PHOSLO 667 MG CAPSULE HARD

Active substance: CALCIUM ACETATE

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If you forget to take PhosLo®

capsule, hard
Calcium Acetate

Read this entire leaflet carefully before
you start using this medicine.
• Keep this leaflet. You may need to read it again.

• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:

3.How to take PhosLo®
4.Possible side effects
5.How to store PhosLo®
6.Further information

4. Possible side effects:
Like all medicines, PhosLo® can cause side effects,
although not everybody gets them. In clinical
studies, patients have occasionally experienced
nausea during PhosLo® therapy.
You may experience hypercalcaemia, an increase in
the calcium level in your blood.
Mild hypercalcaemia may not have any symptoms or
may have symptoms such as constipation,
diarrhoea, loss of appetite, nausea and vomiting.
More severe hypercalcaemia is associated with
confusion, disorientation and loss of consciousness.
Mild hypercalcaemia is easily controlled by reducing
the PhosLo® dose or stopping therapy for a time.

1. What PhosLo® is and what it is
used for
Pharmaco-therapeutic group
PhosLo® is a phosphate binder (able to bind
phosphate present in the food that you eat).

Therapeutic indications
PhosLo® is indicated for the treatment and prevention
of hyperphosphataemia (blood phosphate level too
high) in patients with advanced renal failure on dialysis.

Severe hypercalcaemia can be treated by acute
hemodialysis and discontinuation of PhosLo®
therapy.
There have been some reports of patients getting a
rash after taking PhosLo®, which may be a symptom
of an allergic reaction.
Contact your doctor if you experience a rash.
Your doctor will decide whether to continue
treatment with PhosLo®, depending on how serious
the rash is.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.

2. Before you take PhosLo®:
Do not take PhosLo®

5. How to store PhosLo®

- if you are allergic (hypersensitive) to calcium
acetate or any of the other ingredients of PhosLo®.

Keep out of the reach and sight of children.
Store below 25°C.
Do not use PhosLo® after the expiry date stated on
the bottle label.

- if you are hypercalcaemic (blood calcium level too
high).
- if you suffer from hypercalciuria (calcium excretion
with the urine too high).

6. Further information

Take special care with PhosLo®

What PhosLo® contains

- if you are taking calcium supplements. An
estimate of daily calcium intake should be made
initially and the intake adjusted. Compliance to the
daily dosage is necessary to avoid developing
hypercalcaemia (blood calcium too high). Many
antacids, including those available without a
prescription, contain calcium. Ask a doctor or
nurse before taking an antacid and PhosLo®.

The active substance is calcium acetate, 667 mg.
The other ingredients are:
Macrogols, 8000 (milled), Light Liquid Paraffin
Capsule: Gelatin, Titanium dioxide (CI No. 77891),
Blue SB-6018

Taking other medicines
Supplements containing Vitamin D may increase the
absorption of calcium and increase the risk of
hypercalcaemia (blood calcium too high).
Seek medical advice before taking non-prescription
antacids containing calcium carbonate or other
calcium salts to avoid adding to the calcium load.
PhosLo® may affect the absorption of other
medicines, especially some oral antibiotics. Your
doctor will advise you not to take these medicines
within 3 hours of taking PhosLo®.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

What PhosLo® looks like and contents of
the pack
PhosLo® is an oblong tablet contained in a hard
white gelatine capsule. The capsule is printed in
blue ink with “PhosLo®” on the cap and “667 mg”
on the body.
PhosLo® comes in a white bottle of 200 capsules.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorization Holder:
Fresenius Medical Care Nephrologica
Deutschland GmbH
61346 Bad Homburg v.d.H., Germany
Manufacturer:
Fresenius Medical Care Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H., Germany

POM

Taking PhosLo® with food and drink
PhosLo® should be taken before/during meals.

Further information on this medicine is
available from the local representative of
the Marketing Authorisation Holder:

Pregnancy and Breast-feeding:
No data are available. It is not known whether
PhosLo® can cause foetal effects when administered
during pregnancy or whether it can affect fertility.
PhosLo® should only be administered to pregnant or
breast-feeding women if it is clearly indicated.

Fresenius Medical Care (UK) Ltd.
Nunn Brook Road, Huthwaite
Nottinghamshire NG17 2HU, England
Tel.: 0044 (0) 1623445 100

Driving and using machines:

This medicinal product is authorised in the Member
States of the EEA under the following name:
PhosLo® 667 mg capsule, hard.

PhosLo® has no influence on the ability to drive and
use machines.

This leaflet was last approved on 16/01/2008

Important information about some of the
ingredients of PhosLo®:
Calcium acetate may elevate calcium levels. Control of
calcium supplements may be required to prevent
hypercalcaemia (blood calcium too high).

PhosLo® is an oral dosage form. Swallow each
capsule whole with a little water. Do not chew the
capsules. PhosLo® should be taken with a meal.

Mild hypercalcaemia may not have any symptoms or
may have symptoms such as constipation,
diarrhoea, loss of appetite, nausea and vomiting.
More severe hypercalcaemia is associated with
confusion, disorientation and loss of consciousness.
Mild hypercalcaemia is easily controlled by reducing
the PhosLo® dose or stopping therapy for a time.

Each capsule contains:
Calcium acetate 708.4 mg (anhydrous
calcium acetate 667 mg) equivalent to
169 mg calcium.
For oral use only. Swallow whole with a
meal. Do not chew. Read the package
leaflet before use.
KEEP OUT OF THE REACH AND SIGHT
OF CHILDREN
Store below 25ºC.
Store in the original container.
Keep container tightly closed.
PL: 29386/0006
POM

You may experience hypercalcaemia, an increase in
the calcium level in your blood.

Fresenius Medical Care Nephrologica
Deutschland GmbH
61346 Bad Homburg v.d.H., Germany

If you take more PhosLo® than you should

Calcium Acetate
alcium cetate
phos lo
#667 mg

Always use PhosLo® exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is two
capsules three times daily with each meal initially,
with an increase to three or four capsules with each
meal if your doctor decides it is necessary and safe.

200 CAPSULES, HARD

3. How to take PhosLo®

Each capsule contains:
Calcium acetate 708.4 mg (anhydrous
calcium acetate 667 mg) equivalent to
169 mg calcium.
For oral use only. Swallow whole with a
meal. Do not chew. Read the package
leaflet before use.
KEEP OUT OF THE REACH AND SIGHT
OF CHILDREN
Store below 25ºC.
Store in the original container.
Keep container tightly closed.
PL: 29386/0006
POM

2.Before you take PhosLo®

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

Fresenius Medical Care Nephrologica
Deutschland GmbH
61346 Bad Homburg v.d.H., Germany

1.What PhosLo® is and what it is used for

There is a risk of hyperphosphataemia (blood
phosphate level too high), the condition for which
your doctor prescribed PhosLo®.

Calcium Acetate
alcium cetate

• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If you stop taking PhosLo®

200 CAPSULES, HARD

• If you have any further questions, ask your doctor
or pharmacist.

Take your regular dose at your next meal. Do not
take a double dose to make up for a forgotten dose.
Do not take the forgotten dose between meals.

This production drawing is the property of CCL Label A/S and may not be distributed to a third
party without CCL Label A/S's written consent. You may only copy the material to persons within
your organisation for which you hold full responsibility. You must at any time without delay
return such material to CCL Label A/S when requested by CCL Label A/S in writing.

Dimensions: 63,5 x 177,8mm

PhosLo® 667 mg

003M0504/00UK

Batch:

Contact your doctor if you take more PhosLo® than
you should.

EXP:

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Nyager 11-17 · DK-2605 Brøndby · Phone: +45 43 45 68 00 · Fax: +45 43 43 06 00 · E-mail: cphprepress@ccllabel.dk

Customer name: Fresenius Med. Care Deutschland
Att.: Hr. Dr. Norbert Dinauer
Braille: Yes No

No. of leaves: 6
Winding direction: Outside 4

Overlaminated Fix-a-Form

All pictures have to be placed in 100% - 300 dpi
Include all pictures and fonts
Tolerances for text and important graphic: 2 mm
Remember bleed - 2 mm

Date: 06.11.2008

CCL order no.: 110711
File name: 63,5x177,8(63,5x100,5+7,2+15)mm 6bl
Customer Service ref: Hans Breevaart
Prepress ref: Mette Bruus






The colours on print/sample print must not be considered as an exact version of the colours on the final print. Our printing department does not take the responsibility for mistakes, which are not corrected in the proof.
Please note that some Braille characters can vary from country to country. Please check that all Braille characters are as requested.

Severe hypercalcaemia can be treated by acute
haemodialysis and discontinuation of PhosLo®
therapy.

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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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