Ergocalciferol 50 000 IU Capsules

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

ERGOCALCIFEROL

Доступно од:

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

АТЦ код:

A11CC01

INN (Међународно име):

ERGOCALCIFEROL 50,000 IU

Фармацеутски облик:

HARD CAPSULE

Састав:

ERGOCALCIFEROL 50,000 IU

Тип рецептора:

POM

Терапеутска област:

VITAMINS

Статус ауторизације:

Withdrawn

Датум одобрења:

2015-01-14

Информативни летак

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERGOCALCIFEROL 50 000 IU CAPSULES
_ _ERGOCALCIFEROL
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. See section 4
WHAT IS IN THIS LEAFLET
1.
What Ergocalciferol Capsules are and what they are used for
2.
What you need to know before you take Ergocalciferol Capsules
3.
How to take Ergocalciferol Capsules
4.
Possible side effects
5.
How to store Ergocalciferol Capsules
6.
Contents of the pack and other information
1.
WHAT ERGOCALCIFEROL CAPSULES ARE AND WHAT THEY ARE USED FOR
Ergocalciferol is a form of vitamin D used in the treatment of vitamin
D
deficiency conditions and in the maintenance of vitamin D levels.
Ergocalciferol 50 000 IU Capsules is equivalent to 1.25 milligrams of
vitamin
D
2
which is involved in bone formation.
The active ingredient Ergocalciferol is identical to the
Ergocalciferol that is
found as a
plant-derived form of vitamin D named as vitamin D
2
.
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 REQUIRE
EXTRA
VITAMIN D, DO NOT TAKE IT WITHOUT MEDICAL SUPERVISION.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERGOCALCIFEROL CAPSULES
DO NOT TAKE ERGOCALCIFEROL CAPSULES:
•
if you are
ALLERGIC
(hypersensitive) to ergocalciferol or any of the other
ingredients in the capsules (listed in section 6, Contents of the pack
and
other information)
•
have
HIGH LEVEL

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ergocalciferol 50 000 IU Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ergocalciferol 50 000 IU (equivalent to 1.25mg
vitamin D
2
).
For a full list of excipients, see section 6.1.
3.
PHACEUTICAL FORM
3
PHARMACEUTICAL FORM
Capsule, hard
Orange opaque, unprinted, hard gelatin capsule containing clear,
slightly yellow oily liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of vitamin D deficiency and the maintenance of vitamin D
levels.
Ergocalciferol is indicated in adults and the elderly.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One capsule contains 50 000 IU Ergocalciferol (vitamin D
2
).
-
Treatment of vitamin D deficiency: 50 000 IU (1 capsule) once a week
for 12 weeks,
followed by maintenance therapy of 50 000 IU (1 capsule) every 4
weeks, as directed.
-
Maintenance of vitamin D levels: 50 000 IU (1 capsule) every 4 weeks.
Higher doses may be required in certain populations, see below “
CERTAIN POPULATIONS
”
.
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.
CERTAIN POPULATIONS
are at high risk of vitamin D deficiency, and may require higher doses
and monitoring of serum 25(OH)D:
•
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
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glucocorticoids, anti-retrovirals)
•
Those recently treated for vitamin D deficiency, and requiring
maintenance
therapy
•
Patients with liver or renal disease
•
Patients with malabsorption, including inflammatory bowel disease

and coeliac
disease
INFANTS AND CHILDREN
Not recommended for children under 18 years.
PREGNANCY AND B