CalciviD citrate film-coated tablet

The essential calcium and vitamin D3 combination

Why do we recommend this preparation?

CalciviD Citrate contains calcium in citrate form, the benefits of which are

  • absorption independent of pH,
  • very favourable bioavailability,
  • protection from calcium kidney stone formation,
  • no gastrointestinal side effects.


Adequate calcium intake is essential for normal growth, i.e. the formation of maximum bone mass and maintenance of the balance of bone metabolism in adults. The main role of D-hormone converted from vitamin D3  in our organism is to stimulate calcium absorption in the gastrointestinal tract and to improve its incorporation into the bones.



In what cases is the preparation recommended?

  • To prevent and treat calcium and vitamin D deficiency in elderly people.
  • To complete specific osteoporosis therapies via calcium and vitamin D supplements in patients at risk of having vitamin D3 and calcium deficiency.

 

 

Pack size:
60 film-coated tablets
 

Dosing:

  • 2 film-coated tablets once or twice per day.
  • Take the film-coated tablet within 1-1.5 hour after a meal.

 

Nutritional values per film-coated tablet
 
Name of active substance Active substance content
Calcium (in the form of calcium citrate) 300 mg
Vitamin D3 (in the form of powdered
cholecalciferol concentrate)
5 µg (200 IU)
per film-coated tablet

 

CalciviD Citrate film-coated tablet

calcium, colecalciferol

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- You must talk to a doctor if your symptoms do not ease or get worse.

- If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

In this leaflet:

1.       What CalciviD Citrate film-coated tablet is and what it is used for

2.       What you need to know before you take CalciviD Citrate film-coated tablets

3.       How to take CalciviD Citrate film-coated tablets

4.       Possible side effects

5.       How to store CalciviD Citrate film-coated tablets

6.       Further information

 

 

1.       what CalciviD citrate film-coated tablet is and what it is used for

 

CalciviD Citrate film-coated tablet is a combination of calcium citrate and vitamin D3.

It is recommended to prevent and treat calcium and vitamin D3 deficiency in elderly patients. Calcium and vitamin D are essential for bone formation and normal bone metabolism.

It is also recommended to complete the treatment for osteoporosis patients with calcium and vitamin D3 deficiency.

 

 

2.       What you need to know before you take CalciviD citrate film-coated tablets

 

Do not take CalciviD Citrate film-coated tablets if

  • you are allergic (hypersensitive) to any of the active substances or other ingredients of CalciviD Citrate film-coated tablet
  • you have kidney insufficiency
  • your doctor told you that the calcium level in your urine is high, you have vitamin D overdose, or the calcium level in your blood is high for any reason
  • your doctor has told you that you are sensitive to particular sugars, talk to your doctor before taking CalciviD Citrate.

 

Take special care with CalciviD Citrate film-coated tablets

- talk to you doctor before taking this medicine if you have kidney disease, kidney disorders, sarcoidosis (an inflammatory disease of unknown origin characterised by the formation of clumps and bumps on the skin), or you are unable to move and have osteoporosis. In these cases your doctor needs to decide about the necessity of calcium and/or vitamin D3 supplements.

 

 

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines including non-prescription preparations.

 

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

 

Take CalciviD Citrate exclusively when your doctor recommends you to do so, and under medical supervision if you take thiazide-type diuretics, orally administered or injected corticosteroids (anti-inflammatory medicines) or cardiac glycosides (medicines containing digitalis to treat heart diseases).

Caution should be exercised when taken with ion exchange resins like cholestyramine or laxatives, like liquid paraffin, because these medicines reduce vitamin D absorption.

Calcium may influence the absorption of medicines containing tetracycline (antibiotics) when taken simultaneously with CalciviD Citrate. Take medicines containing tetracycline at least 2 hours before taking a CalciviD Citrate film-coated tablet or 4-6 hours after taking CalciviD Citrate.

If you take medicines containing sodium fluoride, bisphosphonates (preparations for osteoporosis treatment), take these medicines at least 3 hours before taking CalciviD Citrate.

 

CalciviD Citrate film-coated tablet with food and drinks

Oxalic acid (in spinach, sorrel and rhubarb), as well as phytic acid (in cereals) may inhibit calcium absorption because they create insoluble compounds with the calcium ion. Do not take CalciviD Citrate within 2 hours of consuming dishes with a high oxalic and phytic acid content.

 

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines.

During pregnancy, the daily calcium intake cannot increase 1500 mg, and daily vitamin D intake cannot be higher than 600 IU (IU=International Unit). Avoid overdosing calcium and vitamin D during pregnancy, because continuous calcium overdose has a harmful effect on the development of the foetus. You can take CalciviD Citrate during pregnancy only in the recommended dose.

You can take CalciviD Citrate during breast-feeding but you must talk to the paediatrician, because calcium and vitamin D are excreted in breast milk. The paediatrician needs to take it into consideration when prescribing vitamin D to your baby.

 

Driving and using machines

There are no data indicating that this medicine would have negative influences on the ability to drive and use machines.

 

Important information about some of the ingredients of Calcivid Citrate film-coated tablets

CalciviD Citrate film-coated tablet contains a small quantity of sucrose and lactose monohydrate.

If your doctor has told you that you are sensitive to particular sugars, talk to your doctor before taking CalciviD Citrate film-coated tablet.

 

 

3.       HOW TO TAKE CALCIVID CITRATE FILM-COATED TABLETS

 

Always take CalciviD Citrate film-coated tablet as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

 

Adults and elderly people:

The usual dose is 2 film-coated tablets once or twice a 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.

 

It is recommended that you take CalciviD Citrate continuously during a health status requiring calcium and vitamin D supplements or during osteoporosis. Talk to your doctor annually about the duration of the treatment when administered as the supplementary treatment for osteoporosis.

 

If you take more Calcivid Citrate film-coated tablets than you should

Taking doses higher than recommended may cause calcium and vitamin D overdose. Symptoms of calcium overdose: loss of appetite, excessive thirst, feeling sick, vomiting, constipation, abdominal pain, muscle weakness, tiredness, confusion, more urine than normal, bone pain, calcification in the kidneys, kidney stone formation and abnormal heart rhythm in severe cases. Permanently high calcium level causes irreversible renal damage and the calcification of soft tissues.

 

What to do: stop taking CalciviD Citrate and talk to your doctor.

 

If you forget to take Calcivid Citrate film-coated tablets

Do not take a double dose the next time because you cannot make up for the missed quantity this way, but you may increase the likelihood of side effects. Continue as recommended.

 

If you stop taking Calcivid Citrate film-coated tablets

In general, no harmful effects develop when stopping the treatment.

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

 

4.       POSSIBLE SIDE EFFECTS

 

Like all medicines, CalciviD Citrate film-coated tablets can cause side effects, although not everybody gets them.

The side effects of CalciviD Citrate may be classified as follows based on their frequencies:

 

  • Uncommon (affects 1-100 in 1000 users).
  • Rare (affects 1-100 in 10 000 users).

 

Uncommon side effects: a significantly elevated calcium level in the blood (hypercalcemia) – its symptoms: feeling sick, vomiting, loss of appetite, constipation, stomach pain, bone pain, sensing insatiable thirst, frequent urination, muscle weakness, sleepiness, confusion; or the significantly elevated calcium level in the urine (hypercalciuria).

Rare side effects: gastrointestinal complaints (abdominal bloating, constipation, feeling sick, abdominal pain, diarrhoea) and itching, rashes and hives.

 

If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

 

5.       How to store CalciviD citrate film-coated tablets

 

Store at or below 25 °C. Keep the container tightly closed to protect the tablets from moisture.

 

Keep this medicine out of the sight and reach of children.

 

Do not take CalciviD Citrate film-coated tablets after after the expiry date printed on the label and the packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

 

6.       FURTHER INFORMATION

 

What CalciviD Citrate film-coated tablets contain

Active substances in each film-coated tablet: 300 mg calcium (in the form of calcium citrate), 5 mg (200 NE) colecalciferol (vitamin D3).

Other ingredients:

Tablet core: magnesium stearate, crospovidone, sucrose, medium-chain triglycerides, gum arabic, all-rac-a-tocopherol, maize starch.

Tablet coating (Aqua Polish P white): hypromellose (E464), polyethylene glycol, lactose monohydrate (3.0 g), talc, titanium dioxide.

 

What CalciviD Citrate film-coated tablets look like and the contents of the pack

White, oval film-coated tablets scored on one side.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole and not to divide the tablet into equal doses.

 

30, 60, 90 film-coated tablets in a (high-density) polyethylene container sealed with an aluminium/polyethylene foil and closed with a white polypropylene screw cap in a cardboard box.

Not all pack sizes may be marketed.

 

Marketing authorisation holder

Béres Gyógyszergyár Zrt.

1037 Budapest,

Mikoviny u. 2-4.

Tel: +36-1-430-5500

Fax: +36-1-250-7251

E-mail: [email protected]

 

Manufacturer

Béres Gyógyszergyár Zrt.

5005 Szolnok, Nagysándor József út 39.

 

OGYI-T-20779/01-03

 

This leaflet was approved on: 4 January, 2011.

Registration category:Over-the-counter medicinal product

FOR RISKS AND SIDE EFFECTS, PLEASE READ THE PATIENT INFORMATION LEAFLET OR CONSULT YOUR DOCTOR, PHARMACIST!

GOOD TO KNOW – Useful information prior to administration

Gluten-free - Suitability for people with coeliac disease

Lactose-free - Suitability for lactose intolerant people Comment: it contains lactose (3 mg lactose/film-coated tablet)

Suitability for people with diabetes

Suitability for vegetarians

Suitability for pregnant women and nursing mothersComment: close attention is needed when taken simultaneously with other products containing vitamins, minerals and trace elements to avoid exceeding safe quantities

Suitability for people with high blood pressure



© Copyright 2012 Béres Pharmaceuticals Ltd.

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