Extraneal Clear Flex Solution For Peritoneal Dialysis

PACKAGE LEAFLET: INFORMATION FOR THE USER

EXTRANEAL CLEAR-FLEX 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.

- If you have any further questions, ask your doctor or nurse.

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What EXTRANEAL CLEAR-FLEX is and what it is used for

2. What you need to know before you use EXTRANEAL CLEAR-FLEX

3. How to use EXTRANEAL CLEAR-FLEX

4. Possible side effects

5. How to store EXTRANEAL CLEAR-FLEX

6. Contents of the pack and other information

1. WHAT EXTRANEAL CLEAR-FLEX IS AND WHAT IT IS USED FOR

EXTRANEAL CLEAR-FLEX is a solution for peritoneal dialysis. The peritoneal cavity is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. The EXTRANEAL CLEAR-FLEX solution is placed into the peritoneal cavity where it removes water and waste products from your blood. It also corrects abnormal levels of different blood components.

EXTRANEAL CLEAR-FLEX may be prescribed for you if:

- you are an adult with permanent kidney failure which needs peritoneal dialysis.

- standard glucose peritoneal dialysis solutions alone cannot remove sufficient water.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXTRANEAL CLEAR-FLEX

Your doctor must supervise you the first time you use this product.

Do not use EXTRANEAL CLEAR-FLEX

• if you are allergic to icodextrin, starch derivatives (e.g. corn (maize) starch) or any of the other ingredients of EXTRANEAL CLEAR-FLEX.

• if you are intolerant to maltose or isomaltose (sugar coming from starch).

• if you have glycogen storage disease.

• if you already have severe lactic acidosis (too much acid in the blood).

• if you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.

• if you have documented loss of peritoneal function due to severe peritoneal scarring.

Warnings and precautions

Talk to your doctor before using EXTRANEALCLEAR-FLEX

• if you are elderly. There is a risk of dehydration.

• if you are diabetic and using this solution for the first time. You may need to adjust your insulin dose. Your insulin dose may be affected by the type of bag Extraneal is contained in. Your doctor or nurse will advise you on the appropriate dose.

• if you need to test your blood glucose level (for example if you are diabetic). Your doctor will advise you on which test kit to use (see “Other forms of interactions”).

• if you have a high risk of severe lactic acidosis (too much acid in the blood). You are at increased risk of lactic acidosis if:

• you have profoundly low blood pressure

• you have a blood-infection

• you have acute severe kidney failure

• you have an inherited metabolic disease

• you are taking metformin (a medicine used to treat diabetes)

• you are taking medicines to treat HIV, especially medicines called NRTIs

• if you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.

• during peritoneal dialysis your body may lose protein, amino acids and vitamins. Your doctor will know if these need to be replaced.

• if you have problems affecting your abdominal wall or cavity. For example if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines.

• if you had aortic graft placement.

• if you have severe lung disease, e.g. emphysema

• if you have breathing difficulties.

• if you have disorders precluding normal nutrition.

• if you have a potassium deficiency.

You should also take into account that:

• a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You - together with your doctor - should be aware of this possible complication. EPS causes:

• inflammation in your abdomen (belly)

• the growth of sheets of fibrous tissue that cover and bind your organs and affect their normal movement. Rarely this has been fatal.

• you - possibly together with your doctor - should keep a record of your fluid balance and of your body weight. Your doctor will monitor your blood parameters at regular intervals.

• your doctor will check your potassium levels regularly. If they fall too low he may give you some potassium chloride to compensate.

Sometimes treatment with this medicine is not recommended, such as if:

• you have acute kidney disease.

Children

The safety and efficacy of Extraneal in children less than 18 years old has not been demonstrated. Other medicines and EXTRANEAL CLEAR-FLEX

Tell your doctor if you are taking, have recently taken or might take any other medicines. If you use other medicines, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines.

• Take care if you use heart medicines known as cardiac glycosides (e.g. digoxin). Your heart medicine may not be so effective or its toxicity may be increased. You may:

• need potassium and calcium supplements

• develop an irregular heartbeat (an arrhythmia)

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

Other forms of interactions

EXTRANEAL CLEAR-FLEX interferes with the measurement of blood glucose with certain testing

kits. If you need to test your blood glucose, make sure that you use a kit that is glucose-specific. Your doctor will advise you on which kit to use.

Using the wrong test may cause a falsely high blood glucose reading level. This could result in administration of more insulin than needed. This can cause low blood glucose levels (hypoglycaemia), which can result in loss of consciousness, coma, neurological damage or death. Additionally, a false high glucose reading may mask true hypoglycaemia and allow it to go untreated with similar consequences.

False high glucose readings can be seen up to two weeks after you stopped your EXTRANEAL CLEAR-FLEX therapy. In case you are admitted to hospital you should warn the doctors about this possible interaction and they should carefully review the product information of the testing kit to make sure they use a glucose-specific one.

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 taking this medicine.

EXTRANEAL CLEAR-FLEX is not recommended during pregnancy or while breast-feeding unless your doctor advises differently.

Driving and using machines

This treatment may cause fatigue, weakness, blurred vision or dizziness. Do not drive or operate machines if you are affected.

3. HOW TO USE EXTRANEAL CLEAR-FLEX

EXTRANEAL CLEAR-FLEX is to be administered into your peritoneal cavity. The peritoneal cavity

is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the

membrane surrounding your internal organs such as your intestines and liver.

Always use this medicine exactly as instructed by the medical team specialised in peritoneal dialysis.

Check with your doctor if you are not sure.

The recommended dose is

• One bag per day during the longest dwell, (dwell during the daytime) in Automated Peritoneal Dialysis (APD).

• Take between 10-20 minutes to instill the solution.

• The dwell time with EXTRANEAL CLEAR-FLEX is between 14-16 hours in APD.

Method of administration

Before use,

• Warm the bag to 37°C. Use the warming plate specially designed for this purpose. Never immerse in water to warm the bag. Never use a microwave oven to warm the bag.

• Use aseptic technique throughout the administration of the solution as you have been trained.

• Prior to beginning an exchange, ensure you clean your hands and the area where your exchange will be performed.

• Prior to opening the overpouch, check for the correct solution type, amount (volume) and expiration date. Lift the dialysate bag to check for any leaks (excess fluid in the overpouch). Do not use the bag if leaks are discovered.

• After removing the overpouch, inspect the container for signs of leakage by pressing firmly on the bag. Do not use the bag if leaks are discovered.

• Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.

• Ensure all connections are secure before beginning the exchange.

• Ask your doctor or nurse if you have questions or concerns about this product or how to use it.

Use each bag only once. Discard any unused remaining solution.

After use, check that the drained fluid is not cloudy.

Compatibility with other drugs

Your doctor may prescribe you other injectable drugs to be added directly into the EXTRANEAL CLEAR-FLEX bag. In that situation, add the drug through the medication site located at the bottom of the bag. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.

If you use more than one bag of EXTRANEAL CLEAR-FLEX in 24 hours

Contact your doctor or nurse immediately if you believe that you have infused too much EXTRANEAL CLEAR-FLEX.

If you use too much EXTRANEAL CLEAR-FLEX you may get:

• abdominal distension

• a feeling of fullness and/or

• a shortness of breath.

If you stop using EXTRANEAL CLEAR-FLEX

Do not pause or stop the treatment without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences.

4. POSSIBLE SIDE EFFECTS

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

If any of the following happen, tell your doctor or dialysis centre immediately:

• Hypertension.

• Swollen ankles or legs, puffy eyes, shortness of breath or chest pain (hypervolaemia).

• Hypersensitivity (allergic reaction) which may include swelling of face, throat or around the eyes (angioedema).

• Abdominal pain.

• Chills (shivering/flu-like symptoms).

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

Common: may affect up to 1 in 10 people in patients using EXTRANEAL CLEAR-FLEX:

• Redness and scaling of the skin, rash, itching.

• Feeling light headed, dizzy, or thirst (dehydration).

• Decreased blood volume (hypovolaemia).

• Abnormal laboratory tests.

• 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 drained from the peritoneal cavity, stomach-ache.

• Peritoneal bleeding, pus, swelling, pain or infection around the exit site of your catheter, catheter blockage, injury, interaction with the catheter.

• Faintness, cold sweats, hunger, confusion, possibly unconsciousness and seizures due to low blood sugar (hypoglycaemia). It may in some develop into a serious side effect. Talk to your doctor.

• Shock or coma caused by low concentration of sugar in blood.

• Frequent urination, thirst, fatigue due to high blood sugar (blood glucose). It may in some develop into a serious side effect. Talk to your doctor.

• Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhoea, flatulence (passing wind), disorder of the stomach or intestines such as blockage in your intestine, gastric ulcer, abdominal pain, indigestion.

• Abdominal swelling, hernia of the abdominal cavity (this causes a lump in the groin).

• Modification of your blood tests.

• Abnormal liver function test.

• Weight increase or decrease.

• Pain, fever, malaise.

• Heart disease, faster heartbeat, shortness of breath or chest pain.

• Anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness); increase or decrease of white blood cell count; reduction in blood platelets, which increases risk of bleeding or bruising.

• Numbness, tingling, burning sensation.

• Involuntary movements (hyperkinesia).

• Blurred vision.

• Loss of the sense of taste.

• Fluid on the lungs (pulmonary oedema), shortness of breath, difficulty in breathing or wheezing, cough, hiccups.

• Kidney pain.

• Nail disorder.

• Skin disorders such as hives (urticaria), psoriasis, skin ulcer, eczema, dry skin, skin discoloration, blistering of the skin, allergic or contact dermatitis, rashes and itching. Rashes may be itchy with red spots covered with bumps, or shedding of the skin. The following three severe types of skin reaction may occur:

• Toxic epidermal necrolysis (TEN). This causes:

• a red rash over many parts of the body

• shedding of the outer layer of skin.

• Erythema multiforme. An allergic skin reaction causing spots, red welts or purple or blistered areas. It can also affect the mouth, eyes and other moist body surfaces.

• Vasculitis. Inflammation of certain blood vessels within the body. Clinical symptoms will depend on the part of the body involved, but may be characterized on the skin as red or violet spots or welts or have symptoms similar to an allergic reaction, including rash, joint pain and fever.

• Muscle cramps, pain in bones, joints, muscles, back and neck.

• Dizziness, possible fainting when changing from lying to sitting or from sitting to standing position due to low blood pressure (orthostatic hypotension).

• Peritonitis (inflamed peritoneum) including peritonitis caused by fungal or bacterial infection.

• Infections including flu syndrome, boil.

• Abnormal thinking, anxiety, nervousness.

Talk to your doctor or nurse, if you experience side effects not listed in this leaflet. The infusion should be stopped if you get side effects.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal Republic of Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRE - Dublin 2.

Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie;

E-mail: medsafety@hpra.ie

Yellow Card Scheme www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE EXTRANEAL CLEAR-FLEX

• Keep EXTRANEAL CLEAR-FLEX out of the sight and reach of children.

• Do not store below 4 °C.

• The product should be used immediately after the outer bag is removed.

• Do not use EXTRANEAL CLEAR-FLEX after the expiry date which is stated on the pack. The expiry date (EXP) refers to the last day of that month.

Dispose of EXTRANEAL CLEAR-FLEX in the way you have been trained. For environmental reasons, you should not throw away medicine via wastewater or household waste.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor.

What EXTRANEAL CLEAR-FLEX contains

The active substances are:

Icodextrin	75 g/l
Sodium chloride	5.4 g/l
Sodium (S)-lactate solution equivalent to sodium (S)-lactate	4.5 g/l
Calcium chloride dihydrate	0.257 g/l
Magnesium chloride hexahydrate	0.051 g/l

Sodium	133 mmol/l
Calcium	1.75 mmol/l
Magnesium	0.25 mmol/l
Chloride	96 mmol/l
Lactate	40 mmol/l

The other ingredients are:

• Water for Injections.

• Sodium hydroxide or hydrochloric acid.

What EXTRANEAL CLEAR-FLEX looks like and contents of the pack

• EXTRANEAL CLEAR-FLEX is packaged in a plastic bag made from a material that is called Clear-Flex. EXTRANEAL CLEAR-FLEX is packed in a 2500 ml single bag with luer connector.

• The solution in the bags is clear and colourless.

• Each bag is over-wrapped in an overpouch and supplied in carton boxes containing 1, 3 or 4 bags.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Baxter Healthcare Limited Caxton Way, Thetford,

Norfolk, IP24 3SE,

United Kingdom

Manufacturer

Baxter Healthcare S.A Moneen Road Castlebar, County Mayo Ireland

Bieffe Medital S.p.A.

Via Nuova Provinciale 1-23034 Grosotto Italy

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 03/2016.

Baxter, EXTRANEAL and CLEAR-FLEX are trademarks of Baxter International Inc.