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ALFACALCIDOL 0.5 MICROGRAM CAPSULES

Active substance(s): ALFACALCIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Alfacalcidol 0.25 microgram Capsules, soft
Alfacalcidol 0.5 microgram Capsules, soft
Alfacalcidol 1.0 microgram Capsules, soft
Alfacalcidol
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. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours.
− If any of the side effects gets serious,
or you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

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

1. What Alfacalcidol is and what it is
used for
Alfacalcidol belongs to a group of
medicines called vitamin D analogues.
It is a type of vitamin D. Vitamin D
controls the levels of two substances in
your body. These substances are called
calcium and phosphate. Your body needs
both of these substances for healthy bones
and teeth.
Alfacalcidol works by increasing the
amount of vitamin D in your body. This
means the levels of calcium and phosphate
in your body will increase too. Alfacalcidol
is used to treat diseases where the amount
of calcium in your body needs changing.
It is used to treat:
• Changes in bone caused by kidney
failure (osteodystrophy).
• Changes to your parathyroid glands.
These are small glands found in your
neck. They make a substance called the
parathyroid hormone. This changes the
amount of calcium in your body.
• The glands may make the amount
of calcium in your blood too high.
(hyperparathyroidism).
• The glands may make the amount of
calcium in your blood too low
(hypoparathyroidism).
• Low levels of calcium in the blood of
newborn babies (hypocalcaemia).
• Softening and deformity of the bones
due to lack of calcium (rickets or
osteomalacia).

2. What you need to know before you
take Alfacalcidol
Do not take Alfacalcidol:
• If you are allergic (hypersensitive) to
Alfacalcidol, Arachis oil (peanut oil)
or any of the other ingredients. You can
find a list of these ingredients in section
6 of this leaflet.
• If you know you have a condition called
hypercalcaemia. This means you have
high levels of calcium in your blood.
If you are unsure if any of the above apply
to you, talk to your doctor before taking
Alfacalcidol.

Warnings and precautions
Before you take Alfacalcidol tell your
doctor:
• If you are taking another type of
medicine called a cardiac glycoside,
such as digoxin. These medicines are
used to treat problems with your heart.
• If you have any problems with your
kidneys. This includes if you have
kidney stones.
You may get too much calcium or phosphate
in your blood when you take this medicine.
Please read section 4 of this leaflet so you
can spot any signs this may be happening to
you. Your doctor may need to change your
dose.
While you are taking Alfacalcidol your
doctor will take regular blood tests.

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This is very important in children, patients
with kidney problems, or patients on a high
dose of medicine. This is to check the level
of calcium and phosphate in your blood
while you take your medicine.
Your doctor may prescribe another
medicine called a phosphate binding agent
to take as well as Alfacalcidol. This will
help to keep the right amount of phosphate
in your blood.

Taking other medicines
Please tell your doctor or pharmacist if
you are taking, or have recently taken
any other medicines. This includes any
medicines which you have bought without
a prescription.
You must tell your doctor or pharmacist
if you are taking any of the following
medicines:
• Anticonvulsants: for epilepsy or fits. You
may need a larger dose of Alfacalcidol.
• Barbiturates: for sleeping disorders. You
may need a larger dose of Alfacalcidol.
• Cardiac glycosides, such as digoxin: for
heart problems. You may get too much
calcium in your blood. This may cause
an abnormal heart beat.
• Colestyramine: for lowering your
cholesterol level, or to help stop some
types of diarrhoea or itching. Your
Alfacalcidol may not enter your blood
as usual.
• Thiazide diuretics, often called “water
pills”: for increasing the amount of
water (urine) that your body makes.
You may get too much calcium in your
blood.
• Magnesium based antacids and
laxatives: You may get too much
magnesium in your blood.
• Vitamin D or its analogous and calcium
or calcium containing preparations: for
calcium deficiency. You may get too
much calcium in your blood.

Pregnancy and breast-feeding
Please ask your doctor or pharmacist for
advice before taking Alfacalcidol:
• If you are pregnant, or think you are
pregnant
• If you are breast-feeding.
Tell your doctor if you become pregnant
while taking this medicine.

Driving and using machines
Usually your medicine may have very
little effect on your ability to drive or use
machines. Check with your doctor if you
feel any side effect that may stop you from
driving or using machines.

Alfacalcidol contains arachis oil
(peanut oil) and Glycerol:
Glycerol has proven harmful in high
doses and may cause headache, stomach
upset and diarrhoea. Alfacalcidol capsules
contain arachis oil (peanut oil). It you
are allergic to peanut or soya, do not use
Alfacalcidol.

3. How to take Alfacalcidol
Always use Alfacalcidol exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
Your doctor will tell you how many
capsules to take, or to give your child.
At first you will have weekly blood tests to
check the levels of some substances in your
blood. These tests are to check the levels
of calcium, an enzyme called alkaline
phosphatase or the parathyroid hormone.
This is so your doctor knows that you are
taking the dose that is right for you. When
you are getting the correct dose you will
not need blood tests so often.
You may also have other tests such as
X-rays. This is also so your doctor knows
that the dose is right for you.
Your doctor may adjust your dose.
Your doctor may ask you to take more
or less capsules depending on your test
results. You may get too much calcium or
phosphate in your blood when you take
this medicine. Please read section 4 of this
leaflet so you can spot any signs this may
be happening to you. Your doctor will tell
you not to take any more medicine.

Front Side

Adults
The usual starting dose is 1 microgram
each day. People usually take between
1 and 3 micrograms each day. Most people
take between 0.25 and 1 microgram each
day once the blood test results show the
medicine is working.
If you have very low levels of calcium
in your blood, your doctor may prescribe
between 3 and 5 microgram each day.
Your doctor may prescribe another
medicine called a calcium supplement to
take as well as Alfacalcidol. This will help
to keep the right amount of calcium level in
your blood.
Elderly: The usual starting dose is 0.5
microgram each day.

Use in children
The dose depends on the weight of the
child (called bodyweight).
• Newborn and premature babies:
The usual starting dose is 0.05 to
0.1 microgram per kilogram of bodyweight
each day.
If the level of calcium in their blood is very
low, up to 2 micrograms per kilogram of
bodyweight may be needed each day.
A dose of 0.1 microgram per kilogram
bodyweight each day is used to stop low
blood calcium levels in premature babies.
• Children weighing less than 20
kilograms:
The usual starting dose is 0.05 microgram
per kilogram bodyweight each day.
• Children weighing more than 20
kilograms
The usual starting dose is 1 microgram
each day.

If you take more Alfacalcidol than
you should
Tell your doctor straight away. You may
need to stop taking this medicine.
You may get too much calcium or
phosphate in your blood. Please read
section 4 of this leaflet so you can spot any
signs this may be happening to you.

If you forget to take Alfacalcidol
If you forget to take your medicine, take
it as soon as you remember. Then take the
next dose at the usual time.
If you have any further questions about
taking this medicine, please ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, Alfacalcidol can cause
side effects, although not everybody gets
them.
Important side effects to look out for:
You must get urgent medical help if you
have any of the following symptoms.
You may be having an allergic reaction:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash.
You should tell your doctor straight away
if you spot any of the following signs
which may be due to too much calcium or
phosphate in your blood:
• You need to pass water (urine) more
often
• You feel thirsty
• You have a dry mouth, or a metallic
taste in your mouth. You feel weak or
have pain in your muscles or bones
• You feel sick or have constipation.
Other possible side effects:
Skin problems:
• Itching skin
• Rash
• Hives (urticaria).
Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
These are signs that there may be problems
developing with your kidneys. Kidney
stones may be forming. Kidney stones
may cause a sharp spasm in one side of
your lower back.
The possible side effects described in this
section of the leaflet probably affect about
1 in 10,000 people.

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Skin problems or too much calcium in your
blood are the side effects most people get.
If any of the side effects become serious,
or you notice any side effects not listed
in this leaflet, tell your doctor or
pharmacist.

Reporting 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 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 Alfacalcidol

• Keep this medicine out of the sight and
reach of children.
• Do not use the capsules after the expiry
date on the carton. The expiry date is the
last day of that month.
• This medicinal product does not require
any special storage conditions.
Medicines should not be thrown away in
waste water or in household waste. Please
ask your pharmacist how to throw away
any medicine you do not need anymore.
If you do this you will help protect the
environment.

6. Contents of the pack and other
information
What Alfacalcidol contains

• The active ingredient is alfacalcidol.
Alfacalcidol 0.25 microgram Capsules,
Soft contain 0.25 microgram of alfacalcidol
in each capsule.
Alfacalcidol 0.5 microgram Capsules, Soft
contain 0.5 microgram of alfacalcidol in
each capsule.
Alfacalcidol 1.0 microgram Capsules, Soft
contain 1 microgram of alfacalcidol in
each capsule.
Alfacalcidol, also contains hydrogenated
arachis oil. Please refer to section 2 for
more information.
The other ingredients are
• Citric acid, anhydrous
• All-rac-α-Tocopherol
• Propyl gallate
• Ethanol anhydrous.
The capsule shell contains
• Gelatin,
• Glycerol,
• Anidrisorb
• Purified water
• Medium Chain Triglyceride.
The capsules contain the following colours:
0.25 microgram capsules: titanium dioxide
(E171), ferric oxide red (E172) and ferric
oxide black (E172).
0.5 microgram capsules: titanium dioxide
(E171) and ferric oxide red (E172).
1.0 microgram capsules: titanium dioxide
(E171) and ferric oxide yellow (E172).

What Alfacalcidol looks like and
contents of the pack
Alfacalcidol 0.25 mcg Capsule soft:
Reddish brown colored, oval shaped soft
gelatin capsules containing clear oily
liquid.
Alfacalcidol 0.5 mcg Capsule soft: Light
pink colored, oval shaped soft gelatin
capsules containing clear oily liquid.
Alfacalcidol 1.0 mcg Capsule soft: Pale
yellow colored, oval shaped soft gelatin
capsules containing clear oily liquid.
Alfacalcidol comes in white opaque HDPE
container, with white opaque HDPE screw
closure and induction sealing in a pack of
30 capsules, 50 capsules and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS
United Kingdom

Manufacturer and Distributor
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom
This leaflet was last revised in
09/2015

Back Side

10xxxxx

You will need to have some blood tests.
When the blood tests are normal you can
start your medicine again.
It is important that you only take half the
dose you had before.

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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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