CALCIGRAN FORTE TBL 500MG N60

ATC code: A12AX 

Active substances: Calcium, Colecalciferolum

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

CALCIGRAN FORTE 500MG/+400RÜ N60

Package leaflet: Information for the user

Calcigran Forte 500 mg/400 IU chewable tablets

Calcium/cholecalciferol

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 Forte is and what it is used for
2.   What you need to know before you use Calcigran Forte
3.   How to use Calcigran Forte
4.   Possible side effects
5.   How to store Calcigran Forte
6.   Contents of the pack and other information

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

Calcigran Forte contains two active substances: calcium and cholecalciferol (vitamin D₃). Both are found in our everyday food; vitamin D is also produced in the skin from exposure to sunlight. Calcigran Forte ensures an additional amount of calcium and vitamin D if your food or lifestyle does not provide a sufficient amount or if your body’s demand for these substances has increased. Both play an important role in bone formation.
Calcigran Forte is used for the prevention and treatment of calcium and vitamin D deficiency in the elderly, as well as for the treatment of specific osteoporosis in patients at a risk of developing vitamin D and calcium deficiency.

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

-   if you are allergic to calcium, vitamin D, 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 a renal disorder, kidney stones;
-   if you have hypervitaminosis D (high vitamin D levels in the blood, symptoms of which are nausea, vomiting, constipation, loss of appetite, and stomach pain).

Warnings and precautions

Regularly check your blood calcium levels and renal function in the 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.
If you have sarcoidosis, talk to your doctor before using Calcigran Forte. In the case of this disease, the metabolisation of vitamin D into the active form of the vitamin may be much more intense, producing a risk of overdose.
Due to the increased risk of hypercalcemia, Calcigran Forte- should be used with care in osteoporosis patients requiring bed rest.
Concomitant treatment with other major sources of vitamin D / medicines or food with a high calcium content (e.g. milk) causes the risk of hypercalcemia and milk-alkali syndrome, which can cause kidney function disorders. In this case, checking serum calcium levels and kidney function is necessary. Caution must be exercised when using Calcigran Forte- if you have symptoms of hypercalcemia or a renal function disorder; blood calcium and phosphorus levels must be monitored and the possibility of soft tissue calcification taken into consideration.
Ask your doctor or pharmacist for advice before using Calcigran Forte.

Other medicines and Calcigran Forte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Calcium can reduce the absorption of a number of medicines from the digestive tract, as a result of which the intervals below should be followed in the case of concomitant use:
-   tetracycline and quinolone antibiotics (ciprofloxacin, norfloxacin) - take 2 hours before or 4-6 hours after taking Calcigran Forte;
-   biphosphonates used in the treatment of osteoporosis - take at least 1 hour before taking Calcigran Forte;
-   levothyroxine used for treating hypothyroidism - take at least 4 hours before or after taking Calcigran Forte.
Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, preparations containing iron, zinc or strontium ranelate should be taken two hours before or after taking Calcigran Forte.
Treatment with orlistat (an anti-obesity medicine) may reduce the absorption of fat-soluble vitamins (e.g. vitamin D₃).

Calcigran Forte with food and drink

It is important to monitor the amount of calcium and vitamin D received from food when using Calcigran Forte in order to avoid an overdose.

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 Forte- can be used during pregnancy in the case of concomitant calcium and vitamin D deficiency. Talk to your doctor or pharmacist before using Calcigran Forte- during pregnancy.
Calcigran Forte can be used during breast-feeding. Calcium and vitamin D are excreted in breast milk. This must be accounted for if the baby is receiving supplementary vitamin D.
It is important to use sufficient quantities of calcium during pregnancy and breast-feeding.

Driving and using machines

Calcigran Forte does not interfere with the ability to drive or use moving machinery.

Calcigran Forte contains sorbitol, isomalt, sucrose, and aspartame

Calcigran Forte tablets contain sorbitol, isomalt, and sucrose as excipients. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine. Calcigran Forte tablets contain aspartame, as a result of which they should not be used in the case of phenylketonuria.

3. How to use Calcigran Forte

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 Forte is administered as follows:
Adults and elderly
One chewable tablet 2 times per day.
Calcigran Forte should not be used in the case of severe kidney failure.
The tablets may be chewed or sucked.

Use in children

Calcigran Forte is not intended for use in children.

If you take more Calcigran Forte than you should

If you take more Calcigran Forte- than you should, there is a risk of a calcium and vitamin D toxicity. The symptoms can include loss of appetite, thirst, nausea, vomiting, constipation, stomach pain, muscle fatigue, weakness, excessive thirst and urination, bone pain, kidney calcification, kidney stones, and in the case of very severe overdose, arrhythmia. Persistently elevated blood calcium can cause irreversible kidney damage and soft tissue calcification. Talk to your doctor if you get any of the symptoms.
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 (occurring in more than 1 person in 1,000): hypercalcemia and hypercalcuria.
Rare side effects (occurring in more than 1 person in 10,000): constipation, indigestion, flatulence, nausea, stomach pain and diarrhoea.
Very rare side effects (occurring 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.
Hypersensitivity reactions have been reported at an unknown frequency, such as swollen skin or swollen throat.

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 Forte

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C. Keep the bottle tightly sealed to protect it from moisture.
Do not use this medicine after the expiry date which is stated on the carton and bottle. 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 dispose of medicines you no longer use. These measures will help protect the environment.

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

-   The active substances are 500 mg of calcium (in the form of calcium carbonate) and 400 IU (10 micrograms) of colecalciferol (vitamin D₃) in the form of concentrated cholecalciferol powder.
-   Other ingredients are sorbitol (E420), povidone, isomalt (E953), lemon oil, magnesium stearate, aspartame (E951), fatty acid mono- and diglycerides, alpha tocopherol, sucrose, modified corn starch, medium length triglycerides, sodium ascorbate, and anhydrous colloidal silica.

What Calcigran Forte looks like and contents of the pack

Uncoated white round convex chewable tablets. The tablets may have tiny spots.
Calcigran Forte is available as an over-the-counter medicine in a 60 tablet plastic bottle and external carton.

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 June 2016