Package Leaflet: Information for the User

GLUCOTHERA 1.4% w/v, solution for peritoneal dialysis. GLUCOTHERA 2.4% w/v, solution for peritoneal dialysis. GLUCOTHERA 4% w/v, 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 GLUCOTHERA is and what it is used for

2.    What you need to know before you use GLUCOTHERA

3.    How to use GLUCOTHERA

4.    Possible side effects

5.    How to store GLUCOTHERA

6.    Contents of the pack and other information

1.    What GLUCOTHERA is and what it is used for

GLUCOTHERA contains glucose monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride and sodium (S)-lactate.

It is a solution for peritoneal dialysis.

Peritoneal dialysis is a process that removes the waste products from your blood by using the tissue lining your tummy (your peritoneum) as a natural filter. Dialysis also helps control the amount of water and salts, in your blood. GLUCOTHERA contains varying levels of glucose (1.4%, 2.4% or 4%).

This medicine may be prescribed for you if you are suffering from severe kidney failure GLUCOTHERA has a similar acidity (pH) to that of the body and so may be particularly useful for you if other, more acidic, dialysis solutions have caused you tummy pain or discomfort.

2.    What you need to know before you use GLUCOTHERA

This product must only be used by healthcare professionals or patients who have received appropriate training on how to use the product.

Do NOT use GLUCOTHERA if:

•    You are allergic to glucose monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium chloride and sodium (S)-lactate or any of the other ingredients of this medicine (listed in Section 6).

•    You know that your peritoneum is scarred.

•    You know that your peritoneum does not work as well as it should, or you have other problems that mean you should not perform dialysis. For example:

o You have any condition in your tummy that might affect your peritoneum, for example, tumours, hernias or birth defects.

o You have an infection in your peritoneum or any condition that could cause an infection in your tummy.

o You have a serious lung disease or a lung infection, such as pneumonia. o You have a severe infection (sepsis)

o You are feeling weak and have lost a significant amount of weight due to problems with eating

o You have a rare problem of high levels of waste products in your blood which cannot be removed using peritoneal dialysis. o You have very high cholesterol levels in your blood

o You have a condition that increases the amount of lactate in your blood e.g. if your body cannot break down lactate. This may happen: o if your kidney function gets worse suddenly o if you have liver cirrhosis

o if you are taking other medicines that affect the amount of lactate in your blood e.g. metformin (a medicine to treat diabetes) and/or medicines known as NRTIs or

• You are not sure if you will be able to perform dialysis in your tummy without further help from a nurse or doctor

Warnings and Precautions

Talk to your doctor or nurse before using this medicine if you have:

•    A hernia - this is especially common in the elderly

•    Diabetes: (see ‘If you are diabetic’ section)

If you use peritoneal dialysis for a long time it may not work as well. If this happens you may need another type of treatment.

It is very important that your blood is checked regularly to make sure it is correctly balanced. Your doctor may have to give you other medicines to correct any imbalance.

Children and adolescents

GLUCOTHERA must be used very carefully in children and always under the supervision of a doctor or nurse.

Other medicines and GLUCOTHERA

Tell your doctor if you are taking or have recently taken or might take any other medicines. If you take any other medicines your doctor may need to change their dosage.

Tell your doctor if you are taking:

•    Cardiac glycosides, which are a type of medicine used to treat heart failure and certain irregular heartbeats. Your doctor will need to monitor your potassium levels carefully

•    Diuretics (commonly known as ‘water tablets’) that may cause water and electrolyte imbalances

•    Calcium or Vitamin D because these may cause you to have too much calcium in your blood.

If you are diabetic

•    This medicine contains glucose (14, 24 or 40 mg per ml)

•    Your blood glucose must be checked regularly

The dose of your other medication such as insulin may need to be changed Pregnancy, Breastfeeding and Fertility

GLUCOTHERA should not be used if you are pregnant or breastfeeding. During dialysis women are less likely to become pregnant.

Driving and Using Machines

GLUCOTHERA should not affect your ability to drive or operate machinery.

GLUCOTHERA contains:

•    Sodium 3 mg per millilitre.

This must be taken into account by patients on a controlled sodium diet.

3. How to use GLUCOTHERA

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure.

Peritoneal dialysis is a long-term treatment involving repeated use of GLUCOTHERA.

Your doctor will decide the best treatment for you.

There are two types of Peritoneal Dialysis:

•    Continuous ambulatory peritoneal dialysis (CAPD)

-    Patients on CAPD typically perform 4 cycles per day (24 hours)

•    Automated peritoneal dialysis (APD)

-    Patients on APD typically perform 4-5 cycles at night and up to2 cycles during the day How much to use per cycle?

The amount that you need to use in each cycle depends on your body weight and height.

•    The usual amount (dose) is 2 to 2.5 litres

•    Larger people may need 2.5 to 3 litres

Your doctor or nurse will tell you how much should be used.

If your tummy swells and is painful when you start treatment with peritoneal dialysis, your doctor or nurse may advise you to reduce the amount you infuse to between 500 and 1500 ml per cycle.

Your doctor may also adjust the dosage, volume and number of cycles as your treatment continues.

Use in Children and adolescents

A peritoneal dialysis APD machine must be used to give this medicine to children and adolescents. The amount given is strictly controlled and depends on the age, height and body weight (body surface area) of the patient. The usual amount is 800 to 1400 ml/m² (approximately 30-40 ml/kg of body weight).

CAPD is not recommended in children due to the risk of giving too much.

Method of Administration

GLUCOTHERA is administered using a special catheter into your tummy.

It is NOT for intravenous use.

INSTRUCTIONS FOR USE

Follow the instructions below carefully. - ask your doctor or nurse if you have questions or

concerns about this product or how to use it.

Before use:

1.    To reduce the risk of infections you must make sure that you and the area around you are clean before and during the procedure. You should be trained by your doctor or nurse how to do this before you start using the product.

2.    When ready to use, remove the overwrap. Do not use if the overwrap has already been opened or damaged.

3.    Open the breakable seal that divides the chambers by squeezing the bag as shown below.

4.    Mix the solutions by gently pushing the bag with both hands.

5.    Check for leaks. If you find any leaks do not use the bag.

6.    Check the solution. Do not use if the solution is cloudy or contains particles.

7.    Warm the solution to body temperature (37°C).

Use a heating pad or warming plate to do this. Do not heat the bag in water or in a microwave oven because this may overheat the solution.

GLUCOTHERA must be used within 24 hours of mixing the solutions.

The bag is now ready to be used. Remove the cap on the connection tube and connect to your catheter according to the instructions given to you by your doctor or nurse.

Use each bag only once. Do not reconnect a bag that has been partially used.

Ask your doctor, or nurse how to dispose of any excess or unused medicinal product.

Keep records of your Fluids

Keep a record of the dialysis fluids coming in and out of your body and your weight. This is to make sure you don’t have too much or too little water in your body. The wrong amount of water could cause severe problems such as heart failure.

Draining the fluid

Drain the fluid, as your doctor or nurse has trained you. After you have drained off the fluid, check what it looks like. It should look clear. If it is cloudy tell your doctor or nurse immediately. This may mean that you have peritonitis (an inflamed peritoneum) or an infection. Your doctor may decide to perform some tests to find out which antibiotic will be best for you.

Using with other drugs

Your doctor may have prescribed you additional medicines to be added to the solution. They can be added through the injection tube on the bag. If any drug is added, you must use the bag straight away.

If you use more GLUCOTHERA than you should

If you use too much GLUCOTHERA you may get tummy swelling or pain and/or shortness of breath. If this happens drain the fluid out of your body as you have been trained.

If you forget to use GLUCOTHERA

If a cycle has been forgotten you still need to have the same number of cycles of peritoneal dialysis each day. You will need to shorten the time between each of the following cycles to ensure that you use the total amount of required solution per day.

If you stop using GLUCOTHERA

Do not stop using GLUCOTHERA without your doctors’ permission as it is very serious and can be fatal.

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

4. Possible Side Effects

Like all medicines, GLUCOTHERA can cause side effects, although not everyone gets them. If you suffer any of the following side effects tell your doctor immediately as you may need medical attention:

•    Hypertension (higher blood pressure than normal)

•    Swollen ankles or legs, puffy eyes, shortness of breath and/or chest pain.

This may mean you have received too much GLUCOTHERA.

•    Tummy pain and/or feeling sick

•    Chills or Fever

•    Not passing any urine or passing less than normal

•    Skin rashes or lesions

Encapsulating Peritoneal Sclerosis (EPS) is a rare complication of peritoneal dialysis therapy treatment. You must be aware of this as EPS is very serious and can be fatal. .

EPS can cause:

•    Inflammation in your tummy

•    Tummy pain or swelling or being sick, which could be caused by thickening of your intestines.

If you have any of these side effects you must contact your doctor or nurse immediately.

If you notice any of the following side effects, please tell your doctor as soon as possible. Common side effects (may affect up to 1 in10people):

•    Blood has decreased acidity (Alkalosis)

•    Decrease in the amount of potassium in your blood (Hypokalaemia)

•    Increase in the amount of calcium in your blood (Hypercalcemia)

•    High blood pressure (Hypertension)

•    Inflammation of the lining in your tummy (Peritonitis)

•    Having too much fluid (water retention)

•    Swelling caused by having too much fluid (oedema)

•    Weakness or lack of muscle strength (aesthenia)

•    Weight increase

Uncommon side effects (may affect up to 1 in 100 people):

•    Increase in the volume of blood (hypervolaemia)

•    Anorexia

•    Dehydration, thirst

•    Increase in the amount of sugar in your blood (Hyperglycaemia)

•    Build up of lactic acid

•    Dizziness

•    Headache

•    Difficulty in sleeping, tiredness

•    Low blood pressure (Hypotension)

•    Difficult, or faster or painful breathing

•    Cough

•    Lining of your tummy (your peritoneum) not working properly

•    Tummy pain

•    Indigestion (dyspepsia)

•    Flatulence (passing wind)

•    Nausea

•    Chills

•    Swelling of the face

•    Hernia

•    Feeling generally unwell

Side effects of GLUCOTHERA with unknown frequency (frequency cannot be estimated from the available data) are:

•    Increase in white blood cells (Eosinophilia)

•    Increase in the amount of lipid in your blood (Dyslipidaemia)

•    Being sick

•    Diarrhoea

•    Constipation

•    Cloudy solution drained from the peritoneum. This could mean you have an infection

•    Swelling of the skin (Angioedema)

•    Rash

•    Muscle and bone pain

•    Fever

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 the Yellow Card Scheme at: 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 GLUCOTHERA

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 label after EXP. The expiry date refers to the last day of that month.

•    Do not refrigerate or freeze.

•    This product has a shelf life of 18 months.

•    The product must be used within 24 hours after the solutions are mixed.

•    Store this medicine in its original packaging.

•    Do not use this medicine if you notice any leaks, particles in the liquid or if the liquid is cloudy.

•    Do not throw away medicines via wastewater or household waste. Ask your doctor or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What GLUCOTHERA contains:

GLUCOTHERA is available with 3 different concentrations of glucose.

The active substances in the mixed peritoneal dialysis solution for each concentration are:

GLUCOTHERA product	1.4%	2.4%	4%
formula g/litremg/millilitre
Glucose monohydrate	15.4	26.4	44
equivalent to glucose anhydrous	14.0	24.0	40.0
Sodium chloride	5.6
Sodium (S)-lactate	3.9
Calcium chloride dihydrate	0.2
Magnesium chloride hexahydrate	0.1
mmol/litre
Glucose	77.7	133.2	222.0
Sodium	131.9
Calcium	1.3
Magnesium	0.5
Chloride	99.0
Lactate	35.0

What GLUCOTHERA looks like and contents of the pack

GLUCOTHERA is a clear colourless solution

GLUCOTHERA is supplied in a double chambered bag. Mixing of the two solutions by breaking the seal between the two chambers provides a ready to use solution.

An injection tube for adding other medicinal products is attached to the upper chamber.

A connection tube (with a looped cap) is attached to the lower chamber. This connects to your dialysis catheter when you add solution to your tummy.

Each bag is in a protective overwrap and supplied in a carton box.

Pack sizes:

•    4 bags containing 2000 ml of solution

•    2 bags containing 5000 ml of solution Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Glomeria Therapeutics S.r.l.

Via P. U. Frasca, snc 66100 Chieti Italy

Tel: +39 0871 562276 Fax: +39 0871 571902 E-mail: info@glomeria.com

Manufacturer:

Haemopharm Biofluids S.r.l.

Via dell’Industria, snc,

23030 Tovo di Sant’Agata (SO)

Italy

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

To be completed nationally.

This leaflet was last revised in 11/2015