Calciup D3 500 mg/440 IU chewable tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Calcium carbonate; Cholecalciferol concentrate

Inapatikana kutoka:

Rowex Ltd

ATC kanuni:

A12AX

INN (Jina la Kimataifa):

Calcium carbonate; Cholecalciferol concentrate

Kipimo:

500mg/440 international unit(s)

Dawa fomu:

Chewable tablet

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Calcium, combinations with vitamin D and/or other drugs

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2014-08-01

Taarifa za kipeperushi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CALCIUP D
3
500 MG/440 IU CHEWABLE TABLETS
calcium / colecalciferol
_ _
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.
- You must talk to a doctor if you do not feel better or if you feel
worse after one month.
WHAT IS IN THIS LEAFLET
1. What Calciup D
3
500 mg/440 IU chewable tablets are and what they are used for
2. What you need to know before you take Calciup D
3
500 mg/440 IU chewable tablets
3. How to take Calciup D
3
500 mg/440 IU chewable tablets
4. Possible side effects
5. How to store Calciup D
3
500 mg/440 IU chewable tablets
6. Contents of the pack and other information
1. WHAT CALCIUP D
3
500 MG/440 IU CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR
Calciup D
3
500 mg/440 IU chewable tablets contain the active substances calcium
and vitamin D
3
and are
a calcium-vitamin D
3
-supplement.
CALCIUP D
3 500 MG/440 IU CHEWABLE TABLETS ARE USED
-
to prevent and treat a lack of calcium and vitamin D in elderly
-
for vitamin D- and calcium supplementation as supportive treatment of
osteoporosis (brittle bones).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUP D
3 500 MG/440 IU CHEWABLE TABLETS
_ _
DO NOT TAKE CALCIUP D
3 500 MG/440 IU CHEWABLE TABLETS:
-
if you are allergic to calcium, vitamin D
3
or any of the other ingredients of this medicine (listed in
section 6)
-
if you have high levels of calcium in your blood (hypercalcaemia)
-
if you have high levels of calcium in the urine (hypercalciuria)
-
if you suffer from overactive parathyroid glands (hyperparathyroidism)
-
if you suffer from bone marrow canc

Tabia za bidhaa

Health Products Regulatory Authority
04 November 2020
CRN009CQ2
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calciup D3 500 mg/440 IU chewable tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
1250 mg of calcium carbonate (equivalent to 500 mg of calcium).
4.4 mg of colecalciferol concentrate (powder form) (equivalent to 11
micrograms of colecalciferol = 440 IU of vitamin D3).
Excipients with known effect
Each chewable tablet contains 0.5 mg of aspartame (E951), 51.66 mg of
sorbitol (E420), 185.00 mg of isomalt (E953), 0.847 mg
of sucrose and 0.01 mg of benzyl alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablets.
Round, white tablets, diameter 18 mm with a faultless surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calciup D
3
500 mg/440 IU chewable tablets are indicated:

for the prevention and treatment of vitamin D and calcium deficiency
in elderly,

as 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
The product should not be used over a period of one month without
medical advice.
Posology
_Adults and elderly_
One chewable tablet twice daily, corresponding to a total daily dose
of 1,000 mg of calcium and 880 IU of vitamin D
3
_Hepatic impairment_
No dose adjustment is required.
_Renal impairment_
Calciup D
3
500 mg/440 IU chewable tablets are contraindicated in patients with
severe renal impairment (see section 4.3).
_Pregnant patients_
During pregnancy the daily intake should not exceed 1,500 mg of
calcium and 600 I.U. of vitamin D
3
. Therefore, the daily dose
must not exceed one chewable tablet (see section 4.6).
_ _
_Paediatric population_
Calciup D
3
500 mg/440 IU chewable tablets are contraindicated in children and
adolescents below 18 years of age (see section
4.3).
Method of administration
Oral use
Health Products Regulatory Authority
04 Nove