Kalcipos-D forte 500 mg/800 IU chewable tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Cholecalciferol; Calcium

Доступна с:

Imbat Limited

код АТС:

A12AX

ИНН (Международная Имя):

Cholecalciferol; Calcium

дозировка:

500mg/800 international unit(s)

Фармацевтическая форма:

Chewable tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Calcium, combinations with vitamin D and/or other drugs

Статус Авторизация:

Authorised

Дата Авторизация:

2015-01-16

тонкая брошюра

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS
®
-D FORTE 500 MG/800 IU
CHEWABLE TABLETS
calcium/cholecalciferol (Vitamin D
3
)
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 forte is and what it is used for
2.
What you need to know before you take Kalcipos-D forte
3.
How to take Kalcipos-D forte
4.
Possible side effects
5.
How to store Kalcipos-D forte
6.
Contents of the pack and other information
1.
WHAT KALCIPOS-D FORTE IS AND WHAT IT IS
USED FOR
Kalcipos-D forte 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 forte 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 FORTE
DO NOT TAKE KALCIPOS-D FORTE

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 severely impaired kidney function/kidney
failure

if you

Характеристики продукта

Health Products Regulatory Authority
23 January 2019
CRN008PT1
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalcipos-D forte 500 mg/800 IU chewable tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains calcium carbonate equivalent to 500mg
calcium and
cholecalciferol 20 microgram corresponding to 800 IU Vitamin D3.
Excipients of known effect: glucose 200mg and sucrose 1.8mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet
_Product imported from the UK_
White to off-white, round, chewable tablet engraved R152 on one side,
diameter 17
mm.
4 CLINICAL PARTICULARS
As per PA1051/008/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1051/008/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Liquid spray dried glucose
Magnesium stearate
Sodium citrate
Xylitol
All-_rac-_alfa-tocoferol
Acacia
Sodium laurilsulphate
Sucrose
Medium chain triglycerides
Starch sodium octenyl succinate (E1450)
Health Products Regulatory Authority
23 January 2019
CRN008PT1
Page 2 of 3
Silicon dioxide
sodium ascorbate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container
and outer package of the product as marketed in the country of origin.
Shelf-life after first opening container: 6 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original container, in order to protect from light.
Keep container tightly closed in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic container with screw cap
Pack size: 30
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE
MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF
THE
PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/162/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
Jan