Colecalciferol 20,000unit capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Colecalciferol

可用日期:

Colonis Pharma Ltd

ATC代码:

A11CC05

INN（国际名称）:

Colecalciferol

剂量:

20000unit

药物剂型:

Capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF:

资料单张

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 Colecalciferol Capsules are and what
they are used for
2. What you need to know before you take
Colecalciferol Capsules
3. How to take Colecalciferol Capsules
4. Possible side effects
5. How to store Colecalciferol Capsules
6. Contents of the pack and other information
1. What Colecalciferol Capsules are
and what they are used for
Colecalciferol Capsules contain the active
ingredient colecalciferol. Colecalciferol is a form
of vitamin D used in the initial treatment of
clinically relevant vitamin D deficiency conditions
in adults.
Colecalciferol 20 000 IU Capsules contain the
equivalent of 500 micrograms vitamin D
3
which is
involved in bone formation. The active ingredient,
colecalciferol, is identical to the vitamin D
3
that
is found in the human body.
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).
2. What you need to know before
you take Colecalciferol Capsules
DO NOT TAKE COLECALCIFEROL
■ if you are allergic (hypersensitive) to
colecalciferol or any of the other ingredients in
the capsules (these are listed in section 6,
Contents of the pack and other information)
■ if you have high levels of calcium in your blood
(hypercalcaemia) or urine (hypercalciuria)
■ if you suffer from pseudohypoparathyroidism
(disorder of the parathyroid hormone balance)
■ if you suffer from severe renal impairment
■

产品特点

OBJECT 1
COLECALCIFEROL 20 000 IU CAPSULES
Summary of Product Characteristics Updated 04-May-2018 | Colonis
Pharma Ltd
1. Name of the medicinal product
Colecalciferol 20 000 IU Capsules, hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains:
20 000 IU colecalciferol (equivalent to 500 μg vitamin D
3
)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, Hard
Ivory opaque, unprinted, hard gelatin capsule containing a clear,
slightly yellow oily liquid.
4. Clinical particulars
4.1 Therapeutic indications
Initial treatment of clinically relevant vitamin D deficiency in
adults.
4.2 Posology and method of administration
One capsule contains 20 000 IU colecalciferol (vitamin D
3
).
• ADULT POSOLOGY
Initial treatment of clinically relevant vitamin D deficiency:
• 1 capsule twice per week (equivalent to 40,000 IU/week) for 7
weeks (corresponding to a loading dose
of 280,000 IU).
Maintenance therapy with lower doses of vitamin D equivalent to 800 to
1000 IU daily may be
considered one month after the end of initial treatment with
Cholecalciferol 20,000 IU. For this purpose
other preparations are available. The doctor in charge shall decide on
the individual dosage and the
duration of treatment.
• PAEDIATRIC POPULATION
Colecalciferol 20,000 IU should not be used in infants or young
children (under 12 years) as they may not
be able to swallow the capsules and might choke. Instead, it is
advisable to use drops or dissolvable
tablets. Due to the lack of data on posology the administration in
adolescents between the ages of 12 – 18
years is not recommended.
_Patients with renal impairment/hypercalcaemia_
In the event of hypercalcaemia or signs of reduced renal function, the
dose must be reduced or the
treatment discontinued. If hypercalciuria occurs (more than 7.5 mmol
equivalent to 300 mg calcium/24
hours), the dose is to be reduced or treatment discontinued.
METHOD OF ADMINISTRATION
This medicine is taken orally.
The capsule should be swallowed whole with wat