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ALFAD-- 0.25 MICROGRAMS

Active substance: ALFACALCIDOL

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AlfaD® 0.25, 0.5 OR
1 microgram CAPSULES
ALFACALCIDOL

Version:

3

12 May 2015

PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

What AlfaD® is and what it is used for
Before you take AlfaD®
How to take AlfaD®
Possible side effects
How to store AlfaD®
Further information

WHAT AlfaD® IS AND WHAT IT IS
USED FOR

1

TEVA UK Ref:

231-30-67933-X LEA ALFACALCIDOL A/S CAP TUK
AlfaD®

REG0060189

is the brand name of your medicine. The
name of the active ingredient is alfacalcidol.
This medicine will be referred to as AlfaD®
throughout this leaflet.
Alfacalcidol is a vitamin D product which helps
the body to use calcium and phosphate for
healthy bones.
Your medicine is used to:
• treat post menopausal osteoporosis and
osteoporosis caused by treatment with
glucocorticoids (used to treat inflammation,
and problems with the immune system), in
patients who are unable to take medicines
known as bisphosphonates e.g. etidronate
disodium
• treat bone disease related to kidney problems
• treat rickets/osteomalacia (which is a disease
causing the bones to soften and weaken)
• treat patients with low or high activity of the
parathyroid gland (with bone disease)
• maintain normal calcium levels within the
body.

2

BEFORE YOU TAKE AlfaD®

DO NOT take AlfaD® if you:
• are allergic (hypersensitive) to alfacalcidol,
any other vitamin D products or any of the
other ingredients of this medicine
• have a peanut or soya allergy. These capsules
contain small amounts of peanut oil (arachis
oil) which can cause a severe allergic reaction
in sensitive people
• have a condition called hypercalcaemia,
which means you have high levels of calcium
in your blood
• have a condition called calcification, which
means you have high levels of calcium in
your body tissues.
Take special care with AlfaD®
Talk to your doctor before you start to take this
medicine if you:
• have kidney problems (including kidney
stones)
• have a diet deficient in calcium, as AlfaD®
may not work as well.
You may get too much calcium or phosphate in
your blood when you take this medicine. Please
read Section 4 POSSIBLE SIDE EFFECTS to
enable you to spot any of the signs that this
may be happening to you. You should notify
your doctor, who may need to change your
dose.

Version 3.5

While you are taking AlfaD® your doctor will
take regular blood tests. This is very important
in children, patients with kidney problems and
patients on a high dose of AlfaD®. 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 AlfaD®. This will help to keep the right
amount of phosphate in your blood.
Taking other medicines
Talk to your doctor if you are taking any of the
following:
• cardiac glycosides (for heart problems) e.g.
digoxin
• barbiturates (to treat anxiety and insomnia)
e.g. phenobarbital
• anticonvulsants (to control epilepsy or fits)
e.g. phenytoin, carbamazepine, primidone
• mineral oil (to relieve constipation)
• colestyramine, colestipol (to lower
cholesterol levels)
• sucralfate (to treat and prevent ulcers)
• large amounts of aluminium-containing
antacids (to relieve heartburn and
indigestion) e.g. aluminium hydroxide
• magnesium-containing antacids (to relieve
heartburn or indigestion) or laxatives (to treat
constipation) e.g. magnesium hydroxide
• preparations containing calcium (for calcium
deficiency) e.g. calcium gluconate
• thiazide diuretics, often called “water tablets”
,
(for increasing the amount of urine you
produce) e.g. bendroflumethiazide
• any other preparations containing vitamin D
(to treat bone disease), e.g. ergocalciferol.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Important information about some of the
ingredients of AlfaD®
• AlfaD® capsules contain arachis oil (peanut
oil). If you are allergic to peanut or soya, DO
NOT take AlfaD®.
• This medicinal product contains small amounts
of ethanol (alcohol), less than 100 mg per
microgram.
• AlfaD® capsules contain a small amount of
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.
• This medicinal product contains mannitol,
which may have a mild laxative effect.
Pregnancy and breast-feeding
• If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
doctor for advice before taking this medicine.
Driving and using machines
• AlfaD® is not expected to affect your ability to
drive or operate machinery.

3

HOW TO TAKE AlfaD®

Always take AlfaD® exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
During your treatment with AlfaD®, the calcium
and phosphate levels in your blood will be
monitored regularly (especially if you suffer
from kidney problems) and your dosage
adjusted to achieve the correct response.
The capsules should be swallowed preferably
with a drink of water. The usual dose is:
Bone disease related to kidney problems,
rickets, osteomalacia, and parathyroid problems
• Adults and children over 20 kg
1.0 microgram a day
• The elderly
0.5 microgram a day

Approved

• Children under 20 kg
AlfaD® is not recommended for use in
children under 20 kg.
Osteoporosis
• Adults (including the elderly)
1.0 microgram a day.
If you take more AlfaD® than you should
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child has
swallowed any of the capsules, contact your
nearest hospital casualty department or your
doctor immediately.
An overdose is likely to cause loss of appetite,
general weakness, feeling sick, being sick,
weakness, sweating, diarrhoea, headache, weight
loss, vertigo, thirst, and excessive urination.
Please take this leaflet, any remaining capsules,
and the container with you to the hospital or
doctor so that they know which capsules were
consumed.
If you forget to take AlfaD®
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.
If you stop taking AlfaD®
DO NOT stop taking your medicine without
talking to your doctor first even if you feel
better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Reporting of 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 the 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 AlfaD®

Keep out of the reach and sight of children.
Do not store above 25°C. Do not transfer AlfaD®
to another container.
Do not use after the expiry date that is stated on
the outer packaging. The expiry date refers to
the last day of that month.
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 AlfaD® capsules contain:
• The active ingredient is alfacalcidol (1
α-hydroxyvitamin D3) 0.25, 0.5 or 1
microgram.
The other ingredients are citric acid anhydrous
(E330), propyl gallate (E310), α-tocopherol
(vitamin E) (E307), ethanol anhydrous and
arachis oil (peanut oil).
The capsule shell contains gelatin, glycerol 85%
POSSIBLE SIDE EFFECTS
(E422) and anidrisorb 85/70 (sorbitol, sorbitans,
superior polyols and mannitol).
® can cause side
Like all medicines, AlfaD
The printing ink contains shellac 54% (E904)
effects, although not everybody gets them. Side and black iron oxide (E172).
effects are generally caused by having too much The capsules contain the following colours:
calcium in the blood.
• 0.25 microgram capsules: red iron oxide
If the following happens, stop taking the
(E172)
capsules and tell your doctor immediately or go • 0.5 microgram capsules: titanium dioxide
to the casualty department at your nearest
(E171) and red iron oxide (E172)
hospital:
• 1.0 microgram capsules: titanium dioxide
• an allergic reaction (swelling of the lips, face
(E171) and yellow iron oxide (E172).
or neck leading to severe difficulty in
What AlfaD® capsules look like and contents of
breathing; skin rash or hives).
the pack:
This is a very serious but rare side effect. You
• The 0.25 microgram capsules are oval,
may need urgent medical attention or
opaque, reddish-brown, elastic soft gelatin
hospitalisation.
capsules containing clear, pale yellow, oily
Tell your doctor immediately if you notice any of
solution. They are printed ‘0.25’ on one side
the following:
in black ink.
• feeling sick, being sick or diarrhoea
• The 0.5 microgram capsules are oval,
• general weakness and lack of energy, loss of
opaque, pale pink, elastic soft gelatin
appetite, thirst, weight loss
capsules containing clear, pale yellow, oily
• sweating
solution. They are printed ‘0.5’ on one side in
• vertigo
black ink.
• headache
• The 1 microgram capsules are oval, opaque,
• excessive urination
cream to ivory, elastic soft gelatin capsules
• a dry mouth or a metallic taste in your mouth
containing clear, pale yellow, oily solution.
• experiencing pain in your muscles or bones
They are printed ‘1.0’ on one side in black ink.
• constipation.
• The product is available in pack sizes of 7, 10,
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
Other possible side effects include:
150, 160, or 168 capsules.
Skin problems, such as:
Not all pack sizes may be marketed.
• itching skin
Marketing Authorisation Holder and
• rash
Manufacturer
• hives (urticaria).
Marketing Authorisation holder: TEVA UK
Kidney problems, with symptoms such as:
Limited, Eastbourne BN22 9AG England.
• needing to pass water (urine) less often
Company responsible for manufacture:
• swelling of any parts of your body
Pharmachemie B.V., Swensweg 5, PO Box 552
• fever with a pain in your side.
2003 RN Haarlem, Netherlands.
Metabolisim and Nutrition problems:
AlfaD® is a registered trademark of Teva
• increased calcium level in the blood
Pharmaceutical Industries Ltd.
(hypercalcaemia)
• electrolyte disturbance with increased level This leaflet was last revised: May 2015
of phosphate in the blood
PL 00289/0459-0461
(hyperphosphataemia)
These symptoms are signs that problems with
your kidneys may be developing, such as kidney
stones forming. Kidney stones may cause a
67933-X
sharp spasm in one side of your lower back.
322K094260215

4

Page 1 of 2

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
m
psules

APPROVALS
Signed by
Darryl Hill

REG0060189

Meaning of Signature
Regulatory Affairs Approval

Version 3.5

Approved

Server Date
15-May-2015 07:23:25 AM

Page 2 of 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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