Colecalciferol EQL Pharma 2000 IU tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

EQL Pharma AB

ATC code:

A11CC05

INN (International Name):

Colecalciferol

Dosage:

2000 international unit(s)

Pharmaceutical form:

Tablet

Therapeutic area:

colecalciferol

Authorization status:

Not marketed

Authorization date:

2021-07-09

Patient Information leaflet

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLECALCIFEROL EQL PHARMA 800 IU TABLETS
COLECALCIFEROL EQL PHARMA 2000 IU TABLETS
colecalciferol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHAT IS IN THIS LEAFLET
1.
What Colecalciferol EQL Pharma is and what it is used for
2.
What you need to know before you use Colecalciferol EQL Pharma
3.
How to use Colecalciferol EQL Pharma
4.
Possible side effects
5.
How to store Colecalciferol EQL Pharma
6.
Contents of the pack and other information
1.
WHAT COLECALCIFEROL EQL PHARMA IS AND WHAT IT IS USED FOR
Colecalciferol EQL Pharma contains the active substance colecalciferol
(vitamin D
3
). Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Colecalciferol EQL Pharma 800 IU is used to prevent and treat vitamin
D
3
deficiency in adults, elderly
and adolescents.
Your doctor may prescribe Colecalciferol EQL Pharma 800 IU as an
adjunct to specific bone loss
medication in adult and elderly patients.
Colecalciferol EQL Pharma 2000 IU is used to treat vitamin D
3
deficiency in adults, elderly and
adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLECALCIFEROL EQL PHARMA
DO NOT USE COLECALCIFEROL EQL PHARMA:
-
if you are allergic to colecalciferol or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria (increased
levels of calcium in the urine).
-
if you have hypervitaminosis D (increased levels of vitamin

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2021
CRN009N98
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colecalciferol EQL Pharma 2000 IU tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Colecalciferol EQL Pharma 2000 IU tablet: Each tablet contains
colecalciferol 2000 IU (equivalent to 50 microgram vitamin D
3
).
Excipient(s) with known effect
Each tablet contains isomalt 228 mg and sucrose 4 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to off white, oblong, uncoated tablets plain on both sides, 14
mm long
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Treatment of vitamin D deficiency in adults, elderly and adolescents.
Vitamin D deficiency is defined as serum
levels of 25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be established on an individual basis depending on the
desirable serum levels of 25-hydroxycolecalciferol
(25(OH)D), the severity of the disease and the patient´s response to
treatment. The dosage has to be established individually by
a physician. The tablets cannot be divided for dosing and so the
appropriate formulation should be used to achieve the
recommended dose which is as follows:
_Adults and elderly_
Treatment of vitamin D deficiency: 800 – 4000 IU per day.
The daily dose should not exceed 4000 IU (two tablets).
A lower maintenance dose of 800 – 1600 IU/day or weekly or monthly
equivalent should be considered one month after
loading dose.
Adolescents aged 12 – 18 years:
Treatment of vitamin D deficiency: 800 – 1600 IU/day
The daily dose should not exceed 2000 IU per day. A lower maintenance
dose of 800 – 1600 IU/day or weekly or monthly
equivalent should be considered one month after loading dose.
The safety and efficacy of colecalciferol in children under 12 years
have not been established.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment _
Colecalciferol should not be used in patients with