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EVACAL D3 1500 MG/400 IU CHEWABLE TABLETS

Active substance(s): CALCIUM CARBONATE / CHOLECALCIFEROL CONCENTRATE (POWDER FORM) / COLECALCIFEROL

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EVACAL D3® 1500 mg/400 iu
CHEWABLE TABLETS

If any of the above apply to you, talk to your
doctor or pharmacist before taking Evacal D3®
1500 mg/400 iu Chewable Tablets.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Children under 12 years
Evacal D3® 1500 mg/400 iu Chewable Tablets are
not intended for use in children under 12 years.

calcium carbonate and colecalciferol

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
have told you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet.
• You must talk to a doctor if you do not feel
better or if you feel worse.
WHAT IS IN THIS LEAFLET:

1. What Evacal D3® 1500 mg/400 iu Chewable
Tablets are and what they are used for
2. What you need to know before you take
Evacal D3® 1500 mg/400 iu Chewable Tablets
3. How to take Evacal D3® 1500 mg/400 iu
Chewable Tablets
4. Possible side effects
5. How to store Evacal D3® 1500 mg/400 iu
Chewable Tablets
6. Contents of the pack and other information

WHAT EVACAL D3® 1500 mg/400 iu
CHEWABLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Evacal D3® 1500 mg/400 iu Chewable Tablets
are a calcium-vitamin D³-supplement.
It is used
• to prevent and treat a lack of calcium and
vitamin D in the elderly
• for vitamin D- and calcium supplementation
as supportive treatment of osteoporosis
(brittle bones).

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE
EVACAL D3® 1500 mg/400 iu
CHEWABLE TABLETS

Do not take Evacal D3® 1500 mg/400 iu
Chewable Tablets
• if you are allergic to calcium, vitamin D³ or
any of the other ingredients of this medicine
(listed in section 6)
• if you have high levels of calcium in your
blood (hypercalcaemia)
• if you have high levels of calcium in your
urine (hypercalciuria)
• if you suffer from overactive parathyroid
glands (hyperparathyroidism)
• if you suffer from bone marrow cancer
(myeloma)
• if you suffer from cancer that has affected
your bones (bone metastases)
• if you have restriction in movement of the
limbs (prolonged immobilisation)
accompanied with hypercalcaemia and / or
hypercalciuria
• if you have kidney stones (nephrolithiasis)
• if you have calcium deposits in your kidneys
(nephrocalcinosis)
• if you suffer from an excessive supply of
vitamin D (hypervitaminosis D)
• if you have severe kidney problems.
Warnings and precautions
• during long-term treatment the levels of
calcium in your blood and urine and your
kidney function have to be monitored
regularly. This is especially important if you
have a tendency to develop kidney stones.
Depending on your blood levels your doctor
might reduce the dosage or discontinue the
treatment.
• if you are simultaneously being treated with
cardiac glycosides or thiazide diuretics
(water tablets) for heart problems the levels
of calcium in your blood and urine and your
kidney function have to be monitored
regularly. Depending on your blood levels
your doctor might reduce the dosage or
discontinue the treatment.
• if you suffer from kidney problems you have
to take Evacal D3® 1500 mg/400 iu Chewable
Tablets with special care. Your calcium levels
of the blood and urine have to be checked. If
you suffer from severe kidney problems, use
other forms of vitamin D than colecalciferol.
• take additional supplementation of calcium
and vitamin D only under medical
supervision and your doctor will require
frequent monitoring of the calcium levels in
the blood and urine
• take special care when taking Evacal D3®
1500 mg/400 iu Chewable Tablets if you
suffer from sarcoidosis (an immune system
disorder which may affect your liver, lung,
skin or lymph nodes). There is a risk that the
effect of this medicinal product gets too
strong which can result in an overdose of
calcium in the body. The levels of calcium in
the blood and urine have to be monitored.
• if you are immobile and are suffering from
osteoporosis this medicinal product has to
be used with special care, as the level of
calcium in your blood might increase.

Other medicines and
Evacal D3® 1500 mg/400 iu Chewable Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
• In the case of simultaneous treatment with
digitalis glycosides (cardiac glycosides
derived from foxglove), changes in the way
the heart beats (cardiac arrhythmias) can
occur. Rigorous medical monitoring
including an ECG and measurement of the
blood calcium level is therefore necessary.
• In the case of simultaneous administration of
diuretics of the thiazide drug class (also
called water tablets), the blood calcium level
should be regularly monitored since
thiazides decrease the amount of calcium
disposed of in the urine
• The absorption and thus also the
effectiveness of certain antibiotics (called
tetracyclines) are decreased by the
simultaneous administration of Evacal D3®
1500 mg/400 iu Chewable Tablets. These
drugs should be taken at least 2 hours before
or 4-6 hours after Evacal D3® 1500 mg/400 iu
Chewable Tablets.
• Furthermore, other medicines such as
sodium fluoride (used to strengthen the
tooth enamel or to treat osteoporosis) and
bisphosphonate (used to treat osteoporosis)
drugs are affected by interactions. These
products should therefore be taken at least
3 hours before Evacal D3® 1500 mg/400 iu
Chewable Tablets.
• As long an interval as possible should be left
between the administration of
cholestyramine (a product to lower raised
cholesterol levels) or laxatives such as liquid
paraffin and Evacal D3® 1500 mg/400 iu
Chewable Tablets since otherwise vitamin D
is not absorbed properly
• The simultaneous administration of
Evacal D3® 1500 mg/400 iu Chewable Tablets
and phenytoin (a product for the treatment of
epilepsy) or barbiturates (hypnotics) can
result in a reduction in the effect of vitamin D
• The simultaneous administration of
Evacal D3® 1500 mg/400 iu Chewable Tablets
and glucocorticoids (e.g. cortisone) can result
in a reduction in the effect of vitamin D and a
decreased calcium level in the blood
• The additional supplementation of calcium
and vitamin D should be given only under
medical supervision and will require frequent
monitoring of the calcium levels in the blood
and urine
• Calcium can reduce the effect of
levothyroxine (used to treat thyroid
deficiency). For this reason, levothyroxine
should be taken at least four hours before or
four hours after Evacal D3® 1500 mg/400 iu
Chewable Tablets.
• The effect of quinolone antibiotics may be
reduced if taken at the same time as calcium.
Take quinolone antibiotics two hours before
or six hours after taking Evacal D3®
1500 mg/400 iu Chewable Tablets.
Evacal D3® 1500 mg/400 iu Chewable Tablets
with food and drink
You can take Evacal D3® 1500 mg/400 iu
Chewable Tablets at any time, with or without
food.
Please notice that oxalic acid (contained in
spinach and rhubarb) and phytic acid
(contained in wholegrain cereals) can reduce
the amount of calcium you absorb in your
bowel. In the 2 hours before or after eating
food containing high amounts of oxalic or
phytic acid patients should not take medicinal
products that contain calcium.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, Evacal D3® 1500 mg/400 iu Chewable
Tablets should only be used under medical
supervision. Ask your doctor or pharmacist for
advice before taking this medicine.
If you are pregnant you may use Evacal D3®
1500 mg/400 iu Chewable Tablets in case of a
calcium and vitamin D deficiency.
The daily dose of 1 tablet must not be
exceeded. During pregnancy the total daily
amount of calcium should not be higher than
1,500 mg and the total daily amount of vitamin
D³ should not be higher than 600 iu
(International Units).
Long-term overdose of calcium and vitamin D
during pregnancy must be avoided since this
may lead to high levels of calcium in the blood
and may have a negative effect on the unborn
child.
Evacal D3® 1500 mg/400 iu Chewable Tablets
can be used during breast-feeding. As calcium
and vitamin D pass into breast-milk check with
your doctor first if your child receives any
other products containing vitamin D.

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 the Yellow Card
Evacal D3® 1500 mg/400 iu Chewable Tablets
Scheme at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100
contain
• aspartame (E951), a source of phenylalanine 3352 (available from 10 a.m. to 2 p.m. Mondays
to Fridays) or fill in a paper form available from
which may be harmful for people with
your local pharmacy. By reporting side effects
phenylketonuria
you can help provide more information on the
• sorbitol (E420), isomalt (E953) and sucrose.
If you have been told by your doctor that you safety of this medicine.
have an intolerance to some sugars, contact
your doctor before taking this medicine.
Driving and using machines
Evacal D3® 1500 mg/400 iu Chewable Tablets
have no influence on your ability to drive and
use machines.

3

HOW TO TAKE EVACAL D3
1500 mg/400 iu CHEWABLE TABLETS
®

Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
have told you. Check with your doctor or
pharmacist if you are not sure.
Dose
If not told otherwise by your doctor the
recommended dose is:
Adults, elderly and children over 12 years of
age take 2 chewable tablets daily
(corresponding to 1,200 mg of calcium and
800 iu (International Units) of vitamin D³),
preferably one tablet each morning and
evening.
Pregnant women take 1 chewable tablet daily
(corresponding to 600 mg of calcium and
400 iu (International Units) of vitamin D³). The
daily dose of 1 tablet must not be exceeded.
Method of administration
The tablet has to be chewed before it is
swallowed. It should be taken at any time, with
or without food.

5

HOW TO STORE EVACAL D3®
1500 mg/400 iu CHEWABLE TABLETS

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
(EXP) which is stated on the carton and on the
tablet container or on the laminated aluminium
paper foil. The expiry date (EXP) refers to the
last day of that month.
For tablet container:
Keep the tablet container tightly closed in
order to protect from moisture.
For strips: This medicinal product does not
require any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Evacal D3® 1500 mg/400 iu Chewable
Tablets contain
• The active substances are calcium and
colecalciferol. Each chewable tablet contains
1,500 mg of calcium carbonate (equivalent to
600 mg of calcium) and 4.0 mg of
colecalciferol concentrate (powder form)
(equivalent to 10 micrograms of
If you take more Evacal D3® 1500 mg/400 iu
colecalciferol = 400 iu of vitamin D³).
Chewable Tablets than you should
• The other ingredients are isomalt (E953),
Overdose of Evacal D3® 1500 mg/400 iu
xylitol, sorbitol (E420), citric acid, anhydrous,
Chewable Tablets may lead to symptoms such
sodium dihydrogen citrate, magnesium
as feeling sick (nausea), vomiting, thirst or
stearate, carmellose sodium, flavour tutti
excessive thirst, increased urine output,
frutti, silica, colloidal hydrated, aspartame
depletion of body fluids or constipation. If an
(E951), acesulfam potassium, sodium
overdose is suspected, contact your doctor or
ascorbate, all-rac-alpha-tocopherol, modified
pharmacist immediately.
(maize) starch, sucrose, triglycerides medium
chain and silicon dioxide colloidal.
If you forget to take Evacal D3® 1500 mg/400 iu
Chewable Tablets
If you forget to take Evacal D3® 1500 mg/400 iu What Evacal D3® 1500 mg/400 iu Chewable
Tablets look like and contents of the pack
Chewable Tablets, take it as soon as you
remember. However, do not take a double dose Evacal D3® 1500 mg/400 iu Chewable Tablets
are round, white tablets.
to make up for a forgotten tablet.
Duration of treatment
Evacal D3® 1500 mg/400 iu Chewable Tablets
should be taken as long-term treatment. Talk to
your doctor about how long you should take
this medicine for (see also section 2, Warnings
and precautions).

If you stop taking Evacal D3® 1500 mg/400 iu
Chewable Tablets
If you wish to interrupt or prematurely
discontinue the treatment, please consult your
doctor.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The evaluation of side effects is based on the
following frequencies:
Very common: affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in
10,000
Not known:
frequency cannot be
estimated from the available
data
Stop taking Evacal D3® 1500 mg/400 iu
Chewable Tablets and contact a doctor
immediately if you experience the following
allergic reaction (not known as frequency
cannot be estimated from the available data):
• swelling of the face, lips, tongue or throat
with sudden difficulty breathing and severe
rash.
The other side effects reported are:
Rare side effects:
• feeling sick (nausea), diarrhoea, abdominal
pain, constipation, wind, bloating (abdominal
distension)
• rash, itching, hives.
Uncommon side effects:
• high levels of calcium in your blood
(hypercalcaemia) or urine (hypercalciuria).

The chewable tablets are available in
polypropylene tablet containers with
polyethylene stoppers containing a desiccant
in the following package sizes:
10, 20, 30, 50, 56, 60, 90, 100, 112, 120, bundling
pack containing 200 (2 packs of 100) chewable
tablets.
The chewable tablets are available in strips of
laminated aluminium paper foil in the
following package sizes:
10, 20, 30, 50, 56, 60, 90, 100, 112, bundling
pack containing 112 (2 packs of 56), multipack
containing 112 (2 packs of 56), 120, bundling
pack containing 120 (2 packs of 60), bundling
pack containing 200 (2 packs of 100) chewable
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited,
Eastbourne
BN22 9AG.
Manufacturer
Hermes Arzneimittel GmbH
Georg-Kalb-Straße 5-8
82049 Großhesselohe / Munich
Germany.
This leaflet was last revised in 06/2013
PL 00289/1742

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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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