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RENACET 475 MG FILM-COATED TABLETS

Active substance(s): CALCIUM ACETATE

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Package Leaflet: Information for the user

Renacet 475 mg film-coated tablets
Calcium acetate
For use in adults

Read all of this leaflet carefully before you start taking this medicine
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because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist have told you.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in the leaflet. See section 4.
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You must talk to a doctor if you do not feel better or if you feel worse
after eight days.

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

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

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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
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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

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Do not take Renacet 475 mg
- if you are allergic (hypersensitive) to calcium acetate or any of the other ingredients
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of this medicine (listed in section 6),
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- if you have reduced phosphate concentrations in the blood,
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- if you have increased calcium concentrations in the blood,
- in case of increased calcium excretion with the urine associated with the occurrence
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of calcium containing kidney stones,
- if you suffer from decalcifying tumours and metastases in the bones (metastases
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in the bone tissue),
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- if you suffer from severe renal failure without dialysis treatment,
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- if you have constipation,
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- if you have known strictures of the large intestine,
- if you suffer from abnormal bone decalcification as a consequence of long-term
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immobilisation (bed-ridden, wheelchair).
Warning and precautions
Talk to your doctor or pharmacist before taking Renacet 475 mg.

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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
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in agreement with your doctor.
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Other medicines and Renacet 475 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
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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
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other medicines.
Taking Renacet 475 mg at the same time as some other medicines may decrease
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their absorption in the body.
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For example:
- medicines for the treatment of infections (tetracyclines and doxycyclin, quinolones),
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- medicines against osteoporosis (biphosphonates),
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- medicines for caries (tooth decay) prevention (fluorides),
- treatment with medicines belonging to the group of anticholinergics such as atropine,
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- 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.
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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.
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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
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chenodeoxycholic acid as well as fats and fat soluble vitamins.
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Renacet 475 mg with food and drink
Renacet 475 mg film-coated tablets should be taken during or immediately after a meal.
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Tablets should be swallowed with some liquid and must not be chewed.
Pregancy and breast-feeding
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If you are pregnant or breast-feeding, think you may be pregnant or are planning to
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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
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vitamin D are co-administered.
Driving and using machines
Renacet 475 mg has no influence on the ability to drive or use machines.

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Renacet 475 mg contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars,
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contact your doctor before taking this medicinal product.
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How to take Renacet 475 mg

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

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

1-2 film-coated tablets
1-2 film-coated tablets
2-6 film-coated tablets
2-4 film-coated tablets

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

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.
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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).
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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.
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If you take more Renacet 475 mg than you should
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Contact your doctor or pharmacist if you have taken more Renacet 475 mg than stated
in this leaflet or prescribed by your doctor.
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If you forget to take Renacet 475 mg
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Do not take a double dose to make up for a forgotten dose. Continue treatment as prescribed by your doctor.
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4.

Possible side effects

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Like all medicines, this medicine can cause side effects although not everybody gets
them.
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To assess side effects the following frequencies are used:

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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 constipation, especially in case of too high dosages.
Reporting of side effects
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If you get any side effects talk to your doctor or pharmacist. This includes any possible
side effect not listed in this leaflet.
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You can also report side effects via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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By reporting side effects you can help provide more information on the safety of this
medicine.
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5.

How to store Renacet 475 mg

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Keep this medicine out of the sight and reach of children.
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This medicinal product does not require any special storage conditions.
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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.
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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.

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The other excipients are:
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Tablet core: Maize starch, sucrose, gelatin, sodium starch glycolate (Type A), croscarmellose sodium, magnesium stearate, vegetable.
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Film coat: Hypromellose, refined castor oil, saccharin sodium, talc, orange flavour.

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What Renacet 475 mg looks like and contents of the pack
Appearance:
White, round, convex film-coated tablet.

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Pack sizes:
100 film-coated tablets
200 film-coated tablets

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This medical product is authorised in the Member States of the EEA under the
following names:
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Germany:
Renacet 475 mg
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United Kingdom:
Renacet 475 mg
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Spain:
Acetato de calcio RenaCare 475 mg
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Marketing Authorisation Holder and Manufacturer
RenaCare NephroMed GmbH
Werrastr. 1a
35625 Hüttenberg
Germany
Phone:+49 (0) 64 03 9 21 60
Fax: +49 (0) 64 03 9 21 63
E-mail:mail@renacare.com

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This leaflet was last revised in December 2014.

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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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