis. Inflammation of certain blood vessels in the body. The clinical symptoms will depend on the part of the body affected, but on the skin, they can manifest as red or purple spots or rashes, or symptoms similar to those of an allergic reaction, including skin rash, joint pain, and fever.
• Muscle cramps, pain in the bones, joints, muscles, back, and neck.
• Dizziness, possible fainting when standing up from lying down or sitting down, due to a drop in blood pressure (orthostatic hypotension).
• Peritonitis (inflamed peritoneum), including peritonitis caused by fungal or bacterial infection.
• Infections, including flu-like syndrome and boils.
• Abnormal thinking, anxiety, nervousness.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Polithera

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 carton after «EXP». The expiry date is the last day of the month indicated.

Do not refrigerate or freeze.

The medicine should be used immediately after the outer bag has been removed.

Dispose of Polithera as you have been instructed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Package Contents and Additional Information

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

Composition of Polithera

The active substances are:

Theoretical osmolality: 284 (mOsmol/l)

Theoretical osmolarity: 301 (mOsmol/kg)

Electrolyte solution containing per 1000 ml (1 L):

pH = 5 to 6

The other ingredients are: water for injections, sodium hydroxide or hydrochloric acid.

Appearance and Package Contents of the Product

Polithera is a sterile, colorless or slightly yellowish solution.

Polithera is available in the following two formats:

A 2.0-liter polypropylene plastic bag containing the solution and an empty 3.0-liter polypropylene plastic drainage bag with a connecting tube.

Both bags and their connection are inserted into a two-layer protective film made of polypropylene and a polyamide overbag, and are supplied in cardboard boxes containing 4 bags.

A 2.0-liter polypropylene plastic bag containing the solution inserted into a two-layer protective film composed of polypropylene and a polyamide overbag, and is supplied in cardboard boxes containing 4 bags.

Marketing Authorization Holder

Vivisol S.r.l.

Via Gerolamo Borgazzi, 27 - 20900 Monza (MB)

Italy

Manufacturer

Infomed Fluids S.r.l. Bd. Pallady Theodor, 50

032266 Bucuresti - Sector 3, Romania

For further information about this medicine, please contact the local representativeof the marketing authorization holder:

FRESENIUS MEDICAL CARE ESPAÑA S.A.U.

Ronda de Poniente 8, Planta Baja (Parque Empresarial "Euronova")

28760 Tres Cantos –MADRID - Spain

This medicine has been authorized in the EEA member states with the following names:

Date of the last revision of this leaflet: August 2024

Other sources of information

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