CalciviD Extra-D film-coated tablet

Combination of calcium and vitamin D3

In what cases is the preparation recommended?

  • It is recommended in the elderly for the prevention and treatment of deficiency of calcium and vitamin D3 that are essential for bone formation and normal bone metabolism.
  • It is also recommended for Vitamin D and calcium supplementation as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.

 

Pack sizes
60 film-coated tablets
 

Dosing

  • The recommended dose is one tablet per day.
  • It is recommended to take the film-coated tablet within one and a half hours of a meal with a glass of water or juice, without chewing it. The score line is only there to help you break the tablet if you have difficulty swallowing it whole. The tablet can be broken in half, if needed.

 

Quantity of active substance per film-coated tablet

 

Name of active substance Active substance content
Calcium 600 mg
Vitamin D3 800 NE

 

Package leaflet: Information for the patient

 

CalciviD Extra-D film-coated tablet

calcium, cholecalciferol

 

 

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • 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.
  • You must talk to a doctor if you do not feel better or if you feel worse.

 

What is in this leaflet:

1. What CalciviD Extra-D film-coated tablet are and what they are used for

2. What you need to know before you take CalciviD Extra-D film-coated tablet

3. How to take CalciviD Extra-D film-coated tablet

4. Possible side effects

5. How to store CalciviD Extra-D film-coated tablet

6. Content of the pack and other information

 

 

1.         What CalciviD Extra-D film-coated tablet are and what it is used for

 

The product is a combination of calcium (as calcium carbonate) and cholecalciferol (vitamin D3).

 

It is recommended in the elderly for the prevention and treatment of deficiency of calcium and vitamin D3 that are essential for bone formation and normal bone metabolism.

It is also recommended for Vitamin D and calcium supplementation as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.

 

 

2.         What you need to know before you take CalciviD Extra-D film-coated tablet

 

Do not take CalciviD Extra-D film-coated tablet

- if you are allergic to active substances or any of the other ingredients of this medicines (listed in section 6)

- if you have kidney stones or calcium sedimentation has been identified in your kidney tissue

- if you have kidney failure or serious renal impairment

- if you have excessive amounts of vitamin D in the blood

- if you have chronically increased calcium level in your urine or elevated blood-calcium level or if you have a disease which can cause this (eg. malignant disease that effects the bones)

- CalciviD Extra-D film-coated tablet contains hydrogenated soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

 

Warnings and precautions

Talk to your doctor before taking CalciviD Extra-D film-coated tablet

- if you have kidney disease or impaired kidney function

- if you have sarcoidosis (an inflammatory condition diagnosed by a doctor which produces lumps in various organs of the body)

- if you are prone to development of kidney stone

- if you are an immobilised patient with osteoporosis

 

Your doctor should decide whether calcium and/or vitamin D3 supply can be used in these conditions.

 

Before treatment of osteoporosis with CalciviD Extra-D film-coated tablet, your doctor may check your blood-calcium level. In case of long-term use of CalciviD Extra-D film-coated tablet or impaired kidney function, blood-calcium level and kidney function have to be checked regularly. Depending on the result, your doctor may decide to discontinue the treatment. 

 

Children and adolescents

CalciviD Extra-D film-coated tablet is not intended for use in children and adolescents.

 

Other medicines and CalciviD Extra-D film-coated tablet

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

 

Consult your doctor if you are taking:

- any other medicines containing vitamin D or calcium, because concomitant use of such product with CalciviD Extra-D film-coated tablet may lead to harmful elevation of blood-calcium level. During the treatment with CalciviD Extra-D film-coated tablet, do not use any other products containing vitamin D or calcium without medical advice.

- thiazide diuretics

- systemic (per os or injection) corticosteroids (anti-inflammatory drugs)

- cardiac glycosides (digitalis containing medicines, used for the treatment of heart failure)

 

Take special care if you use:

- ion exchange resins such as cholestyramine or laxatives such as paraffin oil, as these medicines may reduce the gastrointestinal absorption of vitamin D.

- tetracycline and quinolone containing preparations (antibiotics), as calcium carbonate may interfere with their absorption. Therefore, tetracycline and quinolone preparations should be administered at least two hours before or four to six hours after using of CalciviD Extra-D film-coated tablet.

- bisphosphonate or sodium fluoride (used for the treatment of osteoporosis) is used concomitantly with CalciviD Extra-D film-coated tablet, these preparations should be administered at least three hours before using CalciviD Extra-D film-coated tablet.

- Rifampicin (a medicine for tuberculosis), actinomycin (antibiotics used for treatment in cancer) and imidazole (antifungal agents), phenytoin (a medicine for epilepsy) and barbiturates (medicines which are used for epilepsy or which help you sleep), as they may make the vitamin D3 less effective.

- Estramustin (a medicine used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed may be reduced. They should be taken at least 2 hours before or after CalciviD Extra-D film-coated tablet.

 

CalciviD Extra-D film-coated tablet with food and drink

Oxalic acid (found in e.g. spinach, sorrel and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption. The patient should not take CalciviD Extra-D film-coated tablet within two hours after eating foods rich in oxalic acid and phytic acid.

 

Pregnancy, breast-feeding and fertility

During pregnancy the daily intake should not exceed 2500 mg of calcium and 4000 IU of vitamin D. CalciviD Extra-D film-coated tablet is not generally recommended during pregnancy but it can used in case of calcium and vitamin D deficiency under medical advice.

CalciviD Extra-D film-coated tablet can be taken during breast-feeding, however, talk to your doctor before starting to take it.

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

 

Driving and using machines

There are no data on the effect of this product on the ability to drive or use machines.

 

CalciviD Extra-D film-coated tablet contains hydrogenated soya oil and sucrose

Invented name> film-coated tablet contains hydrogenated soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

CalciviD Extra-D film-coated tablet contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

 

3.         How to take CalciviD Extra-D film-coated tablet

 

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

 

Adults and the elderly

The recommended dose is one tablet per day.

 

Use in children and adolescents

CalciviD Extra-D film-coated tablet is not intended for use in children and adolescents.

.

It is recommended to take the film-coated tablet within one and a half hours of a meal with a glass of water or juice, without chewing it. The score line is only there to help you break the tablet if you have difficulty swallowing it whole. The tablet can be broken in half, if needed.

 

Please consult your doctor on the duration of therapy if CalciviD Extra-D film-coated tablet is used as an adjunct to normal therapy for osteoporosis.

 

Since the necessity and the extent of calcium supplementation is significantly affected by eating habits, please, consult your doctor, if your eating habits have changed significantly.

 

If you take more CalciviD Extra-D film-coated tablet than you should

If you take too many tablets, you must consult with a doctor immediately. Intake of higher dose than the proposed one may cause unpleasant and potentially harmful side-effects.

Symptoms of overdose may include: lack of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, excess drinking and excess urination, bone pain and in severe cases cardiac arrhythmias. In extreme cases calcium overdose can lead to coma and death. Long term increased calcium level in the blood can lead to irreversible kidney impairment and deposits of calcium in the body.

 

If you forget to take CalciviD Extra-D film-coated tablet

Do not take a double dose to make up for a forgotten dose, as you would not substitute the missing amount, but you risk an overdosing.

Continue the treatment according to the instructions.

 

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

 

4.         Possible side effects

 

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

- Uncommon (affects 1 to 10 users in 1,000): hypercalcaemia (significantly increased blood calcium level).

Symptoms may include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, needing to pass urine more often, muscle weakness, drowsiness and confusion; or markedly increased calcium content of urine (hypercalciuria). If you are on long term treatment, your doctor may, from time to time, wish to check the level of calcium in your blood and urine as well as your kidney function.

 

- Rare (affects 1 to 10 users in 10,000):

Constipation, flatulence, nausea, abdominal pain, diarrhoea, itching, rash and urticaria.

 

Very rare (affects less than 1 in 10,000):

Milk alkali syndrome (can occur after the consumption of large amount of calcium and absorbable alkali (e.g. bicarbonates), the its symptoms include frequent urge to urinate, continuous headache, loss of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis (elevated bicarbonate content of blood) and renal impairment.)

 

If you have impaired renal function, you may be at risk of increased amounts of phosphate in the blood, renal stone formation and increased amounts of calcium in the kidneys.

 

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

 

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 listed below:

National Institute of Pharmacy and Nutrition, P.O.Box 450, H-1372 Budapest

Website: www.ogyei.gov.hu

 

By reporting side effects you can help provide more information on the safety of this medicine.

 

 

5.         How to store CalciviD Extra-D film-coated tablet

 

Do not store above 25°C.

Store in the original package in order to protect from moisture.

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 (EXP)

The expiry date refers to the last day of that month.

 

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 CalciviD Extra-D film-coated tablet contains

The active substances in each film-coated tablet: Calcium 600 mg (as calcium carbonate 1500 mg), cholecalciferol 20 micrograms (equivalent to 800 IU vitamin D3).

 

The other ingredients:

Tablet core: magnesium stearate, crospovidone (Type A), copovidone (K-value: 25.2-30.8), microcrystalline cellulose, sucrose, gelatine, all-rac-α-tocopherol (E307), hydrogenated soya-bean oil, maize starch, silicon dioxide.

 

Coating: red iron oxide (E172), yellow iron oxide (E172), hypromellose, titanium dioxide (E171), macrogol 400, talc.

 

What CalciviD Extra-D film-coated tablet looks like and contents of the pack

Light orange-coloured oval film-coated tablets scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The breakage surface is white.

 

 

7, 10, 14, 20, 28, 30, 40, 50, 60, 70, 80, 90, 100, 120 tablets in PVC/Alu blister and cardboard box.

Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

 

Marketing Authorisation Holder

Béres Pharmaceuticals Ltd.

1037 Budapest, Mikoviny u. 2-4.

Tel: +36-1-430-5500
Fax: +36-1-250-7251
E-mail: info@beres.hu

 

Manufacturer

 

Béres Pharmaceuticals Ltd.

5000 Szolnok, Nagysándor József út 39.

 

OGYI-T-9153/03          7x

OGYI-T-9153/04        10x

OGYI-T-9153/05        14x

OGYI-T-9153/06         20x

OGYI-T-9153/07        28x

OGYI-T-9153/08        30x

OGYI-T-9153/09        40x

OGYI-T-9153/10        50x

OGYI-T-9153/11        60x

OGYI-T-9153/12        70x

OGYI-T-9153/13        80x

OGYI-T-9153/14        90x

OGYI-T-9153/15        100x

OGYI-T-9153/16        120x

 

 

This leaflet was last revised in : February 2015

Registration category:Over-the-counter medicinal preparation

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



© Copyright 2012 Béres Pharmaceuticals Ltd.

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