Mvp baseball 2005 installation. The only baseball game on the market that I can find for the Xbox is P2K Baseball. If not, why??' It's glitchy, laggy, graphics are ok but not great at all. Are you planning on making one?? This game I would consider to be par at best.nothing compared to the standard that people would expect to see in an EA Sports game!
The following figure was draw by taking midpoints on three sides of a regular nonagon. The angles are 20 degrees, 50 degrees, and 50 degrees. That might be the more interesting question, indeed. I first thought it would follow by angle chasing once you know $, alpha,$, but it's not all that obvious.
This change, along with the addition of a wall jump ability, are the only new mechanics, but it creates such a fundamental shift in how the puzzles are approached.In Unravel, players were tethered to a point and could only venture a certain distance before running out of thread; in Unravel Two, that tether point is the other Yarny, who can also move around the level. This unfolds in the background via ghostly imagery as you see glimpses of two kids and their escapades. The arrival of a second Yarny leads into the most obvious change – Unravel Two offers two-player couch co-op. It’s abstract stuff, and it seems surplus to requirement in delivering Unravel Two’s message. Unravel two. After all, the journey of your two characters already hammers home the ‘bonds of friendship’ point perfectly.Wonderful story of friendship aside, the addition of a second character opens a whole host of new puzzle and platforming possibilities.
Active substance(s): ALFACALCIDOL
PDF options: View FullscreenDownload PDF
PDF Transcript
Rare possible side effects which may affect up
to 1 in 1,000 people are:
• Dizziness.
Side effects with unknown frequency (cannot
be estimated from the available data):
• Confusion.
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.
5. HOW TO STORE ONE-ALPHA®
• Keep out of the sight and reach of children.
• Do not use the capsules after the expiry date
on the carton.
The expiry date is the last day of that month.
• Do not store above 25°C.
Medicines should not be thrown away in waste
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
do not need anymore. If you do this you will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What One-Alpha® contains
One-Alpha® Capsules 1 microgram contain 1
microgram of alfacalcidol in each capsule.
The other ingredients are sesame oil, all-rac-αtocopherol, glycerol, gelatin, potassium sorbate,
black iron oxide E172, red iron oxide E172.
What One-Alpha® looks like and contents of
the pack
They are a small plain brown soft gelatin capsule.
Available in blister strips containing 30 or 100
capsules per pack
Manufacturer and Licence Holder
The capsules are manufactured by Leo Pharma
A/S, Ballerup, 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 ORE.
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.
Leaflet revision date: 08/09/17
POM
PL Number: 15184/0418
One-Alpha® 1 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 to
obtain the leaflet in a
format suitable for you
PATIENT INFORMATION LEAFLET
®
Ref: 0418/190717/1/F
®
One-Alpha 1 microgram Capsules
(alfacalcidol)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
• In this leaflet One-Alpha soft capsules will be
called One-Alpha.
Your medicine is called One-Alpha 1
microgram Capsules but will be referred to as
'One-Alpha’ throughout this Patient Information
Leaflet.
What is in this leaflet:
1. What One-Alpha® is and what it is used for
2. What you need to know before you take
One-Alpha®
3. How to take One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Contents of the pack and other information
1. WHAT ONE-ALPHA® IS AND WHAT IT IS
USED FOR
One-Alpha contains the active substance
alfacalcidol. 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. WHAT YOU NEED TO KNOW 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking One-Alpha
• If you are taking any of the medicines in the
‘Taking other medicines” section below.
• If you have any problems with your kidneys.
This includes if you have kidney stones.
• If you have granulomas or sarcoidosis. You may
be more sensitive to One-Alpha.
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.
• Your doctor may also prescribe a calcium
supplement to take as well as One-Alpha. This
is to maintain the right amount of calcium in
your blood.
Other medicines and One-Alpha
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes any medicines which you
have bought without a prescription.
3. HOW TO TAKE ONE-ALPHA®
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
• Anticonvulsants (for example, barbiturates,
phenytoin, carbamazepine or primidone): for
epilepsy or fits. 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.
• 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.
• Calcium-containing medicines. You may get too
much calcium in your blood.
• Other medicines that contain vitamin D. You
may get too much calcium in your blood.
• Antacids containing magnesium: for heartburn
or indigestion. You may get too much
magnesium in your blood.
• Medicines containing aluminium. Too much
aluminium is toxic.
• Bile acid sequestrants such as cholestyramine:
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.
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
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, for
example dizziness, that may stop you from driving
or using machines.
Important information about some of the
ingredients of One-Alpha
One-Alpha contains:
• Sesame oil. This may rarely cause severe
allergic reactions.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
If you have very low levels of calcium in your
blood, your doctor may prescribe between 3 and 5
micrograms each day. Your doctor may prescribe
another medicine called a calcium supplement to
take as well as One-Alpha. This will help to
keep the right amount of calcium level in your
blood.
Elderly:
The usual starting dose is 0.5 microgram each
day. This is either 1 red capsule or 2 white
capsules.
Children:
The dose depends on the weight of the child
(called bodyweight).
• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.
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.
If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.
A dose of 0.1 microgram per kilogram bodyweight
each day is used to stop low blood calcium levels
in premature babies.
• Children weighing less than 20 kilograms
The usual starting dose is 0.05 microgram per
kilogram bodyweight each day.
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 you take more One-Alpha than you should
Tell your doctor straight away. You may need to
stop taking this medicine.
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.
Please read section 4 of this leaflet so you can
spot any signs this may be happening to you.
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 and children weighing more than 20
kilograms:
The usual starting dose is 1 microgram each day.
This is either 1 brown capsule, 2 red capsules or 4
white capsules. People usually take between 1
and 3 micrograms each day.
Most people take between 0.25 and 1 microgram
each day once the blood test results show the
medicine is working. This is usually one white
capsule, or one red capsule or one brown capsule.
If you 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 on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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. These side effects may affect up to
1 in 10 people:
• You feel weak or have pain in your muscles
or bones
• You need to pass water (urine) more often
• You feel thirsty
• You feel fatigue
• You feel sick, vomit, have constipation or
diarrhoea or have lost your appetite
• You are sweating a lot
• You are having headaches
• You feel confused
• You feel drowsy.
You should tell your doctor as soon as
possible if you spot any of the following signs
which may be due to problems developing with
your kidneys. The frequency of these side
effects is not known (cannot be estimated from
the available
data):
• Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
Kidney stones may be forming. Kidney stones may
cause a sharp spasm in one side of your lower
back.
Other possible side effects which may affect
up to 1 in 10 people are:
• Abdominal/stomach pain or discomfort
• Rash
• Itch.
Uncommon possible side effects which may
affect up to 1 in 100 people are:
• Headache
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue
• Calcinosis (deposits of calcium in the body)
• Feeling weak or unwell.
Ref: 0418/080917/1/B
Rare possible side effects which may affect up
to 1 in 1,000 people are:
• Dizziness.
Side effects with unknown frequency (cannot
be estimated from the available data):
• Confusion.
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.
5. HOW TO STORE ONE-ALPHA
• Keep out of the sight and reach of children.
• Do not use the capsules after the expiry date on
the carton.
The expiry date is the last day of that month.
• Do not store above 25°C.
Medicines should not be thrown away in waste
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
do not need anymore. If you do this you will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Alfacalcidol contains
Alfacalcidol Capsules 1 microgram contain 1
microgram of alfacalcidol in each capsule.
The other ingredients are sesame oil, all-rac-αtocopherol, glycerol, gelatin, potassium sorbate,
black iron oxide E172, red iron oxide E172.
What Alfacalcidol looks like and contents of
the pack
They are a small plain brown soft gelatin capsule.
Available in blister strips containing 30 or 100
capsules per pack
Manufacturer and Licence Holder
The capsules are manufactured by Leo Pharma
A/S, Ballerup, 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.
Leaflet revision date: 08/09/17
POM
PL Number: 15184/0418
Alfacalcidol 1 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 to
obtain the leaflet in a
format suitable for you
PATIENT INFORMATION LEAFLET
Ref: 0418/080917/2/F
Alfacalcidol 1 microgram Capsules
(alfacalcidol)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
• In this leaflet Alfacalcidol soft capsules will be
called Alfacalcidol .
Your medicine is called Alfacalcidol 1
microgram Capsules but will be referred to as
'Alfacalcidol ’ throughout this Patient Information
Leaflet.
What is in this leaflet:
1. What Alfacalcidol is and what it is used for
2. What you need to know before you take
Alfacalcidol
3. How to take Alfacalcidol
4. Possible side effects
5. How to store Alfacalcidol
6. Contents of the pack and other information
1. WHAT ALFACALCIDOL IS AND WHAT IT IS
USED FOR
Alfacalcidol contains the active substance
alfacalcidol. 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. WHAT YOU NEED TO KNOW 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 .
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Alfacalcidol
• If you are taking any of the medicines in the
‘Taking other medicines” section below.
• If you have any problems with your kidneys.
This includes if you have kidney stones.
• If you have granulomas or sarcoidosis. You may
be more sensitive to Alfacalcidol .
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.
• Your doctor may also prescribe a calcium
supplement to take as well as Alfacalcidol . This
is to maintain the right amount of calcium in
your blood.
Other medicines and Alfacalcidol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes any medicines which you
have bought without a prescription.
3. HOW TO TAKE Alfacalcidol
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
• Anticonvulsants (for example, barbiturates,
phenytoin, carbamazepine or primidone): for
epilepsy or fits. 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.
• 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.
• Calcium-containing medicines. You may get too
much calcium in your blood.
• Other medicines that contain vitamin D. You
may get too much calcium in your blood.
• Antacids containing magnesium: for heartburn
or indigestion. You may get too much
magnesium in your blood.
• Medicines containing aluminium. Too much
aluminium is toxic.
• Bile acid sequestrants such as cholestyramine:
for lowering your cholesterol level, or to help
stop some types of diarrhoea or itching. Your
Alfacalcidol may not enter your blood as usual.
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
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, for
example dizziness, that may stop you from driving
or using machines.
Important information about some of the
ingredients of Alfacalcidol
Alfacalcidol contains:
• Sesame oil. This may rarely cause severe
allergic reactions.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
If you have very low levels of calcium in your
blood, your doctor may prescribe between 3 and 5
micrograms 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.
Children:
The dose depends on the weight of the child
(called bodyweight).
• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.
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.
If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.
A dose of 0.1 microgram per kilogram bodyweight
each day is used to stop low blood calcium levels
in premature babies.
• Children weighing less than 20 kilograms
The usual starting dose is 0.05 microgram per
kilogram bodyweight each day.
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 you take more Alfacalcidol than you should
Tell your doctor straight away. You may need to
stop taking this medicine.
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.
Please read section 4 of this leaflet so you can
spot any signs this may be happening to you.
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 and children weighing more than 20
kilograms:
The usual starting dose is 1 microgram each day.
This is either 1 brown capsule, 2 red capsules or 4
white capsules. People usually take between 1
and 3 micrograms each day.
Most people take between 0.25 and 1 microgram
each day once the blood test results show the
medicine is working. This is usually one white
capsule, or one red capsule or one brown capsule.
If you 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 on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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. These side effects may affect up to
1 in 10 people:
• You feel weak or have pain in your muscles
or bones
• You need to pass water (urine) more often
• You feel thirsty
• You feel fatigue
• You feel sick, vomit, have constipation or
diarrhoea or have lost your appetite
• You are sweating a lot
• You are having headaches
• You feel confused
• You feel drowsy.
You should tell your doctor as soon as
possible if you spot any of the following signs
which may be due to problems developing with
your kidneys. The frequency of these side
effects is not known (cannot be estimated from
the available
data):
• Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
Kidney stones may be forming. Kidney stones may
cause a sharp spasm in one side of your lower
back.
Other possible side effects which may affect
up to 1 in 10 people are:
• Abdominal/stomach pain or discomfort
• Rash
• Itch.
Uncommon possible side effects which may
affect up to 1 in 100 people are:
• Headache
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue
• Calcinosis (deposits of calcium in the body)
• Feeling weak or unwell.
Ref: 0418/080917/2/B
to 1 in 1,000 people are:
• Dizziness.
Side effects with unknown frequency (cannot
be estimated from the available data):
• Confusion.
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.
5. HOW TO STORE ONE-ALPHA®
• Keep out of the sight and reach of children.
• Do not use the capsules after the expiry date
on the carton.
The expiry date is the last day of that month.
• Do not store above 25°C.
Medicines should not be thrown away in waste
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
do not need anymore. If you do this you will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What One-Alpha® contains
One-Alpha® Capsules 1 microgram contain 1
microgram of alfacalcidol in each capsule.
The other ingredients are sesame oil, all-rac-αtocopherol, glycerol, gelatin, potassium sorbate,
black iron oxide E172, red iron oxide E172.
What One-Alpha® looks like and contents of
the pack
They are a small plain brown soft gelatin capsule.
Available in blister strips containing 30 or 100
capsules per pack
Manufacturer and Licence Holder
The capsules are manufactured by Leo Pharma
A/S, Ballerup, 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 ORE.
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.
Leaflet revision date: 08/09/17
POM
PL Number: 15184/0418
One-Alpha® 1 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 to
obtain the leaflet in a
format suitable for you
PATIENT INFORMATION LEAFLET
®
Ref: 0418/190717/1/F
®
One-Alpha 1 microgram Capsules
(alfacalcidol)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
• In this leaflet One-Alpha soft capsules will be
called One-Alpha.
Your medicine is called One-Alpha 1
microgram Capsules but will be referred to as
'One-Alpha’ throughout this Patient Information
Leaflet.
What is in this leaflet:
1. What One-Alpha® is and what it is used for
2. What you need to know before you take
One-Alpha®
3. How to take One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Contents of the pack and other information
1. WHAT ONE-ALPHA® IS AND WHAT IT IS
USED FOR
One-Alpha contains the active substance
alfacalcidol. 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. WHAT YOU NEED TO KNOW 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.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking One-Alpha
• If you are taking any of the medicines in the
‘Taking other medicines” section below.
• If you have any problems with your kidneys.
This includes if you have kidney stones.
• If you have granulomas or sarcoidosis. You may
be more sensitive to One-Alpha.
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.
• Your doctor may also prescribe a calcium
supplement to take as well as One-Alpha. This
is to maintain the right amount of calcium in
your blood.
Other medicines and One-Alpha
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes any medicines which you
have bought without a prescription.
3. HOW TO TAKE ONE-ALPHA®
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
• Anticonvulsants (for example, barbiturates,
phenytoin, carbamazepine or primidone): for
epilepsy or fits. 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.
• 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.
• Calcium-containing medicines. You may get too
much calcium in your blood.
• Other medicines that contain vitamin D. You
may get too much calcium in your blood.
• Antacids containing magnesium: for heartburn
or indigestion. You may get too much
magnesium in your blood.
• Medicines containing aluminium. Too much
aluminium is toxic.
• Bile acid sequestrants such as cholestyramine:
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.
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
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, for
example dizziness, that may stop you from driving
or using machines.
Important information about some of the
ingredients of One-Alpha
One-Alpha contains:
• Sesame oil. This may rarely cause severe
allergic reactions.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
If you have very low levels of calcium in your
blood, your doctor may prescribe between 3 and 5
micrograms each day. Your doctor may prescribe
another medicine called a calcium supplement to
take as well as One-Alpha. This will help to
keep the right amount of calcium level in your
blood.
Elderly:
The usual starting dose is 0.5 microgram each
day. This is either 1 red capsule or 2 white
capsules.
Children:
The dose depends on the weight of the child
(called bodyweight).
• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.
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.
If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.
A dose of 0.1 microgram per kilogram bodyweight
each day is used to stop low blood calcium levels
in premature babies.
• Children weighing less than 20 kilograms
The usual starting dose is 0.05 microgram per
kilogram bodyweight each day.
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 you take more One-Alpha than you should
Tell your doctor straight away. You may need to
stop taking this medicine.
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.
Please read section 4 of this leaflet so you can
spot any signs this may be happening to you.
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 and children weighing more than 20
kilograms:
The usual starting dose is 1 microgram each day.
This is either 1 brown capsule, 2 red capsules or 4
white capsules. People usually take between 1
and 3 micrograms each day.
Most people take between 0.25 and 1 microgram
each day once the blood test results show the
medicine is working. This is usually one white
capsule, or one red capsule or one brown capsule.
If you 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 on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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. These side effects may affect up to
1 in 10 people:
• You feel weak or have pain in your muscles
or bones
• You need to pass water (urine) more often
• You feel thirsty
• You feel fatigue
• You feel sick, vomit, have constipation or
diarrhoea or have lost your appetite
• You are sweating a lot
• You are having headaches
• You feel confused
• You feel drowsy.
You should tell your doctor as soon as
possible if you spot any of the following signs
which may be due to problems developing with
your kidneys. The frequency of these side
effects is not known (cannot be estimated from
the available
data):
• Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
Kidney stones may be forming. Kidney stones may
cause a sharp spasm in one side of your lower
back.
Other possible side effects which may affect
up to 1 in 10 people are:
• Abdominal/stomach pain or discomfort
• Rash
• Itch.
Uncommon possible side effects which may
affect up to 1 in 100 people are:
• Headache
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue
• Calcinosis (deposits of calcium in the body)
• Feeling weak or unwell.
Ref: 0418/080917/1/B
Rare possible side effects which may affect up
to 1 in 1,000 people are:
• Dizziness.
Side effects with unknown frequency (cannot
be estimated from the available data):
• Confusion.
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.
5. HOW TO STORE ONE-ALPHA
• Keep out of the sight and reach of children.
• Do not use the capsules after the expiry date on
the carton.
The expiry date is the last day of that month.
• Do not store above 25°C.
Medicines should not be thrown away in waste
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
do not need anymore. If you do this you will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Alfacalcidol contains
Alfacalcidol Capsules 1 microgram contain 1
microgram of alfacalcidol in each capsule.
The other ingredients are sesame oil, all-rac-αtocopherol, glycerol, gelatin, potassium sorbate,
black iron oxide E172, red iron oxide E172.
What Alfacalcidol looks like and contents of
the pack
They are a small plain brown soft gelatin capsule.
Available in blister strips containing 30 or 100
capsules per pack
Manufacturer and Licence Holder
The capsules are manufactured by Leo Pharma
A/S, Ballerup, 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.
Leaflet revision date: 08/09/17
POM
PL Number: 15184/0418
Alfacalcidol 1 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 to
obtain the leaflet in a
format suitable for you
PATIENT INFORMATION LEAFLET
Ref: 0418/080917/2/F
Alfacalcidol 1 microgram Capsules
(alfacalcidol)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
• In this leaflet Alfacalcidol soft capsules will be
called Alfacalcidol .
Your medicine is called Alfacalcidol 1
microgram Capsules but will be referred to as
'Alfacalcidol ’ throughout this Patient Information
Leaflet.
What is in this leaflet:
1. What Alfacalcidol is and what it is used for
2. What you need to know before you take
Alfacalcidol
3. How to take Alfacalcidol
4. Possible side effects
5. How to store Alfacalcidol
6. Contents of the pack and other information
1. WHAT ALFACALCIDOL IS AND WHAT IT IS
USED FOR
Alfacalcidol contains the active substance
alfacalcidol. 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. WHAT YOU NEED TO KNOW 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 .
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Alfacalcidol
• If you are taking any of the medicines in the
‘Taking other medicines” section below.
• If you have any problems with your kidneys.
This includes if you have kidney stones.
• If you have granulomas or sarcoidosis. You may
be more sensitive to Alfacalcidol .
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.
• Your doctor may also prescribe a calcium
supplement to take as well as Alfacalcidol . This
is to maintain the right amount of calcium in
your blood.
Other medicines and Alfacalcidol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes any medicines which you
have bought without a prescription.
3. HOW TO TAKE Alfacalcidol
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
• Anticonvulsants (for example, barbiturates,
phenytoin, carbamazepine or primidone): for
epilepsy or fits. 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.
• 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.
• Calcium-containing medicines. You may get too
much calcium in your blood.
• Other medicines that contain vitamin D. You
may get too much calcium in your blood.
• Antacids containing magnesium: for heartburn
or indigestion. You may get too much
magnesium in your blood.
• Medicines containing aluminium. Too much
aluminium is toxic.
• Bile acid sequestrants such as cholestyramine:
for lowering your cholesterol level, or to help
stop some types of diarrhoea or itching. Your
Alfacalcidol may not enter your blood as usual.
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
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, for
example dizziness, that may stop you from driving
or using machines.
Important information about some of the
ingredients of Alfacalcidol
Alfacalcidol contains:
• Sesame oil. This may rarely cause severe
allergic reactions.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
If you have very low levels of calcium in your
blood, your doctor may prescribe between 3 and 5
micrograms 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.
Children:
The dose depends on the weight of the child
(called bodyweight).
• Newborn and premature babies:
The usual starting dose is 0.05 to 0.1 microgram
per kilogram of bodyweight each day.
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.
If the level of calcium in their blood is very low, up
to 2 micrograms per kilogram of bodyweight may
be needed each day.
A dose of 0.1 microgram per kilogram bodyweight
each day is used to stop low blood calcium levels
in premature babies.
• Children weighing less than 20 kilograms
The usual starting dose is 0.05 microgram per
kilogram bodyweight each day.
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 you take more Alfacalcidol than you should
Tell your doctor straight away. You may need to
stop taking this medicine.
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.
Please read section 4 of this leaflet so you can
spot any signs this may be happening to you.
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 and children weighing more than 20
kilograms:
The usual starting dose is 1 microgram each day.
This is either 1 brown capsule, 2 red capsules or 4
white capsules. People usually take between 1
and 3 micrograms each day.
Most people take between 0.25 and 1 microgram
each day once the blood test results show the
medicine is working. This is usually one white
capsule, or one red capsule or one brown capsule.
If you 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 on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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. These side effects may affect up to
1 in 10 people:
• You feel weak or have pain in your muscles
or bones
• You need to pass water (urine) more often
• You feel thirsty
• You feel fatigue
• You feel sick, vomit, have constipation or
diarrhoea or have lost your appetite
• You are sweating a lot
• You are having headaches
• You feel confused
• You feel drowsy.
You should tell your doctor as soon as
possible if you spot any of the following signs
which may be due to problems developing with
your kidneys. The frequency of these side
effects is not known (cannot be estimated from
the available
data):
• Kidney problems:
• Needing to pass water (urine) less often
• Swelling of any parts of your body
• Fever with a pain in your side.
Kidney stones may be forming. Kidney stones may
cause a sharp spasm in one side of your lower
back.
Other possible side effects which may affect
up to 1 in 10 people are:
• Abdominal/stomach pain or discomfort
• Rash
• Itch.
Uncommon possible side effects which may
affect up to 1 in 100 people are:
• Headache
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue
• Calcinosis (deposits of calcium in the body)
• Feeling weak or unwell.
Ref: 0418/080917/2/B
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.