EVACAL D3 1500 MG/400 IU CHEWABLE TABLETS

Evacal D3® 1500 mg/400 iu
ChewableTablets
calcium carbonate and colecalciferol
Package leaflet: Information for the user

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. See
section 4.
• 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

1

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
• before taking <Calcium 600 mg / Vitamin
D3 400 IU, chewable tablets>, calcium and
alkali intake from other sources (e.g. foods,
enriched foods or other medicinal
products) should be considered. If high
doses of calcium are given together with
alkaline agents (such as carbonates), this
can lead to milk-alkali syndrome (Burnett
syndrome). Milk-alkali syndrome is a
disorder of calcium metabolism with an
increase in blood calcium levels. It can be
triggered by the intake of very large
quantities of milk and/or calcium carbonate
from other sources or by excessive use of
antacids (medicines to reduce too much
acid in the stomach). This may lead to side
effects, such as an increase in blood
calcium levels (hypercalcaemia), metabolic
alkalosis (a metabolic condition that
causes an increase in blood pH), kidney
failure and soft tissue calcification (see
section 4.). Therefore, regular medical
surveillance of blood calcium levels is
required.
• 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 and phosphate 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.
If any of the above apply to you, talk to your
doctor or pharmacist before taking Evacal D3®
1500 mg/400 iu Chewable Tablets.
Children under 12 years
Evacal D3® 1500 mg/400 iu Chewable Tablets
are not intended for use in children under 12
years.
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 and its metabolites also pass
into breast-milk check with your doctor first if
your child receives any other products
containing vitamin D.
Driving and using machines
Evacal D3® 1500 mg/400 iu Chewable Tablets
have no influence on your ability to drive and
use machines.
Evacal D3® 1500 mg/400 iu Chewable Tablets
contains
• aspartame (E951), a source of
phenylalanine which may be harmful for
people with phenylketonuria
• sorbitol (E420), isomalt (E953) and sucrose.
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.

3

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.

6

Contents of the pack and other
information

How to take Evacal D3® 1500 mg/400 What Evacal D3® 1500 mg/400 iu Chewable
Tablets contains
iu Chewable Tablets

• 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
Dose
colecalciferol = 400 IU of vitamin D3).
If not told otherwise by your doctor the
•
The
other ingredients are isomalt (E953),
recommended dose is:
xylitol, sorbitol (E420), citric acid, anhydrous,
Adults, elderly and children over 12 years of
sodium
dihydrogen citrate, magnesium
age take 2 chewable tablets daily
stearate, carmellose sodium, flavour tutti
(corresponding to 1,200 mg of calcium and
frutti,
silica,
colloidal hydrated, aspartame
800 IU (International Units) of vitamin D3),
(E951), acesulfam potassium, sodium
preferably one tablet each morning and evening.
ascorbate,
all-rac-alpha-tocopherol,
modified
Pregnant women take 1 chewable tablet daily
(maize) starch, sucrose, triglycerides medium
(corresponding to 600 mg of calcium and
chain
and
silicon
dioxide
colloidal.
400 IU (International Units) of vitamin D3). The
daily dose of 1 tablet must not be exceeded.
What Evacal D3® 1500 mg/400 iu Chewable
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or
pharmacist if you are not sure.

Method of administration
The tablet has to be chewed before it is
swallowed. It should be taken at any time, with
or without food.

Tablets looks like and contents of the pack
Evacal D3®1500 mg/400 iu Chewable Tablets
are round, white tablets.

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).

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.

If you take more Evacal D3® 1500 mg/400 iu
Chewable Tablets than you should
Overdose of Evacal D3® 1500 mg/400 iu
Chewable Tablets may lead to symptoms such
as feeling sick (nausea), vomiting, thirst or
excessive thirst, increased urine output,
depletion of body fluids or constipation. If an
overdose is suspected, contact your doctor or
pharmacist immediately.

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.

If you forget to take Evacal D3® 1500 mg/400
iu Chewable Tablets
If you forget to take Evacal D3® 1500 mg/400 iu
Chewable Tablets, take it as soon as you
remember. However, do not take a double dose
to make up for a forgotten tablet.

Not all pack sizes may be marketed.

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.

Manufacturer
Hermes Arzneimittel GmbH
Georg-Kalb-Straße 5-8
82049 Großhesselohe / Munich
Germany

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

This leaflet was last revised in 09/2017

Marketing Authorisation Holder
TEVA UK Limited,
Eastbourne
BN22 9AG,
UK

PL 00289/1742

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
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:
Uncommon: may affect up to 1 in 100 people
high levels of calcium in your blood
(hypercalcaemia) or urine (hypercalciuria).
Rare: may affect up to 1 in 1,000 people
• feeling sick (nausea), diarrhoea, abdominal
pain, constipation, wind, bloating (abdominal
distension).
• rash, itching, hives.
Not Known: frequency can not be estimated
from the available data
• If you have impaired renal function, you may
be at risk of increased amounts of phosphate
in the blood, renal stone formation and
increased amounts of calcium in the kidneys.
• calcium metabolic disorder (milk-alkali
syndrome) with an increase in blood calcium
levels (hypercalcaemia), too little acid in the
blood (metabolic alkalosis), kidney failure
and soft tissue calcification.
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.

EAS1655a
470 x 165