027467-01 PACKAGE LEAFLET: INFORMATION FOR THE USER 28041324

One-Alpha® Injection

alfacalcidol

Please read all of this leaflet carefully before you start having 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® Injection will be called One-Alpha®.

In this leaflet:

1.    What One-Alpha® is and what it is used for

2.    Before you have One-Alpha®

3.    How to use One-Alpha®

4.    Possible side effects

5.    How to store One-Alpha®

6.    Further information

1.    WHAT ONE-ALPHA® IS AND WHAT IT IS USED FOR

One-Alpha® belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D.

Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth.

One-Alpha® works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too.

One-Alpha® is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat:

•    Changes in bone caused by kidney failure (osteodystrophy).

•    Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body.

° 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 HAVE ONE-ALPHA®

Do not have 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 having One-Alpha®.

Take special care with One-Alpha®

Before you have 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.

•    If this medicine is for a small, premature baby.

•    If you know that you are sensitive to a substance called propylene glycol. This is one of the ingredients in your medicine.

You may get too much calcium or phosphate in your blood when you have 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 having 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 have 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.

•    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 having One-Alpha®:

•    If you are pregnant, or think you are pregnant.

•    If you are breast-feeding.

Tell your doctor if you become pregnant while having 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, less than 100 milligrams (mg) per 1 microgram alfacalcidol dose.

•    Sodium. This medicine is essentially "sodium free". Your medicine contains 3 milligrams (mg) of sodium in each millilitre (ml).

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3. HOW TO USE ONE-ALPHA®

One-Alpha® will be given to you by a doctor or nurse.

How much One-Alpha^® to have

Your doctor or nurse will give you One-Alpha^® because it is an injection.

This injection goes into your vein. This may be called IV (intravenous) by your doctor or nurse.

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 having 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 have more or less medicine depending on your test results.

You may get too much calcium or phosphate in your blood when you have 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 have 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 have half the dose you had before.

Adults:

The usual starting dose is 1 microgram each day. People usually have between 1 and 3 micrograms each day.

Most people have between 0.25 and 1 microgram 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 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 in your blood.

Elderly:

The usual starting dose is 0.5 microgram each day. 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.

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.

•    Children weighing more than 20 kilograms:

The usual starting dose is 1 microgram each day.

If you have more One-Alpha® than you should

Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away. You may need to stop having 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 have One-Alpha®

Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse.

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

4. POSSIBLE SIDE EFFECTS

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

Important side effects to look out for:

You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood:

•    You need to pass water (urine) more often

•    You feel thirsty

•    You have a dry mouth, or a metallic taste in your mouth

•    You feel weak or have pain in your muscles or bones

•    You feel sick or have constipation.

Other possible side effects:

Skin problems:

•    Itching skin

•    Rash

•    Hives (urticaria).

Kidney problems:

•    Needing to pass water (urine) less often

•    Swelling of any parts of your body

•    Fever with a pain in your side.

These are signs that there may be problems developing with your kidneys. Kidney stones may be forming. Kidney stones may cause a sharp spasm in one side of your lower back.

The possible side effects described in this section of the leaflet probably affect about 1 in 10,000 people. Skin problems or too much calcium in your blood are the side effects most people get.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5.    HOW TO STORE ONE-ALPHA®

•    Keep out of the reach and the sight of children.

•    Do not use the injection after the expiry date on the ampoule. The expiry date is the last day of that month.

•    Store at 2 - 8°C (in a refrigerator).

•    Keep the ampoule in the outer carton in order to protect it from light.

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).

•    The other ingredients are citric acid, ethanol, propylene glycol, sodium citrate and water for injections. 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 clear colourless solution for injection.

One-Alpha^® comes in one-point-cut amber glass ampoules containing 0.5 or 1 ml.

There are 10 ampoules in a carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK Manufacturer:

CENEXI SAS, 52 rue Marcel et Jacques Gaucher, 94120 Fontenay-sous-Bois, France

This leaflet was last revised in October 2013 ^® Registered Trade Mark

LEO

027467-01