active CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol ingredients

• 2500 mg calcium carbonate
• 8.80 mg Colecalciferol Dry Concentrate

CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol excipients

• DL-α-tocopherol
• Soybean oil, hydrogenated
• gelatin
• sucrose
• cornstarch
• citric acid
• lactose-1 water
• Povidone K25
• Povidone K25
• sodium bicarbonate
• Sodium saccharine
• sodium cyclamate
• Macrogol 6000
• Macrogol 6000
• orange flavor
• Simeticon Emulsion

Indication/ CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol Application

• Mineral-vitamin combination preparation
• The medicine is applied
  • to support specific osteoporosis treatment in patients with established or high risk of simultaneous calcium and vitamin D deficiency
  • and to compensate for simultaneous calcium and vitamin D deficiencies in the elderly.

CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol dosage

• Always take the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, is the usual dose
• 1 effervescent tablet once a day (equivalent to 1000 mg calcium and 880 IU vitamin D ₃ ).
• Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• Duration of treatment
  • The treatment of calcium deficiency and osteoporosis should be long-term. Please ask your doctor about the necessary duration of use!

• If you take more of the medicine than you should
  • Vitamin D has only a relatively narrow therapeutic range. In adults with normal parathyroid function, the threshold for vitamin D intoxication is between 40,000 and 100,000 IU per day for 1 to 2 months. Babies and young children can be sensitive to much lower doses. Therefore, a warning is given against taking vitamin D without medical supervision.
  • In the case of an overdose, in addition to an increase in phosphorus in the blood and urine, hypercalcaemia syndrome (increased calcium concentration in the blood) occurs, which later also leads to calcium deposits in the tissues and especially in the kidneys (kidney stones and kidney calcification) and the vessels.
  • The symptoms of intoxication are not very characteristic and are expressed in nausea, vomiting, initially often diarrhea, later constipation (constipation), loss of appetite, fatigue, headache, muscle and joint pain, muscle weakness and persistent drowsiness, azotemia (increased nitrogen concentration in the blood), increased thirst and increased urge to urinate and in the final phase dehydration. Typical laboratory findings are hypercalcaemia (increased calcium concentration in the blood), hypercalciuria (increased calcium concentration in the urine) and increased serum values ​​for 25-hydroxycalciferol.
  • Measures in case of overdose
    • In the event of an overdose, measures to treat the often long-lasting and potentially dangerous hypercalcaemia (increased calcium concentration in the blood) are required.
    • The first step is to stop taking the vitamin D preparation; normalization of hypercalcaemia (increased calcium concentration in the blood) as a result of vitamin D intoxication takes several weeks.
    • Graded according to the extent of the hypercalcaemia (increased calcium concentration in the blood), a low-calcium or calcium-free diet, copious fluid intake, increased urination using the drug furosemide and the administration of glucocorticoids (medicines to treat certain allergic diseases) and calcitonin (hormone to regulate the Calcium concentration in the blood) can be used.
    • With adequate kidney function, infusions with isotonic sodium chloride solution (3 - 6 l in 24 hours) with the addition of furosemide (medicine to increase urine excretion) and possibly also 15 mg/kg body weight/hour Sodium edetate (medicine that binds calcium in the blood) reliably reduces calcium under continuous calcium and ECG monitoring. In the case of reduced urine excretion, on the other hand, hemodialysis treatment (blood washing) with a calcium-free dialysate is indicated.
    • There is no specific antidote.
    • Please ask your doctor about the symptoms of a vitamin D overdose.

• If you forget to take the medicine or have taken too little
  • If you have taken too little medicine or have forgotten to take it, please do not take twice the amount of medicine next time, but continue to take it as planned.

• If you stop taking the medicine
  • If treatment is interrupted or ended prematurely, your symptoms may worsen or reappear.

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

CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol way

• The effervescent tablets are dissolved in a glass of water (200 ml).
• You can take the medicine with food or between meals.

side effects

• Like all medicines, this medicine can cause side effects, although not everyone gets them.
• The evaluation of side effects is based on the following frequency information:
  • Very common: more than 1 in 10 people treated
  • Common: less than 1 in 10 but more than 1 in 100 people treated
  • Uncommon: less than 1 in 100 but more than 1 in 1,000 people treated
  • Rare: less than 1 in 1,000 but more than 1 in 10,000 people treated
  • Very rare: less than 1 in 10,000 people treated, or unknown
• Side effects or signs to look out for and what to do if you are concerned
  • After ingestion, constipation, flatulence, nausea, abdominal pain and diarrhea can rarely occur.
  • Rarely, itching, hives and skin rash may occur.
  • In the first few months of administration of the drug, there is an increased excretion of calcium in the urine, which can promote stone formation.
  • Calcium salts reduce the absorption of phosphates by forming poorly soluble salts.
  • Depending on the dose and duration of treatment, an increase in the concentration of calcium in the blood (hypercalcaemia) and increased excretion of calcium in the urine (hypercalciuria) can occur. Severe and long-lasting hypercalcaemia can have acute (cardiac arrhythmia, nausea, vomiting, mental symptoms, impaired consciousness) and chronic (increased urination, increased thirst, loss of appetite, weight loss, kidney stone formation, kidney calcification, calcification in tissues outside the bone) consequences. Fatal courses have been described in individual cases.
  • Very rarely, soybean oil can cause allergic reactions.
• Please tell your doctor or pharmacist if any of the side effects gets serious, or if you notice any side effects that are not listed.

CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol interactions

• When taken with other medicines
• Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
• What other medicines affect the way the medicine works?
  • Vitamin D increases the effect of calcium (increase in absorption).
  • Certain water tablets (thiazide-type diuretics) decrease calcium excretion. Serum calcium levels should therefore be monitored regularly when this medicinal product is taken concomitantly with such medicinal products.
• How does the medicine affect the way other medicines work?
  • If the calcium blood level rises as a result of taking the product, the sensitivity to certain medicines that increase heart strength (cardiac glycosides) increases and the risk of cardiac arrhythmias increases. Patients on concomitant treatment with cardioactive glycosides and calcium should be monitored by ECG and monitoring of serum calcium levels.
  • The absorption and thus the effectiveness of various antibiotics such. B. tetracyclines, quinolones, some cephalosporins and many other drugs (e.g. the antifungal drug ketoconazole, iron, sodium fluoride, estramustine, bisphosphonate preparations) is reduced by taking the drug at the same time. There should therefore generally be a gap of at least 2 hours between taking the medicine and taking other preparations.
  • If you take corticosteroids, it can reduce the absorption of calcium and make vitamin D less effective.
  • Calcium salts reduce the absorption of phosphate by forming poorly soluble salts.
  • Phenytoin (medicines used to treat epilepsy) or barbiturates (medicines used to treat epilepsy and sleep disorders and for anaesthesia) can impair the effect of vitamin D.
• Please note that this information may also apply to medicines that have been used recently.

• When taken with food and drink
  • Please note that dairy products have a high calcium content, which increases the effect of the drug. A liter of milk can contain up to 1200 mg of calcium. This should be taken into account when taking the drug.
  • Interactions can also occur with foods that contain oxalic acid, phytic acid or phosphates such as: B. spinach, rhubarb, grain products.

Contraindications

• The drug must not be taken
  • if you are allergic (hypersensitive) to any of the active substances, soy, peanut or any of the other ingredients of the medicine
  • if the calcium concentration in the blood or urine is too high
  • with calcium-containing kidney stones or calcification of the kidneys
  • in the case of prolonged immobilization of limbs (immobilization)

pregnancy and breast feeding period

• pregnancy and breast feeding period
  • During pregnancy, the drug should only be taken when strictly indicated and only dosed as is absolutely necessary to remedy the deficiency. Overdoses of vitamin D during pregnancy must be avoided because prolonged hypercalcaemia (elevated levels of calcium in the blood) can lead to physical and mental disability and congenital heart and eye diseases in the child.
  • If you are pregnant, you should contact your doctor before taking the medicine.
  • The drug should only be taken during breastfeeding if there is a deficiency. Vitamin D and its metabolites pass into breast milk. An overdose in infants produced in this way has not been observed.
  • If you are breastfeeding your child, you should contact your doctor before taking the medicine.

patient CALCIGEN D forte, osteoporosis, calcium carbonate, Colecalciferol notes

• When can you only take the medicine after consulting your doctor?
  • with a tendency to form kidney stones and kidney calcification
  • with impaired renal function
  • if you have a reduced phosphate concentration in the blood (hypophosphataemia)
• Also ask your doctor for advice if you have a family history of calcium containing kidney stones.
• The drug should not be taken in the case of pseudohypoparathyroidism (disorder of the parathyroid hormone balance), since the vitamin D requirement can be reduced due to the normal vitamin D sensitivity in phases, with the risk of a long-lasting overdose. For this purpose, more easily controllable active ingredients with vitamin D activity are available.
• Special care is required when taking the drug:
  • Taking the drug increases the excretion of calcium in the urine. In the first few months after starting intake, this also increases the tendency to precipitate calcium salts and, under certain circumstances, to form stones in the kidneys and urinary bladder. This can be avoided by drinking plenty of fluids.
  • In the case of renal insufficiency, the drug should only be used with ongoing monitoring of the calcium and phosphate concentrations in the blood and urine.
  • During long-term treatment with the drug, blood and urine calcium levels should be monitored and renal function checked by measuring serum creatinine. This check is particularly important in elderly patients and during concomitant treatment with cardiac glycosides (medicines that stimulate the heart muscles) or diuretics (medicines that stimulate urine output). In case of hypercalcaemia (increased calcium concentration in the blood) or signs of reduced kidney function, the dose must be reduced or the treatment interrupted. It is recommended to reduce the dose or interrupt treatment if the urinary calcium content exceeds 7.5 mmol/24 hours (300 mg/24 hours).
  • If other medicines containing vitamin D are prescribed, the dose of vitamin D in the medicine must be taken into account. Additional administrations of vitamin D or calcium should only be carried out under medical supervision. In such cases, calcium levels in the blood and urine must be monitored.
  • The drug should be used with particular caution in patients with impaired excretion of calcium and phosphate via the kidneys, during treatment with benzothiadiazine derivatives (medicines to promote urine excretion) and in immobilized patients [risk of hypercalcaemia (increased calcium concentration in the blood) and Hypercalciuria (increased calcium concentration in the urine)]. Blood and urine calcium levels should be monitored in these patients.
  • The drug should be used with caution in patients suffering from sarcoidosis due to the risk of increased conversion of vitamin D to its active form. Blood and urine calcium levels should be monitored in these patients.

• Driving and using machines
  • There are no special precautions required.