ONE-ALPHA INJECTION

Active substance: ALFACALCIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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One-Alpha Injection
®

alfacalcidol
Please read all of this leaflet carefully before you start having 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 become serious, or you notice any side effects not listed in this leaflet
please tell your doctor or pharmacist.
• In this leaflet One-Alpha® Injection will be called One-Alpha®.
In this leaflet:
1. What One-Alpha® is and what it is used for
2. Before you have One-Alpha®
3. How to use One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Further information

1. WHAT ONE-ALPHA® IS AND WHAT IT IS
USED FOR
One-Alpha® 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.
One-Alpha® 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.
One-Alpha® 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. BEFORE YOU HAVE ONE-ALPHA®
Do not have One-Alpha®
• If you are allergic (hypersensitive) to alfacalcidol
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 know that you have a condition called
calcification.
This means you have high levels of calcium in
your body tissues.
If you are unsure if any of the above apply to you,
talk to your doctor before having One-Alpha®.
Take special care with One-Alpha®
Before you have One-Alpha® 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.
• If this medicine is for a small, premature baby.
• If you know that you are sensitive to a substance
called propylene glycol. This is one of the
ingredients in your medicine.
You may get too much calcium or phosphate in
your blood when you have 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 having One-Alpha® your doctor will
take regular blood tests. 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 have your medicine.
Your doctor may prescribe another medicine
called a phosphate binding agent to take as well
as One-Alpha®. 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 One-Alpha®.
• Barbiturates: for sleeping disorders. You may
need a larger dose of One-Alpha®.
• Cardiac glycosides, such as digoxin: for heart
problems.
You may get too much calcium in your blood. This
may cause an abnormal heart beat.
• 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.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice
before having One-Alpha®:
• If you are pregnant, or think you are pregnant.
• If you are breast-feeding.
Tell your doctor if you become pregnant while
having 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.
Important information about some of the
ingredients of One-Alpha®
One-Alpha® contains:
• Ethanol. This is an alcohol. This medicine
contains a very small amount of ethanol, less
than 100 milligrams (mg) per 1 microgram
alfacalcidol dose.
• Sodium. This medicine is essentially "sodium
free". Your medicine contains 3 milligrams (mg) of
sodium in each millilitre (ml).
Please ask your doctor if you are worried about
any of the ingredients in this medicine.

3. HOW TO USE ONE-ALPHA®
One-Alpha® will be given to you by a doctor or nurse.
How much One-Alpha® to have
Your doctor or nurse will give you One-Alpha®
because it is an injection.
This injection goes into your vein. This may be
called IV (intravenous) by your doctor or nurse.

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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 have more or less medicine depending on
your test results.
You may get too much calcium or phosphate in
your blood when you have 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 have 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 have half the dose you had
before.
Adults:
The usual starting dose is 1 microgram each day.
People usually have between 1 and 3 micrograms
each day.
Most people have 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, the doctor may prescribe between 3 and 5
micrograms each day. Your doctor may prescribe
another medicine called a calcium supplement to
take as well as One-Alpha®. This will help to keep
the right amount of calcium in your blood.
Elderly:
The usual starting dose is 0.5 microgram each day.
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.

Important side effects to look out for:
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 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.

5. HOW TO STORE ONE-ALPHA®
• Keep out of the reach and the sight of children.
• Do not use the injection after the expiry date on
the ampoule. The expiry date is the last day of
that month.
• Store at 2 - 8°C (in a refrigerator).
• Keep the ampoule in the outer carton in order to
protect it from light.
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. FURTHER INFORMATION
What One-Alpha® contains
• The active ingredient is alfacalcidol.
One-Alpha® contains 2 micrograms of
alfacalcidol in each millilitre (ml).
• The other ingredients are citric acid, ethanol,
propylene glycol, sodium citrate and water for
injections. You can find important information
about some of the ingredients in your medicine
near the end of section 2 of this leaflet.

• Children weighing less than 20 kilograms:
The usual starting dose is 0.05 microgram per
kilogram bodyweight each day.

What One-Alpha® looks like and contents of the pack
One-Alpha® is a clear colourless solution for injection.

• Children weighing more than 20 kilograms:
The usual starting dose is 1 microgram each day.

One-Alpha® comes in one-point-cut amber glass
ampoules containing 0.5 or 1 ml.

If you have more One-Alpha® than you should
Your doctor or nurse will give you this medicine. If
you think you may have been given too much, tell
your doctor or nurse straight away. You may need
to stop having this medicine.

There are 10 ampoules in a carton.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: LEO Laboratories
Limited, Hurley, Berkshire SL6 6RJ, UK
Manufacturer:
CENEXI SAS, 52 rue Marcel et Jacques Gaucher,
94120 Fontenay-sous-Bois, France
This leaflet was last revised in October 2013

If you forget to have One-Alpha®
Your doctor or nurse will give you this medicine. If
you think that you have missed a dose then tell your
doctor or nurse.
If you have any further questions about having this
medicine, please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, One-Alpha® can cause side
effects, although not everybody gets them.

® Registered Trade Mark

LEO
027467-01

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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
having the dose that is right for you. When you are
getting the correct dose you will not need blood
tests so often.

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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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