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

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

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Package leaflet: Information for the user


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. What THORENS is and what it is used for
2. What you need to know before you use
THORENS
3. How to use THORENS
4. Possible side effects
5. How to store THORENS
6. Contents of the pack and other information
1. What THORENS is and what it is used for
THORENS 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).
THORENS 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
THORENS
Do not use THORENS:
• 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);
• if you have high levels of vitamin D3 in your blood
(hypervitaminosis D).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
THORENS 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 THORENS;
• 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 THORENS;
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 THORENS
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).
THORENS 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
THORENS ”.
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. THORENS 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. How to use THORENS
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 THORENS 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, THORENS 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
THORENS 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:
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 THORENS 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 THORENS
If you forget to take a dose of THORENS, 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
THORENS may include:
Uncommon (affects less than 1 in 100 people)
- 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 THORENS
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 THORENS 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 THORENS looks like and contents of pack
THORENS 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.
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
Distributed by
Galen Limited, Craigavon, BT63 5UA, UK
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom/Ireland: THORENS 10,000 I.U./ml
oral drops solution
Belgium: THORENS 10 000 UI/ml solution buvable
en gouttes
This leaflet was last revised in 02/2015

164340-00

Client: Galen

Code: 164340-00

Job Title: Thorens PIL Vitamin 10 000 UK
Revision: 12
Size: 130 x 300mm
Date: 19/5/15
Pharmacode: 947
Barcode:
Keyline/Die Ref

Colours:

Black

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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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