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SANDOCAL+D 1200 EFFERVESCENT TABLETS

Active substance: COLECALCIFEROL CONCENTRATE (POWDER FORM)

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sandocal®+D 1200
Effervescent 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 take Sandocal+D 1200 Effervescent Tablets
carefully to get the best results from it.

Take special care with Sandocal+D 1200 Effervescent Tablets:
• During long-term use with Sandocal+D 1200 Effervescent Tablets, your
blood and urine calcium levels, as well as your kidney function,
should be monitored regularly by your doctor. This is especially
important if you have a tendency to develop kidney stones.
Please consult your doctor before taking Sandocal+D 1200 Effervescent
Tablets and follow your doctor’s instruction carefully if:
• You are taking other calcium and vitamin D products.
• You suffer from a kidney disorder, especially if also taking aluminium
supplements.
• You suffer from certain lung diseases such as sarcoidosis/Besnier-Boeck
disease.

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• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

• have an elevated blood calcium level (hypercalcaemia).
• have increased calcium excretion in the urine (hypercalciuria).
• have kidney stones (nephrolithiasis) and calcium deposits in your kidney
tissue (nephrocalcinosis).
• have too much vitamin D in your body (hypervitaminosis).

Taking other medicines
In this leaflet

Please tell your doctor or pharmacist if you are taking, or have recently
taken any other medicines, including medicines obtained without a
prescription, because calcium and vitamin D can interact with certain other
medicines if taken at the same time. For example, if you are taking or have
recently taken:

1. What Sandocal+D 1200 Effervescent Tablets are and what they are
used for
2. Before you take Sandocal+D 1200 Effervescent Tablets
3. How to take Sandocal+D 1200 Effervescent Tablets
4. Possible side effects
5. How to store Sandocal+D 1200 Effervescent Tablets
6. Further information

1. What Sandocal+D 1200 Effervescent Tablets are and
what they are used for
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Sandocal+D 1200 Effervescent Tablets contain calcium and vitamin D3.

Calcium and vitamin D3 are absorbed from the intestine and distributed
throughout the body in the blood.
99% of the calcium in the human body is located in bone as crystallized
hydroxyapatite and amorphous calcium phosphate. These compounds are
important for the maintenance of strong bones and teeth. Calcium plays an
important role in several body functions. It is essential for nerve, muscle and
heart function as well as for the clotting of blood. In addition, it helps many
hormones to work properly in the body. To carry out these various roles,
calcium must be available in the appropriate concentration.
Vitamin D3 helps the absorption of calcium and phosphorus from the intestine
and their uptake by the bone.
Vitamin D can be found in certain foods or food supplements such as cod
liver oil, oily fish, eggs, and is also produced by the skin in the presence
of sunlight. Nevertheless, vitamin D deficiency can still occur depending
on where you live in the world (latitude), the time you spend outdoors, and
your diet. For instance, vitamin D deficiency (hypovitaminosis) is especially
common during winter and early spring in many countries in Europe due to
less periods of sunlight. Also people who spend a lot of time indoors and so
not exposed to sufficient sunlight can be more prone to vitamin D deficiency
(hypovitaminosis).

2. Before you take Sandocal+D 1200 Effervescent
Tablets
Do not take Sandocal+D 1200 Effervescent Tablets if you:

Sandocal+D 1200 Effervescent Tablets should not be taken within 2 hours of
eating foods rich in oxalic acid or phytic acid such as spinach, rhubarb and
whole cereals.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnant and breast-feeding women require more calcium and vitamin D
than normal.
• If you start using Sandocal+D 1200 Effervescent Tablets during the third
trimester of pregnancy, the daily intake should not exceed 1500 mg
calcium and 1000 I.U. (International Units) vitamin D3, therefore do not
take more than the recommended daily dose.
• Calcium passes into breast-milk, without having a negative effect on
the baby. Vitamin D also passes into breast-milk, and this should be
considered when giving additional vitamin D to the baby.
Driving and using machines
There is no known effect on ability to drive or operate machines caused by
taking Sandocal+D 1200 Effervescent Tablets.
Important information about some of the ingredients of Sandocal+D
1200 Effervescent Tablets:
• Diabetics can take Sandocal+D 1200 Effervescent Tablets (1 effervescent
tablet of 1200 mg / 800 IU contains 0.003 Carbohydrate Units).
• Sandocal+D 1200 Effervescent Tablets contain 164.28 mg of sodium
per tablet. Patients on a controlled sodium diet should seek advice from
health professionals prior to taking Sandocal+D 1200 Effervescent Tablets.
• If you think you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
• Sandocal+D 1200 Effervescent Tablets contain aspartame, a source of
phenylalanine, and may be harmful for people with phenylketonuria.

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• are allergic (hypersensitive) to calcium, vitamin D or any of the other
ingredients in Sandocal+D 1200 Effervescent Tablets (see the list of
ingredients in section 6 at the end of the leaflet).

Taking Sandocal+D 1200 Effervescent Tablets with food and drink
Pharma code ??

Sandocal+D 1200 Effervescent Tablets are used in the prevention and
treatment of calcium and vitamin D deficiency, and may be used, with
other medicines, to prevent and treat a condition called osteoporosis
(weakening of the bones) for patients who are at risk of calcium and
vitamin D deficiency.

• cardiac glycosides, thiazide diuretics, or corticosteroids, you must
follow your doctor’s instructions carefully.
• oral bisphosphonates or sodium fluoride, take Sandocal+D 1200
Effervescent Tablets at least 3 hours after taking these medicines as
calcium reduces the absorption of these compounds.
• a group of antibiotics called tetracyclines, take Sandocal+D 1200
Effervescent Tablets at least 2 hours after or 4 to 6 hours before the
tetracycline as calcium reduces the absorption of these compounds.
• cholestyramine or laxatives preparations, take Sandocal+D 1200
Effervescent Tablets at least 4 to 6 hours after or 1 hour before taking
these medicines.

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3. How to take Sandocal+D 1200 Effervescent
Tablets
Always take Sandocal+D 1200 Effervescent Tablets exactly as your doctor or
pharmacist has told you. You should check with your doctor or pharmacist if
you are not sure. The usual dose is:
– Adolescents and adults: take one effervescent tablet (one single dose)
once a day.
Dissolve Sandocal+D 1200 Effervescent Tablets in a glass of water
(approximately 200 ml) and drink immediately. Do not swallow or chew the
tablet.
Sandocal+D 1200 Effervescent Tablets can be taken at anytime, except if you
are taking certain medicines (see the section 2 “Taking other medicines”),
and can be taken with or without food (see the section 2 “Taking Sandocal+D
1200 Effervescent Tablets with food and drink” for further advice).
How long should you take Sandocal+D 1200 Effervescent Tablets?
Take the recommended daily dose of Sandocal+D 1200 Effervescent Tablets
for as long as you are advised to by your doctor. Given the intended use of
Sandocal+D 1200 Effervescent Tablets, it is likely this will be a long term
treatment.
During long-term use of Sandocal+D 1200 Effervescent Tablets, your
blood and urine calcium levels, as well as kidney function, should be
monitored regularly by your doctor. This is especially important if you have
a tendency to develop kidney stones.
If you take more Sandocal+D 1200 Effervescent Tablets than you
should

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Overdose of Sandocal+D 1200 Effervescent Tablets may lead to symptoms
such as nausea, vomiting, extreme thirst or constipation. If overdose is
suspected, contact your doctor or pharmacist immediately.
If you forget to take Sandocal+D 1200 Effervescent Tablets
Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Sandocal+D 1200 Effervescent Tablets can cause side
effects, although not everybody gets them.
Some rare and very rare side effects might be serious.
If you experience any of the following, STOP taking Sandocal+D 1200
Effervescent Tablets and tell your doctor immediately:
• Very rare side effects (occur in less than 1 in 10’000 people) include:
serious allergic (hypersensitivity) reactions such as swelling of the face,
lips, tongue or throat.
• Rare side effects (occur in less than 1 person out of 1’000) include:
increased calcium levels in the blood (hypercalcaemia) and excessive
excretion of calcium in the urine (hypercalciuria).

Less serious side effects
Other side effects which may occur are usually mild, passing and harmless.
Tell your doctor or pharmacist, as soon as you can, if you notice any of the
following:
• Uncommon side effects (occur in less than 1 person out of 100) may
include: nausea, diarrhoea, abdominal pain, constipation, flatulence,
bloating, itching, redness and/or burning of the skin.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Sandocal+D 1200 Effervescent
Tablets
• Keep out of the reach and sight of children.
• Do not use Sandocal+D 1200 Effervescent Tablets after the expiry date
which is stated on the box and on the tube after “EXP”. The expiry date
refers to the last day of that month.
• Do not store above 30 °C.
• Store in the original package and keep the tube tightly closed.
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 Sandocal+D 1200 Effervescent Tablets contain
The active substances are: calcium lactate gluconate, calcium carbonate
and colecalciferol (vitamin D3).
Each effervescent tablet of 1200 mg / 800 IU contains 2716 mg of calcium
lactate gluconate and 2100 mg of calcium carbonate (equivalent to 1200 mg
of calcium), 20 µg colecalciferol (equivalent to 800 I.U. of vitamin D3) as
active substances.
The other ingredients are: citric acid, sodium hydrogen carbonate,
macrogol 6000, aspartame, orange flavouring (contains: orange essential oils,
maltodextrin, arabic gum, sorbitol (E 420), dextrose), sucrose, gelatin, maize
starch, partially hydrogenated soya oil and alpha-tocopherol.
(see also end of section 2 “Important information about some of the
ingredients of Sandocal+D 1200 Effervescent Tablets” for further
information on sugars, sodium and aspartame).
What Sandocal+D 1200 Effervescent Tablets look like and contents of
the pack
The effervescent tablet is white, circular and has an orange odour.
Sandocal+D 1200 Effervescent Tablets are available in packs of 10,
20 (2 tubes of 10), 30 (3 tubes of 10), 40 (2 packs of 20), 60 (3 packs of 20),
80 (4 packs of 20), 100 (5 packs of 20) effervescent tablets.
Not all pack sizes may be marketed.
Manufactured by the marketing authorisation holder: Novartis Consumer
Health, Horsham, RH12 5AB, UK.
This leaflet was last approved on:
02/2009


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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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