• 1500 mg calcium carbonate
• Colecalciferol Dry Concentrate

• DL-α-tocopherol
• malic acid
• Silica, colloidal
• maltodextrin
• Triglycerides, medium chain
• Corn starch, modified
• sodium ascorbate
• sodium
• sodium cyclamate
• sodium bicarbonate
• Sodium saccharine
• sucrose
• sucrose
• citric acid
• lemon flavor

OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis indication

• This medicinal product is a calcium vitamin D ₃ preparation.
• It is taken
  • with proven calcium and vitamin D ₃ deficiency,
  • for the supportive treatment of osteoporosis.

OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis dosage

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • Adults take 1 effervescent tablet twice a day (1 effervescent tablet in the morning and 1 in the evening, equivalent to 1,200 mg calcium and 800 IU vitamin D3).

• Duration of treatment
  • It should be taken long-term. Talk to your doctor about how long you should take the medicine.

• If you take more of the medicine than you should
  • An overdose can lead to nausea, vomiting, abnormal thirst, increased urination or constipation.
  • If you suspect an overdose, please contact your doctor immediately. If necessary, he can initiate necessary measures.
  • Have the package of the medicine ready so that the doctor can find out about the active substance taken up.

• If you forget to take the medicine
  • Do not take a double dose to make up for a forgotten dose. Take the preparation the next day as usual in the usual dosage.

• If you stop taking it
  • If you interrupt the treatment or stop taking it prematurely, you must expect that the desired effect will not occur or that the symptoms will intensify again. Therefore, please consult your doctor if you want to stop or interrupt the treatment.

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

OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis way

• The effervescent tablet is dissolved in a glass of water (approx. 200 ml) and drunk immediately.
• You can take the medicine with food or between meals.

side effects

• Like all medicines, the preparation can have side effects, although not everyone gets them.
• The frequency of side effects is based on the following categories:
  • Very common: affects more than 1 in 10 people
  • Common: affects 1 to 10 users in 100
  • Uncommon: affects 1 to 10 users in 1,000
  • Rare: affects 1 to 10 users in 10,000
  • Very rare: affects less than 1 in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• Metabolic and nutritional disorders
  • Rare: Increased calcium blood level (hypercalcaemia), increased excretion of calcium in the urine (hypercalcuria).
  • Very rare: Milk-alkali syndrome (also known as Burnett's syndrome) usually only occurs after excessive calcium intake. The symptoms are frequent urination, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, together with increased blood calcium levels and kidney dysfunction.
• Diseases of the gastrointestinal tract
  • Uncommon: nausea, diarrhea, abdominal pain, constipation, flatulence.
• Skin and subcutaneous tissue disorders
  • Uncommon: Rash, itching, hives.
• Other possible side effects
  • Partially hydrogenated soybean oil can very rarely cause allergic reactions.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis interactions

• Taking with other medicines
  • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
    • Concomitant treatment with certain drugs that increase heart strength (digitalis glycosides or cardioactive glycosides) can lead to cardiac arrhythmia. Strict medical control, including an ECG examination and control of the calcium blood level, is therefore necessary.
    • If diuretics from the thiazide group are taken at the same time, the serum calcium level should be checked regularly by the doctor, since thiazides limit the excretion of Calcium D3 effervescent tablets calcium with the urine and there is a risk of increased calcium levels in the blood (hypercalcaemia).
    • 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 this preparation at the same time. The absorption of aluminum and bismuth salts and thus their toxicity is increased by the citric acid contained in this preparation. There should therefore generally be a gap of at least 2 hours between taking this medicine and taking other preparations.
    • There should be a gap of at least 2 hours between the administration of cholestyramine and the drug, otherwise the vitamin D will not be properly absorbed.
    • Concomitant administration of this preparation and rifampicin, phenytoin, barbiturates or glucocorticoids may reduce the effectiveness of vitamin D.
• Take with food and drink
  • Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) can inhibit calcium absorption by forming insoluble compounds with calcium ions. You should not take medicines containing calcium for 2 hours before and after eating foods with a high content of oxalic or phytic acid.

Contraindications

• The drug must not be taken
  • if you are allergic to calcium, colecalciferol (vitamin D ₃ ) or any of the other ingredients of the medicine,
  • if you have an increased calcium content in the blood (hypercalcaemia),
  • with increased excretion of calcium in the urine (hypercalciuria),
  • in kidney limestone (nephrolithiasis),
  • with tissue calcification of the kidneys (nephrocalcinosis),
  • if you have impaired kidney function (renal insufficiency),
  • If the parathyroid gland is overactive, which is usually caused by a parathyroid gland adenoma with increased parathyroid hormone secretion (primary hyperparathyroidism),
  • if the vitamin D level is too high (hypervitaminosis D),
  • if you have multiple bone marrow tumors (myeloma),
  • in secondary tumors in the bone (bone metastases),
  • in the case of immobilization of limbs (immobilization).

pregnancy OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis and breast feeding period

• 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.
• pregnancy
  • This medicine can be taken during pregnancy if there is a calcium and vitamin D deficiency.
  • During pregnancy, a daily intake of 500 IU of vitamin D should not be exceeded. It is therefore not allowed to take more than 1 effervescent tablet (400 IU of vitamin D) per day.
  • So far, no risks are known in the specified dose range.
  • Prolonged overdoses of vitamin D must be avoided during pregnancy, as the resulting hypercalcaemia (increased calcium concentration in the blood) can lead to physical and mental disability as well as congenital heart and eye diseases in the child.
  • Vitamin D and its metabolites pass into breast milk. An overdose in infants produced in this way has not been observed. Calcium passes into breast milk in small amounts without having an adverse effect on the child.
  • _{During pregnancy, the daily dose} should not exceed 1,500 mg of calcium and 600 IU of vitamin D3. Therefore, only one effervescent tablet (400 IU of vitamin D) may be taken daily.
  • Overdose should be avoided during pregnancy because prolonged hypercalcaemia can lead to physical and mental developmental disorders, supravalvular aortic stenosis and non-inflammatory retinal diseases in the child. However, there are also several case reports showing that mothers suffering from reduced or absent production of parathyroid hormone gave birth to healthy children after taking very high doses of the vitamin. There is no evidence that vitamin D is teratogenic in humans at therapeutic doses.
  • If calcium and vitamin D deficiency occurs during pregnancy, the drug can be used.
• lactation
  • The drug can be taken while breastfeeding. Calcium and vitamin D3 pass into breast milk. This must be taken into account if the child receives additional doses of vitamin D.

patient OSSOFORTIN forte, calcium, vitamin D, treatment of osteoporosis notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • During long-term treatment with the preparation, your doctor must monitor the calcium level in the blood and the kidney function by measuring the serum creatinine level. Monitoring is particularly important in elderly patients and in patients who are also taking certain medicines that increase heart strength (cardiac glycosides) or water tablets (diuretics). This also applies to patients with a pronounced tendency to stone formation. If the calcium level in the blood is too high (hypercalcaemia) or there are signs of kidney dysfunction, the dose must be reduced or the intake stopped.
  • If you suffer from kidney dysfunction, you should only take vitamin D with caution and with monitoring of calcium and phosphate levels. In severe renal dysfunction, vitamin D in the form of colecalciferol is not metabolized normally. Your doctor should therefore prescribe you another vitamin D supplement.
  • Additional intake of other medicines containing calcium may only take place under close medical supervision, including weekly monitoring of the calcium level in the blood and urine.
  • If you are prescribed other vitamin D preparations at the same time, your doctor should take into account the administered amount of 400 IU per effervescent tablet.
  • The drug should be used with caution by patients suffering from sarcoidosis due to the risk of increased conversion of vitamin D to its active form. In these patients, blood and urine calcium levels should be monitored by the doctor.
  • Certain tumors such as lung cancer (bronchial carcinoma), breast cancer (mammary carcinoma), kidney cancer (hypernephroma) and blood cancer (plasmacytoma) can cause increased levels of calcium in the blood. These patients should take the drug with caution. The calcium levels in the blood and urine should be monitored by the doctor.
  • children
    • The medicine is not intended for use in children.
• Ability to drive and use machines
  • There are no data on the effect of this medicine on the ability to drive or use machines. However, an influence is unlikely.