Calcium and Ergocalciferol tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium lactate; Calcium phosphate; Ergocalciferol

Available from:

Almus Pharmaceuticals Ltd

ATC code:

A12AX

INN (International Name):

Calcium lactate; Calcium phosphate; Ergocalciferol

Dosage:

300mg ; 150mg ; 10microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 05060057401729

Patient Information leaflet

83.6mm
C
L
210mm +/- 0.5mm to centre line of next eye mark
65mm
15mm
15mm
Pharmacode
Position
Calcium and Ergocalciferol tablets
User Test Pil
item no: 50130495
0044 1271 311400
0044 1271 311449
[e-mail]
0044 1271 327411
print proof no: 06
origination date: 23/08/07
originated by: R.Wrey
revision date: 19/12/08
revised by: R.Wrey
dimensions: 148x210 Reel Fed
pharmacode:
design repeat (single):
web:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
Supplier: MYH
MOCK UP
ONLY
50130495
_Continued over page_
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CALCIUM AND ERGOCALCIFEROL TABLETS
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 or pharmacist.
•
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.
INDEX
1
WHAT CALCIUM AND
ERGOCALCIFEROL TABLETS ARE
AND WHAT THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6
FURTHER INFORMATION
1
WHAT CALCIUM AND ERGOCALCIFEROL
TABLETS ARE AND WHAT THEY ARE USED FOR
Calcium and Ergocalciferol (vitamin D
2
)
tablets may be used to treat vitamin D
deficiency including rickets (weak bones and
teeth).
2
BEFORE YOU TAKE
DO NOT TAKE Calcium and Ergocalciferol
tablets and
TELL your doctor if you:
• are ALLERGIC (hypersensitive) to calcium lactate,
calcium phosphate, ergocalciferol (vitamin D)
or any of the other ingredients in Calcium and
Ergocalciferol tablets (see secion 6)
• have
HIGH levels of CALCIUM in the blood
(hypercalcaemia) or urine (hypercalciuria)
• have an
OVERACTIVE THYROID GLAND
(hyperthyroidism)
• have severe
KIDNEY FAILURE
• have
OSTEOPOROSIS (brittle bones) caused by
immobility or tumours
• have recently had a large intake of
VITAMIN D.
CHECK WITH YOUR DOCTOR OR PHARMACIST
before taking Calcium and Ergocalciferol tablets
if you:
• have
KIDNEY or HEART

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CALCIUM AND ERGOCALCIFEROL TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Lactate 300mg, Calcium Phosphate 150mg
equivalent to 2.415mmol of calcium (Ca
2+
) and Ergocalciferol (Vitamin D
2
)
10µg (equivalent to 400iu).
3
PHARMACEUTICAL FORM
White uncoated tablets.
White circular, biconvex uncoated tablets impressed with the
identifying
letters “C” and “CV” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of nutritional deficiency in:
1) Vitamin D deficiency including nutritional rickets.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
_and _
_children _
_over _
_6 _
_years:_
One
tablet
daily,
crushed
before
administration. It is recommended that the tablets are taken after
meals.
_Children under 6 years:_ Not recommended.
_Elderly:_ Continuous regular use in the elderly (more than 1-2
months) is not
recommended.
For oral administration.
4.3
CONTRAINDICATIONS
Patients with known hypersensitivity to calcium or ergocalciferol
(vitamin D)
or any ingredient in the tablet.
Severe
hypercalcaemia
and
hypercalciuria
(_eg_
in
hypervitaminosis
D,
hyperthyroidism, severe renal failure, osteoporosis due to immobility
and
decalcifying tumours such as plasmocytoma and skeletal metastases).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with rare hereditary
problems of
galactose intolerance, the
lapp
lactase deficiency or glucose – galactose malabsorption should not
take this
medicine.
Patients
with
rare
hereditary
problems
of
fructose
intolerance,
glucose
-
galactose malabsorption or sucrase - isomaltase insufficiency should
not take
this medicine. Calcium salts should be given cautiously to patients
with
impaired renal function or cardiac disease.
During long-term treatment, serum calcium levels should be followed
and
renal function should be monitored through measurements of serum
creatinine.
Monitoring
is
especially
important
in
elderly
patients
on
concomitant
treatment wi