CalciD-Denk tablets effervescent

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

calcium (calcium carbonate), colecalciferol

Tilgjengelig fra:

Losan Pharma GmbH

ATC-kode:

առկա չէ (A12AX)

INN (International Name):

calcium (calcium carbonate), colecalciferol

Dosering :

1000mg+ 22mcg(880IU)

Legemiddelform:

tablets effervescent

Enheter i pakken:

(20) in plastic container

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2022-04-12

Informasjon til brukeren

SPECIFICATION - DENK PHARMA
product name:
CalciD-Denk
artwork:
leaflet
language(s):
EN, FR, PT
material number:
5201/003
revision of text:
03/2021
open format:
420 x 200 mm
fold:
1 x pre-folded (Einbruchfalz)
folded format:
210 x 200 mm
pharma code:
676
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 22.03.2021, KRi
2 / 31.03.2021, KRi
3 / 01.04.2021, KRi
4 / 01.04.2021, KRi
5 / 16.04.2021, KRi
6 / 16.04.2021, KRi
_CalciD-Denk_
Effervescent tablet | oral use
Mineral and vitamin combi‑
nation preparation
Active ingredients: calcium and vitamin D
3
(colecalciferol)
For use in adults
Package leaflet:
Information for the patient
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 doc‑
tor or pharmacist has 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 in‑
cludes any possible side effects not
listed in this leaflet. See section 4.
– You must talk to a doctor if you do
not feel better or if you feel worse.
What is in this leaflet
1.
WHAT CALCID‑DENK IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCID‑DENK
3. HOW TO TAKE CALCID‑DENK
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CALCID‑DENK
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What CalciD-Denk is and what it
is used for
CalciD‑Denk is a combined mineral and vita‑
min product for the treatment of calcium and
vitamin D
deficiency states.
It is used:
• as an addition to treatments for osteoporo‑
sis (a skeletal disorder with decreased bone
mass) in patients with simultaneous calcium
and
vitamin D deficiency.
•
to correct a simultaneous calcium and
vitamin D deficiency in the elderly.
You must talk to a doctor if you do not feel
better or if you feel worse.
2.
What you need to know

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CalciD-Denk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: calcium, colecalciferol
Each effervescent tablet contains 1,000 mg calcium (as calcium
carbonate) and 22 µg colecalciferol
(vitamin D
3
, equivalent to 880 I.U.).
Excipients with known effect: Each effervescent tablet contains 396 mg
lactose monohydrate, 3.7 mg
sucrose, 94.5 mg sodium and soya oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet
Round, white to off-white biplane effervescent tablets with bevelled
edges on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As support for a specific osteoporosis treatment in patients with
proven or high risk of simultaneous
calcium and vitamin D deficiencies.
Compensation for simultaneous calcium and vitamin D deficiency in the
elderly.
Calcium carbonate and colecalciferol are for use by adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 effervescent tablet once a day.
_Paediatric population_
Calcium carbonate and colecalciferol are not intended for use in
children and adolescents.
_Dosage in patients with hepatic impairment_
No dose adjustment is required.
_Dosage in patients with renal impairment_
Calcium carbonate and colecalciferol are not permitted to be used in
patients with severe renal
impairment.
2
Method of administration
Oral ingestion after dissolving. The effervescent tablets are to be
dissolved in a glass of water for
immediate drinking.
Length of use
Treatment of the calcium deficiency and osteoporosis is to be applied
for the long term. Treatment
duration is based on the targeted therapeutic goal.
4.3
CONTRAINDICATIONS
Calcium carbonate and colecalciferol are not permitted to be used in
patients with:
-
Hypersensitivity to the active substances, soy, peanuts, or any of the
excipients listed in section 6.1.
-
Illnesses or circumstances that can cause hypercalcaemia or
hypercalciuria.
-
Severe renal insufficiency.
-
Kidney stones, nephrocalc