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ALFACALCIDOL DROPS

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Ref: 1038/060114/1/F

®

One - Alpha Drops
(alfacalcidol)
Patient Information Leaflet
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called One - Alpha® Drops but will be referred to as
One - Alpha® throughtout 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®

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.

6 Further information

1

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.

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).

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
2

How to take One-Alpha

®

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.

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.
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.

Ref: 1038/060114/1/B

®

One - Alpha Drops
(alfacalcidol)
Patient Information Leaflet (continued)
Adults:
The usual starting dose is 10 drops each day. People usually take between
10 and 30 drops each day.
Most people take between 3 and 10 drops 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 30 to 50 drops 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 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.

5

How to store One-Alpha®

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Store in a refrigerator (2°C - 8°C)
* Keep the bottle in the outer carton.
Do not use this medicine after the expiry date shown on the carton label or
bottle label. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured or
shows any other signs of deterioration, consult your pharmacist who will tell
you what to do.

6

Further information

What this medicine contains:
Each drop contains 0.1 micrograms of alfacalcidol as the active ingredient.
One-Alpha® also has the following inactive ingredients: Ethanol 14% v/v,
polyoxyl 40 hydrogenated castor oil, methylparahydroxybenzoate, citric acid
monohydrate, sodium citrate, sorbitol, α - tocopherol and purified water.
What this medicine looks like and contents of the pack
One-Alpha® is a slightly hazy or clear colourless solution.
One-Alpha® comes in 10ml glass bottles.
Manufacturer and Licence Holder
Your medicine is manufactured by LEO Pharmaceutical Products,
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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1038 One-Alpha® Drops

One-Alpha ® is a registered trademark of Leo Pharmaceutical Products Ltd
Revision date: 06/01/14

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 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.

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

Ref: 1038/060114/2/F

Alfacalcidol Drops
(alfacalcidol)
Patient Information Leaflet
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Alfacalcidol Drops but will be referred to as
Alfacalcidol throughtout 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.
° 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 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.
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.

Ref: 1038/060114/2/B

Alfacalcidol Drops
(alfacalcidol)
Patient Information Leaflet (continued)
Adults:
The usual starting dose is 10 drops each day. People usually take between
10 and 30 drops each day.
Most people take between 3 and 10 drops 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 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 help provide more information on the safety of
this medicine.

5

How to store Alfacalcidol

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Store in a refrigerator (2°C - 8°C)
* Keep the bottle in the outer carton.
Do not use this medicine after the expiry date shown on the carton label or
bottle label. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your medicine becomes discoloured or
shows any other signs of deterioration, consult your pharmacist who will tell
you what to do.

A dose of 2 drops per 2 kilograms bodyweight each day is used to stop low
blood calcium levels in premature babies.
6
• 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.

Further information

What this medicine contains:
Each drop contains 0.1 micrograms of alfacalcidol as the active ingredient.
Alfacalcidol also has the following inactive ingredients: Ethanol 14% v/v,
polyoxyl 40 hydrogenated castor oil, methylparahydroxybenzoate, citric acid
monohydrate, sodium citrate, sorbitol, α - tocopherol and purified water.
What this medicine looks like and contents of the pack
Alfacalcidol is a slightly hazy or clear colourless solution.
Alfacalcidol comes in 10ml glass bottles.
Manufacturer and Licence Holder
Your medicine is manufactured by LEO Pharmaceutical Products,
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.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

4

Possible side effects

POM

PL 15184/1038 Alfacalcidol Drops

Like all medicines, Alfacalcidol can cause side effects, although not everybody gets them.

Revision date: 06/01/14

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.

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

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.

Expand Transcript

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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