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GLUCOTHERA 2.4% W/V SOLUTION FOR PERITONEAL DIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM (S)-LACTATE SOLUTION / SODIUM (S)-LACTATE SOLUTION 50% / SODIUM CHLORIDE

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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
o
o
o
o
o

You have a serious lung disease or a lung infection, such as pneumonia.
You have a severe infection (sepsis)
You are feeling weak and have lost a significant amount of weight due to problems
with eating
You have a rare problem of high levels of waste products in your blood which cannot
be removed using peritoneal dialysis.
You have very high cholesterol levels in your blood
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)
You and your doctor must be aware of a rare complication of the peritoneal dialysis therapy
which is called Encapsulating Peritoneal Sclerosis (EPS).
EPS is very serious and can be fatal. See Section 4.
It can cause:
• inflammation in your tummy
• tummy pain or swelling, or sickness (vomiting), which could be caused by thickening of
your intestines.
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.
5.
6.
7.

Mix the solutions by gently pushing the bag with both hands.
Check for leaks. If you find any leaks do not use the bag.
Check the solution. Do not use if the solution is cloudy or contains particles.
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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