CalciD-Denk tablets effervescent

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

calcium (calcium carbonate), colecalciferol

Available from:

Losan Pharma GmbH

ATC code:

առկա չէ (A12AX)

INN (International Name):

calcium (calcium carbonate), colecalciferol

Dosage:

1000mg+ 22mcg(880IU)

Pharmaceutical form:

tablets effervescent

Units in package:

(20) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Patient Information leaflet

1
Version: 50001095-005
CALCID-DENK
Effervescent tablet - oral use
Mineral and vitamin combination preparation
Active substances: calcium + cholecalciferol (vitamin D
3
)
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 doctor 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
includes 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 are effervescent tablets containing calcium and vitamin D
3
- two important
substances in bone formation.
CalciD-Denk is taken

for the prevention and treatment of calcium and vitamin D deficiency
states in the elderly

as an adjunct to specific osteoporosis therapy for patients at risk of
vitamin D and calcium
deficiency.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCID-DENK
DO NOT TAKE CALCID-DENK:

if you are allergic to calcium, cholecalciferol (vitamin D
3
) or any of the other ingredients of this
medicine (listed in section 6)

if you have an abnormally high level of calcium in your blood or urine

if you have severely impaired kidney function

if you have kidney stones

if you have abnormally high levels of vitamin D in your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Calci

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CalciD-Denk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: calcium, cholecalciferol (vitamin D
3
)
Each effervescent tablet contains 1,000 mg calcium (as calcium
carbonate) and 22 µg cholecalciferol
(vitamin D
3
, equivalent to 880 I.U. as cholecalciferol dry concentrate).
Excipients with known effect: Each effervescent tablet contains 396 mg
lactose monohydrate, 3.7 mg
sucrose, 96.1 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
Prevention and treatment of vitamin D and calcium deficiency states in
the elderly.
Calcium and vitamin D supplement as an adjunct to specific
osteoporosis therapy for patients who are
at risk of vitamin D and calcium deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and the elderly
1 effervescent tablet each day.
Paediatric population
Calcium carbonate and cholecalciferol 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 cholecalciferol are not permitted to be used in
patients with severe renal
impairment.
The duration of treatment is to be decided on a case-by-case basis.
2
METHOD OF ADMINISTRATION
Oral ingestion after dissolving.
The effervescent tablets are to be dissolved in a glass of water for
immediate drinking.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances, soya, peanuts, or any of
the excipients listed in section
6.1.
-
Illnesses and/or circumstances that lead to hypercalcaemia and/or
hypercalciuria.
-
Severe renal insufficiency.
-
Kidney stones.
-
Hypervitaminosis D.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During long-term treatment the calcium level in the serum must be
monitored and the renal funct