Calcium lactate 300mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Calcium lactate

Διαθέσιμο από:

Actavis UK Ltd

Φαρμακολογική κατηγορία (ATC):

A12AA05

INN (Διεθνής Όνομα):

Calcium lactate

Δοσολογία:

300mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 09050101; GTIN: 5012617010711

Φύλλο οδηγιών χρήσης

Actavis BST - Packing Technical
[e-mail]
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Calcium Lactate Tablets
300mg x 84’s (UK)
130x210 (Reel Fed)
50828447
Leaflet for Bottles
7815
R.Wrey
15/10/14
130x210 Leaflet Reel Fed Profile (BST)
Calcium Lactate BP 300mg 84 Tablets PIL - UK
item no: AAAH3708
print proof no: 3
origination date: 29.10.14
originated by: DR
revision date: 21.11.14
revised by: DR
dimensions: 130x210 Reel Fed
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Profile
2.
3.
date sent:
supplier: Actavis UK
technically app. date:
15.10.14
min pt size: 7pt
TECHNICAL APPROVAL
50828447 AAAH3708
_Continued over page_
_Continued top of next column_
CALCIUM LACTATE
300MG 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 LACTATE 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 LACTATE TABLETS
ARE AND WHAT THEY ARE USED FOR
Calcium Lactate tablets may be used in
those who:
• have a calcium deficiency.
• have osteoporosis (brittle bones).
• have reduced absorption of nutrients
after surgery to remove all or part
of the stomach (post-gastrectomy
malabsorption).
• have bone softening due to vitamin D
deficiency (osteomalacia).
• have bone disease due to vitamin D
deficiency (rickets).
• are pregnant or breast-feeding.
2 BEFORE YOU TAKE
DO NOT TAKE Calcium Lactate tablets and
TELL your doctor if you:
• are ALLERGIC (hypersensitive) to calcium
lactate or any of the other ingredients in
Calcium Lactate tablets (see section 6).
• have HIGH levels of CALCIUM in the
blood (hyper

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
CALCIUM LACTATE TABLETS BP 300mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Calcium Lactate BP equivalent to 0.96mmol
calcium (Ca
2+
).
3.
PHARMACEUTICAL FORM
White uncoated tablets.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
1) Indicated for the treatment of calcium deficiency states as a
therapeutic supplement in pregnancy,
lactation, osteoporosis, post-gastrectomy malabsorption, osteomalacia
and rickets.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Calcium Lactate Tablets BP should not be taken for long periods
without medical advice.
_Adults including elderly: _1-2 tablets (300-600mg) daily.
_Pregnant women: _(During the third trimester and also during
lactation) 3-4 tablets (0.9-
1.2g) daily.
_Children over 3 years: _One tablet (300mg) daily.
For oral administration.
4.3.
CONTRA-INDICATIONS
Severe hypercalcaemia and hypercalciuria (_eg_ hypervitaminosis D,
hyperparathyroidism,
severe renal failure, osteoporosis due to immobility and decalcifying
tumours such as
plasmocytoma and skeletal metastases). Patients receiving therapy with
cardiac glycosides
such as digoxin must not be given calcium supplements.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Careful monitoring of blood levels and urinary calcium excretion is
necessary, particularly
when high dose calcium therapy has been used, especially in children.
Treatment should be suspended if calcium blood levels exceed
2.625-2.75mmol/litre (105-
110mg/litre) or if urinary calcium excretion exceeds 5mg/kg.
Calcium salts should be administered with care to infants with
hypokalaemia, as elevation of
serum calcium levels may further reduce serum potassium levels.
Calcium salts should be administered with caution to patients with
impaired renal function,
cardiac disease, or sarcoidosis.
4.5.
INTERACTION WITH OTHER MEDICATIONS AND OTHER FORMS OF INTERACTION
Calcium Lactate Tablets BP must be used with care in patients
receiving alternative
compound vitamin or mineral preparations, which often contain