Medication Guide App

ONE-ALPHA 0.25 MICROGRAM CAPSULES

Active substance: ALFACALCIDOL

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6. FURTHER INFORMATION

PATIENT INFORMATION LEAFLET
®

WHAT ONE-ALPHA® CONTAINS
Each capsule contains 0.25 microgram of
alfacalcidol as the active ingredient.
Your medicine also contains the following Inactive
ingredients: sesame oil, all-rac-α-tocopherol,
gelatin, glycerol, potassium sorbate, titanium
dioxide E171
What One-Alpha® looks like and the contents
of the pack
They are a small white soft gelatin capsules.
Available in blister strips containing 10 capsules.
Comes in pack sizes of 30 and 100 capsules.
IMPORTANT
This medicine is for you. Only a doctor can
prescribe it. This leaflet does not contain
everything about this medicine, if you have any
questions or are not sure about anything then
contact your doctor or pharmacist. He/she will
have additional information about this medicine
and will be able to advise you.
MANUFACTURER AND LICENCE HOLDER
The capsules are manufactured by Leo
Pharmaceutical Products Limited A/S,
Industriparken 55, Ballerup, DK-2750, Denmark
and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Leaflet revision date: 14/06/12

POM

PL Number: 15184/1126
One-Alpha® 0.25 microgram Capsules

One-Alpha® is a registered trademark of LEO
Pharma A/S

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

One-Alpha 0.25 microgram Capsules

Ref: 1126/140612/1/F

®

(alfacalcidol)
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 medicine is called One-Alpha 0.25
microgram Capsules but will be referred to as
'One-Alpha’ throughout this Patient Information
Leaflet.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What One-Alpha® is and what it is used for
Before you take One-Alpha®
How to take One-Alpha®
Possible side effects
How to store One-Alpha®
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 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.
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.
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.
• 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

Children:
The dose depends on the weight of the child
(called bodyweight).

• You feel weak or have pain in your muscles
or bones
• You feel sick or have constipation.

• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.

Other possible side effects:
Skin problems
• Itching skin
• Rash
• Hives (urticaria)

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 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.

If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.

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.

If you take more One-Alpha® than you should
Tell your doctor straight away. You may need to
stop taking this medicine.

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.

If you have any further questions about taking this
medicine, please ask your doctor or pharmacist.

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.

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.

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.

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:
• You need to pass water (urine) more often
• You feel thirsty
• You have a dry mouth, or a metallic taste in
your mouth.

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 THIS MEDICINE OUT OF REACH
AND SIGHT OF CHILDREN.

* Do not store above 25°C
Do not use this medicine after the expiry date
shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine,
return any unused capsules to your pharmacist
(chemist) for safe disposal. Only keep this
medicine if your doctor tells you to. If your
capsules become discoloured or show any other
signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
Medicines should not be thrown away in the 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.

Ref: 1126/140612/1/B

6. FURTHER INFORMATION
WHAT ALFACALCIDOL® CONTAINS
Each capsule contains 0.25 microgram of
alfacalcidol as the active ingredient.
Your medicine also contains the following Inactive
ingredients: sesame oil, all-rac-α-tocopherol,
gelatin, glycerol, potassium sorbate, titanium
dioxide E171.
What Alfacalcidol® looks like and the contents
of the pack
They are a small white soft gelatin capsules.
Available in blister strips containing 10 capsules.
Comes in pack sizes of 30 and 100 capsules.
IMPORTANT
This medicine is for you. Only a doctor can
prescribe it. This leaflet does not contain
everything about this medicine, if you have any
questions or are not sure about anything then
contact your doctor or pharmacist. He/she will
have additional information about this medicine
and will be able to advise you.
MANUFACTURER AND LICENCE HOLDER
The capsules are manufactured by Leo
Pharmaceutical Products Limited A/S,
Industriparken 55, Ballerup, DK-2750, Denmark
and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Leaflet revision date: 14/06/12

POM

PL Number: 15184/1126
Alfacalcidol® 0.25 microgram Capsules

Alfacalcidol® is a registered trademark of LEO
Pharma A/S

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
®

Ref: 1126/140612/1/F

®

Alfacalcidol 0.25 microgram Capsules
(alfacalcidol)
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 Alfacalcidol® capsules will be called
Alfacalcidol®.
Your medicine is called Alfacalcidol® 0.25
microgram Capsules but will be referred to as '
alfacalcidol’ throughout this Patient Information
Leaflet.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What Alfacalcidol® is and what it is used for
Before you take Alfacalcidol®
How to take Alfacalcidol®
Possible side effects
How to store Alfacalcidol®
Further 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. BEFORE YOU TAKE ALFACALCIDOL®
Do not take Alfacalcidol®
• 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 Alfacalcidol®.
Take special care with Alfacalcidol®
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 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.
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.
Important information about some of the
ingredients of Alfacalcidol®
Alfacalcidol® 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 ALFACALCIDOL®
Always use Alfacalcidol® 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

Children:
The dose depends on the weight of the child
(called bodyweight).

• You feel weak or have pain in your muscles
or bones
• You feel sick or have constipation.

• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.

Other possible side effects:
Skin problems
• Itching skin
• Rash
• Hives (urticaria)

How much Alfacalcidol® 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 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.

If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.

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.

If you take more Alfacalcidol® than you should
Tell your doctor straight away. You may need to
stop taking this medicine.

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.

If you have any further questions about taking this
medicine, please ask your doctor or pharmacist.

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 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. This is either 1 red capsule or 2 white
capsules.

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.

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.

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.

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 ALFACALCIDOL®

* KEEP THIS MEDICINE OUT OF REACH
AND SIGHT OF CHILDREN.

* Do not store above 25°C
Do not use this medicine after the expiry date
shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine,
return any unused capsules to your pharmacist
(chemist) for safe disposal. Only keep this
medicine if your doctor tells you to. If your
capsules become discoloured or show any other
signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
Medicines should not be thrown away in the 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.

Ref: 1126/140612/1/B

Expand view ⇕

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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