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CALCITRIOL 0.5 MICROGRAM CAPSULES

Active substance(s): CALCITRIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CALCITRIOL 0.5 MICROGRAM CAPSULES
Calcitriol Capsules are available in the following strengths: 0.25
and 0.5 microgram. Calcitriol 0.5 microgram Capsules will be
referred to as Calcitriol throughout this leaflet.

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.
2.
3.
4.
5.
6.

What Calcitriol is and what it is used for
What you need to know before you take Calcitriol
How to take Calcitriol
Possible side effects
How to store Calcitriol
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
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 diseases). 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.

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


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 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, e.g. 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 longlasting effects. These medicines include ergocalciferol and
colecalciferol.

Breast-feeding








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.

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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 begin able to drive or use
any tools or machines.

Calcitriol contains sorbitol

Calcitriol 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.

3. How to take Calcitriol
Always take Calcitriol 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 test to check that the level of calcium in your blood
does not get too high.

Bone disease in people with kidney problems (renal
osteodystrophy)




Calcitriol with food and drink


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.

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 (postmenopausal osteoporosis)


The recommended dose for adult and elderly women is one
0.25 microgram capsules twice a day.

Use in Children

Calcitriol is not recommended for use in children.

If you take more Calcitriol than you should

5. How to store Calcitriol

If you forget to take Calcitriol

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not transfer them to another container.
Store in the original package.
Do not use Calcitriol after the expiry date that is stated on the
outer packaging. The expiry date refers to the last day of that
month.
If your capsules appear to be discoloured or show any other signs
of deterioration, take them to your pharmacist who will advise
you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

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 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 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

6. Contents of the pack and other
information
What Calcitriol contains:

The active ingredient is calcitriol. Each capsule contains
0.5 micrograms of calcitriol.

The following side effects may happen rarely with this medicine:

The other ingredients are:
Capsule content: butylated hydroxyanisole (E320),
butylated hydroxytoluene (E321) and fractionated coconut oil.
Capsule shell: gelatine, glycerol, sorbitol, titanium dioxide (E171),
patent blue (E131) and quinoline yellow (E104).
Printing ink: refined shellac and black iron oxide (E172).

High levels of calcium in your blood

What Calcitriol looks like and contents of the pack:

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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 heartbeat.
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 the 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
test).

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.

Calcitriol are opaque, green, oblong, soft gelatine capsules
imprinted ‘0.5’ in black ink.
Calcitriol is available in bottles containing 30 capsules.

Manufacturer

Manufactured by: RP Scherer GmbH, Postfach 1243,
69412 Eberbach Baden, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0374

POM

This leaflet only gives a brief outline of some of the more
important points about Calcitriol. If you want to know more about
these capsules or their effects, please ask your doctor or
pharmacist.
Leaflet revision and issue date (Ref): 03.03.15

By reporting side effects you can help provide more information
on the safety of this medicine.
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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.

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