Aviticol / Cholecalciferol Capsules Hard 800IU

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

COLECALCIFEROL

Available from:

Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL 800 IU

Pharmaceutical form:

HARD CAPSULE

Composition:

COLECALCIFEROL 800 IU

Prescription type:

POM

Therapeutic area:

VITAMINS

Authorization status:

Withdrawn

Authorization date:

2016-03-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVITICOL / COLECALCIFEROL
800 IU CAPSULES
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, 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Aviticol Capsules are and what they are used for
2.
What you need to know before you take Aviticol Capsules
3.
How to take Aviticol Capsules
4.
Possible side effects
5.
How to store Aviticol Capsules
6.
Contents of the pack and other information
1.
WHAT AVITICOL CAPSULES ARE AND WHAT THEY ARE USED FOR
Aviticol Capsules contain the active ingredient colecalciferol.
Colecalciferol is a form of
vitamin D used in the prevention and treatment of vitamin D deficiency
conditions. It may
also be prescribed for certain bone conditions, such as thinning of
the bone (osteoporosis)
when it will be given to you with other medicines.
Aviticol 800 IU is the equivalent of 20 micrograms vitamin
D
3
,
which is involved in bone
formation.
The active ingredient colecalciferol is identical to the
Colecalciferol that is found in the
human body. It is found in the diet and is also produced in the skin
after exposure to the sun.
Deficiency of vitamin D may occur when your diet or lifestyle does not
provide you with
enough vitamin D or when your body requires more vitamin D (for
instance when you are
pregnant).
IF YOU ARE PLANNING TO GET PREGNANT OR YOU ARE PREGNANT AND YOU
REQUIRE EXTRA VITAMIN D
DO NOT TAKE IT WITHOUT MEDICAL SUPERVISION.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVITICOL CAPSULES
DO NOT TAKE AVITICOL CAPSULES

If you are ALLERGIC (hypersensit

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aviticol / Colecalciferol 800 IU Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
800 IU Colecalciferol (equivalent to 20 micrograms vitamin D
3
)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, Hard capsule
Unprinted, hard gelatin yellow capsule containing clear, slightly
yellow oily liquid.
Capsule length: 21.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment and prevention of vitamin D deficiency.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or
at risk of vitamin D insufficiency.
Aviticol 800 IU Capsules is indicated in adolescents and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One capsule contains 800 IU colecalciferol (vitamin D
3
).
ADULT POSOLOGY
-
Treatment of vitamin D deficiency: 1-5 capsules (800- 4 000 IU) daily
for 10 weeks
dependent upon the severity of the disease and the patient's response
to treatment,
followed by maintenance therapy of 1-2 capsules (800- 1 600 IU) daily,
as directed by
your doctor. Follow-up serum 25(OH)D measurements should be made
approximately
three to four months after initiating maintenance therapy to confirm
that the target level
has been achieved.
-
Prevention of vitamin D deficiency or treatment of vitamin D
insufficiency: 1-2 capsules
(800- 1 600 IU) daily. Higher doses may be required in certain
populations, see below:
CERTAIN POPULATIONS are at high risk of vitamin D deficiency, and may
require higher doses
and monitoring of serum 25(OH)D:
Page 2 of 8

Institutionalised or hospitalised individuals

Dark skinned individuals

Individuals with limited effective sun exposure due to protective
clothing or
consistent use of sun screens

Patients being evaluated for osteoporosis

Obese individuals

Use of certain concomitant medications (e.g. anticonvulsant
medications
glucocorticoids, anti-retrovirals)

Those recently treated for vitamin D defici