Renacet 475mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Calcium acetate

Tillgänglig från:

Stanningley Pharma Ltd

ATC-kod:

V03AE07

INN (International namn):

Calcium acetate

Dos:

475mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 09050202; GTIN: 4027052102113 4027052102120

Bipacksedel

Content of this leaflet:
1. What Renacet 475 mg is and what it is used for
2. 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. Further information
1. WHAT RENACET 475 mg IS AND WHAT IT IS USED FOR
Use
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.
2. BEFORE YOU TAKE RENACET 475 mg
Do not take Renacet 475 mg
- if you are allergic (hypersensitive) to calcium acetate or any of
the excipients of Renacet
475 mg (see 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 calci-
um 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 immobilisa-
tion (bed-ridden, wheelchair).
Take special care with 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 cal-
cium therapy (e.g. calcium as food supplement) should only be
performed in agreement with
your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medi-
cines, 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 absorp-
tion in the body:
For example:
- medicines for the treatment of infections

Produktens egenskaper

OBJECT 1
RENACET 475MG TABLET
Summary of Product Characteristics Updated 29-Jun-2011 | Stanningley
Pharma Limited
1. Name of the medicinal product
Renacet 475 mg, film-coated tablets
2. Qualitative and quantitative composition
Active substance: Calcium acetate
Each film-coated tablet contains:
475 mg calcium acetate (anhydrous) equivalent to 120.25 mg calcium.
Excipients: Contains sucrose, see section 4.4.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet
white, round, convex film-coated tablets.
4. Clinical particulars
4.1 Therapeutic indications
Hyperphosphatemia associated with chronic renal insufficiency in
patients undergoing dialysis.
4.2 Posology and method of administration
Dosage should be effected individually. Unless a different dose has
been prescribed, adults should take no
more than 14 Renacet 475 mg film-coated tablets daily.
To achieve optimal efficacy, Renacet 475 mg should be taken during or
immediately after meals
The usual dose is:
with breakfast:
1 to 2 film-coated tablets Renacet 475 mg,
with a snack:
1 to 2 film-coated tablets Renacet 475 mg,
with a main meal:
2 to 6 film-coated tablets Renacet 475 mg,
with supper:
2 to 4 film-coated tablets Renacet 475 mg.
Renacet 475 mg film-coated tablets should be taken with some liquid
during or immediately after meals
and must not be chewed.
Experience with children is not available.
4.3 Contraindications
Renacet 475 mg must not be used in patients with:
Hypersensitivity to the active substance or to any of the excipients.
Hypophosphatemia, severe hypophosphatemia, hypercalcemia,
hypercalciuria associated with calcium-
containing kidney stones, decalcifying tumors and skeletal metastases;
severe renal failure without
dialysis treatment; constipation; known stenosis of the large
intestine, osteoporosis due to immobilisation.
4.4 Special warnings and precautions for use
Treatment with Renacet 475 mg film-coated tablets requires regular
measurement of the serum calcium
and serum phosphate levels. Under no circumstan