Calcium Acetate 500mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Calcium acetate

Disponibil de la:

Pinewood Laboratories Ltd

Codul ATC:

A12AA; A12AA12

INN (nume internaţional):

Calcium acetate

Dozare:

500 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Calcium; calcium acetate anhydrous

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1998-01-23

Prospect

PATIENT INFORMATION LEAFLET
CALCIUM ACETATE 500 MG TABLETS
CALCIUM ACETATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Calcium acetate tablets are and what they are used for
2.
Before you take Calcium acetate tablets
3.
How to take Calcium acetate tablets
4.
Possible side effects
5.
How to store Calcium acetate tablets
6.
Further information
1.
WHAT CALCIUM ACETATE TABLETS ARE AND WHAT THEY ARE
USED FOR
Calcium acetate tablets are ‘phosphate binding agents’ and are
prescribed as part of the
management of kidney failure in patients on regular haemodialysis or
continuous ambulatory
peritoneal dialysis (CAPD).In kidney failure the phosphate levels in
the blood can be high.
These tablets control the phosphate levels by removing phosphate from
the food in your
stomach before it gets into the bloodstream.
2.
BEFORE YOU TAKE CALCIUM ACETATE TABLETS
DO NOT TAKE THE TABLETS IF YOU:

are allergic (hypersensitive) to calcium acetate or any of the other
ingredients in
the tablets (_see Section 6 and end of Section 2_),

have high levels of calcium in your blood or urine,

have low levels of phosphate in your blood.
TAKE SPECIAL CARE
Your doctor will monitor your blood-calcium levels regularly. If your
levels are too high,
your dose will be reduced or treatment stopped immediately.
Long-term high calcium levels in your blood may lead to a build-up of
calcium in your blood
vessels or soft tissues.
Tell your doctor if you have heart problems or are taking medication
for heart problems.
TAKING OTHER MEDICINES
Please tell your doctor if you are taking, or have recently taken any
other med

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium Acetate 500mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of Calcium Acetate.
Excipient: each tablet contains 28.15 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A white 12.5 mm round tablet with bevelled edges and a breakline on
one side.
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium Acetate Tablets are recommended in the treatment and
prevention of hyperphosphatemia in chronic renal
failure particularly for patients on regular haemodialysis therapy and
continuous ambulatory peritoneal dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hyperphosphatemia
Dosage must be determined according to the requirements of the
individual patient.
Usual dose is 1-2 tablets three times daily. In special cases up to 4
tablets can be taken three times a day.
4.3 CONTRAINDICATIONS
Hypersensitivity to calcium acetate or to any of the excipients.
Hypercalcemia and hypercalciuria.
Hypophosphataemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Excessive dosage may induce hypercalcemia. In patients with renal
dysfunction the blood-calcium level should be
monitored regularly. Should hypercalcemia occur dosage should be
reduced or treatment discontinued immediately
depending on the severity of the hypercalcemia. Chronic hypercalcemia
may lead to vascular calcification, and other
soft tissue calcification.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lastase deficiency or glucose – galactose
malabsorption, should not take this medicinal product.
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