Patient information leaflet

CALCIVID film-coated tablet calcium carbonate, colecalciferol

Read this patient information leaflet carefully which contains information important to you.

This is an over-the-counter medicine. For the optimal effect however, it is essential that the preparation is administered carefully.
Please keep the patient information leaflet, because you might need the information in it later on as well.
For further information or advice, consult your pharmacist.
Urgently contact your doctor if your symptoms do not ease or get more severe.
If any of the side effects get severe or if you perceive side effects not listed in the patient information leaflet, please inform your doctor or pharmacist.

Contents of the patient information leaflet:

1.What type of medicine is CalciviD film-coated tablet and what diseases is it recommended for?
2.Before taking CalciviD film-coated tablet
3.How to take CalciviD film-coated tablet?
4.Possible side effects
5.How to store CalciviD film-coated tablet?
6.Additional information

1. WHAT TYPE OF MEDICINE IS CALCIVID FILM-COATED TABLET AND WHAT DISEASES IS IT RECOMMENDED FOR?

The preparation is a combination of calcium carbonate and colecalciferol (Vitamin D₃).
Its application is recommended for old people to prevent and treat calcium and colecalciferol (Vitamin D₃) deficiencies which substances are essential for bone formation and normal bone metabolism.
It is also recommended as a calcium and vitamin D supply for osteoporosis treatment for patients with a possibility of vitamin D and calcium deficiency.

2. BEFORE TAKING CALCIVID FILM-COATED TABLET

Avoid taking CalciviD film-coated tablet if

you are allergic (hypersensitive) to the active substances or other constituents of CalciviD film-coated tablet
you have kidney stones
you have vitamin D overdose
you have diseases and/or conditions accompanied by abnormally high calcium level in the blood and/or abnormally high calcium level in the urine
CalciviD film-coated tablet contains hydrogenated soybean oil. Do not take the preparation if you have soy or peanut allergy.

Take the preparation with caution
If you have kidney diseases, renal function disorder, sarcoidosis (an inflammatory disease accompanied by the formation of nodules in various parts of the organism, the origin of which is still unknown), if you are prone to kidney stone formation or you are an immobile patient with osteoporosis, consult your doctor before application, because in these cases, a professional is to make a decision about the necessity of calcium and/or vitamin D₃ supply!

Other medicines taken during the treatment
Inform your doctor or pharmacist by all means about other medicines including over-the-counter products you presently take or took in the near past.

Do not take it simultaneously with other preparations containing calcium and vitamin D, owing to the risk of overdose.

Prior medical recommendation and medical supervision are required if you take thiazide-type diuretics, orally administered or injected corticosteroids (anti-inflammatory medicines) or cardiac glycosides (medicines to treat heart diseases).

Caution is required when taken with ion exchange resins like cholestyramine or laxatives, like liquid paraffin, because these medicines reduce the absorption of vitamin D.
Calcium carbonate may influence the absorption of simultaneously taken medicines containing tetracycline (antibiotic). So, take medicines containing tetracycline at least 2 hours before or 4-6 hours after the CalciviD film-coated tablet.
In the case of taking CalciviD film-coated tablet and sodium fluoride, bisphosphonates (preparations for osteoporosis treatment), take these medicines at least 3 hours before CalciviD film-coated tablet.

Simultaneous application of CalciviD film-coated tablet with particular dishes or drinks

The oxalic acid in spinach, sorrel and rhubarb, as well as phytic acid in whole-grain cereals may inhibit calcium absorption. Do not take a CalciviD film-coated tablet within 2 hours of consuming dishes with a high oxalic and phytic acid content.

Pregnancy and lactation
Consult your doctor or pharmacist prior to starting to take any medicine.

During pregnancy, the daily calcium intake cannot increase 1500 mg, and daily vitamin D intake cannot be higher than 600 IU (IU=International Unit). During pregnancy, calcium and vitamin D overdoses are to be avoided because the permanently high calcium level in the blood is harmful for the development of the baby. CalciviD film-coated tablet can be taken in the case of calcium and vitamin D deficiencies during pregnancy.
You can take CalciviD film-coated tablet during nursing. Calcium and vitamin D gets into the mother’s milk. The paediatrician needs to take this into consideration when prescribing vitamin D to your baby.

The effects of the preparation on driving capabilities and capabilities of the operation of machines

No data indicates that taking the medicine would negatively influence capabilities necessary for driving and the operation of machines.

Important information about the particular constituents of CalciviD film-coated tablet
CalciviD film-coated tablet contains hydrogenated soybean oil; so if you are allergic to soy or peanut (owing to the danger of possible cross allergy), do not take CalciviD film-coated tablet.
If your doctor has informed you about your hypersensitivity to particular carbohydrates and sugars, consult your doctor before taking CalciviD film-coated tablet.

3. HOW TO APPLY CALCIVID FILM-COATED TABLET?

Its usual dose for adults and elderly people is 2x1 film-coated tablet per day. Take the film-coated tablet whole with a glass of water or fruit juice within 1-1.5 hour after a meal. It can be broken in two if necessary.
Take the preparation continuously in the case of a state or disease (osteoporosis) that justifies calcium and vitamin D supply. In the case of osteoporosis applied as a supplementary treatment, consult your doctor yearly regarding the duration of its application.

If you took more CalciviD film-coated tablets than prescribed
Taking higher doses than recommended may cause calcium and vitamin D overdose. The symptoms of calcium overdose: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pains, muscle weakness, fatigability, confusion, unquenchable thirst, more urine than normal, bone pains, calcification in the kidneys, kidney stone formation, even heart rate disorder in severe cases. In an extreme case, calcium overdose may lead to coma and death. Permanently high calcium level in the blood causes irreversible renal damage and the calcification of soft tissues.
What to do: stop taking CalciviD film-coated tablet and contact your doctor.

If you missed a dose of CalciviD film-coated tablet
Do not take a double dose from the film-coated tablet the next time, because the omitted quantity cannot be substituted this way, but the risk of overdose may increase. Continue the treatment as prescribed.

If you have any further questions about the application of the preparation, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

As every medicine CalciviD film-coated tablet may also cause side effects, which however do not occur in everyone.

The side effects of CalciviD film-coated tablet can be grouped as follows based on their incidence rates:

Not frequent: occurring in more than one of a 1000, but less than one of a 100 patients.
Rare: occurring in more than one of a 10 000, but less than one of a 1000 patients.

Not frequent side effects: significant increase of the calcium level of the blood (hypercalcemia), or the significant increase of the urine’s calcium content (hypercalciuria).
Rare side effects: constipation, bloating, nausea, abdominal pains, diarrhoea, itching, rashes and hives.

Should any of the side effects turn severe or should you perceive any symptom not listed among the side effects of the patient information leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE CALCIVID FILM-COATED TABLET?

Store it below 25 ^oC in a dry place in the original packaging.
The medicine is to be stored out of reach of children!
Do not take CalciviD film-coated tablet after the expiry date (Felh.:) printed on the box. The expiry date is the last day of the month indicated. Do not discard medicines with wastewater or household waste. Ask your pharmacist how to discard medicines you do not need any longer. These measures help protect the environment

6. ADDITIONAL INFORMATION

What does CalciviD film-coated tablet contains?
The active substances of the preparation: 400 IU colecalciferol (3-vitDarnin), 600 mg calcium (in the form of 1500 mg calcium carbonate) per film-coated tablet.

Additional compounds:

Tablet core:
magnesium stearate, crospovidone, copovidone, microcrystalline cellulose, sucrose, gelatine, dl--tocopherol, hydrogenated soybean oil, cornstarch, maltodextrin, polysorbate 80.

Coating:
Sepifilm 4202 yellow: yellow iron dioxide (E172), hypromellose, titanium dioxide (E 171), macrogol, talc.

What does CalciviD film-coated tablet look like and what does the packaging contain?
3x10 or 6x10 ochre yellow oval film-coated tablets in a PVC/Alu blister and a carton box.

Marketing authorisation holder and manufacturer:
Béres Gyógyszergyár Zrt.
1037 Budapest, Mikoviny u. 2-4.

If you have further questions ask the marketing authorisation holder:
Béres Gyógyszergyár Zrt.,1037 Budapest, Mikoviny u. 2-4.
Tel: 06-1 -430-5500
Fax: 06-1-250-7251
E-mail:
Patient information leaflet approval date: December 17, 2007.

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!