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ACCRETE D3 ONE A DAY 1000 MG/880 IU CHEWABLE TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Accrete D3 One a Day 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 Accrete D3 One a Day
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 Accrete D3 One a Day Chewable Tablets
are and what they are used for
2. Before you take Accrete D3 One a Day
Chewable Tablets
3. How to take Accrete D3 One a Day Chewable
Tablets
4. Possible side effects
5. How to store Accrete D3 One a Day Chewable
Tablets
6. Further information

1

What Accrete D3 One A Day Chewable
Tablets are and what they are used for



Accrete D3 One a Day Chewable Tablets is 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



Before you take Accrete D3 One A Day
Chewable Tablets

Do not take Accrete D3 One a Day Chewable Tablets
• if you are allergic (hypersensitive) to calcium,
vitamin D3 or any of the other ingredients of
Accrete D3 One a Day 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

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Take special care with Accrete D3 One a Day
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 Accrete D3 One a Day 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 cholecalciferol .
• 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 Accrete D3 One a
Day 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.

Accrete D3 One a Day 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
Accrete D3 One a Day Chewable Tablets. These
drugs should be taken at least 2 hours before or
4-6 hours after Accrete D3 One a Day 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 Accrete D3 One a Day 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 Accrete D3
One a Day Chewable Tablets since otherwise
vitamin D is not absorbed properly.
The simultaneous administration of Accrete D3
One a Day 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 Accrete D3
One a Day 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 Accrete D3 One a Day
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 Accrete D3 One a Day Chewable Tablets.

Taking Accrete D3 One a Day Chewable Tablets
with food and drink
You can take Accrete D3 One a Day 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 Accrete D3 One a
Day 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 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.

Accrete D3 One a Day 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.

Continued on the next page >>

Artwork Proof Box
Ref: V015 - Resub of UK product name change + RFI
Proof no.
008.1

Date prepared:
06/01/2017

Colours:
Black
Black 20%
Dimensions: 165 x 470 mm

Font size:
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Driving and using machines
Accrete D3 One a Day Chewable Tablets has no
influence on your ability to drive and use machines.

You can also report side effects directly via the
Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

Important information about some of the
ingredients of Accrete D3 One a Day 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

5

Keep this medicine out of the sight and reach of
children.

Do not use Accrete D3 One a Day 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.

How to take Accrete D3 One A Day
Chewable Tablets

For tablet container:
Keep the tablet container tightly closed in order to
protect from moisture.

Always take Accrete D3 One a Day Chewable Tablets
exactly as your doctor or pharmacist has told you.
You should check with your doctor or pharmacist if
you are not sure.

For strips:
This medicinal product does not require any special
storage conditions.

Always take Accrete D3 One a Day Chewable
Tablets exactly as described in this leaflet. You
should check with your doctor or pharmacist if
you are not sure.

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.

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 D3).
Pregnant women take only half a chewable tablet
daily (corresponding to 500 mg of calcium and
440 IU (International Units) of vitamin D3). The daily
dose of half a tablet must not be exceeded.

6

Duration of treatment
Accrete D3 One a Day Chewable Tablets should be
taken as long-term treatment. Talk to your doctor
how long you should take Accrete D3 One a Day
Chewable Tablets (see also section 2, Take special
care with Accrete D3 One a Day Chewable Tablets).

If you take more Accrete D3 One a Day Chewable
Tablets than you should
Overdose of Accrete D3 One a Day 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.

What Accrete D3 One a Day Chewable Tablets
looks like and contents of the pack
Accrete D3 One a Day Chewable Tablets are round,
white tablets with faultless surface and a breakmark.
The tablet can be divided into equal halves.

If you forget to take Accrete D3 One a Day
Chewable Tablets
If you forget to take Accrete D3 One a Day Chewable
Tablets, take it as soon as you remember. However,
do not take a double dose to make up for a forgotten
tablet.

The chewable tablets are available in polypropylene
tablet containers with polyethylene stoppers
containing a desiccant in the following package
sizes:

10, 20, 28, 30, 40, 50, 56, 60, 90, 100 (bundling
package 5 x 20) chewable tablets

If you stop taking Accrete D3 One a Day
Chewable Tablets
If you wish to interrupt or prematurely discontinue
the treatment, please consult your doctor.

The chewable tablets are available in strips of
laminated aluminium paper foil in the following
package sizes:

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

10, 20, 28, 30, 40, 48, 56, 60, 60 (bundling package
2x30), 90, 90 (bundling package 3x30), 96, 100
(bundling package 5x20) and 120 chewable tablets

Possible side effects

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom

Like all medicines, Accrete D3 One a Day Chewable
Tablets can cause side effects, although not
everybody gets them.

The evaluation of side effects is based on the
following frequencies:
Very common
Common
Uncommon
Rare
Very rare
Not known

Further information

What Accrete D3 One a Day 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 D3).
• 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-rac-alpha-tocopherol,
modified (maize) starch, sucrose, triglycerides
medium chain and silicon dioxide colloidal.

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

4

How to store Accrete D3 One A Day
Chewable Tablets

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated
from the available data

Manufacturer
Hermes Arzneimittel GmbH,
Georg-Kalb-Straße 5-8,
82049 Großhesselohe/Munich,
Germany
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany.

Stop taking Accrete D3 One a Day 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.

This leaflet was last revised in 01/2017.

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 you have renal impairment, you are at increased
risk for high level of phosphate in the blood, increased
calcium levels in the kidneys and kidney stones.

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.

SZ00000LT000

Artwork Proof Box
Ref: V015 - Resub of UK product name change + RFI
Proof no.
008.1

Date prepared:
06/01/2017

Colours:
Black
Black 20%
Dimensions: 165 x 470 mm

Font size:
8.5pt
Fonts:
Helvetica

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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