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Alfacalcidol 0.25, 0.5 & 1 microgram Capsules

PL 00289/1555-7

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alfacalcidol 0.25, 0.5 and 1 microgram Capsules

(Referred to as Alfacalcidol Capsules in the leaflet)

Read all of this leaflet carefully before you start using 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Alfacalcidol Capsules

3.    How Alfacalcidol Capsules are taken

4.    Possible side effects

5.    Storing Alfacalcidol Capsules

6.    Further information

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

Each capsule contains 0.25, 0.5 or 1 microgram of alfacalcidol. Alfacalcidol is a vitamin D product that helps the body to use calcium and phosphate for healthy bones.

Your medicine is used to treat renal (kidney) bone diseases as well as rickets, osteomalacia (which is a disease causing the bones to soften and weaken) and patients with high or low activity of the parathyroid gland. It is used to maintain normal calcium levels within the body.

2.    BEFORE YOU TAKE ALFACALCIDOL CAPSULES Do not take Alfacalcidol Capsules if:

•    You are sensitive to any of the ingredients in the medicine (listed in section 6).

•    You have a condition called hypercalcaemia. This means you have high levels of calcium in your blood.

•    You have a condition called calcification. This means you have high levels of calcium in your body tissues.

These capsules contain small amounts of peanut oil (arachis oil), which may cause a severe allergic reaction in sensitive people.

Before taking Alfacalcidol Capsules, tell your doctor if:

•    You have kidney problems

•    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.

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 that 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 Alfacalcidol Capsules with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Such medicines include:

•    Cardiac glycosides, such as digoxin used for heart problems

•    Barbiturates e.g. phenobarbital, or anticonvulsants (anti-epileptic medication) e.g. phenytoin

•    Mineral oil, colestyramine, colestipol or sucralfate

•    Large amounts of aluminium-containing antacids e.g. aluminium hydroxide

•    Magnesium-containing antacids or laxatives e.g. magnesium hydroxide

•    Preparations containing calcium e.g. calcium gluconate

•    Diuretics (“water tablets”) e.g. bendroflumethiazide

•    Any other preparations containing vitamin D, e.g. ergocalciferol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

•    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

Alfacalcidol Capsules are unlikely to affect your ability to drive or operate machinery. 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 Capsules

The capsule contains small amounts of sorbitol, which should be avoided if you have an intolerance to fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sorbitol may cause stomach upset and diarrhoea.

These capsules contain arachis oil (peanut oil). If you are allergic to peanut or soya, do not use Alfacalcidol Capsules

Alfacalcidol Capsules contain small amounts of ethanol (alcohol), approximately 1mg per capsule.

3. HOW ALFACALCIDOL CAPSULES SHOULD BE TAKEN

Always take Alfacalcidol Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The capsules should be swallowed whole with a drink of water.

The usual starting dose is:

Alfacalcidol per day

1.0    microgram

1.0    microgram Not recommended 0.5 microgram

At the beginning of your treatment calcium levels in your blood should be measured weekly. The dosage can then be adjusted to achieve the correct response. Doses may be increased by 0.25 - 0.5 microgram per day. When the correct dosage has been found your calcium levels may be measured every 2 - 4 weeks.

If your diet is deficient in calcium, Alfacalcidol may not work as well.

Levels of phosphate in your blood may also be measured regularly, especially if you suffer from kidney problems.

If you take more Alfacalcidol Capsules than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has accidentally swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. If you or anyone else has taken too many capsules, there may be signs of nausea, vomiting, weakness, sweating, diarrhoea, headache, vertigo, thirst and excessive urination.

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 missed doses. Take the remaining doses at the correct time.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Alfacalcidol can cause side effects, although not everyone gets these.

Side effects are generally caused by having too much calcium in the blood.

•    Feeling sick, stomach pains or diarrhoea

•    General weakness, anorexia, thirst, weight loss

•    Sweating, vertigo, dizziness, headache,

•    Excessive urination

•    Elevated calcium level in the blood

•    Abnormally elevated level of phosphate in the blood

•    Itching

•    Rash (change of the skin which affects its colour, appearance or texture)

•    Hives

•    Dry mouth

•    Constipation

•    Kidney problems:

-    Needing to pass water (urine) less often.

-    Swelling of any parts of your body.

-    Fever with a pain in your side.

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

5.    STORING ALFACALCIDOL CAPSULES

Store in the original package and keep blisters in the outer carton. Keep them out of the reach and sight of children. Do not store above 25°C. Do not use after the expiry date shown on the outer packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Alfacalcidol Capsules contain

The active ingredient is alfacalcidol. Each capsule contains 0.25, 0.5 or 1 microgram of alfacalcidol.

Other ingredients are citric acid, propyl gallate, a-tocopherol (vitamin E), ethanol and arachis oil (peanut oil). The capsule shell contains gelatin, glycerol and sorbitol, with shellac, black iron oxide (E172) and propylene glycol in the printing ink.

The Capsules also contain the following colours:

0.25 microgram - red iron oxide (E172).

0.5 microgram - titanium dioxide (E171) and red iron oxide (E172).

1 microgram - titanium dioxide (E171) and yellow iron oxide (E172).

What Alfacalcidol Capsules look like and contents of the pack

Alfacalcidol Capsules are soft gelatin capsules coloured reddish brown printed with “0.25”

(0.25 microgram), pale pink printed with “0.5” (0.5 microgram) or cream printed with “1.0”

(1 microgram). The product is available in blister packs. The pack size is 30 capsules.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne BN22 9AG

Manufacturer

TEVA Pharmaceutical Works plc, Debrecen, H-4042, Hungary.

This leaflet was last revised in August 2012