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COLECACIFEROL 800 IU FILM-COATED TABLETS

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

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Package leaflet: Information for the user

Colecaciferol 800 IU Film-coated Tablets
Colecaciferol 1000 IU Film-coated Tablets
Colecalciferol (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. What Colecaciferol is and what it is used for
2. What you need to know before you take Colecaciferol
3. How to take Colecaciferol
4. Possible side effects
5. How to store Colecaciferol
6. Contents of the pack and other information
1. What Colecaciferol is and what it is used for
The active substance of Colecaciferol is vitamin D3.
Vitamin D helps the body to absorb calcium and enhances
bone formation and decreases the level of parathyroid
hormone (PTH).
This medicine is recommended in the following cases:
- For certain bone conditions, such as thinning of the
bone (osteoporosis), when it will be given to you with other
medicines.
- To prevent or treat vitamin D deficiency. Vitamin D
deficiency may occur when your diet or lifestyle does not
provide you enough vitamin D or when your body requires
more vitamin D (e.g. when you are pregnant).
Colecaciferol is used in adults, the elderly and adolescents
2. What you need to know before you take
Colecaciferol
Do not take Colecaciferol, if:
- you are allergic to vitamin D or any of the other
ingredients of this medicine (listed in section 6),
- you have high levels of calcium in the blood or urine,
- you have kidney stones or calcium deposits in your
kidneys,
- you have severe renal impairment,
- you are already taking additional doses of vitamin D
(e.g. multivitamins or food supplements containing
vitamin D).
Warnings and precautions
If any of the following applies to you, please tell your
doctor:
- You have a high tendency to kidney stone formation.
- You have cancer or any other condition that may have
affected your bones.
- You have parathyroid hormone imbalance
(pseudohypoparathyroidism).

If you have any of the following conditions, your doctor
will monitor the levels of calcium or phosphate in your
blood, or the level of calcium in your urine:
- If you are on long term treatment with this medicine.
- If you have kidney problems.
- If you suffer from “sarcoidosis”; an immune system
disorder which may affect your liver, lungs, skin or
lymph nodes.
Other medicines and Colecaciferol
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of
the following medicines:
- diuretics (water tablets) – your blood calcium levels will
be monitored regularly;
- corticosteroids
(‘steroids’
e.g.
prednisolone,
dexamethasone) – your dose of Vitamin D may need to
be increased;
- cholestyramine (a cholesterol lowering medicine)
or laxatives (e.g. paraffin oil) – they reduce vitamin D
absorption;
- heart medicines (cardiac glycosides) – you should be
monitored by a physician and possibly your ECG and
your blood calcium levels will be monitored,
- anticonvulsants (for the treatment of epilpsy), sleeping
medicines (e.g. hydantoin, barbiturates) or primidone –
these reduce the effect of vitamin D;
- calcitonin, etidronate, gallium nitrate, pamidronate or
plicamycin – these decrease blood calcium levels;
- calcium containing products in high doses: these
increase the risk of high blood calcium levels;
- magnesium containing products (e.g. antacids) – these
should not be used during treatment with vitamin D
because of the risk of high magnesium levels;
- phosphorus containing products in large doses – these
increase the risk of high phosphate blood levels.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are
planning to have a baby, or breast-feeding, ask your doctor
for advice before taking this medicine.
If you are breast-feeding, your doctor will monitor the
levels of calcium or phosphate in your blood, or the level of
calcium in your urine.
Driving and using machines
There is no known effect on your ability to drive or use
machines.
Colecaciferol contains sucrose and lactose
This medicine contains sucrose and lactose. If you have
been told by your doctor that you have an intolerance
to certain sugars, talk to your doctor before taking this
medicine.
3. How to take Colecaciferol
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The tablets can be taken with or without food.

Dosage
Your doctor will usually prescribe 1 tablet daily. In severe
vitamin D deficiency for the adult and the elderly, the
amount will depend on your vitamin D levels and on the
response given to the treatment.
Patients with kidney problems
Your doctor may arrange regular blood and/or urine tests
for you.
Use in children
Colecaciferol is not suitable for children under 12 years.
If you take more Colecaciferol than you should
You may develop the following symptoms: loss of appetite,
thirst, nausea, vomiting, constipation, abdominal pain,
muscle weakness, tiredness, confusion, having to pass
more urine than usual, bone pain, kidney problems, and
in severe cases, irregular heartbeat, coma or even death.
If you take too many tablets, contact your doctor
immediately or go to the emergency department of the
nearest hospital. Take the packet and any remaining
tablets with you.
If you forget to take Colecaciferol
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.
Stop taking Colecaciferol and seek immediate
medicinal help if you experience symptoms of serious
allergicreactions, such as:
• swollen face, lips, tongue or throat
• difficult to swallow
• hives and difficulty breathing
Uncommon side effects (may affect up to 1 in 100
people):
• too much calcium in your blood (hypercalcaemia) –
symptoms include nausea, vomiting, lack of appetite,
constipation, stomach ache, bone pain, extreme thirst,
a need to pass more water than usual, muscle
weakness, drowsiness and confusion.
• too much calcium in your urine (hypercalciuria).
Rare side effects (may affect up to 1 in 1,000 people):
• pruritus, rash and urticaria.

Do not use Colecaciferol after the expiry date which is
stated on the carton or on the bottle after Exp date. The
expiry date refers to the last day of the month.
Do not store above 25°C. Store the tablets in the original
container, in order to protect from light. Keep the container
tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
any medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Colecaciferol contains
- The active substance is colecalciferol.
Each tablet contains 20 microgram of colecalciferol
corresponding to 800 IU Vitamin D3 or 25 microgram of
colecalciferol corresponding to 1000 IU of Vitamin D3.
- The other ingredients are dl-alpha-tocopherol,
sodium ascorbate, modified food starch, medium chain
triglyceride, silicon dioxide, sucrose,magnesium
stearate, silica colloidal anhydrous, lactose
monohydrate,
cellulose
microcrystalline,
croscaramellose sodium, maize starch, polyvinyl
alcohol, macrogol, titanium dioxide, coloring agent
(quinoline yellow aluminum lake, iron oxide yellow),
talc.
What Colecaciferol looks like and contents of the pack
Colecaciferol is a yellow, round, biconvex film-coated
tablet.
30, 60 or 90 film-coated tablets in white, opaque PVC/
PVdC/Alu blisters
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NTC Srl
Via Luigi Razza 3
20124 Milano
Italy
Manufacturer
ExtractumPharma zrt.
IV. Körzet 6.
6413 Kunfehértó
Hungary
This leaflet was last revised in 10/2016

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
national reporting system .
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Colecaciferol
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 or on the bottle after Exp date. The
expiry date refers to the last day of the month.

00028NTC

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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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