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EVACAL D3 1500 MG/400 IU CHEWABLE TABLETS

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

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Evacal D3® 1500 mg/400 iu
ChewableTablets

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.
Read all of this leaflet carefully before you start - In the case of simultaneous treatment with
digitalis glycosides (cardiac glycosides
taking this medicine because it contains
derived from foxglove), changes in the way
important information for you.
the heart beats (cardiac arrhythmias) can
Always take this medicine exactly as described
occur. Rigorous medical monitoring
in this leaflet or as your doctor or pharmacist
including an ECG and measurement of the
have told you.
blood calcium level is therefore necessary.
- Keep this leaflet. You may need to read it
In
the case of simultaneous administration of
again.
diuretics of the thiazide drug class (also
- Ask your pharmacist if you need more
called
water tablets), the blood calcium level
information or advice.
should be regularly monitored since
- If you get any side effects, talk to your doctor
thiazides
decrease the amount of calcium
or pharmacist. This includes any possible
disposed of in the urine.
side effects not listed in this leaflet.
The
absorption
and thus also the
- You must talk to a doctor if you do not feel
effectiveness of certain antibiotics (called
better or if you feel worse.
tetracyclines) are decreased by the
What is in this leaflet
simultaneous administration of Evacal D3®
1500 mg/400 iu Chewable Tablets. These
1. What Evacal D3® 1500 mg/400 iu Chewable
drugs should be taken at least 2 hours before
Tablets are and what they are used for
or 4-6 hours after Evacal D3® 1500 mg/400 iu
2. What you need to know before you take
Chewable Tablets.
Evacal D3® 1500 mg/400 iu Chewable Tablets
- Furthermore, other medicines such as
3. How to take Evacal D3® 1500 mg/400 iu
sodium fluoride (used to strengthen the
Chewable Tablets
tooth enamel or to treat osteoporosis) and
4. Possible side effects
bisphosphonate (used to treat osteoporosis)
5. How to store Evacal D3® 1500 mg/400 iu
drugs are affected by interactions. These
Chewable Tablets
products should therefore be taken at least
6. Contents of the pack and other information
3 hours before Evacal D3® 1500 mg/400 iu
Chewable Tablets.
1 What Evacal D3® 1500 mg/400 iu
- As long an interval as possible should be left
Chewable Tablets are and what they
between the administration of
are used for
cholestyramine (a product to lower raised
Evacal D3® 1500 mg/400 iu Chewable Tablets
cholesterol levels) or laxatives such as liquid
are a calcium-vitamin D3-supplement.
paraffin and Evacal D3® 1500 mg/400 iu
Chewable Tablets since otherwise vitamin D
It is used
is not absorbed properly.
- to prevent and treat a lack of calcium and
- The simultaneous administration of Evacal
vitamin D in the elderly.
D3® 1500 mg/400 iu Chewable Tablets and
- for vitamin D- and calcium supplementation
phenytoin (a product for the treatment of
as supportive treatment of osteoporosis
epilepsy) or barbiturates (hypnotics) can result
(brittle bones).
in a reduction in the effect of vitamin D.
- The simultaneous administration of Evacal D3®
2 What you need to know before you
®
1500 mg/400 iu Chewable Tablets and
take Evacal D3 1500 mg/400 iu
glucocorticoids (e. g. cortisone) can result in
Chewable Tablets
a reduction in the effect of vitamin D and a
Do not take Evacal D3® 1500 mg/400 iu
decreased calcium level in the blood.
Chewable Tablets
- The additional supplementation of calcium
- if you are allergic to calcium, vitamin D3 or
and vitamin D should be given only under
any of the other ingredients of this medicine
medical supervision and will require frequent
(listed in section 6)
monitoring of the calcium levels in the blood
- if you have high levels of calcium in your
and urine.
blood (hypercalcaemia)
- Calcium can reduce the effect of
- if you have high levels of calcium in your
levothyroxine (used to treat thyroid
urine (hypercalciuria)
deficiency). For this reason, levothyroxine
- if you suffer from overactive parathyroid
should be taken at least four hours before or
glands (hyperparathyroidism)
four hours after Evacal D3® 1500 mg/400 iu
- if you suffer from bone marrow cancer
Chewable
Tablets.
(myeloma)
- The effect of quinolone antibiotics may be
- if you suffer from cancer that has affected
reduced
if
taken at the same time as calcium.
your bones (bone metastases)
Take quinolone antibiotics two hours before
- if you have restriction in movement of the
or
six
hours
after taking Evacal D3® 1500 mg/
limbs (prolonged immobilisation)
400 iu Chewable Tablets.
accompanied with hypercalcaemia and / or
hypercalciuria
Evacal D3® 1500 mg/400 iu Chewable Tablets
- if you have kidney stones (nephrolithiasis)
with food and drink
- if you have calcium deposits in your kidneys You can take Evacal D3® 1500 mg/400 iu
(nephrocalcinosis)
Chewable Tablets at any time, with or without
- if you suffer from an excessive supply of
food.
vitamin D (hypervitaminosis D)
Please notice that oxalic acid (contained in
- if you have severe kidney problems
spinach and rhubarb) and phytic acid
calcium carbonate and colecalciferol

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.

REG0098418

Version 2.4

Pharma code 969

2
Version:

231-30-13343-C LEA CALCIUM & VITAMIN D CHEWABLE TABLETS 600MG/400MG TAB TUK
Pharma code 969

TEVA UK Ref:

(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.

Approved

Page 1 of 3

Pharma code 969

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 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.

Pharma code 969

07 January 2016

Package leaflet: Information for the user

3

How to take 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 contains
- The active substances are calcium and
colecalciferol. Each chewable tablet contains
1,500 mg of calcium carbonate (equivalent to
Dose
600 mg of calcium) and 4.0 mg of
If not told otherwise by your doctor the
colecalciferol concentrate (powder form)
recommended dose is:
(equivalent to 10 micrograms of
Adults, elderly and children over 12 years of
colecalciferol = 400 IU of vitamin D3).
age take 2 chewable tablets daily
- The other ingredients are isomalt (E953),
(corresponding to 1,200 mg of calcium and
xylitol, sorbitol (E420), citric acid, anhydrous,
800 IU (International Units) of vitamin D3),
sodium dihydrogen citrate, magnesium
preferably one tablet each morning and
stearate, carmellose sodium, flavour tutti
evening.
frutti, silica, colloidal hydrated, aspartame
Pregnant women take 1 chewable tablet daily
(E951), acesulfam potassium, sodium
(corresponding to 600 mg of calcium and
ascorbate, all-rac-alpha-tocopherol, modified
400 IU (International Units) of vitamin D3).
(maize) starch, sucrose, triglycerides medium
The daily dose of 1 tablet must not be exceeded.
chain and silicon dioxide colloidal.
Method of administration
What Evacal D3® 1500 mg/400 iu Chewable
The tablet has to be chewed before it is
Tablets looks like and contents of the pack
swallowed. It should be taken at any time, with Evacal D3® 1500 mg/400 iu Chewable Tablets
or without food.
are round, white tablets.

TEVA UK Ref:

231-30-13343-C LEA CALCIUM & VITAMIN D CHEWABLE TABLETS 600MG/400MG TAB TUK
Version:

2

07 January 2016

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.

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 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
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
If you forget to take Evacal D3® 1500 mg/400 iu tablets.
Chewable Tablets
Not all pack sizes may be marketed.
If you forget to take Evacal D3® 1500 mg/400 iu
Marketing Authorisation Holder
Chewable Tablets, take it as soon as you
remember. However, do not take a double dose Teva UK Limited,
Eastbourne
to make up for a forgotten tablet.
BN22 9AG
If you stop taking Evacal D3® 1500 mg/400 iu
Manufacturer
Chewable Tablets
Hermes Arzneimittel GmbH
If you wish to interrupt or prematurely
discontinue the treatment, please consult your Georg-Kalb-Straße 5-8
82049 Großhesselohe / Munich
doctor.
Germany
If you have any further questions on the use of
This leaflet was last revised in 06/2013
this medicine, ask your doctor or pharmacist.

4

PL 00289/1742

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
- Serious allergic reaction which causes
swelling of the face or throat or voice box.
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 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.

13343-C
470 x 165
79639A

REG0098418

Version 2.4

Approved

Page 2 of 3

Expand Transcript

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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