KALCIPOS-D FORTE 500mg/800 International Unit Film Coated Tablet

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

CALCIUM CARBONATE, COLECALCIFEROL

Dostopno od:

Meda AB

Koda artikla:

A12AX

INN (mednarodno ime):

CALCIUM CARBONATE, COLECALCIFEROL

Odmerek:

500mg/800 International Unit

Farmacevtska oblika:

Film Coated Tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Calcium, combinations with other drugs

Status dovoljenje:

Authorised

Datum dovoljenje:

2012-05-11

Navodilo za uporabo

mock ups (replace 689139)
Pia Salonen
Bookletetikett Kalcipos-D forte
60 tablets
-
44x120 mm
2017-05-16
Pharma code
Prepared by
Country
Ireland
Project Number
Product
Date
Size/Template
Black
EAN code
Art Works team
Solna, Sweden
Braille
PMS186
PMS307
60 FILM-COATED TABLETS
60 FILM-COATED TABLETS
Norway: Kalcipos-Vitamin D 500 mg/800 IE
filmdrasjerte tabletter
Portugal: Recifor 500mg/800UI comprimido revestido
Slovakia: Kombi-Kalz 500 mg/800 IU filmom
obalené tablety
Spain: KALCIPOS-D 500 MG/800 IU COMPRIMI-
DOS RECUBIERTOS
Sweden: Recikalc-D forte, 500 mg/800 IE
filmdragerad tablett
THIS LEAFLET WAS LAST REVISED IN NOVEMBER 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
KALCIPOS-D FORTE 500 MG/800 IU FILM-COATED 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.
Iceland: Kalcipos-D forte 500 mg/ 800 a.e. filmuhúðuð tafla
Ireland, United Kingdom: Kalcipos-D Forte 500mg/800IU
film coated tablets
Italy: Calciduran 500 mg + 800 UI compresse rivestite con
film
Latvia: Kalcipos-D forte 500 mg/ 800 SV apvalkotās
tabletes
Lithuania: Kalcipos-D forte 500 mg/800 TV plėvele dengtos
tabletės
Netherlands: Kalcipos-D 500 mg/800 IE filmomhulde tablet
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER
STATES OF THE EEA UNDER THE FOLLOWING NAMES:
Austria: Calciduran Vit D3 500mg/800IU - Filmtabletten
Begium, Luxembourg: Maxical 500 mg/800 IU comprimés
pelliculés
Denmark, Poland: Kalcipos-D
Finland: Kalcipos-D forte 500 mg/800 IU kalvopäällysteinen
tabletti
Germany: Calcipot, 500 mg/800 I.E., Filmtablette
Greece: Kalcipos-D forte
- If you get any side effects, talk to your doctor or
pharmacist.This includes any possible side effects not

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kalcipos-D forte 500mg/800 IU film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains calcium carbonate equivalent to 500
mg calcium, cholecalciferol (Vitamin D
3
) 800 IU
(20 microgram).
Excipients with known effect: sucrose 1.8 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, engraved R150, 8.5 x 19 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.
Kalcipos-D forte film-coated tablets is indicated in adults aged 18
years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and older people_
One film-coated tablet (500 mg/800 IU) daily.
The amount of calcium in Kalcipos-D forte is less than the usually
recommended daily intake.
Kalcipos-D forte 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 use of Kalcipos-D forte film-coated tablets in
children or adolescents.
Method of administration
Tablets shall be swallowed with water, whole, crushed or divided.
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