CALCIGEN D Forte 1000 mg/880 I.E. Jumper tablets, 50 pcs

Instructions for use for CALCIGEN D Forte 1000 mg/880 I.E. Jumper tablets, 50 pcs

Application notes

Adults and elderly patients

1 Effervescent tablet

1 times a day

during or between meals

Application areas

Mode of action

How do the ingredients of the drug work?

Calcium ions are of crucial importance in the activation of biological systems. A lack of calcium in the blood increases, but an excess reduces neuromuscular excitability. Oral calcium intake promotes the remineralization of the skeleton in the case of calcium deficiency. Colecalciferol is physiological vitamin D3, which is converted into the kidney and liver to calcitriol, the effective substance of the vitamin D3. Calcitriol is responsible for taking the calcium and phosphate from the intestine. The recovery of calcium and its resumption from the kidney vitamin D are also dependent. The substance promotes the mineralization of the bones and thus inhibits their dismantling.

Composition

Contradictions

What speaks against an application?

- Increased calcium values
- Increased calcium excretion in the urine
- Kidney limestones
- Lime deposits in the kidney
- Limited kidney function
- Passage gland diseases
- Vitamin D overdosing
- Myeloma
- Bone metastases
- Immensing the body for treatment purposes
- Sarcoidosis (Boeck illness)

Which age group must be observed?
- Children and adolescents under the age of 18: The drug must not be used.

What about pregnancy and lactation?
- Pregnancy: Contact your doctor. Various considerations play a Rolle, whether and how the drug can be used during pregnancy.
- Still -time: Contact your doctor or pharmacist. He will check your special starting position and advise you accordingly whether and how you can continue with breastfeeding.

If the medicine has been prescribed to you despite a counter -notification, speak to your doctor or pharmacist. The therapeutic benefit can be higher than the risk of using the application.

Side effects

What adverse effects may occur?

- Increased calcium values
- Increased calcium excretion in the urine
- Constipation
- Flatulence
- Stomach pain
- Nausea
- Nessel addiction
- Itching
- Skin rash
- Shifting of the acid-base equilibrium in the blood to the alkaline side (alkalosis)

If you notice a disorder or change during treatment, contact your doctor or pharmacist.

For information at this point, side effects are taken into account that occurs in at least one of 1,000 patients treated.

Hints

What should you consider?
- Be careful with allergy against the sweetener saccharin (E 954)!
- Be careful with allergy against the sweetener cyclamat (E 952)!
- Beware of an intolerance to lactose. If you have to adhere to a diabetes diet, you should take the sugar content into account.
- Beware of an intolerance to sucrose. If you have to adhere to a diabetes diet, you should take the sugar content into account.
- Beware of allergy to peanuts and soy.

Detailed instructions for CALCIGEN D Forte 1000 mg/880 I.E. Jumper tablets, 50 pcs

Field of use

• Mineral vitamin combination preparation
• The medicine is used
  • to support specific osteoporosis treatment in patients with proven or high risk of simultaneous calcium and vitamin D deficiency
  • and to compensate for a simultaneous calcium and vitamin D deficiency in older people.

 

Active ingredients / ingredients / ingredients

2500 mg calcium carbonate
1000 mg calcium ion
8.8 mg Colecalciferol drying concentrate
880 Ie Colecalciferol
22 µg Colecalciferol
alpha-tocopherol auxiliary material (+)
Citronic acid, water -free auxiliary material (+)
Gelatine auxiliary substance (+)
Lactose 1-water auxiliary substance (+)
396 mg lactose auxiliary substance (+)
Macrogol 6000 Hedge Terms (+)
Corn starch auxiliary substance (+)
Sodium cyclamat auxiliary substance (+)
Sodium hydrogen carbonate auxiliary material (+)
Povidon K25 Hedge substance (+)
Saccharin, sodium salt auxiliary material (+)
3.68 mg sucrose auxiliary material (+)
Simeticon emulsion HILDVERSTOFT (+)
Silicium dioxide, high disperser auxiliary substance (+)
Methylcellulose auxiliary substance (+)
Simeticon Hedge substance (+)
0.73 mg soybean oil, hardened auxiliary material (+)
97 mg total sodium ion hedge material (+)
4.22 mmol total sodium ion helper (+)
Apple Aroma Hedge substance (+)

Contradictions

• The medicine must not be taken,
  • if you are hypersensitive (allergic) against one of the active ingredients, soy, peanut or one of the other components of the drug
  • if calcium concentrations are too high in the blood or in the urine
  • with kidney stones containing calcium or calcification of the kidney
  • if the limbs (immobilization) are immobilized for a long time

dosage

• Always take the medicine exactly according to the instruction. Please ask your doctor or pharmacist if you are not quite sure.
• Unless otherwise prescribed by the doctor, the usual dose is
• 1 effervescent tablet 1 times a day (corresponding to 1000 mg calcium and 880 I. E. Vitamin D₃).
• Please speak to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.

 

• Duration of treatment
  • The treatment of calcium lack and osteoporosis can be created in the long term. Please ask I about the necessary duration of the applicationhen doctor!

 

• If you have taken a larger amount of the drug than you should
  • Vitamin D has only a relatively low therapeutic width. In adults with a normal function of the parathyroid glands, the threshold for vitamin D intoxications is between 40,000 and 100,000 I. E. per day over 1 to 2 months. Infants and toddlers can react sensitively to far lower doses. Therefore, warnings are carried out without medical control before the supply of vitamin D.
  • In the case of overdose, there is an increase in phosphorus in the blood and urine to the hypercalcalcemia syndrome (increased calcium concentration in the blood), later also to calcium deposits in the tissues and especially in the kidney (kidney stones and kidney calcification) and vessels.
  • The symptoms of intoxication are not very characteristic and express themselves in nausea, vomiting, initially often diarrhea, later constipation (constipation), loss of appetite, weary, head, muscle and joint pain, muscle weakness as well as stubborn sleepiness, azotemia (increased nitrogen concentration in the blood), Increased thirst and increased urge to urinate and drying out in the final phase. Typical laboratory findings are hypercalcemia (increased calcium concentration in the blood), hypercalciuria (increased calcium concentration in urine) and increased serum values for 25-hydroxycalciferol.
  • Measures for overdose
    • In the case of overdose, measures to treat the often long -term and possibly threatening hypercalcemia (increased calcium concentration in the blood) are required.
    • The first measure is the vitamin D preparation; A normalization of hypercalcemia (increased calcium concentration in the blood) as a result of vitamin D intoxication takes several weeks.
    • Reduced to the extent of the hypercalcemia (increased calcium concentration in the blood), calcium -free diet or calcium -free nutrition, plenty of fluid intake, increase in urine excretion by means of the drug Furosemide and the administration of glucocorticoids (medicines for the treatment of certain allergic diseases) and calcitonin (hormone Calcium concentration in the blood).
    • With sufficient kidney function, infusions with isotonic table salt solution (3 - 6 l in 24 hours) with the addition of furosemide (medicinal products to increase urine excretion) and possibly also 15 mg/kg kg/h. Sodium defeat (medicinal products that binds calcium in the blood) under continuous calcium and EKG control quite reliably reducing calcium-lowering. In the case of reduced urinary excretion, on the other hand, hemodialysis treatment (blood wash) with a calcium -free dialysate is indicated.
    • There is no special antidote.
    • Please ask your doctor about the symptoms of an overdose of vitamin D.

 

• If you forgot to take the medicine or have taken too little
  • If you have taken the medicine too little or forgotten an intake, please do not take double drugs next time, but continue taking it as intended.

 

• If you cancel the intake of the drug
  • In the event of an interruption or early end of the treatment, your symptoms can deteriorate or reappear.

 

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

 

Taking

• The effervescent tablets are taken up in a glass of water (200 ml).
• You can take the medicine for eating or between meals.

 

Patient information

 

• When can you only take the medicine after consultation with your doctor?
  • if the kidney stones and kidney calcification are tended to form
  • with limited kidney function
  • with humiliated phosphate concentration in the blood (hypophosphatemia)
• Also ask your doctor for advice if kidney stones containing calcium in your family have occurred.
• The medicine should not be taken in pseudohypoparathyroidism (disturbance of the parathormone housetS), since the vitamin D requirement can be reduced by the phases of normal vitamin D sensitivity, with the risk of long overdose. For this purpose, more controllable active ingredients with vitamin D activity are available.
• Particular caution when taking the drug is required:
  • By taking the drug increases, the excretion of calcium in the urine increases. 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.
  • In the case of renal failure, the medicine should only be used in the blood and urine while monitoring calcium and phosphate concentrations.
  • During long -term treatment with the medicine, the calcium levels in the blood and urine should be monitored and the kidney function should be checked by measuring the serum creatinine. This review is particularly important in older patients and at the same time treatment with heart glycosides (medicines to promote the function of the cardiac muscles) or diuretics (medicines to promote urine excretion). In the case of hypercalcemia (increased calcium concentration in the blood) or signs of reduced kidney function, the dose must be reduced or the treatment is interrupted. It is advisable to reduce the dose or to interrupt the treatment if the calcium content in the urine is 7.5 mmol/24 hours (300 mg/24 hours).
  • If other medicinal products containing vitamin D are prescribed, the dose of vitamin D must be taken into account in the medicine. Additional administration of vitamin D or calcium should only be carried out under medical monitoring. In such cases, the calcium levels in the blood and urine must be monitored.
  • In patients with disturbed excretion of calcium and phosphate, the medicine should only be used with special caution in the case of treatment with benzothiadiazin derivatives (medicinal products for promoting urine excretion) and for immobilized patients [Risiko der Hypercalcämie (erhöhte Calciumkonzentration im Blut) und Hypercalciurie (erhöhte Calciumkonzentration im Harn)]. The calcium levels in the blood and urine should be monitored in these patients.
  • In patients who suffer from sarcoidosis, the medicine should only be used with caution, since the risk of increased conversion of vitamin D insists into its active shape. The calcium levels in the blood and urine should be monitored in these patients.

 

• Wateriness and operating machines
  • There are no special precautions required.

Pregnancy

• Pregnancy and breast feeding period
  • During pregnancy, the medicine should only be taken after a strict indication and only dosed as it is absolutely necessary to fix the defect. Overdoses of vitamin D during pregnancy must be prevented because long-lasting hypercalcemia (increased calcium concentration in the blood) can lead to physical and intellectual disabilities as well as congenital heart and eye diseases of the child.
  • If you are pregnant, you should contact your doctor before taking the drug.
  • The drug should only be taken during breastfeeding if there is a deficiency. Vitamin D and its metabolic products pass into breast milk. An overdose in the infant generated in this way has not been observed.
  • If you breastfeed your child, you should contact your doctor before taking the drug.
    

Hints

Manufacturer:  MEDA Pharma GmbH & Co.KG, Benzstraße 1, 61352 Bad Homburg