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ALFACALCIDOL 0.25 MICROGRAM CAPSULES SOFT

Active substance(s): ALFACALCIDOL / ALFACALCIDOL / ALFACALCIDOL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Alfacalcidol 0.25microgram Capsules, soft
Alfacalcidol 0.5microgram Capsules, soft
Alfacalcidol 1.0microgram 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:

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• 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. This is very important in children,
patients with kidney problems, or patients on a high dose

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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 diarrhea 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 deficeny. 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 diarrhea. 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. 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.
Adults
The usual starting dose is 1 microgram each day. People

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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.

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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. Skin

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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 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) & 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: Reddish brown colored,
oval shaped soft gelatin capsules containing clear oily
liquid.
Alfacalcidol 0.5 mcg Capsule: Light pink colored, oval
shaped soft gelatin capsules containing clear oily liquid.
Alfacalcidol 1.0 mcg Capsule: 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire
WD 189 SS UNITED KINGDOM
Manufacturer
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire WD 189 SS
United Kingdom
This leaflet was last approved in
This leaflet was last approved in 07/2014

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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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