Calcichew D3 500mg/400unit caplets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Calcium carbonate; Colecalciferol

Διαθέσιμο από:

Takeda UK Ltd

Φαρμακολογική κατηγορία (ATC):

A12AX

INN (Διεθνής Όνομα):

Calcium carbonate; Colecalciferol

Δοσολογία:

1.25gram ; 400unit

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 09060400; GTIN: 5022690004545

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCICHEW-D
3 500MG/400IU CAPLETS
calcium / colecalciferol (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.
You must contact a doctor if your symptoms worsen or do not improve
after two weeks.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Calcichew-D
3
Caplets are and what they are used for
2.
What you need to know before you take Calcichew-D
3
Caplets
3.
How to take Calcichew-D
3
Caplets
4.
Possible side effects
5.
How to store Calcichew-D
3
Caplets
6.
Contents of the pack and other information
1.
WHAT CALCICHEW-D
3 CAPLETS ARE AND WHAT THEY ARE USED FOR
Calcichew-D
3
Caplets are film-coated tablets containing calcium and vitamin D3,
which both are important
substances in bone formation. Calcichew-D
3
Caplets is used in the prevention and treatment of calcium and
vitamin D deficiency in the elderly, and as a supplement to specific
treatment of osteoporosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW-D
3 CAPLETS
DO NOT TAKE CALCICHEW-D
3 CAPLETS:
-
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
Caplets
-
if you are on long-term treat

Αρχείο Π.Χ.Π.

OBJECT 1
CALCICHEW-D3 500 MG/400 IU CAPLETS
Summary of Product Characteristics Updated 25-May-2016 | Takeda UK Ltd
1. Name of the medicinal product
Calcichew-D
3
500 mg/400 IU Caplets
2. Qualitative and quantitative composition
One tablet contains:
Calcium carbonate equivalent to 500 mg calcium
Colecalciferol concentrate (powder form) equivalent to 400 IU (10
microgram) colecalciferol (vitamin
D
3
)
Excipient(s) with known effect:
Sorbitol (E420), 154 mg
Sucrose, 1.6 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Oval, white/off white, film-coated tablets. May have hardly visible
grey spots.
4. Clinical particulars
4.1 Therapeutic indications
Prevention and treatment of vitamin D and calcium deficiency in the
elderly.
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
500mg/400 IU Caplets is not intended for use in children.
_IMPAIRED RENAL FUNCTION:_
Calcichew-D
3
500mg/400 IU Caplets 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
Oral. The tablet should be swallowed or chewed.
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
hypercalcuria
• Renal calculi (nephrolithiasis)
• Hypervitaminosis D
4.4 Special warnings and precautions for use
During long-term treatment, serum calcium levels should be followed
and renal function should be
monitored through measurements of serum creatinine. Monitoring is
especially important in elderly
patients on concomitant treatment with cardiac glycosi