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SAPVIT-D3 14 400 IU/ML ORAL DROPS SOLUTION

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL / CHOLECALCIFEROL / COLECALCIFEROL

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Package leaflet: Information for the user
14,400 IU/ml oral drops, solution
cholecalciferol (vitamin D3)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
– 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1
2
3
4
5
6

What Sapvit-D3 is and what it is used for
What you need to know before you take Sapvit-D3
How to take Sapvit-D3
Possible side effects
How to store Sapvit-D3
Contents of the pack and other information

1 What Sapvit-D3 is and what it is used for
Vitamin D is produced in the skin in the presence of ultraviolet light or is absorbed from the
gastrointestinal tract in the presence of bile. In case of reduced fat intake, the uptake of vitamin D
is also reduced.
Sapvit-D3 is used:
– for prevention and treatment of vitamin D deficiency.
– for treatment of rickets (a condition that affects bone development in children).
– as an adjunct to osteoporosis treatment of patients who are at risk of vitamin D deficiency.

2 What you need to know before you take Sapvit-D3

Do not take Sapvit-D3:






if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
if you suffer from medical conditions that result in a high calcium level in the blood or increased
calcium excretion in the urine (as with treatment with certain medicines [benzothiazine derivates] or if
you are bedridden).
if you suffer or have a tendency to suffer from calcium-containing kidney stones.
if you suffer from an excess of vitamin D.
if you have severe arteriosclerosis (hardening of the arteries).
if you suffer from severe kidney dysfunction.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sapvit-D3.
Special care when taking Sapvit-D3 is required,
– if you are being treated with certain heart drugs (cardiac glycosides) or thiazide-type diuretic drugs.
– if you suffer from kidney dysfunction. Your doctor will monitor the calcium and phosphate levels in the
blood in this case. The risk of soft tissue calcification has to be considered.
– in severe kidney dysfunction, cholecalciferol is not utilized. Your doctor will possibly recommend
another vitamin D supplement.
– if you suffer from sarcoidosis (Boeck’s disease), there is a risk of increased formation of the active form
of vitamin D.
– in case of reduced bone mass due to inactivity (e.g. bedrest) there is an increased risk of occurrence of
elevated calcium levels in the blood.
During long-term use, your doctor will check the levels of calcium in your blood and urine regularly
and monitor your kidney function. If necessary, your doctor may tell you to reduce the dose or stop the
treatment.
Raised parathyroid hormone levels can enhance the vitamin D metabolism and this increases the
vitamin D requirement.
Additional doses of vitamin D should only be taken under close medical supervision.

Children and adolescents

Avoid the use of other vitamin D-containing products, especially in infants. If in doubt, your doctor will
decide about the additional use of vitamin-enriched foods or baby foods and vitamin D-containing
medicines.

Other medicines and Sapvit-D3

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking:



Rifampicin or isoniazid (against tuberculosis).
Certain heart medicines (cardiac glycosides): they may enhance their harmful effects by increasing the
blood calcium levels (risk of arrhythmias). A strict medical supervision is required, possibly including
electrocardiogram (ECG) examination and control of the calcium level in the blood.
• Thiazide diuretics: they increase the risk for the occurrence of elevated calcium levels in the blood,
because these drugs reduce the urinary excretion of calcium. Your doctor will check your blood
calcium levels regularly in this case.
• Medicines for the treatment of epilepsy (carbamazepine, phenobarbital, phenytoin, primidone) or
certain hormones of the adrenal cortex (glucocorticoids, ‘cortisone’): they may increase your vitamin D
requirement.
• Medicines to lower blood lipids (e.g. orlistat and cholestyramine): they may reduce the absorption of
vitamin D through the intestines.
• Medicines containing magnesium (e.g. antacids): they should not be used during Sapvit-D3-therapy as
this may lead to high levels of magnesium in the blood (hypermagnesaemia).
• Aluminium-containing pills (against heartburn).

Sapvit-D3 with food and drink

Caution is advised concerning vitamin-enriched food or infant formula.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
If your doctor prescribes Sapvit-D3 when you are pregnant, be careful to keep strictly to the dose your
doctor has prescribed, since overdose of vitamin D3 may involve a risk of physical and mental retardation,
as well as heart and eye diseases of your child.
Breast-feeding
Vitamin D and its metabolites pass into breast milk. Overdose in infants induced by nursing has not been
observed. This fact, however, should be taken into account if the child receives additional vitamin D.

Driving and using machines

Sapvit-D3 has no or negligible influence on the ability to drive and use machines.

3 How to take Sapvit-D3
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Unless otherwise prescribed by your doctor, the recommended dose is:

Prevention of vitamin D deficiency:
0–6 months
6–12 months
1–3 years
4–8 years
9 –18 years
19 –70 years
70+

Drops/day
1–2
1–2
1–2
1–3
1–3
1–4
2–4

International Units/day
400–800
400–800
400–800
600–1,000
600–1,000
600–1,500
800–1,500

The following scheme is a guideline for prevention of vitamin D deficiency (rickets) in newborns
and infants: Prophylaxis is generally conducted from the second week of life, during the first year of life
and during the low-sunlight time of the following 2 years with 1–2 drops of Sapvit-D3 per day.

• Newborns and infants during the first year of life:
from the second week of life 1 drop (= 400 international units [IU]) of Sapvit-D3 daily
• Premature infants during the first year of life:
from the second week of life 2 drops (= 800 IU) of Sapvit-D3 daily
• Infants aged 1–3 years at risk during the winter months (low-sunlight time):
2 drops (= 800 IU) of Sapvit-D3 daily

Treatment of rickets

The total amount of required vitamin D depends on the severity of the disease.
In existing rickets, treatment is started with 200,000 IU. Subsequently, take 1,000 to 5,000 IU daily
(approximately 2 to 12 drops of Sapvit-D3 (= 800 to 4,800 IU)).
Your doctor will prescribe a preparation with a higher concentration of vitamin D for the initial treatment
in order to ease the dosing.
0–6 months
6–12 months
1–3 years
4–8 years
9 –18 years

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Drops/day
Higher dosed administration
forms are recommended for
the initial treatment.
Subsequently:
2–12

International Units/day
Individual therapy!
Initial administration of
200,000 IU,
subsequently:
1,000 to 5,000 IU

Laetus code:
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Laetus code:
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Treatment of vitamin D deficiency
0–6 months
6–12 months
1–3 years
4–8 years
9 –18 years
19 –70 years
70+

Drops/day
For 6 weeks: 5
Then: 1–3

International Units/day
For 6 weeks: 2,000
Then: 400–1,000

For 6 weeks: 5
Then: 1–3

For 6 weeks: 2,000
Then: 600–1,000

For 8 weeks: 15
Then: 3–5

For 8 weeks: 6,000
Then: 1,500–2,000

Adjunct to osteoporosis treatment of patients who are at risk of
vitamin D deficiency
19 –70+ years

Drops/day
2–4

Drops/week
14–26

International Units/day
800–1,500

Method of administration

Sapvit-D3 drops are taken directly orally. The best way is to drip them straight into the mouth or, if
necessary, administer with a spoon and some liquid.
Sapvit-D3 can be mixed and administered directly with tube feeding.
Please talk to your doctor or pharmacist if you have the impression that the effect of Sapvit-D3 is too
strong or too weak.

Instruction for handling

For withdrawal, hold the bottle vertically and gently tap the bottom
of the bottle with your finger until the first drop appears.

If you take more Sapvit-D3 than you should

The doctor decides on the severity of poisoning and determines the required treatment.

If you forget to take Sapvit-D3

Do not take a double dose to make up for a forgotten dose.

If you stop taking Sapvit-D3

No withdrawal symptoms are known.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vitamin D can cause the following undesirable effects, especially in overdose:
Metabolism and nutrition disorders:
Too high calcium levels in blood and urine (hypercalcaemia, hypercalciuria).
Gastrointestinal disorders:
Constipation, bloating, feeling sick, stomach ache, diarrhoea.
Frequency of the occurrence of the above mentioned side effects is not known (cannot be estimated
from the available data).

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

5 How to store Sapvit-D3





Do not store above 30°C.
Keep the bottle in the outer carton in order to protect from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
– After opening the container, use Sapvit-D3 oral drops within 10 months. Residues have to be discarded.
Do not store above 25°C after first opening.
– Do not use this medicine if you notice the following: turbidity or discolouration of the solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information
What Sapvit-D3 contains




The active substance is: cholecalciferol (vitamin D3).
1 ml (= 36 drops) contains:
14,400 IU (360 µg) cholecalciferol (vitamin D3)
1 drop = 400 IU (10 µg) cholecalciferol (vitamin D3)
The other ingredient is:
Medium-chain triglycerides

What Sapvit-D3 looks like and contents of the pack

Sapvit-D3 are clear, colourless to slightly yellowish oral drops (oily solution) and are available in brown
glass bottles of 12.5 ml each (corresponding to 450 drops) with dropper applicator and screw cap with
tamper evident ring.

Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Austria GmbH​
Hafnerstraße 36 ​
8055 Graz
Austria
tel:
+43 (0)316 249 0
fax: +43 (0)316 249 1470
email: info-atgr@fresenius-kabi.com

Distributor:
Stirling Anglian Pharmaceuticals Ltd,
Hillington Park Innovation Centre,
1 Ainslie Road, Hillington Park,
Glasgow G52 4RU
United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:

Colecalciferol Fresenius 14.400 I.E./ml Tropfen zum Einnehmen, Lösung

Bulgaria:

Олеовит D3 14 400 IU/ml перорални капки, разтвор

Czech Republic: Olvit D3
Germany:

Oleo-De3 Tropfen zum Einnehmen

Hungary:

Oleovit-D3 cseppek

Ireland:

Sapvit-D3 14,400 IU/ml Oral Drops, Solution

Luxembourg:

Oleo-De3 Tropfen zum Einnehmen

Slovakia:

Oleovit D3

Slovenia:

Fresuvit D3 14400 i.e./ml peroralne kapljice, raztopina

Sweden:

Oleo-De3 Orala droppar

This leaflet was last revised in 01/2017

The following information is intended for healthcare professionals only:
Overdose
Overdose can lead to hypervitaminosis and hypercalcaemia. Hypervitaminosis is expressed in
uncharacteristic symptoms such as headache, loss of appetite, weakness, weight loss, gastrointestinal
disturbances (nausea, vomiting, constipation) and growth disorders.
Persisting hypercalcaemia may lead to polyuria, polydipsia, nausea, vomiting, constipation, muscle
weakness, paresis, adynamia, nocturia, proteinuria, anorexia, hypercholesterolaemia, elevated
transaminase levels, cardiac arryhthmias, hypertension and radiographically detectable soft tissue
calcification.
The vitamin D effect is reversed in severe overdose. Bones are decalcified and calcium levels in blood and
urine increase. Calcification can occur in tissue, blood vessels and kidneys. Furthermore, mental changes
up to psychosis can occur.
Treatment
Treatment with vitamin D must be discontinued immediately and dehydration corrected in case of an
intoxication. Other measures: diet low in calcium, calcitonin, glucocorticoids.

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Laetus code:
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Laetus code:
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In case of overdose with Sapvit-D3 drops you should contact a doctor.
Symptoms of overdose may include: headache, loss of appetite, weakness, weight loss, disorders of
the gastrointestinal tract (feeling sick, vomiting, constipation), growth disorders, increased urine volume,
increased fluid intake, signs of paralysis, feebleness, increased blood pressure and in severe cases
irregular heart beat.

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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