Renacet 950mg 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:

950mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 09050202; GTIN: 4027052102212 4027052102229

Bipacksedel

Content of this leaflet:
1. What Renacet 950 mg is and what it is used for
2. Before you take Renacet 950 mg
3. How to take Renacet 950 mg
4. Possible side effects
5. How to store Renacet 950 mg
6. Further information
1. WHAT RENACET 950 mg IS AND WHAT IT IS USED FOR
Use
Renacet 950 mg is used to reduce increased concentrations of phosphate
in the blood.
Renacet 950 mg is used for treatment of chronically reduced kidney
function where dialysis
treatment is required.
2. BEFORE YOU TAKE RENACET 950 mg
Do not take Renacet 950 mg
- if you are allergic (hypersensitive) to calcium acetate or any of
the excipients of Renacet
950 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 950 mg
Therapy with Renacet 950 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 950 mg and other
medicines.
Taking Renacet 950 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 950MG TABLETS
Summary of Product Characteristics Updated 29-Jun-2011 | Stanningley
Pharma Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Renacet 950 mg, film-coated tablets
2. Qualitative and quantitative composition
Active substance: Calcium acetate
Each film-coated tablet contains:
950 mg calcium acetate (anhydrous) equivalent to 240.50 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, oval, convex film-coated tablets scored on both sides.
4. Clinical particulars
4.1 Therapeutic indications
Hyperphosphatemia associated with chronic renal insufficiency in
patients undergoing dialysis.
4.2 Posology and method of administration
The tablet can be divided into equal halves. Dosage should be effected
individually. Unless a different
dose has been prescribed, adults should take no more than 7 Renacet
950 mg film-coated tablets daily.
To achieve optimal effic