Calcivid

An efficient combination for the prevention and supplementary treatment of osteoporosis.

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 D and calcium deficiency

 

Pack sizes
30 and 60 film-coated tablets
 

Dosing

  • 1 film-coated tablet per day for adults
  • This dose can be doubled to 2 film-coated tablets by the doctor if justified
  • Take the film-coated tablet whole with a glass of water or fruit juice within 1-1.5 hour after a meal.

 

Quantity of active substance per film-coated tablet

 

Name of active substance Active substance content
Calcium 600 mg
Vitamin D3 400 NE
 

 

CalciviD Béres 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 within a month.
  • 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 Béres film-coated tablet is and what it is used for

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

3.       How to take CalciviD Béres film-coated tablets

4.       Possible side effects

5        How to store CalciviD Béres film-coated tablets

6        Further information

 

1.       WHAT CalciviD Béres film-COATED TABLET IS AND WHAT IT IS USED FOR

 

CalciviD Béres is a combination of calcium (in the form of calcium carbonate) and colecalciferol (vitamin D3).

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

It is also recommended to complete osteoporosis treatment via calcium and vitamin D supplements in patients at risk of having vitamin D and calcium deficiency.

 

2.       WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIVID BÉRES FILM-COATED TABLETS

 

Do not take CalciviD Béres film-coated tablets if

  • you are allergic (hypersensitive) to any of the active substances or other ingredients of CalciviD Béres film-coated tablets
  • you have kidney stones
  • you have renal insufficiency
  • you have high levels of vitamin D in your blood
  • the calcium level of your urine is permanently elevated, or you have a high level of calcium in your blood
  • you have soy or peanut allergy, because CalciviD Béres film-coated tablets contain hydrogenated soybean oil.

 

Take special care with CalciviD Béres film-coated tablets

Talk to your doctor before taking CalciviD Béres if:

 

  • you have kidney disease or impaired renal functions
  • you have sarcoidosis (an inflammatory disease diagnosed by the doctor, characterised by the formation of clumps and bumps in various organs)
  • you are prone to kidney stones
  • you are unable to move and have osteoporosis

 

In these cases you doctor needs to decide about the necessity of calcium and/or vitamin D3 supplements.

 

Do not take CalciviD Béres film-coated tablets longer than a month without medical supervision.

In case of osteoporosis, your doctor may want to check the calcium level of your blood prior to starting a treatment with CalciviD Béres.

The calcium level in the blood must be checked on a regular basis in case of the long-term administration of CalciviD Béres. Depending on the results, your doctor may reduce the dose or decide to stop the treatment.

CalciviD Béres film-coated tablet is a medicine not recommended in children and adolescents.

 

Taking other medicines

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

 

You must talk to your doctor if you take the following medicines:

  • other preparations containing calcium or vitamin D, because co-administration of these preparations with CalciviD Béres film-coated tablets may lead to the harmful elevation of calcium levels in the blood. Do not take other preparations containing calcium or vitamin D with CalciviD Béres film-coated tablets unless your doctor recommends you to do so.
  • thiazide-type diuretics
  • orally administered or injected corticosteroids (anti-inflammatory medicines)
  • cardiac glycosides (medicines containing digitalis to treat heart diseases)

 

Caution should be exercised with the following medicines

  • ion exchange resins like cholestyramine or laxatives, like liquid paraffin, because these medicines reduce vitamin D absorption.
  • medicines containing tetracycline (antibiotics), because calcium carbonate may influence their absorption. Take medicines containing tetracycline at least 2 hours before taking a CalciviD Béres film-coated tablet or 4-6 hours after taking CalciviD Béres.
  • if you take medicines containing sodium fluoride, bisphosphonates (preparations for osteoporosis treatment) take these medicines at least 3 hours before you take CalciviD Béres film-coated tablet.
  • rifampicin (a medicine used for tuberculosis), phenitoin (a substance against epilepsy) and barbiturates (substances against epilepsy and tranquilizers), because they might reduce the effect of vitamin D.
  • estramustine (a substance used in chemotherapy), or preparations containing thyroid hormone or iron, zinc, strontium, because their absorption may decrease. Take these medicines 2 hours before or after you take CalciviD Béres.

 

CalciviD Béres film-coated tablet with food and drinks

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 high oxalic and phytic acid contents.

 

Pregnancy and breast-feeding

During pregnancy and breast-feeding, CalciviD Béres film-coated tablet can be taken exclusively if your doctor recommends you to do so and under medical supervision. Ask your doctor or pharmacist for advice before taking any medicines.

 

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 Béres film-coated tablets

CalciviD Béres film-coated tablets contain hydrogenated soybean oil, so if you have soy or peanut allergy, do not take CalciviD Béres film-coated tablets.

CalciviD Béres film-coated tablet contains a small quantity of sucrose. If your doctor has told you that you are sensitive to particular carbohydrates and sugars, talk to your doctor before taking CalciviD Béres film-coated tablet.

 

3.       HOW TO TAKE CALCIVID BÉRES FILM-COATED TABLETS

 

Always take CalciviD Béres film-coated tablets 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 2x1 film-coated tablets per day.

 

Take the film-coated tablet whole (without chewing) with a glass of water or fruit juice within 1-1.5 hour after a meal. You can break the film-coated tablet in two if necessary.

 

Ask your doctor about the duration of administration if you use it as the supplementary treatment for osteoporosis.

Do not take CalciviD Béres film-coated tablets longer than a month without medical supervision.

 

If you take more CalciviD Béres film-coated tablets than you should

Talk to your doctor right away if you took too many tablets. Taking doses higher than recommended may cause unpleasant and harmful side effects.

Symptoms of overdose: loss of appetite, increased thirst, feeling sick, vomiting, constipation, abdominal pain, muscle weakness, tiredness, confusion, more urine than normal, bone pain and abnormal heart rhythm 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 calcium deposition in the whole body.

 

If you forget to take CalciviD Béres 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

4.       POSSIBLE SIDE EFFECTS

 

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

 

-           Uncommon (affects 1-100 in 1000 users):

hypercalcemia (a significantly elevated calcium level in the blood).

Possible 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). If you take CalciviD Béres on the long term, your doctor may want to check the calcium level of your blood and urine, as well as renal functions on a regular basis.

 

-           Rare (affects 1-100 in 10 000 users): constipation, abdominal bloating, feeling sick, abdominal pain, diarrhoea, 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 béres film-COATED TABLETS

 

Store at or below 25 °C.

Keep it in the original packaging to protect from moisture.

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

 

Do not take CalciviD Béres film-coated tablets after the expiry date printed on the packaging (Felhasználható:).

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.

 

 

  1. Further information

 

What CalciviD Béres film-coated tablets contain

Active substances in each film-coated-tablet:

600 mg calcium (in the form of 1500 mg calcium carbonate) and

10 mg colecalciferol (equals 400 NE vitamin D3).

 

Other ingredients:

Tablet core: magnesium stearate, crospovidone (type A), copovidone (K value: 25.2-30.8), microcrystalline cellulose, sucrose, gelatin, all-rac-a-tocopherol (E307), hydrogenated soybean oil, corn starch.

 

Tablet coating: (Sepifilm 4202 yellow): yellow iron oxide (E172), hypromellose (15mPa s), titanium dioxide (E 171), macrogol 400, talc.

 

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

Ochre yellow, oblong film-coated tablet scored on one side.

Its break surface is white.

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 film-coated tablets in PVC/Al blister packaging and 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: info@beres.hu
 

Manufacturer

Béres Gyógyszergyár Zrt.

5005 Szolnok, Nagysándor József út 39.

 

OGYI-T-20349/01      30 film-coated tablets

OGYI-T-20349/02      60 film-coated tablets

 

This leaflet was approved in: August, 2012.

Categorie de înregistrare:Over-the-counter medicinal preparation

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

Bine de știut

Fără gluten - Se poate consuma și de către persoanele intolerante la gluten

Fără lactoză - Se poate consuma și de către persoanele intolerante la lactoză

Poate fi consumat şi de către diabetici

Poate fi consumat şi de vegetarieniComment: it contains gelatin of animal origin in vitamin D3

Poate fi consumat şi de către gravide, mame care alăpteazăComment: close attention is needed when taken simultaneously with other products containing vitamins, minerals and trace elements to avoid exceeding safe quantities

Poate fi consumat și de hipertensivi



© Copyright 2012 Béres Pharmaceuticals Ltd.

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