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THEICAL-D3 1000 MG / 880 IU CHEWABLE TABLETS

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

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Package leaflet: Information for the user

1000 mg / 880 IU chewable tablets
Calcium and Colecalciferol
Read all of this leaflet carefully because
it contains important information for
you.
This medicine is available without
prescription. However, you still need
to take TheiCal-D 3 1000 mg / 880 IU
chewable tablets carefully to get the
best results from it.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What TheiCal-D 3 1000 mg / 880 IU
chewable tablets is and what it is
used for
2. Before you take TheiCal-D 3
1000 mg / 880 IU chewable tablets
3. How to take TheiCal-D 3
1000 mg / 880 IU chewable tablets
4. Possible side effects
5. How to store TheiCal-D 3
1000 mg / 880 IU chewable tablets
6. Further information

1. What TheiCal-D3
1000 mg / 880 IU chewable
tablets is and what it is used for
TheiCal-D 3 1000 mg / 880 IU chewable
tablets is a calcium-vitamin D 3 -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. Before you take TheiCal-D3
1000 mg / 880 IU chewable
tablets
Do not take TheiCal-D3
1000 mg / 880 IU chewable tablets
- if you are allergic (hypersensitive) to
calcium, vitamin D 3 or any of the other
ingredients of TheiCal-D 3
1000 mg / 880 IU chewable tablets
- if you have high levels of calcium in
your blood (hypercalcaemia)
- if you have increased excretion of
calcium with 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 a restraint 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

Client:

StirlingAnglian Pharma

Version: 8



Chewable Tablets

Date: 29-01-2016

Size:

148 x 497 mm

Print area: 128 x 480 mm

Leaflet:

theiCal-D3

Colour No: 1
Font:

30 tablets

Colour: Black

Univers (45-Light), 65-Bold), size 9 pt, leading 11 pt

Take special care with TheiCal-D3
1000 mg / 880 IU chewable tablets
- 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 TheiCal-D 3 1000 mg / 880 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 TheiCal-D 3
1000 mg / 880 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.
TheiCal-D 3 1000 mg / 880 IU chewable
tablets are not intended for use in children
and adolescents.
Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
- In the case of simultaneous treatment
with digitalis glycosides (cardiac
glycosides derived from foxglove),
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 excretion of calcium in
the urine.
- The absorption and thus also the
effectiveness of certain antibiotics
(called tetracyclines) are decreased
by the simultaneous administration of
TheiCal-D 3 1000 mg / 880 IU chewable
tablets. These drugs should be taken at
least 2 hours before or 4–6 hours after
TheiCal-D 3 1000 mg / 880 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 TheiCal-D 3 1000 mg / 880 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 TheiCal-D 3
1000 mg / 880 IU chewable tablets
since otherwise vitamin D is not
absorbed properly.
- The simultaneous administration of
TheiCal-D 3 1000 mg / 880 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
TheiCal-D 3 1000 mg / 880 IU chewable
tablets and glucocorticoids (e.g.
cortisone) can result in a reduction
in the effect of vitamin D and to 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 TheiCal-D 3
1000 mg / 880 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
TheiCal-D 3 1000 mg / 880 IU chewable
tablets.
Taking TheiCal-D3 1000 mg / 880 IU
chewable tablets with food and drink
You can take TheiCal-D 3 1000 mg / 880 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 and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are pregnant you may use TheiCal-D 3
1000 mg / 880 IU chewable tablets in case
of a calcium and vitamin D deficiency.
The daily dose of half a 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 D 3 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.
TheiCal-D 3 1000 mg / 880 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.
Driving and using machines
TheiCal-D 3 1000 mg / 880 IU chewable
tablets has no influence on your ability to
drive and use machines.
Important information about some
of the ingredients of TheiCal-D3
1000 mg / 880 IU chewable tablets
This medicine contains aspartame (E951),
a source of phenylalanine which may be
harmful for people with phenylketonuria.
This medicine also contains 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. How to take TheiCal-D3
1000 mg / 880 IU chewable tablets
Always take TheiCal-D 3 1000 mg / 880 IU
chewable tablets exactly as described in
this leaflet. You should check with your
doctor or pharmacist if you are not sure.
Dosage
If not told otherwise by your doctor the
usual dose is:
Adults and elderly take 1 chewable tablet
daily (corresponding to 1,000 mg of
calcium and 880 IU (International Units) of
vitamin D 3).
Pregnant women take only half a
chewable tablet daily (corresponding
to 500 mg of calcium and 440 IU
(International Units) of vitamin D 3). The
daily dose of half a 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.
Duration of treatment
TheiCal-D 3 1000 mg / 880 IU chewable
tablets should be taken as long-term
treatment. Talk to your doctor how long
you should take TheiCal-D 3
1000 mg / 880 IU chewable tablets (see
also section 2, Take special care with
TheiCal-D 3 1000 mg / 880 IU chewable
tablets).
If you take more TheiCal-D3
1000 mg / 880 IU chewable tablets
than you should
Overdose of TheiCal-D 3 1000 mg / 880 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.
If you forget to take TheiCal-D3
1000 mg / 880 IU chewable tablets
If you forget to take TheiCal-D 3
1000 mg / 880 IU chewable tablets, take
it as soon as you remember. However, do
not take a double dose to make up for a
forgotten tablet.
If you stop taking TheiCal-D3
1000 mg / 880 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 product, ask your doctor or
pharmacist.

4. Possible side effects

Client:

Leaflet:

StirlingAnglian Pharma
theiCal-D3

Version: 8
30 tablets



Chewable Tablets

Date: 29-01-2016

Size:

148 x 497 mm

Print area: 128 x 480 mm

Colour No: 1
Font:

Colour: Black

Univers (45-Light), 65-Bold), size 9 pt, leading 11 pt

Like all medicines, TheiCal-D 3
1000 mg / 880 IU chewable tablets
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 TheiCal-D3
1000 mg / 880 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).
If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

5. How to store TheiCal-D3
1000mg / 880 IU chewable tablets
Keep out of the reach and sight of
children.
Do not use TheiCal-D 3 1000 mg / 880 IU
chewable tablets 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.
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 TheiCal-D3 1000 mg / 880 IU
chewable tablets contains
- The active substances are calcium
and colecalciferol. Each chewable
tablet contains 2,500 mg of calcium
carbonate (equivalent to 1,000 mg of
calcium) and 8.8 mg of colecalciferol
concentrate (powder form) (equivalent
to 22 micrograms of colecalciferol =
880 IU of vitamin D 3).
- The other ingredients are isomalt
(E953), xylitol, sorbitol (E420),
citric acid, anhydrous, sodium
dihydrogen citrate, magnesium
stearate, carmellose sodium, flavour
orange “CPB” and flavour orange
“CVT” (which both contain sorbitol
(E420)), aspartame (E951), acesulfam
potassium, sodium ascorbate, all-racalpha-tocopherol, modified (maize)
starch, sucrose, triglycerides medium
chain and silicon dioxide colloidal.
What TheiCal-D3 1000 mg / 880 IU
chewable tablets looks like and
contents of the pack
TheiCal-D 3 1000 mg / 880 IU chewable
tablets are round, white tablets with
faultless surface and a breakmark. The
tablet can be divided into equal halves.
The chewable tablets are available in
polypropylene tablet containers with
polyethylene stoppers containing a
desiccant in the following package sizes:
20, 28, 30, 50, 56, 60, 90, 100 (bundling
package 5 x 20) chewable tablets.
The chewable tablets are available in
strips of laminated aluminium paper foil in
the following package sizes:
20, 28, 30, 48, 56, 60, 90, 96, 100
(bundling package 5 x 20) chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Stirling Anglian Pharmaceuticals Limited
Hillington Park Innovation Centre
1 Ainslie Road
Hillington Park
Glasgow
G52 4RU
UK
Manufacturer
Hermes Arzneimittel GmbH
Georg-Kalb-Strasse 5-8
82049 Großhesselohe / Munich
Germany
This leaflet was last revised in
January 2016.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Germany:
theiCal-D 3 1000 mg / 880 I.E. Kautabletten
Italy:
theiCal-D 3 1000 mg / 880 UI compresse
masticabili

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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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