Package Leaflet: Information for the user

Renacet 475 mg film-coated tablets

Calcium acetate

For use in adults

What is in this leaflet

1.    What Renacet 475 mg is and what it is used for

2.    What you need to know before you take Renacet 475 mg

3.    How to take Renacet 475 mg

4.    Possible side effects

5.    How to store Renacet 475 mg

6.    Contents of the pack and other information

1.    What Renacet 475 mg is and what it is it used for

Renacet 475 mg is used to reduce increased concentrations of phosphate in the blood. Renacet 475 mg is used for treatment of chronically reduced kidney function where dialysis treatment is required.

You must talk to a doctor if you do not feel better or if you feel worse after eight days.

2.    What you need to know before you take Renacet 475 mg Do not take Renacet 475 mg

-    if you are allergic (hypersensitive) to calcium acetate or any of the other ingredients of this medicine (listed in section 6),

-    if you have reduced phosphate concentrations in the blood,

-    if you have increased calcium concentrations in the blood,

-    in case of increased calcium excretion with the urine associated with the occurrence of calcium containing kidney stones,

-    if you suffer from decalcifying tumours and metastases in the bones (metastases in the bone tissue),

-    if you suffer from severe renal failure without dialysis treatment,

-    if you have constipation,

-    if you have known strictures of the large intestine,

-    if you suffer from abnormal bone decalcification as a consequence of long-term immobilisation (bed-ridden, wheelchair).

Warning and precautions

Talk to your doctor or pharmacist before taking Renacet 475 mg.

Therapy with Renacet 475 mg requires regular measurement of the calcium and phosphate levels in the blood. To avoid an increase in calcium level beyond the normal range, a further calcium therapy (e.g. calcium as food supplement) should only be performed in agreement with your doctor.

Other medicines and Renacet 475 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including medicines obtained without a prescription).

You must allow a time interval of 1-2 hours between the intake of Renacet 475 mg and other medicines.

Taking Renacet 475 mg at the same time as some other medicines may decrease their absorption in the body.

For example:

-    medicines for the treatment of infections (tetracyclines and doxycyclin, quinolones),

-    medicines against osteoporosis (biphosphonates),

-    medicines for caries (tooth decay) prevention (fluorides),

-    treatment with medicines belonging to the group of anticholinergics such as atropine,

-    treatment with vitamin D preparations.

The effect of heart glycosides, which are used to treat cardiac insufficiency (when the heart is unable to supply sufficient blood flow to the body), may be increased if taken at the same time as Renacet 475 mg. Whereas taking this medicine at the same time as calcium antagonists, which are also used to treat cardiac insufficiency, may reduce their effect.

For patients treated with thiazide diuretics, there is an increased risk of higher calcium concentrations in the blood. Use of adrenaline may lead to severe heart rhythm disturbances when the calcium concentration in the blood is increased.

Intake of larger quantities of calcium salts may cause a precipitation of fatty and bile acids as calcium soaps. This may impair the absorption of ursodeoxycholic acid and chenodeoxycholic acid as well as fats and fat soluble vitamins.

Renacet 475 mg with food and drink

Renacet 475 mg film-coated tablets should be taken during or immediately after a meal. Tablets should be swallowed with some liquid and must not be chewed.

Pregancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The likelihood of hypercalcaemia is increased in pregnant women in whom calcium and vitamin D are co-administered.

Driving and using machines

Renacet 475 mg has no influence on the ability to drive or use machines.

Renacet 475 mg contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Renacet 475 mg

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Unless your doctor has prescribed a different dose, the recommended dose is:

Adults:

with breakfast: with a snack: with a main meal: with supper:

Dosage varies from patient to patient. Since Renacet 475 mg binds phosphate from food, the number of film-coated tablets must be adjusted in accordance with the amount of food (serving size) and thus with the amount of phosphate ingested. For example 4 film-coated tablets with breakfast consisting of only one slice of bread with jam would lead to a calcium excess and thus to the risk of an increased calcium concentration in the blood.

On the other hand only 2 film-coated tablets may be insufficient to bind the larger amount of phosphate ingested with a rich main meal (thus insufficiently effective).

Renacet 475 mg film-coated tablets should be taken during or immediately after a meal. The tablets should be swallowed with some liquid and must not be chewed.

If you take more Renacet 475 mg than you should

Contact your doctor or pharmacist if you have taken more Renacet 475 mg than stated in this leaflet or prescribed by your doctor.

If you forget to take Renacet 475 mg

Do not take a double dose to make up for a forgotten dose. Continue treatment as prescribed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

To assess side effects the following frequencies are used:

Very common:	more than 1 patient out of 10
Common:	1 to 10 patients out of 100
Uncommon:	1 to 10 patients out of 1,000
Rare:	1 to 10 patients out of 10,000
Very rare:	fewer than 1 patient out of 10,000
Not known:	frequency cannot be estimated from the available data

General disorders:

Uncommon:    Soft tissue calcification (e. g. in the fatty tissue under the

skin) usually occurring only after many years of intake and frequently associated with increased calcium levels in the blood.

Cardiac / vascular disorders:

Uncommon:    Increased calcium levels in the blood, especially after

overdosage.

Gastrointestinal disorders:

Rare:    Gastrointestinal disorders such as nausea and constipa

tion, especially in case of too high dosages.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

You can also report side effects via the national reporting system:

United Kingdom

Yellow Card Scheme

Website: 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 Renacet 475 mg

-    Keep this medicine out of the sight and reach of children.

-    This medicinal product does not require any special storage conditions.

-    Do not use Renacet 475 mg after the expiry date (EXP) which is stated on the carton and blister. The expiry date refers to the last day of that month.

6.    Contents of the pack and other information

What Renacet 475 mg contains

The active substance is:

475 mg Calcium acetate (anhydrous) equivalent to 120.25 mg calcium.

The other excipients are:

Tablet core: Maize starch, sucrose, gelatin, sodium starch glycolate (Type A), croscar-mellose sodium, magnesium stearate, vegetable.

Film coat: Hypromellose, refined castor oil, saccharin sodium, talc, orange flavour.

What Renacet 475 mg looks like and contents of the pack

Appearance:

White, round, convex film-coated tablet.

Pack sizes:

100 film-coated tablets 200 film-coated tablets

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

Germany:    Renacet 475 mg

United Kingdom:    Renacet 475 mg

Spain:    Acetato de calcio    RenaCare 475 mg

Marketing Authorisation Holder and Manufacturer

RenaCare NephroMed GmbH Werrastr. 1a 35625 Huttenberg Germany

Phone:+49 (0) 64 03 9 21 60 Fax: +49 (0) 64 03 9 21 63 E-mail:mail@renacare.com

This leaflet was last revised in December 2014.