CALCIGRAN KOŠĻ.TBL 500MG N100 AR APELS.G

ATC code: A12AX 

Active substances: Calcium, Cholecalciferolum

Vendor, principal: Nycomed Pharma. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

CALCIGRAN SINE 1250MG N100

Package leaflet: Information for the user Calcigran Sine 500 mg chewable tablets

Calcium carbonate

Read all of this leaflet carefully before you start using 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 has told you.
-   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 you do not feel better or if you feel worse.
-   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 Calcigran Sine is and what it is used for
2.   What you need to know before you use Calcigran Sine
3.   How to use Calcigran Sine
4.   Possible side effects
5.   How to store Calcigran Sine
6.   Contents of the pack and other information

1. What Calcigran Sine is and what it is used for

The active substance of Calcigran Sine is calcium. Calcium is also found in our everyday food, especially dairy products. Calcigran Sine ensures an additional amount of calcium if your food or lifestyle does not provide a sufficient amount or if your organism’s demand for this substance has increased. Sufficient calcium consumption is extremely important during the period of growth, as well as during pregnancy and breast-feeding.
Calcigran Sine- is used for the prevention and treatment of calcium deficiency, as well as for the treatment of specific osteoporosis in patients at a risk of developing calcium deficiency.
Calcigran Sine- is also used for binding phosphates in case of renal failure in order to reduce blood phosphate levels.

2. What you need to know before you use Calcigran Sine Do not use Calcigran Sine:

-   if you are allergic to calcium or any of the other ingredients of this medicine (listed in section 6);
-   if you have high blood (hypercalcemia) and/or urine (hypercalcuria) calcium levels;
-   if you have nephrolithiasis.

Warnings and precautions

Regularly check your blood calcium levels and renal function in case of extended use of the medicine. This is especially important in elderly patients concomitantly using heart glycosides (heart failure medicine) or diuretics (medicines excreting water) and patients with a high risk of developing kidney stones. Talk to your doctor if you have any of the conditions listed above.
In case of the administration of large doses of Calcigran Sine, especially in case of the concomitant use of medicines or food (e.g. milk) containing calcium and/or vitamin D, there is a risk of hypercalcemia and milk-alkali syndrome, which can cause impaired renal function.
Caution must be exercised when using Calcigran -Sine if you have hypercalcemia or a renal function disorder; blood calcium and phosphorus levels must be monitored and the possibility of soft tissue calcification must be taken into consideration.
Talk to your doctor or pharmacist before using Calcigran Sine.

Other medicines and Calcigran Sine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tetracycline and quinolone antibiotics (ciprofloxacin, norfloxacin) should be taken at least 2 hours before or 4-6 hours after the oral administration of Calcigran Sine, as calcium can reduce their absorption.
Calcigran Sine should be taken at least 1 hour after bisphosphonates or sodium fluoride (medicines used in the treatment of osteoporosis), as Calcigran Sine can reduce the absorption of these substances from the digestive tract.
Calcium carbonate forms insoluble compounds with levothyroxine (used for treating hypothyroidism), reducing the absorption of this substance. Because of this, the interval between the administration of these medicines must be at least 4 hours.
Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, formulations containing iron, zinc or strontium ranelate should be taken two hours before or after taking calcium carbonate.

Calcigran Sine with food and drink

In case of hyperphosphatemia, the tablets should be taken during a meal in order to bind the phosphates found in food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Calcigran Sine can be used during pregnancy and breast-feeding. Large doses of calcium should be avoided in case of pregnancy, as persisent hypercalcemia has been shown to be harmful to the developing foetus.
Calcium is absorbed into breast milk, but no problems have been reported in breastfed children when using therapeutic doses.

Driving and using machines

Calcigran Sine does not interfere with the ability to drive or use moving machines.

Calcigran Sine contains sorbitol, isomalt, sucrose, and aspartame

Calcigran Sine tablets contain sorbitol and isomalt as excipients. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before using this medicine.
Calcigran Sine tablets contain aspartame, a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. How to use Calcigran Sine

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless prescribed otherwise by your doctor, Calcigran Sine is administered as follows:
Adults
Prevention and treatment of calcium deficiency 1-3 tablets per day.
Supplementary treatment in case of osteoporosis
1- 3 tablets per day.
Hyperphosphatemia
2- 8 g of calcium per day divided into 2-4 individual doses.

Use in children

Calcigran Sine- is used in children for the prevention and treatment of calcium deficiency, 1-2 tablets per day.
The tablets may be chewed or sucked.

If you take more Calcigran Sine than you should

If you take more Calcigran Sine than you should over an extended period of time, there is a risk of excessive calcium levels.

If you forget to take Calcigran Sine

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.
Uncommon side effects (occur in more than 1 person in 1,000): hypercalcemia and hypercalcuria.
Rare side effects (occur in more than 1 person in 10,000): constipation, indigestion, flatulence, nausea, stomach pain, and diarrhoea.
Very rare side effects (occur in less than 1 person in 10,000):
pruritus, rash and hives, milk-alkali syndrome (also referred to as the Burnett’s syndrome and is usually expressed only after administering a large dose of calcium), the symptoms of which are a frequent need to urinate, persisting headache and loss of appetite, nausea or vomiting, unusual tiredness or fatigue, elevated blood calcium levels, and renal damage.

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

5. How to store Calcigran Sine

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C. Keep the container tightly sealed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the package. 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 protect the environment.

6. Contents of the pack and other information What Calcigran Sine contains

-   The active substance is calcium. One chewable tablet contains 500 mg of calcium (corresponding to 1,250 mg of calcium carbonate).
-   The other excipients are sorbitol, povidone, isomalt, orange oil (flavouring), magnesium stearate, aspartame, and fatty acid mono- and diglycerides.

What Calcigran Sine looks like and contents of the pack

Uncoated white round convex tablets. The tablets may have tiny spots.
Calcigran Sine is available in packages of 30, 60, or 100 chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma AS Jaama 55B 63308 Polva Estonia

Manufacturer

Takeda AS Drammensveien 852 NO-1383 Asker Norway
or
Takeda Pharma AS Jaama 55B 63308 Polva Estonia

This leaflet was last revised in July 2015

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