ACCRETE D3 FILM-COATED TABLETS

Active substance: COLECALCIFEROL

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Accrete D3®

Film-Coated Tablets
Calcium, 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 use Accrete D3
film-coated 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 after one month.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Accrete D3 film-coated tablet is and
what it is used for
2. Before you take Accrete D3 film-coated tablets
3. How to take Accrete D3 film-coated tablets
4. Possible side effects
5. How to store Accrete D3 film-coated tablets
6. Further information

1. WHAT ACCRETE D3 FILM-COATED
TABLET IS AND WHAT IT IS USED FOR
The product is a combination of calcium (as
calcium carbonate) and colecalciferol (Vitamin D3).
It is recommended in the elderly for the
prevention and treatment of deficiency of
calcium and vitamin D3 that are essential for
bone formation and normal bone metabolism.
It is also recommended for Vitamin D and
calcium supplementation as an adjunct to
specific osteoporosis treatment of patients who
are at risk of vitamin D and calcium deficiency.

2. BEFORE YOU TAKE ACCRETE D3
FILM-COATED TABLETS
Do not take Accrete D3 film-coated tablets
- if you are allergic (hypersensitive) to active
substances or any of the other ingredients
- if you have kidney stones
- if you have kidney failure
- if you have excessive amounts of Vitamin D in
the blood
- if you have chronically increased calcium level
in your urine or elevated blood-calcium level
- Accrete D3 film-coated tablets contain
hydrogenated soya oil. If you are allergic to
peanut or soya, do not use this medicinal
product.
Take special care with Accrete D3 filmcoated tablets
Before taking Accrete D3 film-coated tablets
consult your doctor:
- if you have kidney disease or impaired kidney
function
- if you have sarcoidosis (an inflammatory
condition diagnosed by a doctor which
produces lumps in various organs of the body)
- if you are prone to development of kidney
stone
- if you are an immobilised patient with
osteoporosis
Your doctor should decide whether calcium
and/or vitamin D3 supply can be used in these
conditions.
Do not continue to take this medicine for longer
than one month without seeking advice from
your doctor.
If you use Accrete D3 film-coated tablets in
osteoporosis, your doctor may measure your
blood-calcium level (calcaemia) before starting
the treatment with the product Accrete D3
film-coated tablets.
In the case of long-term treatment with Accrete
D3 film-coated tablets, the blood-calcium level
must be regularly monitored. Depending upon
the results, your doctor may reduce the dosage
or decide to discontinue the treatment.
Accrete D3 film coated 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.

Consult your doctor if you are taking:
- any other medicines containing vitamin D or
calcium, because taking these with Accrete
D3 film-coated tablets may lead to a harmful
increase in your blood-calcium level. During
the treatment with Accrete D3 film-coated
tablets, do not use any other products
containing vitamin D or calcium without
medical advice.
- thiazide diuretics
- corticosteroids (anti-inflammatory drugs)
- cardiac glycosides (digitalis containing
medicines, used for the treatment of heart
failure)
Take special care if you use:
- ion exchange resins such as cholestyramine
or laxatives such as paraffin oil, as these
medicines may reduce the gastrointestinal
absorption of vitamin D.
- tetracycline containing preparations (antibiotics),
as calcium carbonate may interfere with their
absorption. Therefore, tetracycline preparations
should be administered at least two hours
before or four to six hours after using of
Accrete D3 film-coated tablets.
- bisphosphonate (used for the treatment of
osteoporosis) or sodium fluoride is used
concomitantly with Accrete D3 film-coated
tablets, these preparations should be
administered at least three hours before
using Accrete D3 film-coated tablets.
- Rifampicin (a medicine for tuberculosis),
phenytoin (a medicine for epilepsy) and
barbiturates (medicines which are used for
epilepsy or which help you sleep), as they
may make the vitamin D3 less effective.
- Estramustin (a medicine used in chemotherapy),
thyroid hormones or medicines containing
iron, zinc or strontium, as the amount
absorbed may be reduced. They should be
taken at least 2 hours before or after Accrete
D3 film-coated tablets.
Taking Accrete D3 film-coated tablets with
food and drink
Oxalic acid (found in e.g. spinach, sorrel and
rhubarb) and phytic acid (found in whole cereals)
may reduce calcium absorption. The patient
should not take Accrete D3 film-coated tablets
within two hours after eating foods rich in oxalic
acid and phytic acid.
Pregnancy and breast-feeding
During pregnancy or when breast feeding
Accrete D3 film-coated tablets should only be
used under medical advice and supervision.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
There are no data on the effect of this product
on driving capacity and using machines.
Important information about some of the
ingredients of Accrete D3 film-coated tablets
Accrete D3 film-coated tablets contain
hydrogenated soya oil. If you are allergic to
peanut or soya, do not use this medicinal
product.
Accrete D3 film-coated tablets contain sucrose.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. HOW TO TAKE ACCRETE D3 FILMCOATED TABLETS

5. HOW TO STORE ACCRETE D3 FILMCOATED TABLETS

Always use Accrete D3 film-coated tablets as
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.

Do not store above 25°C. Store in the original
package in order to protect from moisture.
Keep out of the reach and sight of children.

Adults and the elderly
The usual dose is one tablet twice a day.

Do not use Accrete D3 film-coated tablets after the
expiry date (EXP) which is stated on the carton.
The expiry date refers to the last day of that month.

Tablets should be swallowed (without chewing)
with water or fruit juice, ideally within an hour
and a half after meals. The tablet can be
broken in half, if needed.
You should obtain advice as to how long to
continue this medicine if it is being used to help
treat osteoporosis.
Accrete D3 film-coated tablets should not be
taken for longer than one month without
medical advice.
If you take more Accrete D3 film-coated
tablets than you should
If you take too many tablets, seek urgent
medical advice. Taking more than the
recommended dose may cause unpleasant and
potentially harmful side-effects. Symptoms of
overdose may include:
lack of appetite, thirst, nausea, vomiting,
constipation, abdominal pain, muscle
weakness, fatigue, mental disturbances, excess
drinking and excess urination, bone pain and in
severe cases cardiac arrhythmias. In extreme
cases calcium overdose can lead to coma and
death. Long term increased calcium level in the
blood can lead to irreversible kidney damage
and deposits of calcium in the body.
If you forget to take Accrete D3 filmcoated tablets:
Do not take a double dose to make up for a
forgotten dose, as you would not substitute the
missing amount, but you risk an overdosing.
Continue the treatment according to the
instructions.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines Accrete D3 film-coated
tablets can cause side effects, although not
everybody gets them.
- Uncommon (affecting less than 1 in 100 users):
hypercalcaemia (too much calcium in your blood).
Symptoms may include nausea, vomiting, lack
of appetite, constipation, stomach ache, bone
pain, extreme thirst, needing to pass urine more
often, muscle weakness, drowsiness and
confusion; or markedly increased calcium in
urine (hypercalciuria). If you are on long term
treatment, your doctor may, from time to time,
wish to check the level of calcium in your blood
and urine as well as your kidney function.
- Rare (affecting less than 1 in 1000 users):
constipation, flatulence, nausea, abdominal
pain, diarrhoea, itching, rash and urticaria.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please inform your doctor or pharmacist.

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 Accrete D3 film-coated tablets contains
The active substances: Colecalciferol 10
micrograms (equivalent to 400 IU ), calcium
600 mg (as calcium carbonate) in each filmcoated tablet.
The other ingredients:
Tablet core: magnesium stearate, crospovidone
(Type A), copovidone (K-value: 25.2-30.8),
microcrystalline cellulose, sucrose, gelatin,
all-rac-α-tocopherol (E307), hydrogenated
soya-bean oil, maize starch.
Coating (Sepifilm 4202 yellow): yellow iron oxide
(E172), hypromellose (15 mPa s), titanium
dioxide (E171), macrogol 400, talc.
What Accrete D3 film-coated tablets looks
like and contents of the pack
Ochre-coloured oval film-coated tablets scored
on one side, 10 tablets in PVC/Alu blister and 3
or 6 blisters in cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Jenson Pharmaceutical Services Ltd.
Carradine House, 237 Regent's Park Road,
London, N3 3LF, UK.
Distributed by: Internis Pharmaceuticals Ltd.
237 Regent’s Park Road, London, N3 3LF, UK.
Manufacturer:
Béres Pharmaceuticals Ltd.,
H-5005 Szolnok,
Nagysándor József út 39.,
Hungary

This medicinal product is authorised in
the Member States of the EEA under the
following names:
UK: Accrete D3 film-coated tablets
Hungary: CalciviD Béres film-coated tablets
This leaflet was last approved in January 2011
ADUK 1/11

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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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