CC-NEFRO film -coated tablets, 100 pcs

Instructions for use for CC-NEFRO film -coated tablets, 100 pcs

Field of use

• The medicine is a phosphate binder.
• Field of use:
  • Increased serum phosphate (hyperphosphatemia) in chronic renal failure, especially in patients under dialysis treatment.

Active ingredients / ingredients / ingredients

500 mg calcium carbonate
200 mg calcium ion
Cellulose, microcrystalline auxiliary material (+)
Crospovidon auxiliary material (+)
Hypromellic auxiliary substance (+)
Lactose 1-water auxiliary substance (+)
Macrogol 6000 Hedge Terms (+)
Magnesium stair (Ph. EUR.) [pflanzlich] Hedge substance (+)
Polyoxyethylene (8) Monostetarat Home (+)
Povidon K30 auxiliary material (+)
Silicium dioxide, high disperser auxiliary substance (+)
Talcum auxiliary material (+)
Titan dioxide HILDBOFT (+)

Contradictions

• The medicine must not be taken
  • if you are allergic to calcium carbonate or one of the other components of this medicine.
  • in the case of too high calcium concentrations in the blood (hypercalcemia).
    • An increase in calcium concentration occurs regularly with an overfunction of the parathyroid gland (hyperparathyreodism). It can also be present with vitamin D overdosing; certain tumors such as lung cancer (bronchial carcinoma), breast cancer (mamma carcinoma), kidney cancer (hypernephrome), certain forms of blood cancer (plasmocytom) and in bone metastases, certain lung diseases (sarcoidosis, disease); Implementation of limbs (immobilization osteoporosis).
  • with low serum phosphate (hypophosphatemia).
  • with kidney stones containing calcium.
  • in the absence of free hydrochloric acid in the gastric juice.

dosage

• Always take the medicine exactly as described or exactly after the agreement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
• The dosage depends on the amount of the serum phosphate.
• The recommended dose is:
  • Adult
    • The dosage is generally carried out in consultation with the treating doctor. The phosphate content and the number of meals must be taken into account when determining the individual and daily dates.
    • The dose area consists of 1 - 3 tablets 3 times a day, for example 1 tablet for breakfast, 3 tablets for lunch and 2 tablets for dinner. The maximum dose of 7 tablets (corresponding to 1400 mg calcium) should not be exceeded.
  • Children and adolescents (under the age of 18)
    • There is no data on the application for children and adolescents under the age of 18. The application cannot therefore be recommended for these patients.

 

 

• Duration of the application:
  • Therapy with the preparation for phosphate binding in patients with chronic kidney failure is long -term therapy and requires regular medical monitoring.
  • Please speak to your doctor or pharmacist if you have the impression that the effect of the preparation is too strong or too weak.

 

• If you have taken a larger amount of the drug than you should:
  • The overdose of calcium can lead to a high concentration of calcium in the blood (hypercalcemia). Please contact your doctor if you have accidentally taken too many tablets. Symptoms of overdose can include muscle weakness, abdominal pain, constipation, nausea, vomiting, strong thirst, cardiac arrhythmias and unconsciousness.

 

• If you forgot to take the medicine:
  • Do not take the double amount if you have forgotten the prior intake, but continue with the prescribed income.
  • Under no circumstances should the intake be taken after a meal.

 

• If you stop taking the medicine:
  • Take is not allowed without consulting your doctorcan be vomited or ended.

 

• If you have any further questions about the application of the drug, ask your doctor or pharmacist.

Taking

• The film -coated tablets should possibly be taken with some liquid immediately before or at meals.

Patient information

• Warnings and Precautions
  • Please speak to your doctor or pharmacist before taking the preparation.
  • Particular caution when taking the medicine is required:
    • with limited kidney function, kidney stones and kidney calcification (nephrocalcinosis).
    • with increased calcium excretion in urine (hypercalciurie).
    • with a downgraded phosphate concentration in the blood (pituitary memia).
    • with additional intake of calcium or alkalis (basic substances) with food or other medicines. Increased concentrations of calcium together with alkaline substances can lead to milk alkali syndrome (Burnett syndrome). If high doses are taken, the calcium level in the blood and urine should therefore be monitored
  • Also ask your doctor for advice if kidney stones containing calcium in your family have occurred.
  • If the kidney function still exists, the excretion of calcium in the urine increases by taking the drug. In the first few months after the start of income, this also increases the tendency to precipitate calcium salts and, under certain circumstances, to form stones in the kidney and urine bladder. This can be avoided by a ample supply of liquid.
  • Therapy with the preparation requires regular control of serum calcium and serum phosphate levels. The serum calcium level should be under the therapy in
    Standard range. The calcium x phosphate product should by no means
    exceeding, in such a case, the therapy must be canceled.
• Wateriness and operating machines:
  • No studies were carried out on the effects on traffic and the ability to use machines.

Pregnancy

• If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking/using this drug.
• Reports on harmful effects of calcium during pregnancy and during the breastfeeding period in humans have not become known. In pregnancy, serum calcium levels must be checked well, since long -lasting hypercalcemia can lead to physical malformation and intellectual disabilities of the child.

Hints

Miscellaneous

- The active ingredient calcium carbonate is transferred to soluble calcium chloride in the stomach and in this way bioavailing.
- With Achlorhydrie, solubility can be impaired and bioavailability can be reduced. However, bioavailability is largely guaranteed if the medicine is taken together with a meal.

-If in the family, kidney stones containing calcium have already occurred should be excluded an absorptive hypercalciuria.

Therapy monitoring/control measures:
- Treatment with the medicine requires regular control of serum calcium and serum phosphate levels. The calcium phosphate product should never exceed 5.3 mmol per liter, in such a case the treatment must be canceled.

- If permanent treatment with the medicine is required in chronic reduced kidney function, serum phosphate and serum calcium level must be checked, especially when taking vitamin D preparations at the same time.

Manufacturer:  Medice Arzneimittel Pütter GmbH&, Kuhloweg 37, 58638 Iserlohn