Skip to Content

CALCITRIOL 0.25 MICROGRAM CAPSULES

Active substance(s): CALCITRIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
Rocaltrol® 0.25 microgram Capsules

2882
06.06.16[2]

(calcitriol)
PATIENT INFORMATION LEAFLET
Read all of the 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.
This medicine is available using the above name but will be referred to as
Rocaltrol throughout the following leaflet. Other strength of 0.5 microgram is
also available.
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 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 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.
- Do not store above 25°C.
- Store in their original package
- Keep blisters in the outer carton to protect from light and moisture.
- 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
The active substance is calcitriol.
Each soft capsule contains 0.25 microgram calcitriol.
Other ingredients are butylhydroxyanisole (E 320), butylhydroxytoluene
(E 321), medium-chain triglycerides, gelatin, glycerol, Karion 83 (sorbitol (E
420), 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 Capsules are orange on one side and white on the other.
Rocaltrol Capsules are supplied in blister packs containing 20, 30 and 100
Capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Roche Farma S.A., C/Severo Ochoa 13, Leganes E-28914, Spain.
F. Hoffmann - La Roche Ltd., Grenzacherstrasse 124, Basel CH-4070,
Switzerland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2882

Leaflet revision and issue date (Ref) 06.06.16[2]
Rocaltrol is a trademark of Roche Products Limited.

Calcitriol 0.25 microgram Capsules

2882
06.06.16[2]

PATIENT INFORMATION LEAFLET
Read all of the 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.
This medicine is available using the above name but will be referred to as
Calcitriol throughout the following leaflet. Other strength of 0.5 microgram is
also available.
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.

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 CALCITRIOL
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.

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).

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 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).
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 CALCITRIOL
- 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.
- Do not store above 25°C.
- Store in their original package
- Keep blisters in the outer carton to protect from light and moisture.
- 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 contains
The active substance is calcitriol.
Each soft capsule contains 0.25 microgram calcitriol.
Other ingredients are butylhydroxyanisole (E 320), butylhydroxytoluene
(E 321), medium-chain triglycerides, gelatin, glycerol, Karion 83 (sorbitol (E
420), mannitol, hydrogenated hydrolysed starch), titanium dioxide (E171),
red iron oxide (E172) and yellow iron oxide (E172).
What Calcitriol looks like and contents of the pack
Calcitriol Capsules are orange on one side and white on the other.
Calcitriol Capsules are supplied in blister packs containing 20, 30 and 100
Capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Roche Farma S.A., C/Severo Ochoa 13, Leganes E-28914, Spain.
F. Hoffmann - La Roche Ltd., Grenzacherstrasse 124, Basel CH-4070,
Switzerland.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2882

Leaflet revision and issue date (Ref) 06.06.16[2]

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