Skip to Content

ROCALTROL 0.25 MICROGRAM CAPSULES

Active substance(s): CALCITRIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
10152079

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

11 pt

Drawing Norm

NP9344

make-up code

GB

Good To Print

Version

Date

1

16.12.13

11.08.10

Signature

Genisys-No.

Date

1517

97.4.3524

Checked and
approved

KAU-Nr.

Signature

MMBFMM8W
MMBFMM8Z

Reichert

Package leaflet: Information for the patient

Rocaltrol® 0.25 microgram Capsules
Rocaltrol® 0.5 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.

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

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.

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).

Bone disease after the menopause
(post-menopausal osteoporosis)

Other medicines and Rocaltrol

● 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.

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).

● 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 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
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.

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.

10152079 GB 1312.1075

10152079_NP9344.indd 1

16.12.2013 17:08:06

10152079

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

11 pt

Drawing Norm

NP9344

make-up code

GB

Good To Print

Version

Date

1

16.12.13

11.08.10

Signature

Genisys-No.

Date

1517

97.4.3524

Signature

MMBFMM8W
MMBFMM8Z

Reichert

Checked and
approved

KAU-Nr.

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 or pharmacist. 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 Rocaltrol
● Keep this medicine out of the sight and
reach of children.
● Do not use this medicine after the
expiry date which is stated on the
carton, after EXP. The expiry date
refers to the last day of that month.
● Rocaltrol capsules should be kept in
their original blisters
and outer carton
(to protect them from
light and moisture).
● Do not store above
25°C.
● 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 Rocaltrol contains

Rocaltrol Capsules come in two different
strengths.
The active substance in ‘Rocaltrol
0.25 microgram Capsules’ is calcitriol.
Each capsule contains 0.25 microgram
(a quarter of a microgram) of calcitriol.
The active substance in ‘Rocaltrol
0.5 microgram Capsules’ is calcitriol.
Each capsule contains 0.5 microgram
(half a microgram) of calcitriol.
Other ingredients in both strength capsules
are butylhydroxyanisole,
butylhydroxytoluene, medium-chain
triglycerides, gelatin, glycerol, sorbitol,
mannitol, hydrogenated hydrolysed starch,
titanium dioxide (E171), red iron oxide
(E172) and yellow iron oxide (E172).

What Rocaltrol looks like and
contents of the pack

Rocaltrol 0.25 microgram Capsules are
brown-orange to red-orange in colour at
one end and white to grey-yellow or
grey-orange in colour at the other.
Rocaltrol 0.5 microgram Capsules are
brown-orange to red-orange in colour at
both ends.
Rocaltrol capsules are supplied in blister
packs containing 100 capsules.

Marketing Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

This leaflet was last revised in
November 2013

10152079 GB 1312.1075

10152079_NP9344.indd 2

16.12.2013 17:08:07

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