THORENS 10 000 I.U. /ml oral drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cholecalciferol

Available from:

Italfarmaco S.p.A.

ATC code:

A11CC; A11CC05

INN (International Name):

Cholecalciferol

Dosage:

10 000 international unit(s)/millilitre

Pharmaceutical form:

Oral drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

vitamin D3 and analogues, cholecalciferol

Therapeutic area:

Vitamin D and analogues; colecalciferol

Therapeutic indications:

Prophylaxis of rickets and osteomalacia in children and adults
Prophylaxis of rickets in preterm newborns
Prophylaxis of vitamin D deficiency in children and adults with an identified risk
Prophylaxis of vitamin D deficiency in children and adults with malabsorption
Treatment of rickets and osteomalacia in children and adults

Authorization status:

Marketed

Authorization date:

2014-02-14

Patient Information leaflet

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, or nurse.
–
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, or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1.
What THORENS is and what it is used for
2.
What you need to know before you use
THORENS
3.
How to use THORENS
4.
Possible side effects
5.
How to store THORENS
6. Contents of the pack and other information
1.
What THORENS is and what it is used for
THORENS oral drops, solution contains colecalciferol
(vitamin D
3
). Vitamin D
3
, can be found in some
foods and is also produced by the body when skin is
exposed to sunlight. Vitamin D
3
helps the kidneys and
intestine absorb calcium and it helps build bones.
Vitamin D
3
deficiency is the predominant cause of
rickets (defective mineralization of bones in children)
and
osteomalacia
(inadequate
mineralization
of
bones in adults).
THORENS oral drops, solution is used to prevent and
treat vitamin D
3
deficiency in adults, adolescents and
children with an identified risk of vitamin D deficiency.
THORENS oral drops, solution can also be used as an
adjunct to specific bone loss medication.
2.
What you need to know before you use
THORENS
Do not use THORENS:
•
if you are allergic to 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) or urine (hypercalciuria);
•
if you have kidney stones (renal calculi) or serious
kidney problems;
•
if you have high levels of vitamin D
3
in your blood
(hypervitaminosis D).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
u

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2018
CRN008HHD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
THORENS 10 000 I.U. /ml oral drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral drops, solution (50 drops) contains 10 000 I.U.
colecalciferol (vitamin D
3
),
equivalent to 0.25 mg.
1 drop contains 200 I.U. colecalciferol (vitamin D
3
), equivalent to 0.005 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear and colorless to greenish-yellow oily solution without visible
solid particles
and/or precipitate
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults,
adolescents and children
with an identified risk.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D
deficiency or at risk of vitamin D insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Preventionof vitamin D deficiency and as an adjunct to specific
therapy for osteoporosis_:
Recommended dose is 3-4 drops (600 I.U. - 800 I.U.) per day.
_Treatment of vitamin D deficiency_:
4 drops (800 I.U.) per day. Higher doses should be adjusted dependent
upon
desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the
severity of the
disease and the patient´s response to treatment. The daily dose
should not exceed 4
000 I.U. (20 drops per day).
Paediatric population
Health Products Regulatory Authority
14 September 2018
CRN008HHD
Page 2 of 8
_Prevention_:
For prevention in children (0 years to 11 years old) with an
identified risk, the
recommended dose is 2 drops (400 I.U.) per day.
For prevention in adolescents (12 years to 18 years old) with an
identified risk, the
recommended dose is 3-4 drops (600-800 I.U.) per day.
_Treatment of deficiency in children and adolescents_:
The dose should be adjusted dependent upon desirable serum levels of
25-hydroxycolecalciferol (25(OH)D), the severity of the disease and
the patient´s
response to treatment.
The d