Alfacalcidol Capsules 0.25 MicrogramOut of date information, search another
PACKAGE LEAFLET: INFORMATION FOR THE USER
One-Alpha® Capsules 0.25 microgram One-Alpha® Capsules 0.5 microgram One-Alpha® Capsules 1 microgram
• 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®.
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
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).
• 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.
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.
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.
• 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.
Always use One-Alpha® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Press on the shiny side of the blister. The capsule will come out through the printed side of the foil. Please see the diagram.
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 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.
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.
The usual starting dose is 0.5 microgram each day. This is either 1 red capsule or 2 white capsules.
The dose depends on the weight of the child (called bodyweight).
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.
The usual starting dose is 0.05 microgram per kilogram bodyweight each day.
The usual starting dose is 1 microgram each day.
Tell your doctor straight away. You may need to stop taking this medicine.
You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.
If you forget to take your medicine, take it as soon as you remember. Then take the next dose at the usual time.
If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
Like all medicines, One-Alpha® can cause side effects, although not everybody gets them.
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 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.
• Itching skin
• Hives (urticaria)
• 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.
• Keep out of the reach and the sight 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.
What One-Alpha® contains
• The active ingredient is alfacalcidol.
One-Alpha® Capsules 0.25 microgram contain 0.25 microgram of alfacalcidol in each capsule.
One-Alpha® Capsules 0.5 microgram contain 0.5 microgram of alfacalcidol in each capsule.
One-Alpha® Capsules 1 microgram contain 1 microgram of alfacalcidol in each capsule.
• The other ingredients are sesame oil, all-rac-a-tocopherol, gelatin, glycerol, and potassium sorbate.
The 0.25 microgram capsules also contain titanium dioxide (E171).
The 0.5 microgram capsules also contain titanium dioxide (E171) and red iron oxide (E172).
The 1 microgram capsules also contain black iron oxide (E172) and red iron oxide (E172).
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.
One-Alpha® Capsules 0.25 microgram are white capsules. One-Alpha® Capsules 0.5 microgram are red capsules. One-Alpha® Capsules 1 microgram are brown capsules. One-Alpha® comes in blister packs of 30 capsules.
Marketing Authorisation Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
LEO Pharma A/S, DK 2750, Ballerup, Denmark.
This leaflet was last revised in October 2013.
®Registered Trade Mark