Kalcipos-D 500mg/800unit chewable tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
18-06-2018
Summary of Product characteristics
(SPC)
18-06-2018
Active ingredient:
Calcium carbonate; Colecalciferol
Available from:
Viatris UK Healthcare Ltd
ATC code:
A12AX
INN (International Name):
Calcium carbonate; Colecalciferol
Dosage:
1.25gram ; 800unit
Pharmaceutical form:
Chewable tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09060400; GTIN: 5060035247356
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS-D 500 MG/800 IU CHEWABLE TABLETS
Calcium/cholecalciferol (Vitamin D3)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Kalcipos-D is and what it is used for
2.
What you need to know before you take Kalcipos-D
3.
How to take Kalcipos-D
4.
Possible side effects
5.
How to store Kalcipos-D
6.
Contents of the pack and other information
1. WHAT KALCIPOS D IS AND WHAT IT IS USED FOR
Kalcipos-D is used to prevent and treat calcium and vitamin D
3
deficiency in the elderly, and
as an additional treatment in the management of osteoporosis, when a
risk of deficiency of
calcium and vitamin D
3
is suspected.
Kalcipos-D contains calcium and vitamin D
3
which both are important components for the
formation of bone. Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Ask your doctor, pharmacist or other health personal if you have
further questions and always
follow their instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KALCIPOS D
DO NOT TAKE KALCIPOS-D
-
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or
hypercalciuria (increased levels in the urine).
-
if you have kidney stones
-
if you have calcium depositions in the kidneys
-
if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
-
if you have kidney failure
-
if you are allergic (hypersensitive) to the active substances or any
of the other
ingredients of this medicine (listed in section 6).
WAR
Read the complete document
Summary of Product characteristics
OBJECT 1
KALCIPOS-D 500 MG/ 800 IU CHEWABLE TABLETS
Summary of Product Characteristics Updated 12-Jan-2016 | Meda
Pharmaceuticals
1. Name of the medicinal product
Kalcipos-D 500 mg/ 800 IU chewable tablets
2. Qualitative and quantitative composition
Each chewable tablet contains calcium carbonate equivalent to 500 mg
calcium, cholecalciferol (Vitamin
D
3
) 800 IU (20 microgram).
Excipients with known effect: glucose 200 mg and sucrose 1.8 mg.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
White to off white, round, engraved R 152 on one side, diameter 17 mm.
4. Clinical particulars
4.1 Therapeutic indications
Prevention and treatment of calcium and vitamin D deficiency in the
elderly. Vitamin D and calcium
supplement in addition to specific osteoporosis treatment of patients
who are at risk of vitamin D and
calcium deficiency.
4.2 Posology and method of administration
Posology
_Adults and older people_
One chewable tablet (500 mg/800 IU) daily.
The amount of calcium in Kalcipos-D is less than the usually
recommended daily intake.
Kalcipos-D is therefore primarily to be used by patients with need of
D-vitamin substitution but with a
dietary intake of calcium of 500 mg-1000 mg per day. The patients
dietary intake of calcium should be
estimated by the prescriber.
_Patients with hepatic impairment_
No dose adjustment is required
_Patients with renal impairment_
Kalcipos-D should not be used in patients with severe renal impairment
(see section 4.3).
_Paediatric population _
There is no relevant indication for use of Kalcipos-D chewable tablets
in children or adolescents.
Method of administration
Tablet can be chewed or slowly melted in the mouth.
4.3 Contraindications
• Diseases and/or conditions resulting in hypercalcaemia or
hypercalciuria.
• Nephrolithiasis.
• Nephrocalcinosis
• Hypervitaminosis D.
• Renal failure.
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Kalcipos-D
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