Pill Identifier App

ONE-ALPHA DROPS

Active substance: ALFACALCIDOL

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

One-Alpha Drops
®

alfacalcidol
Please read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell
your doctor or pharmacist.
• In this leaflet One-Alpha® Drops will be called One-Alpha®.

1. WHAT ONE-ALPHA® IS AND WHAT IT IS
USED FOR
One-Alpha® belongs to a group of medicines called
vitamin D analogues. It is a type of vitamin D.
Vitamin D controls the levels of two substances in
your body. These substances are called calcium and
phosphate. Your body needs both of these
substances for healthy bones and teeth.
One-Alpha® works by increasing the amount of
vitamin D in your body. This means the levels of
calcium and phosphate in your body will increase too.
One-Alpha® is used to treat diseases where the amount
of calcium in your body needs changing. It is used
to treat:
• Changes in bone caused by kidney failure
(osteodystrophy).
• Changes to your parathyroid glands. These are
small glands found in your neck. They make a
substance called the parathyroid hormone. This
changes the amount of calcium in your body.
° The glands may make the amount of calcium in
your blood too high (hyperparathyroidism).
° The glands may make the amount of calcium in
your blood too low (hypoparathyroidism).
• Low levels of calcium in the blood of newborn
babies (hypocalcaemia).
• Softening and deformity of the bones due to lack
of calcium (rickets or osteomalacia).

2. BEFORE YOU TAKE ONE-ALPHA®
Do not take One-Alpha®
• If you are allergic (hypersensitive) to alfacalcidol or
any of the other ingredients. You can find a list of
these ingredients in section 6 of this leaflet.
• If you know you have a condition called
hypercalcaemia. This means you have high levels
of calcium in your blood.
• If you know that you have a condition called
calcification. This means you have high levels of
calcium in your body tissues.
• If you know that you have any sugar intolerance.
You may have inherited this condition from
someone else in your family.
If you are unsure if any of the above apply to you,
talk to your doctor before taking One-Alpha®.
Take special care with One-Alpha®
Before you take One-Alpha® tell your doctor:
• If you are taking another type of medicine called a
cardiac glycoside, such as digoxin. These medicines
are used to treat problems with your heart.
• If you have any problems with your kidneys. This
includes if you have kidney stones.
You may get too much calcium or phosphate in your
blood when you take this medicine. Please read
section 4 of this leaflet so you can spot any signs
this may be happening to you. Your doctor may need
to change your dose.
While you are taking One-Alpha® your doctor will
take regular blood tests. This is very important in
children, patients with kidney problems, or patients
on a high dose of medicine. This is to check the
level of calcium and phosphate in your blood while
you take your medicine.

Your doctor may prescribe another medicine called a
phosphate binding agent to take as well as One-Alpha®.
This will help to keep the right amount of phosphate
in your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken any other medicines. This
includes any medicines which you have bought
without a prescription.
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
• Anticonvulsants: for epilepsy or fits. You may need
a larger dose of One-Alpha®.
• Barbiturates: for sleeping disorders. You may need
a larger dose of One-Alpha®.
• Cardiac glycosides, such as digoxin: for heart
problems. You may get too much calcium in your
blood. This may cause an abnormal heart beat.
• Colestyramine: for lowering your cholesterol level,
or to help stop some types of diarrhoea or itching.
Your One-Alpha® may not enter your blood as usual.
• Thiazide diuretics, often called "water pills": for
increasing the amount of water (urine) that your
body makes. You may get too much calcium in
your blood.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice
before taking 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.

017010-06

In this leaflet:
1. What One-Alpha® is and what it is used for
2. Before you take One-Alpha®
3. How to take One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Further information

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.
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.

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)

017010-06

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.

Kidney problems:
• Needing to pass water (urine) less often.
• Swelling of any parts of your body.
• Fever with a pain in your side.
These are signs that there may be problems
developing with your kidneys. Kidney stones may
be forming. Kidney stones may cause a sharp spasm
in one side of your lower back.
The possible side effects described in this section of
the leaflet probably affect about 1 in 10,000 people.
Skin problems or too much calcium in your blood
are the side effects most people get.
If any of the side effects become serious, or you
notice any side effects not listed in this leaflet, tell
your doctor or pharmacist.

5. HOW TO STORE ONE-ALPHA®
• Keep out of the reach and the sight of children.
• Do not use the drops after the expiry date on the
carton.
The expiry date is the last day of that month.
• Store in a refrigerator (2-8°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.
• Store the bottle in the outer carton.
Medicines should not be thrown away in waste
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
do not need anymore. If you do this you will help
protect the environment.

6. FURTHER INFORMATION
What One-Alpha® contains
• The active ingredient is alfacalcidol.
One-Alpha® contains 2 micrograms of alfacalcidol
in each millilitre (ml).
Each drop contains 0.1 microgram of alfacalcidol.
• The other ingredients are citric acid monohydrate,
ethanol, methylparahydroxybenzoate, polyoxyl 40
hydrogenated castor oil, purified water, sodium
citrate, sorbitol and d,l-α-tocopherol.
You can find important information about some of
the ingredients in your medicine near the end of
section 2 of this leaflet.
What One-Alpha® looks like and contents of the pack
One-Alpha® is a solution of oral drops. One-Alpha®
is a slightly hazy or clear colourless solution.
One-Alpha® comes in an amber glass bottle
containing 10 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
LEO Pharma A/S, DK-2750, Ballerup, Denmark.
This leaflet was last revised in October 2013.
®

Registered Trade Mark

4. POSSIBLE SIDE EFFECTS
Like all medicines, One-Alpha® can cause side
effects, although not everybody gets them.

LEO

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)