Skip to Content

CALCITRIOL 0.5MCG CAPSULES

Active substance(s): CALCITRIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
231-30-85810-Z LEA CALCITRIOL A/S CAPS TUK
CALCITRIOL 0.25 microgram and
0.5 microgram CAPSULES
Calcitriol
Package leaflet: Information for the user
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 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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Calcitriol is and what it is used for
2. What you need to know before you take
Calcitriol
3. How to take Calcitriol
4. Possible side effects
5. How to store Calcitriol
6. Contents of the pack and other information

1

What Calcitriol is and what it is used
for

Calcitriol is a vitamin D product.
Calcitriol is used to treat the following:
• Bone disease in people with kidney problems
(renal osteodystrophy).
• Weakening of the bones in women after the
menopause (change of life). This is also known
as post-menopausal osteoporosis.
Calcitriol works by making your body absorb
more calcium from your diet. This helps to form
healthy bones and reduce bone damage.

2

What you need to know before you
take Calcitriol

Version:

1

24 June 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

3

132

132

Do not take Calcitriol if you are allergic to:
• calcitriol or any of the other ingredients of
this medicine (listed in section 6)
• any other “vitamin D metabolite” medicines
(used to treat bone disease). These include
alfacalcidol and colecalciferol
Do not take Calcitriol if any of the above apply
to you. If you are not sure, talk to your doctor
or pharmacist before taking Calcitriol
Do not take Calcitriol if you:
• have high levels of calcium in your blood
(hypercalcaemia)
• have extra deposits of calcium in your body
(metastatic calcification).
• are unwell because of high levels of vitamin D
in your body.
• Do not take Calcitriol if any of the above apply
to you. If you are not sure, talk to your doctor
or pharmacist before taking Calcitriol
Warnings and precautions
Talk to your doctor or pharmacist before taking
Calcitriol if you:
• are finding it difficult to move about (for
example, after an operation).
• have kidney problems (the doctor may need to
monitor the phosphate levels in your blood
and diet).

Other medicines and Calcitriol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
This is because Calcitriol can affect the way
some medicines work. Also some other
medicines can affect the way Calcitriol works.
In particular, tell your doctor or pharmacist if
you are taking any of the following medicines:
• Other medicines containing vitamin D.
• Diuretics, also called ‘water tablets’ (used to
treat high blood pressure). These include
bendroflumethiazide, chlortalidone and
indapamide.
• Medicines like digoxin or digitoxin (used to
treat heart disease).
• Medicines containing magnesium, such as
antacids (used to treat indigestion).
• Steroid medicines, such as hydrocortisone,
prednisolone and dexamethasone.
• Cholestyramine, or other ‘ion-exchange resins’
(used to treat high levels of cholesterol in
your blood).
• Phosphate (the doctor may need to monitor
phosphate levels in your blood).
Also tell your doctor or pharmacist if you have
taken a medicine containing vitamin D over the
last few months that has long-lasting effects.
These medicines include ergocalciferol and
colecalciferol.
Calcitriol with food and drink
• DO NOT take any vitamin or food supplements
that contain vitamin D while you are taking
Calcitriol
• DO NOT eat food which has vitamin D added
(food which is ‘fortified’ with vitamin D) while
you are taking Calcitriol.
• It is very important to keep to any diet that
your doctor has given to you.
• If you change how much calcium or vitamin D
you have in your diet this can increase the risk
of side effects (for example, if you eat more
dairy products like milk and cheese, or take
vitamins without your doctor knowing).
• Drink plenty of fluids (such as water) as it is
important not to become dehydrated. This
does not apply if you have kidney problems.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
• Talk to your doctor before taking Calcitriol if
you are pregnant, think you may be pregnant
or are planning to have a baby, plan to get
pregnant. Your doctor will then decide if you
should take Calcitriol.
Breast-feeding
• You can take Calcitriol if you are breast-feeding.
However, your doctor will take blood samples
from you and your child to check that there
are no unwanted effects.
Driving and using machines
• Calcitriol is not likely to affect you being able
to drive or use any tools or machines.
Calcitriol contains sorbitol
Calcitriol Capsules contains sorbitol, which is a
type of sugar. If your doctor has told you that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.

No
217 mm
135 mm
N/A
N/A

How to take Calcitriol

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the capsules whole with a little water.
While you are taking Calcitriol, your doctor will
want you to have regular blood tests to check
that the level of calcium in your blood does not
get too high.
Bone disease in people with kidney problems
(renal osteodystrophy)
• The recommended starting dose for adults
and elderly people is one 0.25 microgram
capsule once a day.
• After 2 to 4 weeks your doctor may start
increasing your dose slowly by 0.25 microgram
at a time.
• Eventually, depending on your blood test
results, your doctor may need to adjust your
dose again. He or she may ask you to take
Calcitriol two or three times a week instead of
every day. The maximum dose each week is
12 micrograms.
Bone disease after the menopause
(post-menopausal osteoporosis)
• The recommended dose for adult and elderly
women is one 0.25 microgram capsule twice
a day.
Use in children
Calcitriol is not recommended for use in children.
If you take more Calcitriol than you should
If you take more Calcitriol than you should, talk
to a doctor or go to a hospital straight away.
Take the medicine pack with you.
If you take too many capsules, you may get too
much calcium in your blood (hypercalcaemia).
The signs include loss of appetite, weight loss,
feeling sick, being sick, constipation, headache
and feeling sluggish, drowsy or weak.
If you forget to take Calcitriol
If you forget to take a dose, skip the missed dose.
Then take your next dose as normal. Do not take
a double dose (two doses at the same time) to
make up for a forgotten dose.
If you stop taking Calcitriol
Do not stop taking Calcitriol without talking to
your doctor. This is because weakness of your
bones needs long term treatment.
If someone else takes your Calcitriol capsules
by mistake, they should talk to a doctor or go to
a hospital straight away.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects may happen rarely
with this medicine:
High levels of calcium in your blood
The signs include loss of appetite, weight loss,
feeling sick, being sick, headache and feeling
sluggish, drowsy or weak.
Very high levels of calcium in your blood may
lead to high temperature (fever), feeling thirsty,
dehydration, passing more water than normal,
wetting the bed, constipation, stomach pain,
blockage of the bowel and an uneven heart beat.
There may be infections in the bladder and
normal growth may stop.

Occasionally, mental problems may occur. Also
there may be deposits of calcium in areas other
than your bone (for example, in your kidneys
as ‘kidney stones’). Your doctor may change
your dose of Calcitriol if this happens.
Kidney
Changes in how well your kidney is working
(shown by blood tests).
Allergic reactions
The signs can include itchy skin, skin rashes and
reddening of the skin (which may be severe).
Reporting of side effects
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.
You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

5

How to store Calcitriol

Keep this medicine out of the sight and reach
of children.
These capsules should be stored in the package
or container supplied. Do not store above 30°C.
Do not transfer them to another container.
Do not use this medicine after the expiry date
which is stated on the outer packaging after EXP.
The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Calcitriol Capsules contains:
• The active substance is calcitriol.
• The other ingredients are fractionated coconut
oil, butylated hydroxyanisole (E320), butylated
hydroxytoluene (E321), gelatine, glycerol
(E422), sorbitol (E420) and the dyes titanium
dioxide (E171) and quinoline yellow (E104).
The 0.5 microgram capsule also includes the
dye patent blue (E131).
Both strengths of capsule are printed with
black ink that contains shellac (E904) glaze
and black iron oxide (E172).
What Calcitriol Capsules looks like and
contents of the pack:
• The Calcitriol 0.25 microgram Capsules are
opaque, yellow, oval, soft gelatine capsules
imprinted ‘0.25’.
• The Calcitriol 0.5 microgram Capsules are
opaque, green, oblong, soft gelatin capsules
imprinted ‘0.5’.
• The product is available in pack sizes of 7, 10,
14, 20, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
120, 150, 160, and 168 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK
Limited, Eastbourne, BN22 9AG.
The company responsible for manufacture is
TEVA UK Limited, Eastbourne, BN22 9AG.
Or
Teva Pharmaceuticals Europe B.V.
Swensweg 5, 2031 GA Haarlem, The Netherlands
This leaflet was last revised: June 2016
PL 00289/0941-0942

85810-Z
322K055900616

132

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

132

TEVA UK Ref:

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide