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MercuryPharma

PATIENT INFORMATION LEAFLET

Alfacalcidol 0.25 microgram, 0.5 microgram & 1 microgram Capsules

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 or pharmacist

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet

1.    What Alfacalcidol Capsules are and what they are used for.

2.    What you need to know before you take Alfacalcidol Capsules.

3.    How to take Alfacalcidol Capsules.

4.    Possible side effects.

5.    How to store Alfacalcidol Capsules.

6.    Contents of the pack and other information.

1. WHAT ALFACALCIDOL CAPSULES ARE AND WHAT THEY ARE USED FOR

Alfacalcidol is a biologically active form of vitamin D. Alfacalcidol promotes the uptake of calcium from food and assists in growth of healthy bones.

They are used in conditions where there is a disturbance in the body’s calcium levels, for example in kidney disorders. They are mainly used to treat the following conditions:

•    changes in bone caused by kidney failure

•    disorders of the parathyroid glands

•    low blood calcium in newborn babies

•    softening and deformity of the bones due to lack of calcium.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALFACALCIDOL CAPSULES

Do not take Alfacalcidol Capsules:

•    If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients of this medicine (listed in section 6)

•    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. Warnings and precautions

Talk to your doctor or pharmacist before taking Alfacalcidol Capsules:

•    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 Alfacalcidol Capsules 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 Capsules. This will help to keep the right amount of phosphate in your blood.

Other medicines and Alfacalcidol Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular 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 Capsules

•    Barbiturates: for sleeping disorders. You may need a larger dose of Alfacalcidol Capsules

•    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 Capsules 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

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.

Please tell your doctor if you become pregnant while taking this medicine.

Driving and using machines

Usually your medicine may have very little or no 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.

Alfacalcidol Capsules contains sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE ALFACALCIDOL CAPSULES

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should continue to take these capsules for as long as your doctor tells you to.

The capsules should be swallowed with a drink of water.

To remove the capsules from the blister, press on the shiny side of the blister so that the capsule comes out through the printed foil (see diagram).

The recommended dose is:

Adults

•    The normal starting dose for adults is 1 microgram per day. This dosage may then be adjusted, depending on your particular needs

•    Most adults respond to a dose between 1 and 3 micrograms per day. Once the dose is stabilised, the maintenance dose is in the range of 0.25 to 1 microgram per day

•    Doses of 3 to 5 micrograms of Alfacalcidol Capsules may be given with calcium supplements where there are very low blood calcium levels which have been caused by underactivity of the parathyroid glands (parathyroid glands regulate calcium levels in the body).

Children

The dose depends on the weight of the child and will be calculated by your child's doctor.

Elderly

The starting dose is 0.5 micrograms per day.

At the beginning of your treatment calcium levels in your blood should be measured regularly. The dosage of alfacalcidol can then be adjusted to achieve the correct response. When the correct dosage has been found, your calcium levels may continue to be measured but less often. Also, if your doctor thinks it is necessary he/she may prescribe extra calcium supplements to be taken during your treatment.

If you take more Alfacalcidol Capsules 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 if this may be happening to you.

If you forget to take Alfacalcidol Capsules

If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

Ask your doctor or pharmacist if you have any further questions on the use of this product.

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:

•    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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE ALFACALCIDOL CAPSULES

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep blisters in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

Do not throw away any medicines viawastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Alfacalcidol Capsules contain:

The active ingredient is alfacalcidol

•    Each Alfacalcidol 0.25 microgram Capsule contains 0.25 microgram of alfacalcidol

•    Each Alfacalcidol 0.5 microgram Capsule contains 0.5 microgram of alfacalcidol

•    Each Alfacalcidol 1 microgram Capsule contains 1 microgam of alfacalcidol

•    The other ingredients are butylhydroxyanisole, butylhydroxytoluene, triglycerides, gelatin, glycerol, sorbitol 70% solution, purified water.

Alfacalcidol 0.25 microgram Capsules also contain titanium dioxide.

Alfacalcidol 0.5 microgram Capsules also contain titanium dioxide, iron oxide yellow, brilliant blue FCF and allura red AC. Alfacalcidol 1 microgram Capsules also contain iron oxide black and iron oxide red.

What Alfacalcidol Capsules look like and contents of the pack:

•    Alfacalcidol 0.25 microgram Capsules are opaque, white, oval, soft gelatine capsules

•    Alfacalcidol 0.5 microgram Capsules are opaque, red, oval, soft gelatine capsules

•    Alfacalcidol 1 microgram Capsules are opaque, brown, oval, soft gelatine capsules.

Alfacalcidol Capsules are available in pack sizes of 30 Capsules.

Marketing Authorisation Holder & Manufacturer:

Mercury Pharmaceuticals Limited,

Capital House, 85 King William Street, London EC4N 7BL, UK

This leaflet was last revised in December 2013.    101164/LF/4, 101165/LF/4, 101988/LF/4

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