ALFAD 0.5 MICROGRAM CAPSULES
Active substance(s): ALFACALCIDOL
AlfaD® 0.25, 0.5 OR
1 microgram CAPSULES
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:
What AlfaD is and what it is used for
Before you take AlfaD®
How to take AlfaD®
Possible side effects
How to store AlfaD®
WHAT AlfaD® IS AND WHAT IT IS
AlfaD® 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
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
• 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.
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.
231-30-67933-Y LEA ALFACALCIDOL A/S CAP TUK
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
• cardiac glycosides (for heart problems)
• barbiturates (to treat anxiety and insomnia)
• anticonvulsants (to control epilepsy or fits)
e.g. phenytoin, carbamazepine, primidone
• mineral oil (to relieve constipation)
• colestyramine, colestipol (to lower
• 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
• 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
• 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.
15 February 2016
• The elderly
0.5 microgram a day
• Children under 20 kg
AlfaD® is not recommended for use in
children under 20 kg.
• 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
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
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.
POSSIB LE SIDE EFFECTS
Like all medicines, AlfaD® can cause side effects,
although not everybody gets them. Side effects
are generally caused by having too much
calcium in the blood.
If the following happens, stop taking the
capsules and tell your doctor immediately or go
to the casualty department at your nearest
• an allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You may
need urgent medical attention or hospitalisation.
Tell your doctor immediately if you notice any of
• feeling sick, being sick or diarrhoea
• general weakness and lack of energy, loss of
appetite, thirst, weight loss
• excessive urination
• a dry mouth or a metallic taste in your mouth
• experiencing pain in your muscles or bones
Other possible side effects include:
Skin problems, such as:
• itching skin
• hives (urticaria).
Kidney problems, with symptoms such as:
• needing to pass water (urine) less often
• swelling of any parts of your body
• fever with a pain in your side.
Metabolisim and Nutrition problems:
• increased calcium level in the blood
• electrolyte disturbance with increased level of
phosphate in the blood (hyperphosphataemia)
These symptoms are signs that problems with
your kidneys may be developing, such as kidney
stones forming. Kidney stones may cause a
sharp spasm in one side of your lower back.
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
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.
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.
What AlfaD® capsules contain:
• The active ingredient is alfacalcidol
(1 α-hydroxyvitamin D3) 0.25, 0.5 or
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% (E422) and anidrisorb 85/70 (sorbitol,
sorbitans, superior polyols and mannitol).
The printing ink contains shellac 54% (E904)
and black iron oxide (E172).
The capsules contain the following colours:
• 0.25 microgram capsules: red iron oxide
• 0.5 microgram capsules: titanium dioxide
(E171) and red iron oxide (E172)
• 1.0 microgram capsules: titanium dioxide
(E171) and yellow iron oxide (E172).
What AlfaD® capsules look like and contents of
• The 0.25 microgram capsules are oval, opaque,
reddish-brown, elastic soft gelatin capsules
containing clear, pale yellow, oily solution.
They are printed ‘0.25’ on one side in black ink.
• The 0.5 microgram capsules are oval, opaque,
pale pink, elastic soft gelatin capsules
containing clear, pale yellow, oily solution.
They are printed ‘0.5’ on one side in black ink.
• The 1 microgram capsules are oval, opaque,
cream to ivory, elastic soft gelatin capsules
containing clear, pale yellow, oily solution.
They are printed ‘1.0’ on one side in black ink.
• The product is available in pack sizes of 7, 10,
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
150, 160, or 168 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation holder: TEVA UK
Limited, Eastbourne BN22 9AG England.
Company responsible for manufacture:
Pharmachemie B.V., Swensweg 5,
2031 GA Haarlem, Netherlands.
AlfaD® is a registered trademark of Teva
Pharmaceutical Industries Ltd.
This leaflet was last revised: 01/2016
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
Meaning of Signature
Regulatory Affairs Approval
15-Sep-2016 11:46:34 AM
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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.