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ALFACLCIDOL 2 MICROGRAMS/ML ORAL DROPS

Active substance(s): ALFACALCIDOL

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Package Leaflet: Information for the User

One-Alpha® Drops
(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.
• The name of this medicine is One-Alpha® Drops but will be referred to
as One-Alpha throughout the remainder of this leaflet.
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
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.
o The glands may make the amount of calcium in your blood too high
(hyperparathyroidism).
o 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 know that you have any sugar intolerance. You may have
inherited this condition from someone else in your family.
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 OneAlpha:
• 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:
• Ethanol. This is an alcohol. This medicine contains a very small
amount of ethanol.
• Methylparahydroxybenzoate. This is a preservative. It may give you an
allergic reaction. This may happen at any time after you take your
medicine. Please read section 4 of this leaflet so you can spot any
signs this may be happening to you.
• Polyoxyl 40 hydrogenated castor oil. This is used to make your
medicine. It may give you an upset stomach or diarrhoea.
• Sorbitol. This is a type of sugar. If you cannot tolerate any sugar
(sometimes called sugar intolerance) contact your doctor before you
take this medicine. Your medicine contains 22.6 milligrams of sorbitol
in one drop.
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 measure a drop
Do not shake the bottle. Unscrew the bottle cap. You will see a dropper
in the top of the bottle. It is ready to use. Hold the bottle upside down. A
drop will form at the end of the dropper. Let the drop fall directly into your
mouth. You can catch the drop on a spoon if this is easier.
If the drops do not come out of the bottle straight away, tap the bottle
gently until a drop forms.
How much One-Alpha to take
Your doctor will tell you how many drops to take, or to give your child.
One-Alpha is only to be taken by mouth.
Be careful not to take more drops than you should. You must check with
your doctor or pharmacist if you are not sure how to take this medicine
correctly. This medicine is very strong (concentrated).

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.

• 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).

Your doctor may adjust your dose. Your doctor may ask you to take more
or less drops 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.

Kidney problems:
• Needing to pass water (urine) less often.
• Swelling of any parts of your body.
• Fever with a pain in your side.

Adults:
The usual starting dose is 10 drops each day. People usually take
between 10 and 30 drops each day.

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.

Most people take between 3 and 10 drops each day once the blood test
results show the medicine is working.

Reporting of 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 the 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.

If you have very low levels of calcium in your blood, the doctor may
prescribe between 30 to 50 drops each day. Your doctor may prescribe
another medicine called a calcium supplement to take as well as OneAlpha. This will help to keep the right amount of calcium in your blood.
Elderly:
The usual starting dose is 5 drops each day.
Children:
The dose depends on the weight of the child (called bodyweight).
• Newborn and premature babies:
The usual starting dose is 1 to 2 drops per 2 kilograms of bodyweight
each day.
If the level of calcium in their blood is very low, up to 40 drops per
2 kilograms of bodyweight may be needed each day.
A dose of 2 drops per 2 kilograms 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 1 drop per 2 kilograms bodyweight each
day.
• Children weighing more than 20 kilograms:
The usual starting dose is 10 drops 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.
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

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.

5) HOW TO STORE ONE-ALPHA
• Keep out of the sight and the reach of children.
• Do not use the drops after the expiry date on the carton. The expiry
date is the last day of that month.
• Store in a refrigerator (2-8oC).
• Discard the drops 28 days after first opening. Write the date you first
opened the bottle in the space provided on the carton.
• Store in the original package to protect from light.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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.
Each millilitre (ml) contains 2 micrograms of alfacalcidol.
Each drop contains 0.1 microgram (100 nanograms) of alfacalcidol.
Also contains ethanol, polyoxyl 40 hydrogenated castor oil,
Methylparahydroxybenzoate E218, citric acid monohydrate, sodium
citrate, sorbitol, d,l-α-tocopherol and purified water.
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 is a solution of oral drops. One-Alpha is a clear colourless to
slightly hazy solution. One-Alpha comes in an amber glass bottle
containing 10 ml. The bottle has a plastic screw cap incorporating a
security seal and plastic dropping device.
Manufactured by
LEO Pharma A/S, Industriparken 55, 2750 – Ballerup, Denmark.
Procured from within the EU by PL Holder: MPT Pharma Ltd,
Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge,
Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0662

POM
th

Leaflet dated 17 June 2016
Leaflet coded xxxxxxxx
One-Alpha® is a registered trademark of LEO Pharma A/S

Package Leaflet: Information for the User

Alfacalcidol 2 micrograms/ml Oral Drops
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.
• The name of this medicine is Alfacalcidol 2 micrograms/ml Oral Drops
but will be referred to as Alfacalcidol throughout the remainder of this
leaflet.
In this leaflet:
1) What Alfacalcidol is and what it is used for
2) Before you take Alfacalcidol
3) How to take Alfacalcidol
4) Possible side effects
5) How to store Alfacalcidol
6) 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.
o The glands may make the amount of calcium in your blood too high
(hyperparathyroidism).
o 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 know that you have any sugar intolerance. You may have
inherited this condition from someone else in your family.
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:
• Ethanol. This is an alcohol. This medicine contains a very small
amount of ethanol.
• Methylparahydroxybenzoate. This is a preservative. It may give you an
allergic reaction. This may happen at any time after you take your
medicine. Please read section 4 of this leaflet so you can spot any
signs this may be happening to you.
• Polyoxyl 40 hydrogenated castor oil. This is used to make your
medicine. It may give you an upset stomach or diarrhoea.
• Sorbitol. This is a type of sugar. If you cannot tolerate any sugar
(sometimes called sugar intolerance) contact your doctor before you
take this medicine. Your medicine contains 22.6 milligrams of sorbitol
in one drop.
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 measure a drop
Do not shake the bottle. Unscrew the bottle cap. You will see a dropper
in the top of the bottle. It is ready to use. Hold the bottle upside down. A
drop will form at the end of the dropper. Let the drop fall directly into your
mouth. You can catch the drop on a spoon if this is easier.
If the drops do not come out of the bottle straight away, tap the bottle
gently until a drop forms.
How much Alfacalcidol to take
Your doctor will tell you how many drops to take, or to give your child.
Alfacalcidol is only to be taken by mouth.
Be careful not to take more drops than you should. You must check with
your doctor or pharmacist if you are not sure how to take this medicine
correctly. This medicine is very strong (concentrated).

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.

• 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).

Your doctor may adjust your dose. Your doctor may ask you to take more
or less drops 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.

Kidney problems:
• Needing to pass water (urine) less often.
• Swelling of any parts of your body.
• Fever with a pain in your side.

Adults:
The usual starting dose is 10 drops each day. People usually take
between 10 and 30 drops each day.

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.

Most people take between 3 and 10 drops each day once the blood test
results show the medicine is working.

Reporting of 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 the 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.

If you have very low levels of calcium in your blood, the doctor may
prescribe between 30 to 50 drops 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 in your
blood.
Elderly:
The usual starting dose is 5 drops each day.
Children:
The dose depends on the weight of the child (called bodyweight).
• Newborn and premature babies:
The usual starting dose is 1 to 2 drops per 2 kilograms of bodyweight
each day.
If the level of calcium in their blood is very low, up to 40 drops per
2 kilograms of bodyweight may be needed each day.
A dose of 2 drops per 2 kilograms 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 1 drop per 2 kilograms bodyweight each
day.
• Children weighing more than 20 kilograms:
The usual starting dose is 10 drops 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

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.

5) HOW TO STORE ALFACALCIDOL
• Keep out of the sight and the reach of children.
• Do not use the drops after the expiry date on the carton. The expiry
date is the last day of that month.
• Store in a refrigerator (2-8oC).
• Discard the drops 28 days after first opening. Write the date you first
opened the bottle in the space provided on the carton.
• Store in the original package to protect from light.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• 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 Alfacalcidol contains
The active ingredient is alfacalcidol.
Each millilitre (ml) contains 2 micrograms of alfacalcidol.
Each drop contains 0.1 microgram (100 nanograms) of alfacalcidol.
Also contains ethanol, polyoxyl 40 hydrogenated castor oil,
Methylparahydroxybenzoate E218, citric acid monohydrate, sodium
citrate, sorbitol, d,l-α-tocopherol and purified water.
You can find important information about some of the ingredients in your
medicine near the end of section 2 of this leaflet.
What Alfacalcidol looks like and contents of the pack
Alfacalcidol is a solution of oral drops. Alfacalcidol is a clear colourless to
slightly hazy solution. Alfacalcidol comes in an amber glass bottle
containing 10 ml. The bottle has a plastic screw cap incorporating a
security seal and plastic dropping device.
Manufactured by
LEO Pharma A/S, Industriparken 55, 2750 – Ballerup, Denmark.
Procured from within the EU by PL Holder: MPT Pharma Ltd,
Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge,
Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0662

POM
th

Leaflet dated 17 June 2016
Leaflet coded xxxxxxxx

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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