2. Before you take PhosLo®:

Do not take PhosLo®

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

-    if you are hypercalcaemic (blood calcium level too high).

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

Take special care with PhosLo^®

-    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®______

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.

Taking PhosLo® with food and drink

PhosLo® should be taken before/during meals.

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.

Driving and using machines:

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

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).

3. How to take PhosLo®

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.

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.

If you take more PhosLo® than you should

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.

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

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

If you forget to take PhosLo®

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.

If you stop taking PhosLo®

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

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

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.

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.

5. How to store 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.

6. Further information

What PhosLo® contains

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

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:    |pqm|

Fresenius Medical Care Deutschland GmbH Else-Kroner-StraBe 1 61352 Bad Homburg v.d.H., Germany

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

Fresenius Medical Care (UK) Ltd.

Nunn Brook Road, Huthwaite Nottinghamshire NG17 2HU, England Tel.: 0044 (0) 1623445 100

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

PhosLo^® 667 mg capsule, hard.

This leaflet was last approved on 16/01/2008