COLECALCIFEROL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

COLECALCIFEROL

Available from:

SYRI Limited, t/a Thame Laboratories

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL

Dosage:

3000 IU/ML

Pharmaceutical form:

Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

colecalciferol

Authorization status:

Not Marketed

Authorization date:

2015-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL 3000 IU/ML ORAL SOLUTION
(colecalciferol)
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.
The name of your medicine is Colecalciferol 3000 IU/ml Oral Solution
but it will be referred to as
Colecalciferol Oral Solution or Colecalciferol throughout this
leaflet.
WHAT IS IN THIS LEAFLET
1. What Colecalciferol Oral Solution is and what it is used for
2. What you need to know before you take Colecalciferol Oral Solution
3. How to take Colecalciferol Oral Solution
4. Possible side effects
5. How to store Colecalciferol Oral Solution
6. Contents of the pack and other information
1. WHAT COLECALCIFEROL ORAL SOLUTION IS AND WHAT IT IS USED FOR
Colecalciferol Oral Solution is an oily solution which contains the
active substance called colecalciferol
(Vitamin D
3
).
Vitamin D is found in the diet and is also produced in the skin after
exposure to the sun. Often vitamin
D is given in combination with calcium. Vitamin D
3
is also essential for bone formation and normal
bone metabolism.
Colecalciferol Oral Solution is used for prevention and treatment of
Vitamin D deficiency in adults,
elderly and children over 12 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLECALCIFEROL ORAL SOLUTION
DO NOT TAKE COLECALCIFEROL :
►
If you are allergic (hypersensitive) to colecalciferol or any of the
other ingredients of this medicine
(listed in section 6).
►
If you have high blood levels of calcium (hypercalcaemia) or high
urine levels of calcium
(hypercalciuria).
►
If you ha

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol 3000IU/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Colecalciferol Oral Solution contains the active substance,
colecalciferol. Each ml contains 3000IU colecalciferol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
A clear, yellow coloured solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colecalciferol is indicated for treatment and prevention of vitamin D
deficiency in adults, elderly and children over
12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
For oral use
Posology
The dosage regimen based on the ‘National
Osteoporosis Society Guideline 2013’ proposed for Colecalciferol
3000IU/ml Oral Solution in the treatment and prevention of vitamin D
deficiency is as follows:
_Adults and Elderly:_
·
Treatment dose: 4000 IU daily (1.33ml) for 10 weeks (280,000 IU in
total).
·
Maintenance dose: 800-2000 IU daily (0.27ml-0.67ml) (occasionally up
to 4000 IU daily may be
required).
_Adolescents (children >12 years)_
For treatment and maintenance
·
500 - 2000 IU/day (equivalent to 0.17 ml – 0.67 ml per day).
_Dosage in hepatic impairment:_
No dose adjustment is required.
_Dose in renal impairment:_
Colecalciferol should not be used in patients with severe renal
impairment (typically defined as a patient with
eGFR of <30 ml/min/1.73m
2
, where the normal eGFR is typically >90 ml/min/1.73m
2
).
_Dose in pregnancy and lactation:_
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