PACKAGE LEAFLET: INFORMATION FOR THE USER Alfacalcidol 0.25microgram Capsules, soft Alfacalcidol 0.5microgram Capsules, soft Alfacalcidol 1.0microgram Capsules, soft

Alfacalcidol

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet

1.    What Alfacalcidol is and what it is used for

2.    What you need to know before you take Alfacalcidol

3.    How to take Alfacalcidol

4.    Possible side effects

5.    How to store Alfacalcidol

6.    Contents of the pack and other information

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.

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.

•    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. What you need to know before you take Alfacalcidol Do not take Alfacalcidol:

•    If you are allergic (hypersensitive) to alfacalcidol, arachis oil (peanut oil) 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 are unsure if any of the above apply to you, talk to your doctor before taking Alfacalcidol

Warnings and precautions

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.

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 diarrhea 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.

•    Magnesium based antacids and laxatives: You may get too much magnesium in your blood.

•    Vitamin D or its analogous and calcium or calcium containing preparations: for calcium deficeny. 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.

Alfacalcidol contains arachis oil (peanut oil) and Glycerol:

Glycerol has proven harmful in high doses and may cause headache, stomach upset and diarrhea. Alfacalcidol capsules contain arachis oil (peanut oil). It you are allergic to peanut or soya, do not use Alfacalcidol.

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.

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.

Adults

The usual starting dose is 1 microgram each day. People

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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.

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.

Use in 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.

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.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov. uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Alfacalcidol

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

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

•    This medicinal product does not require any special storage conditions

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.    Contents of the pack and other information What Alfacalcidol contains

•    The active ingredient is alfacalcidol.

Alfacalcidol 0.25 microgram Capsules, Soft contain 0.25 microgram of alfacalcidol in each capsule. Alfacalcidol 0.5 microgram Capsules, Soft contain 0.5 microgram of alfacalcidol in each capsule.

Alfacalcidol 1.0 microgram Capsules, Soft contain 1 microgram of alfacalcidol in each capsule.

Alfacalcidol, also contains hydrogenated arachis oil. Please refer section 2 for more information.

The other ingredients are

•    Citric acid, anhydrous

•    All-rac-a-Tocopherol

•    Propyl gallate

•    Ethanol anhydrous

The capsule shell contains

•    Gelatin,

•    Glycerol,

•    Anidrisorb

•    Purified water

•    Medium Chain Triglyceride

The capsules contain the following colours:

0.25 microgram capsules: titanium dioxide (E171), ferric oxide red (E172) & ferric oxide black(E172)

0.5 microgram capsules: titanium dioxide (E171) and ferric oxide red (E172)

1.0 microgram capsules: titanium dioxide (E171) and ferric oxide yellow (E172)

What Alfacalcidol looks like and contents of the pack

Alfacalcidol 0.25 mcg Capsule: Reddish brown colored, oval shaped soft gelatin capsules containing clear oily liquid.

Alfacalcidol 0.5 mcg Capsule: Light pink colored, oval shaped soft gelatin capsules containing clear oily liquid. Alfacalcidol 1.0 mcg Capsule: Pale yellow colored, oval shaped soft gelatin capsules containing clear oily liquid. Alfacalcidol comes in white opaque HDPE container, with white opaque HDPE screw closure and induction sealing in a pack of 30 capsules.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Strides Arcolab International Limited

Unit 4, Metro Centre, Tolpits Lane, Watford,

Hertfordshire

WD 189 SS UNITED KINGDOM Manufacturer

Co-Pharma Limited

Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD 189 SS United Kingdom

This leaflet was last approved in

This leaflet was last approved in 07/2014

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Font Size: 8.5pt