ONE-ALPHA CAPSULES 0.25 MICROGRAM

Active substance: ALFACALCIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

One-Alpha Capsules 0.25 microgram
One-Alpha Capsules 0.5 microgram
One-Alpha Capsules 1 microgram
®

®

®

alfacalcidol

In this leaflet:
1. What One-Alpha® is and what it is used for
2. Before you take One-Alpha®
3. How to take One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Further information

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.

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 TAKE ONE-ALPHA®
Do not take 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 taking One-Alpha®.
Take special care with One-Alpha®
Before you take 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.
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.

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.
• Colestyramine: for lowering your cholesterol level, or to
help stop some types of diarrhoea or itching. Your
One-Alpha® 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.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before taking
One-Alpha®:
• 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.
Important information about some of the ingredients of
One-Alpha®
One-Alpha® contains:
• Sesame oil. Sesame oil is used to make your capsules.
It may rarely give you severe allergic reactions. Please
read section 4 of this leaflet so you can spot any signs
this may be happening to you.
Please ask your doctor if you are worried about any of the
ingredients in this medicine.

3. HOW TO TAKE ONE-ALPHA®
Always use One-Alpha® exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
How to take the capsule out of the blister
Press on the shiny side of the blister. The capsule will come out
through the printed side of the foil. Please see the diagram.
shiny side

printed foil

While you are taking 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 take your medicine.

How much One-Alpha® to take
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

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Please 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or
pharmacist.
• In this leaflet One-Alpha® capsules will be called One-Alpha®.

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. This is either
1 brown capsule, 2 red capsules or 4 white capsules. 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. This
is usually one white capsule, or one red capsule or one brown
capsule.
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 One-Alpha®. 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. This is
either 1 red capsule or 2 white capsules.
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 One-Alpha® 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 One-Alpha®
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.

• 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 capsules after the expiry date on the carton.
The expiry date is the last day of that month.
• Do not store above 25°C.
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® Capsules 0.25 microgram contain
0.25 microgram of alfacalcidol in each capsule.
One-Alpha® Capsules 0.5 microgram contain
0.5 microgram of alfacalcidol in each capsule.
One-Alpha® Capsules 1 microgram contain 1 microgram
of alfacalcidol in each capsule.
• The other ingredients are sesame oil, all-rac-α-tocopherol,
gelatin, glycerol, and potassium sorbate.
The 0.25 microgram capsules also contain titanium
dioxide (E171).
The 0.5 microgram capsules also contain titanium
dioxide (E171) and red iron oxide (E172).
The 1 microgram capsules also contain black iron oxide
(E172) and red iron oxide (E172).
You can find important information about some of the
ingredients in your medicine near the end of section 2 of
this leaflet.
What One-Alpha® looks like and contents of the pack
One-Alpha® Capsules 0.25 microgram are white capsules.
One-Alpha® Capsules 0.5 microgram are red capsules.
One-Alpha® Capsules 1 microgram are brown capsules.
One-Alpha® comes in blister packs of 30 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
LEO Pharma A/S, DK 2750, Ballerup, Denmark.
This leaflet was last revised in October 2013.
®Registered Trade Mark

4. POSSIBLE SIDE EFFECTS
Like all medicines, One-Alpha® 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:

LEO

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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.

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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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