One-Alpha 0.25 Microgram Capsules
Out of date information, search anotherWHAT ONE-ALPHA® CONTAINS
Each capsule contains 0.25 microgram of alfacalcidol as the active ingredient.
Your medicine also contains the following Inactive ingredients: sesame oil, all-rac-a-tocopherol, gelatin, glycerol, potassium sorbate, titanium dioxide E171
What One-Alpha® looks like and the contents of the pack
They are a small white soft gelatin capsules. Available in blister strips containing 10 capsules. Comes in pack sizes of 30 and 100 capsules.
IMPORTANT
This medicine is for you. Only a doctor can prescribe it. This leaflet does not contain everything about this medicine, if you have any questions or are not sure about anything then contact your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.
MANUFACTURER AND LICENCE HOLDER
The capsules are manufactured by Leo Pharmaceutical Products Limited A/S, Industriparken 55, Ballerup, DK-2750, Denmark and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Leaflet revision date: 14/06/12
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® capsules will be called One-Alpha®.
Your medicine is called One-Alpha 0.25
microgram Capsules but will be referred to as
’One-Alpha' throughout this Patient Information
Leaflet.
In this leaflet:
1. What One-Alpha® is and what it is used for
2. Before you take One-Alpha®
3. How to take One-Alpha®
4. Possible side effects
5. How to store One-Alpha®
6. Further information
POM
PL Number: 15184/1126
One-Alpha® 0.25 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 for help.
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 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:
• Sesame oil. Sesame oil is used to make your capsules. It may rarely give you severe allergic reactions. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.
Please ask your doctor if you are worried about any of the ingredients in this medicine.
Shiny side
Printed Foil
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.
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 capsules 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.
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 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.
Adults:
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 have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 microgram 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.
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 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.
• 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 THIS MEDICINE OUT OF REACH AND SIGHT OF CHILDREN.
* Do not store above 25°C
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 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.
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to. If your capsules become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Medicines should not be thrown away in the 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.
Ref: 1126/140612/1/B
WHAT ALFACALCIDOL® CONTAINS
Each capsule contains 0.25 microgram of alfacalcidol as the active ingredient.
Your medicine also contains the following Inactive ingredients: sesame oil, all-rac-a-tocopherol, gelatin, glycerol, potassium sorbate, titanium dioxide E171.
What Alfacalcidol® looks like and the contents of the pack
They are a small white soft gelatin capsules. Available in blister strips containing 10 capsules. Comes in pack sizes of 30 and 100 capsules.
IMPORTANT
This medicine is for you. Only a doctor can prescribe it. This leaflet does not contain everything about this medicine, if you have any questions or are not sure about anything then contact your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.
MANUFACTURER AND LICENCE HOLDER
The capsules are manufactured by Leo Pharmaceutical Products Limited A/S, Industriparken 55, Ballerup, DK-2750, Denmark and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Leaflet revision date: 14/06/12
PATIENT INFORMATION LEAFLET ® Ref 1126/140612/1/F Alfacalcidol®).25 microgram Capsules®
(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 Alfacalcidol® capsules will be called Alfacalcidol®.
Your medicine is called Alfacalcidol® 0.25 microgram Capsules but will be referred to as ’ alfacalcidol' throughout this Patient Information Leaflet.
In this leaflet:
1. What Alfacalcidol® is and what it is used for
2. Before you take Alfacalcidol®
3. How to take Alfacalcidol®
4. Possible side effects
5. How to store Alfacalcidol®
6. Further information
POM
PL Number: 15184/1126 Alfacalcidol® 0.25 microgram Capsules
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.
• 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 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.
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 for help.
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.
You may get too much calcium or phosphate in your blood when you take this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor may need to change your dose.
While you are taking Alfacalcidol® your doctor will take regular blood tests. This is very important in children, patients with kidney problems, or patients on a high dose of medicine. This is to check the level of calcium and phosphate in your blood while you take your medicine.
Your doctor may prescribe another medicine called a phosphate binding agent to take as well as Alfacalcidol® . This will help to keep the right amount of phosphate in your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.
You must tell your doctor or pharmacist if you are taking any of the following medicines:
• Anticonvulsants: for epilepsy or fits. You may need a larger dose of Alfacalcidol®.
• Barbiturates: for sleeping disorders. You may need a larger dose of Alfacalcidol®.
• Cardiac glycosides, such as digoxin: for heart problems.
You may get too much calcium in your blood. This may cause an abnormal heart beat.
• Colestyramine: for lowering your cholesterol level, or to help stop some types of diarrhoea or itching. Your Alfacalcidol® may not enter your blood as usual.
• Thiazide diuretics, often called "water pills": for increasing the amount of water (urine) that your body makes. You may get too much calcium in your blood.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before taking Alfacalcidol®:
• If you are pregnant, or think you are pregnant.
• If you are breast-feeding.
Tell your doctor if you become pregnant while taking this medicine.
Driving and using machines
Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
Important information about some of the ingredients of Alfacalcidol®
Alfacalcidol® contains:
• Sesame oil. Sesame oil is used to make your capsules. It may rarely give you severe allergic reactions. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.
Please ask your doctor if you are worried about any of the ingredients in this medicine.
Shiny side
Printed Foil
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.
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 capsules 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.
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 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.
Adults:
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 have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5 microgram 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.
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 take more Alfacalcidol® than you should
Tell your doctor straight away. You may need to stop taking this medicine.
You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.
If you forget to take Alfacalcidol®
If you forget to take your medicine, take it as soon as you remember. Then take the next dose at the usual time.
If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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)
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 ALFACALCIDOL®
* KEEP THIS MEDICINE OUT OF REACH AND SIGHT OF CHILDREN.
* Do not store above 25°C
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to. If your capsules become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Medicines should not be thrown away in the 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.
Ref: 1126/140612/1/B