Calcichew-D3 Melon 500 mg/400 IE Tuggtablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

kalciumkarbonat; kolekalciferol

Dostupné z:

Orifarm Healthcare A/S

ATC kód:

A12AX

INN (Medzinárodný Name):

calcium carbonate; cholecalciferol

Dávkovanie:

500 mg/400 IE

Forma lieku:

Tuggtablett

Zloženie:

isomalt Hjälpämne; kalciumkarbonat 1250 mg Aktiv substans; xylitol Hjälpämne; kolekalciferol 10 mikrog Aktiv substans; sackaros Hjälpämne

Trieda:

Apotek

Typ predpisu:

Receptbelagt

Terapeutické oblasti:

kombinationer med vitamin D och/eller övriga läkemedel

Prehľad produktov:

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

Stav Autorizácia:

Godkänd

Dátum Autorizácia:

2015-05-27

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCICHEW-D
3 MELON 500 MG/400 IU CHEWABLE TABLETS
calcium/cholecalciferol (vitamin D
3
)
For medicines available only on prescription:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
For medicines available without a prescription:
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.
[To be completed nationally]
WHAT IS IN THIS LEAFLET
1.
What Calcichew-D
3
Melon is and what it is used for
2.
What you need to know before you take Calcichew-D
3
Melon
3.
How to take Calcichew-D
3
Melon
4.
Possible side effects
5.
How to store Calcichew-D
3
Melon
6.
Contents of the pack and other information
1.
WHAT CALCICHEW-D
3 MELON IS AND WHAT IT IS USED FOR
Calcichew-D
3
Melon are chewable tablets containing calcium and vitamin D
3
, which both are
important substances in bone formation. Calcichew-D
3
Melon 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-D
3 MELON
DO NOT TAKE CALCICHEW-D
3 MELON:
-
if you are allergic to calci

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcichew-D
3
Melon 500 mg/400 IU chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Cholecalciferol concentrate (powder form) equivalent to 400 IU (10
microgram) cholecalciferol
(vitamin D
3
)
Excipient(s) with known effect:
One tablet contains 0.8 mg sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Round, white, uncoated and convex tablets of 14 mm. 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
Posology
_Adults and elderly_
One tablet twice daily.
SPECIAL PATIENT POPULATIONS
_PAEDIATRIC POPULATION:_
Calcichew-D
3
Melon is not intended for use in children.
_Impaired renal function_
Calcichew-D
3
Melon should not be used in patients with severe renal impairment (see
section 4.3).
_Impaired hepatic function_
No dose adjustment is required
Method of administration
2
Oral. The tablets should be chewed or sucked.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.

Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m
2
)

Diseases and/or conditions resulting in hypercalcaemia and/or
hypercalciuria

Renal calculi (nephrolithiasis)

Hypervitaminosis D
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During long-term treatment, serum calcium levels should be monitored.
Renal function should also be
monitored through measurements of serum creatinine. Monitoring is
especially important in elderly
patients on concomitant treatment with cardiac glycosides or diuretics
(see section 4.5) and in patients
with a high tendency to calculus formation. In case of hypercalca