Pill Identifier App

CALCIUM / VITAMIN D3 1000 MG / 880 IU CHEWABLE TABLETS

Active substance: COLECALCIFEROL CONCENTRATE (POWDER FORM)

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Calcium / Vitamin D3 1000 mg / 880 IU chewable tablets

Calcium and Colecalciferol

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• 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.

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 Calcium/Vitamin D3
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 Calcium / Vitamin D3 chewable tablets are
and what they are used for
2. Before you take Calcium / Vitamin D3 chewable
tablets
3. How to take Calcium / Vitamin D3 chewable
tablets
4. Possible side effects
5. How to store Calcium / Vitamin D3 chewable
tablets
6. Further information

1

What Calcium / Vitamin D3 chewable
tablets are and what they are used for

Calcium / Vitamin D3 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

Before you take Calcium / Vitamin D3
chewable tablets

Do not take Calcium / Vitamin D3 chewable
tablets
• if you are allergic (hypersensitive) to calcium,
vitamin D3 or any of the other ingredients of
Calcium / Vitamin D3 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.

Take special care with Calcium / Vitamin D3
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 Calcium / Vitamin D3 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 Calcium / Vitamin
D3 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.
Calcium / Vitamin D3 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
Calcium / Vitamin D3 chewable tablets. These
drugs should be taken at least 2 hours before or
4-6 hours after Calcium / Vitamin D3 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 Calcium / Vitamin D3
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
Calcium / Vitamin D3 chewable tablets since
otherwise vitamin D is not absorbed properly.
• The simultaneous administration of
Calcium / Vitamin D3 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
Calcium / Vitamin D3 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 Calcium / Vitamin D3
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 Calcium / Vitamin D3 chewable tablets.
Taking Calcium / Vitamin D3 chewable tablets
with food and drink
You can take Calcium / Vitamin D3 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.

Continued on the next page >>

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

If you are pregnant you may use Calcium / Vitamin
D3 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.

Calcium / Vitamin D3 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
Calcium / Vitamin D3 chewable tablets has no
influence on your ability to drive and use machines.

Important information about some of the
ingredients of Calcium / Vitamin D3 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 Calcium / Vitamin D3
chewable tablets

Always take Calcium / Vitamin D3 chewable tablets
exactly as your doctor or pharmacist has told you.
You should check with your doctor or pharmacist if
you are not sure.
Always take Calcium / Vitamin D3 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 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.

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
Calcium / Vitamin D3 chewable tablets should be
taken as long-term treatment. Talk to your doctor
how long you should take Calcium / Vitamin D3
chewable tablets (see also section 2, Take special
care with Calcium / Vitamin D3 chewable tablets).

If you take more Calcium / Vitamin D3 chewable
tablets than you should
Overdose of Calcium / Vitamin D3 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 Calcium / Vitamin D3
chewable tablets
If you forget to take Calcium / Vitamin D3 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 Calcium / Vitamin D3 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

Like all medicines, Calcium / Vitamin D3 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

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

Stop taking Calcium / Vitamin D3 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 Calcium / Vitamin D3
chewable tablets

Keep out of the reach and sight of children.

Do not use Calcium / Vitamin D3 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 Calcium / Vitamin 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 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.

What Calcium / Vitamin D3 1000 mg / 880 IU
chewable tablets looks like and contents of the
pack
Calcium/Vitamin D3 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:
10, 20, 28, 30, 40, 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:

10, 20, 28, 30, 40, 48, 56, 60, 60 (bundling package
2 x 30), 90, 90 (bundling package 3 x 30), 96, 100
(bundling package 5 x 20) chewable tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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

This leaflet was last approved on 03/2012 (to be
amended after approval).

SZ00000LT000

Expand view ⇕

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.

Hide
(web1)