Colecalciferol 3000 IU/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Syri Pharma Limited t/a Thame Laboratories

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

3000 international unit(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

colecalciferol

Authorization status:

Not marketed

Authorization date:

2015-01-30

Patient Information leaflet

VAR/IA-022
1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL 3000IU/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 3000IU/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
(hyp

Summary of Product characteristics

Health Products Regulatory Authority
04 March 2020
CRN009KK2
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol 3000 IU/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 3000IU colecalciferol.
_Excipients with known effect: _
Each ml contains 0.1ml almond oil.
_ _
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:_
The recommended daily intake for pregnant and breast-feeding women is
400 IU (0.13ml), however, in women who are
considered to be vitamin D deficient a higher dose may be required as
recommended by the doctor.
Health Products Regulatory Authority
04 March 2020
CRN009KK2
Page 2 of 7
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Diseases and/or conditions resulting in hyperca