Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Calcium carbonate; Colecalciferol

Dostopno od:

PCO Manufacturing Ltd.

Koda artikla:

A12AX

INN (mednarodno ime):

Calcium carbonate; Colecalciferol

Odmerek:

500 mg/400 IU mg/IU

Farmacevtska oblika:

Chewable tablet

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Calcium, combinations with vitamin D and/or other drugs

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-09-28

Navodilo za uporabo

_ _
PATIENT INFORMATION LEAFLET
CALCICHEW-D
3
® FORTE
500 MG/400 IU CHEWABLE TABLETS
calcium / colecalciferol
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Always take this medicine exactly as described in this leaflet or
as your doctor or pharmacist have told you. Keep this leaflet.
You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must talk to a doctor if you do not feel better or if you feel
worse after two weeks.

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.
IN THIS LEAFLET:
1.
What Calcichew-D
3
Forte is and what it is used for
2.
What you need to know before you take Calcichew-D
3
Forte
3.
How to take Calcichew- D
3
Forte
4.
Possible side effects
5.
How to store Calcichew- D
3
Forte
6.
Contents of the pack and other information
1.
WHAT CALCICHEW- D
3 FORTE IS AND WHAT IT IS USED
FOR
Calcichew- D
3
Forte Chewable Tablets are lemon flavoured
chewable tablets containing calcium and vitamin D
3
which are both
important substances in bone formation.
Both are found in the diet and vitamin D is also produced in the skin
after exposure to the sun.
Calcichew- D
3
Forte is used to treat and prevent vitamin D/calcium
deficiency, which may occur when your diet or lifestyle does not
provide enough, or when body requirements are increased. This
medicine may also be prescribed or recommended for certain bone
conditions, for example osteoporosis, or during pregnancy.
2.
BEFORE YOU TAKE CALCICHEW- D
3 FORTE
DO NOT TAKE CALCICHEW- D
3 FORTE CHEWABLE TABLETS IF YOU:

are allergic to calcium, vitamin D, or any of the other
ingredients of this medicine (_listed in section 6_)

have severe kidney problems

have a condition that causes excessive amounts of calcium in
your blood or urine (hypercalcaemia or hypercalciuria) e.g.
•
renal (kidney failure)
•
cancer that has affected your bones

have excessive amounts of v

Lastnosti izdelka

Health Products Regulatory Authority
11 November 2020
CRN009Y8G
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Forte 500 mg/400 IU Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Calcium carbonate 1250 mg
(equivalent to 500 mg of elemental calcium)
Colecalciferol 400 IU
(equivalent to 10 micrograms vitamin D
3
)
Excipients with known effect: Sucrose, sorbitol (E 420), isomalt
(E953), aspartame (E951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
_Product imported from the UK_
Round, white, uncoated and convex tablet. May have small specks.
4 CLINICAL PARTICULARS
As per PA2229/005/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2229/005/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sorbitol (E420)
Povidone
Isomalt (E953)
Flavouring (lemon)
Fatty acid mono- and di-glycerides
Aspartame (E951)
Magnesium stearate
Sucrose
Tocopherol
Modified Maize starch
Medium chain triglycerides
Sodium ascorbate
Anhydrous colloidal silica
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
11 November 2020
CRN009Y8G
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C. Keep the container tightly closed to
protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
White, high density polyethylene bottles.
Bottles containing 60 or 100 tablets with tamper evident seal. Not all
pack sizes may be marketed.
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/156/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORIS