CALCITRIOL 0.25MCG CAPSULES

Active substance: CALCITRIOL

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CALCITRIOL
0.25 microgram AND
0.5 microgram CAPSULES
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

• barbiturates e.g. amobarbital, phenobarbital,
used to treat epilepsy
• anticonvulsants e.g. phenytoin, clonazepam,
used to treat epilepsy
• steroid medicines, e.g. hydrocortisone,
prednisolone and dexamethasone
• colestyramine or other ‘ion-exchange resins’,
used to treat high levels of cholesterol.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Taking Calcitriol with food and drink
• DO NOT consume any foods or drinks that are
‘fortified’ with vitamin D (e.g. margarines,
breakfast cereals, multivitamin drinks, fortified
milk or yogurt drinks) whilst you are taking
Calcitriol. If you need further information,
discuss this matter with your doctor
IN THIS LEAFLET:
• DO NOT take any vitamin or food
1. What Calcitriol is and what it is used for
supplements that contain vitamin D while
2. Before you take Calcitriol
you are taking Calcitriol
3. How to take Calcitriol
• Ask your doctor for advice concerning
4. Possible side effects
consumption of foods that are high in vitamin D
5. How to store Calcitriol
(e.g. oily fish, eggs) or high in calcium (dairy
6. Further information
products, etc.) It is very important to keep to
any diet that your doctor has given you
WHAT CALCITRIOL IS AND WHAT IT IS • Drink plenty of fluids (such as water) as it is
USED FOR
important not to become dehydrated. This
does not apply if you have kidney problems.
Calcitriol is a vitamin D product.
Important information about some of the
Calcitriol Capsules are used to treat a form of
ingredients of Calcitriol
bone disease called renal osteodystrophy,
• Calcitriol Capsules contain a small amount of
which is found in patients with chronic kidney
sorbitol. If your doctor has told you that you
failure, by correcting abnormal calcium and
have an intolerance to some sugars, contact
phosphate breakdown.
your doctor before taking this medicine.
The lower strength of Calcitriol Capsules
Pregnancy and breast-feeding
(0.25 microgram) are also used to treat post
• If you are pregnant, planning to become
menopausal osteoporosis, which is the
pregnant or are breast-feeding, ask your
weakening of bones in women following the
doctor for advice before taking this medicine.
“change of life”
.
Driving and using machines
• Calcitriol is not known to affect your ability to
BEFORE YOU TAKE CALCITRIOL
drive or operate machinery.
Do NOT take Calcitriol if you:
• are allergic (hypersensitive) to calcitriol or
HOW TO TAKE CALCITRIOL
any of the other ingredients of this medicine
Always take Calcitriol exactly as your doctor has
• are allergic to any vitamin D products e.g.
told you. You should check with your doctor or
alfacalcidol, colecalciferol
• suffer from high levels of calcium or minerals pharmacist if you are not sure.
in the blood or tissues
At the beginning of your treatment calcium levels
• have a rare hereditary problem of fructose
in your blood should be measured regularly. The
intolerance.
dosage of Calcitriol can then be adjusted to
achieve the correct response. When the correct
Taking other medicines
• DO NOT take any other medicines containing dosage has been found your calcium levels may
vitamin D (e.g. vitamin D supplements) whilst continue to be measured but less often.
Also, if your doctor thinks it is necessary he/she
you are taking Calcitriol
may prescribe extra calcium supplements to be
• Ask your doctor for advice concerning
taken during your treatment.
calcium-containing medicines (e.g. calcium
supplements, etc.)
The capsules should be swallowed preferably
with a drink of water. The usual dose is:
Talk to your doctor if you are taking any of the
Adults (including the elderly)
following medicines:
• Renal osteodystrophy:
• diuretics e.g. bendroflumethiazide,
Initially one 0.25 microgram capsule per day.
chlortalidone, indapamide, used to treat high
If necessary, your doctor may increase your
blood pressure
dosage by 0.25 micrograms at 2 - 4 week
• digoxin or digitoxin, used to treat heart disease
intervals to find the correct dose for you.
• medicines containing magnesium e.g.
antacids, used to treat indigestion
• Post menopausal osteoporosis:
• phosphate binding agents e.g. aluminium
One 0.25 microgram capsule twice a day.
hydroxide, calcium carbonate, used to treat
high levels of phosphate in the blood

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Children
Calcitriol is not recommended for use in children.
If you take more Calcitriol than you should
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child has
swallowed any of the capsules, contact your
nearest hospital casualty department or your
doctor immediately.
An overdose is likely to cause high levels of
calcium in the blood and urine. This causes
constipation, feeling sick, being sick, lack of
appetite, weakness, headache, sleepiness, and
numbed emotions.
Please take this leaflet, any remaining capsules,
and the container with you to the hospital or
doctor so that they know which capsules were
consumed.
If you forget to take Calcitriol
If you forget to take a capsule, take one as soon
as you remember, unless it is nearly time to
take the next one. Never take two doses
together to make up for a forgotten dose. Take
the remaining doses at the correct time.
If you stop taking Calcitriol
You should continue to take these capsules for
as long as your doctor tells you to.
DO NOT stop taking your medicine without
talking to your doctor first even if you feel better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Calcitriol can cause side
effects, although not everybody gets them.
Calcitriol is taken by many patients without any
problems.
Stop taking the capsules and tell your doctor
immediately or go to the casualty department
at your nearest hospital if the following
happens:
• an allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
Tell your doctor immediately if you experience
any of the following effects:
• fever, dehydration, thirst, excessive urination
and/or an increased need to pass water
during the night, an irregular heartbeat,
stomach pain or a swollen stomach,
constipation, feeling sick, being sick, loss of
appetite, weakness, headache, sleepiness, or
numbed emotions. There may be infections
in the bladder and normal growth may stop.
These effects are rare, and may be symptoms of
hypercalcaemia (high levels of calcium in the
blood).
The following side effects have been reported
rarely:
• calcium may become deposited in parts of
the body other than the bone (for example, in
your kidneys as ‘kidney stones’)
• psychotic symptoms (you lose touch with
what is real and what is not, have confused
disturbed thought, or see, hear or feel things
that aren’t there).

The following side effect has been reported
very rarely
• an increased level of some of the liver
enzymes may be found in the results of tests
to check your liver function, but this effect is
mild and reversible.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE CALCITRIOL

Keep out of the reach and sight 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 Calcitriol after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
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.

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FURTHER INFORMATION

What Calcitriol Capsules contain:
• The active ingredient 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 refined shellac (E904)
and black iron oxide (E172).
What Calcitriol Capsules look 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.
This leaflet was last revised: June 2011
PL 00289/0941-0942

85810-V
322K055900611

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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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