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CALCITRIOL 0.25 MICROGRAM SOFT CAPSULES

Active substance(s): CALCITRIOL / CALCITRIOL

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Package leaflet: Information for the user patient

Rocaltrol® 0.25 microgram Capsules
(calcitriol)
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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is Rocaltrol
0.25 microgram Capsules but will be
referred to as Rocaltrol throughout this
leaflet. Please note that the leaflet also
contains information about other strength
Rocaltrol 0.5 microgram Capsules.

What is in this leaflet
1. What Rocaltrol is and what it is used for
2. What you need to know before you take
Rocaltrol
3. How to take Rocaltrol
4. Possible side effects
5. How to store Rocaltrol
6. Contents of the pack and other
information

1. What Rocaltrol is and what it is
used for
Rocaltrol contains a medicine called
calcitriol. This belongs to a group of
medicines called ‘vitamin D metabolites’.
Rocaltrol 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.
Rocaltrol 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 Rocaltrol
Do not take Rocaltrol:
if you are allergic (hypersensitive) to:
Calcitriol or any of the other ingredients
of this medicine (listed in section 6).
Other ‘vitamin D metabolite’ medicines
(used to treat bone disease). These
include alfacalcidol and colecalciferol.
Do not take Rocaltrol if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Rocaltrol.
Do not take Rocaltrol if:
You have high levels of calcium in your
blood (hypercalcaemia).
You have extra deposits of calcium in
your body (metastatic calcification).
You are unwell because of high levels
of vitamin D in your body.
Do not take Rocaltrol if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Rocaltrol.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Rocaltrol if:
You are finding it difficult to move about
(for example, after an operation).
You have kidney problems (the doctor
may need to monitor the phosphate
levels in your blood and diet).
Other medicines and Rocaltrol
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 Rocaltrol can affect the way some
medicines work. Also some other
medicines can affect the way Rocaltrol
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.
Rocaltrol with food and drink
Do not take any vitamin or food
supplements that contain vitamin D
while you are taking Rocaltrol.
Do not eat food which has vitamin D
added (food which is ‘fortified’ with
vitamin D) while you are taking
Rocaltrol.
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
Talk to your doctor before taking
Rocaltrol if you are pregnant, think you
are pregnant, or plan to get pregnant.
Your doctor will then decide if you
should take Rocaltrol.
You can take Rocaltrol 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
Rocaltrol is not likely to affect you being
able to drive or use any tools or machines.
Rocaltrol contains sorbitol
Rocaltrol contains sorbitol, which is a type
of sugar. If you have been told by your
doctor that you cannot tolerate or digest
some sugars (have an intolerance to some
sugars), talk to your doctor before taking
this medicine.

3. How to take Rocaltrol
Always take this medicine exactly as your
doctor has told you. Check with your doctor
if you are not sure.
Swallow the capsules whole with a little
water.
While you are taking Rocaltrol, 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 usual 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 Rocaltrol 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 usual dose for adult and elderly
women is one 0.25 microgram capsule
twice a day.
If you take more Rocaltrol than you
should
If you take more Rocaltrol 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 Rocaltrol
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 Rocaltrol
Do not stop taking Rocaltrol without talking
to your doctor. This is because weakness
of your bones needs long-term treatment.
If someone else takes your Rocaltrol 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 Rocaltrol 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).
If any of the side effects become serious or
troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
Reporting of side effects
If you get any side effects talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report any 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 Rocaltrol
Keep out of the sight and reach of
children.
Do not store above 25°C.
Store in the original package.
Keep blisters in outer carton in order to
protect from light and moisture.
Do not take the capsules after the expiry
date which is stated on the carton and
blister label after ‘Exp’. The expiry date
refers to the last day of the month.
If the capsules become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.

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.

6. Contents of the pack and other
information
What Rocaltrol contains:
The active ingredient in Rocaltrol is
calcitriol.
Each capsule contains 0.25 microgram
calcitriol.
The other ingredients are
butylhydroxyanisole, butylhydroxytoluene,
medium-chain triglycerides, gelatin,
glycerol 85%, noncrystallizing sorbitol,
titanium dioxide (E171), red iron oxide
(E172) and yellow iron oxide (E172).
What Rocaltrol looks like and contents of
the pack
Rocaltrol is an oblong, opaque soft gelatin
capsule, brown-orange to red-orange in
colour on one side and white to grey-yellow
or grey-orange in colour on the other side.
It contains clear oil inside, almost colourless
to slightly yellow, slightly brown or light
brown-yellow liquid.
It is available in blister packs of 30 soft
capsules.
Manufactured by: Roche s.r.o.,
Dukelskych hrdinu 52, 17000 Praha 7,
Czech Republic.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®

Rocaltrol 0.25 microgram Capsules;
PL 18799/2990

POM

Leaflet date: 05.12.2016
Rocaltrol is the registered trademark of
Roche Products Limited.

Package leaflet: Information for the user patient

Calcitriol 0.25 microgram Soft
Capsules
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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is Calcitriol
0.25 microgram Soft Capsules but will be
referred to as Calcitriol throughout this
leaflet. Please note that the leaflet also
contains information about other strength
Calcitriol 0.5 microgram Soft Capsules.

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 contains a medicine called
calcitriol. This belongs to a group of
medicines called ‘vitamin D metabolites’.
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 (hypersensitive) to:
Calcitriol or any of the other ingredients
of this medicine (listed in section 6).
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).
You have extra deposits of calcium in
your body (metastatic calcification).
You 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).
You 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
Talk to your doctor before taking
Calcitriol if you are pregnant, think you
are pregnant, or plan to get pregnant.
Your doctor will then decide if you
should take Calcitriol.
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 contains sorbitol, which is a type
of sugar. If you have been told by your
doctor that you cannot tolerate or digest
some sugars (have an intolerance to some
sugars), talk to your doctor before taking
this medicine.

3. How to take Calcitrol
Always take this medicine exactly as your
doctor has told you. Check with your doctor
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 usual 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 usual dose for adult and elderly
women is one 0.25 microgram capsule
twice a day.
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 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).
If any of the side effects become serious or
troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
Reporting of side effects
If you get any side effects talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report any 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 out of the sight and reach of
children.
Do not store above 25°C.
Store in the original package.
Keep blisters in outer carton in order to
protect from light and moisture.
Do not take the capsules after the expiry
date which is stated on the carton and
blister label after ‘Exp’. The expiry date
refers to the last day of the month.
If the capsules become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.

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.

6. Contents of the pack and other
information
What Calcitriol contains:
The active ingredient in Calcitriol is
calcitriol.
Each capsule contains 0.25 microgram
calcitriol.
The other ingredients are
butylhydroxyanisole, butylhydroxytoluene,
medium-chain triglycerides, gelatin,
glycerol 85%, noncrystallizing sorbitol,
titanium dioxide (E171), red iron oxide
(E172) and yellow iron oxide (E172).
What Calcitriol looks like and contents of
the pack
Calcitriol is an oblong, opaque soft gelatin
capsule, brown-orange to red-orange in
colour on one side and white to grey-yellow
or grey-orange in colour on the other side.
It contains clear oil inside, almost colourless
to slightly yellow, slightly brown or light
brown-yellow liquid.
It is available in blister packs of 30
capsules.
Manufactured by: Roche s.r.o.,
Dukelskych hrdinu 52, 17000 Praha 7,
Czech Republic.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Calcitriol 0.25 microgram Soft Capsules;
PL 18799/2990
Leaflet date: 05.12.2016

POM

Expand Transcript

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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