ONE-ALPHA DROPS

Assessed against UK PIL dated October 2013
PACKAGE LEAFLET: INFORMATION FOR THE USER

One-Alpha® Drops
(alfacalcidol)
Your medicine is available using the name One-Alpha Drops but
will be referred to as One-Alpha throughout this 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 become serious, or you notice any
side effects not listed in this leaflet please tell your doctor or
pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

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).

Final draft mock up
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.

Page 1 of 2

By kariri at 3:27 pm, May 11, 2015

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:

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.

If you forget to take One-Alpha

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

Do not use the drops after the expiry date on the carton and
bottle. The expiry date is the last day of that month.

You may also have other tests such as X-rays. This is also so your
doctor knows that the dose is right for you.

4. Possible side effects

Store in a refrigerator (2-8°C). After opening, you should discard
the drops after 28 days. Write the date you first opened the bottle
in the space provided on the carton.

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.

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 your medicine take it as soon as you
remember. Then take the next dose at the usual time.

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
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)

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store the bottle in the outer carton.
If your doctor decides to stop your treatment, take any leftover
medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any other
signs of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via household wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect
the environment.

6. Further information
What One-Alpha contains

The active ingredient is alfacalcidol.
Each drop contains 0.1 microgram (100 nanograms) alfacalcidol.
Also contains ethanol, polyoxyl 40 hydrogenated castor oil,
methylparahydroxybenzoate, citric acid monohydrate,
sodium citrate, sorbitol α-tocopherol and purified water.

What One-Alpha looks like and contents of the pack

Kidney problems:




5. How to store One-Alpha

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.

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 can help provide more information
on the safety of this medicine.

Page 2 of 2

One-Alpha is a solution of oral drops. One-Alpha is a clear,
colourless solution.
One-Alpha is available in amber glass bottles containing 10ml.

Manufacturer

One-Alpha is manufactured by: LEO Pharmaceutical Products,
Ballerup, Denmark.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0543

POM

Leaflet issue and revision date: 30.01.15
One-Alpha® is a registered trademark of LEO Pharma A/S.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alfacalcidol 2 micrograms/ml Oral Drops
Your medicine is available using the name Alfacalcidol
2 micrograms/ml Oral Drops but will be referred to as Alfacalcidol
throughout this 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 become serious, or you notice any
side effects not listed in this leaflet please tell your doctor or
pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

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 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.

Page 1 of 2

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.

If you forget to take Alfacalcidol

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

Do not use the drops after the expiry date on the carton and
bottle. The expiry date is the last day of that month.

You may also have other tests such as X-rays. This is also so your
doctor knows that the dose is right for you.

4. Possible side effects

Store in a refrigerator (2-8°C). After opening, you should discard
the drops after 28 days. Write the date you first opened the bottle
in the space provided on the carton.

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.

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.
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 your medicine take it as soon as you
remember. Then take the next dose at the usual time.

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
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)

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store the bottle in the outer carton.
If your doctor decides to stop your treatment, take any leftover
medicine back to the pharmacy.
If your medicine appears to be discoloured or shows any other
signs of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via household wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect
the environment.

6. Further information
What Alfacalcidol contains

The active ingredient is alfacalcidol.
Each drop contains 0.1 microgram (100 nanograms) alfacalcidol.
Also contains ethanol, polyoxyl 40 hydrogenated castor oil,
methylparahydroxybenzoate, citric acid monohydrate,
sodium citrate, sorbitol α-tocopherol and purified water.

What Alfacalcidol looks like and contents of the
pack

Kidney problems:




5. How to store Alfacalcidol

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.

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 can help provide more information
on the safety of this medicine.

Page 2 of 2

Alfacalcidol is a solution of oral drops. Alfacalcidol is a clear,
colourless solution.
Alfacalcidol is available in amber glass bottles containing 10ml.

Manufacturer

Alfacalcidol is manufactured by: LEO Pharmaceutical Products,
Ballerup, Denmark.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0543

POM

Leaflet issue and revision date: 30.01.15