Skip to Content

DELTIUS 10 000 I.U./ML ORAL DROPS SOLUTION

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

DELTIUS 10 000 I.U. /ml oral drops, solution
Cholecalciferol (vitamin D3)
Read all of this leaflet carefully before you start using 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, or nurse.
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, or nurse. 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 DELTIUS is and what it is used for
What you need to know before you use DELTIUS
How to use DELTIUS
Possible side effects
How to store DELTIUS
Contents of the pack and other information

1.

What DELTIUS is and what it is used for

DELTIUS oral drops contains cholecalciferol (vitamin D3). Vitamin D3, can be found in some
foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps
the kidneys and intestine absorb calcium and it helps build bones. Vitamin D3 deficiency is
the predominant cause of rickets (defective mineralization of bones in children) and
osteomalacia (inadequate mineralization of bones in adults).

DELTIUS oral drops are used:

to prevent rickets in children (defective mineralization of bones predominantly due to
vitamin D3 deficiency) and osteomalacia in adults (inadequate mineralization of bones
predominantly due to vitamin D3 deficiency).

to prevent rickets in preterm newborns.

to prevent vitamin D3 deficiency in children and adults when a risk of deficiency is
identified.

to prevent vitamin D3 deficiency in children and adults with problems in absorbing
food (malabsorption) defined by doctor.

to treat rickets in children and osteomalacia in adults.

2.

What you need to know before you use DELTIUS

Do not use DELTIUS:

if you are allergic to vitamin D3 or any of the other ingredients of this medicine (listed
in section 6);

if you have high levels of calcium in your blood (hypercalcaemia) or urine
(hypercalciuria);

if you have kidney stones (renal calculi);
2
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014



if you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using DELTIUS if you:








are undergoing treatment with certain medicines used to treat heart disorders (eg,
cardiac glycosides, such as digoxin);
have sarcoidosis (an immune system disorder which may cause increased levels of
vitamin D3 in the body);
are taking medicines containing vitamin D3 or eating foods or milk enriched with
vitamin D3;
are likely to be exposed to a lot of sunshine whilst using DELTIUS;
take additional supplements containing calcium. Your doctor will monitor your blood
levels of calcium to make sure they are not too high whilst you are using DELTIUS;
have kidney damage or disease. Your doctor may want to measure the levels of
calcium in your blood or urine.
take a daily dose of vitamin D3 exceeding 1,000 I.U. over a long period of time, your
doctor should monitor the level of calcium in your blood by lab test.

Other medicines and DELTIUS
Tell your doctor or pharmacist if you are using or have recently used or might use any other
medicines. This is especially important if you are taking:

medicines that act on the heart or kidneys, such as cardiac glycosides (eg, digoxin) or
diuretics (eg, bendroflumethazide). When used at the same time as vitamin D3, these
medicines may cause a large increase in the level of calcium in the blood and urine;

medicines containing vitamin D3 or eating food rich in vitamin D3, such as some types
of vitamin D3-enriched milk;

actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals
(eg, clotrimazole and ketoconazole, medicines used to treat fungal disease). These
medicines may interfere with the way your body processes vitamin D3;

the following medicines because they can interfere with the effect or the absorption of
vitamin D3;
- antiepileptic medicines (anticonvulsants), barbiturates,
- glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These
can decrease the effect of vitamin D3,
- medicines that lower the level of cholesterol in the blood (such as cholestyramine, or
colestipol),
- certain medicines for weight loss that reduce the amount of fat your body absorbs
(eg, orlistat),
- certain laxatives (such as liquid paraffin).

DELTIUS with food, drink and alcohol
You should take this medicine preferably together with a large meal to help your body absorb
the vitamin D3. You can also mix the drops with cold or lukewarm food, to help you take this
medicine. For detailed information see section 3 “How to use DELTIUS ”.
Pregnancy, breast-feeding and fertility
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. DELTIUS should
be used during pregnancy and breast-feeding only if recommended by your doctor.
Driving and using machines
There is limited information on the possible effects of this medicine on your ability to drive.
However, it is not expected that it would affect your ability to drive or to operate machinery.
3
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014

3.

How to use DELTIUS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
1 drop contains 200 IU vitamin D3.
Shake before use.
You should take DELTIUS preferably together with a large meal.
This medicine has a delicate taste of olive oil. It can be taken on its own or you can mix the
prescribed number of drops with a spoonful or a small amount of cold or lukewarm food
immediately before use. Make sure the entire dose is taken.
Use in children and adolescents
The recommended dose for:

-

Prevention of deficiency 0-1 years: 400 IU/day (2 drops)

-

Prevention of deficiency 1-18 years: 600 IU/day (3 drops)

-

Higher doses may be required, based on the advice of your doctor.

-

Treatment of deficiency 0-18 years: 2000 IU/day (10 drops) for 6 weeks, followed by
maintenance therapy of 400-1000 IU/day (2-5 drops).

In children, DELTIUS can be mixed with a small amount of children’s foods, yogurt, milk,
cheese or other dairy products. Do not mix this medicine into a bottle of milk or container of
soft food, in case your child does not consume the whole portion, and does not receive the full
dose. You should make sure that the entire dose is taken. For children who are no longer
breast-feeding you should give the prescribed dose with a substantial meal.
Do not store any product or food mixture that contains DELTIUS for use at a later time or a
next meal.

Use in pregnancy and breast-feeding
The recommended dose for:
-

Prevention of deficiency: 400 IU/day (2 drops)

-

Higher doses may be required based on the advice of your doctor.

Use in adults
The recommended dose for:
-

Prevention of vitamin D3 deficiency: 600 – 800 IU/day (3 – 4 drops). Higher doses may
be required based on the advice of your doctor.

-

Addition to specific therapy for osteoporosis: 800 IU/day (4 drops).

Instructions for use
The pack contains 1 bottle and a dropper applicator cap. The bottle is sealed with a plastic
childproof cap. The dropper is protected by a plastic cylinder. Shake the bottle before use and
follow the instructions below:
4
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014

a.

To open the bottle, press down and twist the cap at the same time (see Figure 1);

b.

Before using the dropper applicator cap for the first time, twist off the plastic cylinder
by unscrewing the plastic cylinder stem from the dropper applicator cap (see Figure
2);

c.

Insert the dropper applicator cap into the bottle to take up the contents. Collect the
prescribed number of drops onto a spoon;

d.

To close the bottle, carefully screw the dropper applicator cap until closed (there is no
need to press down) (see Figure 3);

e.

Place the medicine bottle back into the original package.

Figure 1

Figure 2

Figure 3

If you take more DELTIUS than you should
If you or your child take more medicine than prescribed, stop using this medicine and contact
your doctor. If it is not possible to talk to a doctor go to the nearest hospital emergency
department and take the medicine package with you.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the
production of large amounts of urine over 24 hours, constipation and dehydration, high levels
of calcium in the blood and in urine (hypercalcaemia and hypercalciuria) shown by lab test.
If you forget to take DELTIUS
If you forget to take a dose of DELTIUS, take the forgotten dose as soon as possible. Then
take the next dose at the correct time. However, if it is almost time to take the next dose, do
not take the dose you have missed; just take the next dose as normal.
Do not take a double dose to make up for a forgotten dose.
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.
Possible side effects reported with the use of DELTIUS may include:
Uncommon (affects less than 1 in 100 people)
5
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014

-

Too much calcium in your blood (hypercalcaemia)
Too much calcium in your urine (hypercalciuria)

Rare (affects less than 1 in 1000 people)
- Skin rash
- Itching
- Hives
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: 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 DELTIUS

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 carton and bottle after
"Exp". The expiry date refers to the last day of that month.
Do not store above 30° C.
Keep the bottle in the outer carton in order to protect from light.
Do not freeze or refrigerate.
After the first opening of the bottle: the product may be stored for a maximum of 6 months.
Do not use this medicine if you notice the solution is cloudy.
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 to protect the
environment.
6.

Contents of the pack and other information

What DELTIUS contains
The active substance is cholecalciferol (vitamin D3).
1 ml oral solution (50 drops) contains 10 000 I.U. cholecalciferol (vitamin D3), equivalent to
0.25 mg.
1 drop contains 200 I.U. cholecalciferol (vitamin D3).
The other ingredient is refined olive oil.
What DELTIUS looks like and contents of pack
DELTIUS 10 000 I.U./ml oral drops is a clear and colourless to greenish-yellow oily solution
without visible solid particles and/or precipitate. It is supplied in a 10 ml amber glass bottle
sealed with a plastic childproof cap.
Each pack contains 1 amber glass bottle containing 10 ml solution (corresponding to 500
drops), and 1 dropper applicator cap.

6
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014

Marketing authorisation holder
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 – Milano, Italy
Manufacturer
Abiogen Pharma S.p.A.
Via Meucci, 36 – Pisa (Italy)
info@abiogen.it
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom, France, Greece, Spain and Portugal: DELTIUS 10,000 I.U./ml
This leaflet was last revised in (Date of approval to be inserted in MM/YYYY)

7
DELTIUS PIL Version 05_ Proposed with var. UK/H/05177/01-02/IB/001_eCTD
seq005_Nov 2014

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