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ADDIPHOS

Active substance(s): DISODIUM PHOSPHATE DIHYDRATE / POTASSIUM DIHYDROGEN PHOSPHATE / POTASSIUM HYDROXIDE

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01-58-01-017D

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

1. WHAT ADDIPHOS IS AND WHAT IT IS USED FOR

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Addiphos provides salts into your blood stream when you cannot eat normally. Salts are chemicals
required in small amounts for the body to work normally.
Addiphos is usually used as part of a balanced intravenous diet, together with proteins, fats,
carbohydrates, other salts and vitamins.

Addiphos® Concentrate
for Solution for Infusion
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, pharmacist or nurse
• If you get any side effects, talk to your doctor, pharmacist or nurse.

Do not use Addiphos:

• if you are allergic to the active substance(s) or any other of the ingredients of this medicine

This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Addiphos is and what it is used for
2. What you need to know before you use Addiphos
3. How to use Addiphos
4. Possible side effects
5. How to store Addiphos
6. Contents of the pack and other information

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADDIPHOS

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(listed in section 6). If you develop a rash or other allergic reactions (like itching,
swollen lips or face or shortness of breath), please inform your doctor, pharmacist
or nurse.
• have high potassium levels (hyperkalaemia)
• have severely impaired kidneys
• have problems with adrenal glands
• are dehydrated (not enough water in your body)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Addiphos if you suffer from:
- impaired liver and/or kidney function
- diabetes
- heart problems
Your doctor may want to do regular blood tests to check your condition.

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Addiphos must be diluted before use. It will be added to another solution before it is given to
you. Your doctor, pharmacist or nurse will make sure it is prepared correctly before you receive
Addiphos.

3. HOW TO USE ADDIPHOS
You will receive your medicine by infusion (IV drip).
Your doctor or pharmacist will decide on the correct dose for you to receive.

Addiphos should not be used if it has got particles in it. The doctor, pharmacist or nurse will
check that the solution is particle free before it is administered to you.

Dosage
The recommended dose of Addiphos for adults is 5 millilitres up to 20 millilitres each day.

Other medicines and Addiphos
Tell your doctor or pharmacist is you are taking, have recently taken or might take any other
medicines.
Inform your doctor or pharmacist if you are taking heart drugs such as digoxin or digitoxin.

Children and Adolescents
Addiphos may be used in children and adolescents, and your doctor or pharmacist will reduce the
dose for your child, according to their age and weight.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask you doctor or pharmacist for advise before using this medicine.
Driving and using machines
Addiphos has no effect on the ability to drive and use machines.

If you use more Addiphos than you should
It is very unlikely that you will receive more Addiphos than you should as your doctor, pharmacist
or nurse will monitor you during the treatment. An overdose of Addiphos may lead to
hyperkalaemia (high potassium levels), symptoms may include:
• Nausea
• Fatigue
• Muscle weakness
• Tingling sensations
If you think that you have received too much Addiphos, inform your doctor, pharmacist or nurse
immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

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MASTER ARTWORK/LABEL SPECIFICATION
Halden article number:
Label spec. number:
Code 128
Code lines:
Colour coding:

FBV 1992
01-58-01-017D
653
1076
Black

Size:

480 x 84 mm folded to 120 x 48 mm

MS:

08.22.B
Prepared by: Sven-Erik Arneberg

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE ADDIPHOS

Although no known undesirable effects have been reported with the use of Addiphos, like all
medicines, this medicine may cause side effects..

Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist and nurse are responsible for the correct storage, use and disposal of
Addiphos.
Do not use this medicine after the expiry date stated on the carton and vial label. The expiry date
refers to the last day of that month.
Do not store above 25 °C.
Keep vial in outer carton.
Do not use this medicine if it is cloudy or contains particles.
Any unused solution should be discarded. Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines that you no longer used. These measure will help
protect the environment.

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;
For UK - Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For Ireland – Via;
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.

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6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Addiphos infusions contains
1 millilitre of Addiphos contains the following active ingredients:
Potassium Dihydrogen Phosphate
170.1 mg
Disodium Phosphate Dihydrate
133.5 mg
Potassium Hydroxide
14 mg
One vial (20 ml Addiphos) provides the following:
Phosphate
40 mmol
Potassium
30 mmol
Sodium
30 mmol
Addiphos also contains water for injections.

What Addiphos looks like and contents of the pack
Addiphos is a clear, almost colourless solution of salts. It is available in plastic ampoules that
contain 20 ml of the concentrate for solution for infusion.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK

Manufacturer:
Fresenius Kabi Norge AS
NO-1753 Halden
Norway

This leaflet was last revised in May 2016

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2016-05-23 10:40:45

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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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