Calcichew-D3 Mite Apelsin 500 mg/200 IE Tuggtablett

Država: Švedska

Jezik: švedski

Izvor: Läkemedelsverket (Medical Products Agency)

Aktivni sastojci:

kalciumkarbonat; kolekalciferol

Dostupno od:

Orifarm Healthcare A/S

ATC koda:

A12AX

INN (International ime):

calcium carbonate; cholecalciferol

Doziranje:

500 mg/200 IE

Farmaceutski oblik:

Tuggtablett

Sastav:

kalciumkarbonat 1250 mg Aktiv substans; xylitol Hjälpämne; kolekalciferol 5 mikrog Aktiv substans; sackaros Hjälpämne; isomalt Hjälpämne

Razred:

Apotek

Tip recepta:

Receptbelagt

Područje terapije:

kombinationer med vitamin D och/eller övriga läkemedel

Proizvod sažetak:

Förpacknings: Burk, 168 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 168 tabletter; Blister, 180 tabletter; Burk, 20 tabletter; Burk, 30 tabletter; Burk, 50 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter; Burk, 180 tabletter

Status autorizacije:

Godkänd

Datum autorizacije:

2005-07-01

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Calcichew-D3 Mite Apelsin 500 mg/200 IU chewable tablets
calcium / cholecalciferol (vitamin D
3
)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 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.
-
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 Calcichew-D3 Mite Apelsin is and what it is used for
2.
What you need to know before you take Calcichew-D3 Mite Apelsin
3.
How to take Calcichew-D3 Mite Apelsin
4.
Possible side effects
5.
How to store Calcichew-D3 Mite Apelsin
6.
Contents of the pack and other information
1.
WHAT CALCICHEW-D3 MITE APELSIN IS AND WHAT IT IS USED FOR
Calcichew-D3 Mite Apelsin are chewable tablets containing calcium and
vitamin D
3
, which both are
important substances in bone formation. Calcichew-D3 Mite Apelsin is
used in the prevention and treatment
of calcium and vitamin D deficiency, and as a supplement to specific
treatment of osteoporosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D3 MITE APELSIN
DO NOT TAKE CALCICHEW-D3 MITE APELSIN
-
if you are allergic to calcium, vitamin D or any of the other
ingredients of this medicine (listed in
section 6)
-
If you have severe kidney problems
-
if you have excessive amounts of calcium in the blood or in the urine.
-
if you have kidney stones
-
if you have excessive amounts of vitamin D in the blood
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Calcichew-D
3
Mite Apelsin
-
if you are on long-term treatment, especially if you also take
diuretics (used in the treatment of high
blood pressure or oedema) or cardiac glycosides (used to treat heart
disorders).
-
if you have signs of impaired rena

Svojstava lijeka

Produktinformationen för Calcichew-D3 Mite Apelsin 500 mg/200 IE
tuggtablett, MTnr
21889, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att
uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma
anledning finns inte
någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Mite Apelsin 500 mg/200 IU chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 200 IU (5
microgram) cholecalciferol
(vitamin D3)
Excipients:
Aspartame (E951)
Isomalt (E953)
Sorbitol (E420)
Sucrose
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable tablet
Round, white and convex tablets. May have small specks.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D and calcium deficiency.
Vitamin D and calcium supplement as an adjunct to specific
osteoporosis treatment of patients who
are at risk of vitamin D and calcium deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adjunctive therapy in osteoporosis_
One chewable tablet 2-3 times per day
_Calcium and vitamin D deficiency_
Adults: 1 chewable tablet 1-3 times per day
Children: 1 tablet 1-2 times per day
The tablet may be chewed or sucked.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Calcichew-D
3
Mite Apelsin tablets should not be used in patients with severe renal
impairment.
4.3
CONTRAINDICATIONS

Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalciuria

Nephrolithiasis

Hypervitaminosis D

Hypersensitivity to the active substances or t