Calci APS D3 effervescent tablets, 100 pcs

Instructions for use for Calci APS D3 effervescent tablets, 100 pcs

Important notes (compulsory information):

Calcias D3, Calcium ++ 1000 mg and colecalciferol (vitamin D3) 880 I.e./ shower tablet. Applications: To compensate for simultaneous calcium and vitamin D-deficiency in older people and the supportive treatment of osteoporosis in patients with a proven or high risk of simultaneous calcium and vitamin D-deficiency.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Calcias D3, Calcium ++ 1000 mg and colecalciferol (vitamin D3) 880 I.e./ shower tablet
Active ingredients: Calcium carbonate and colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet:

1. What is CALCIAPS D3 and what is it used for?
2. What should you consider before taking Calcias D3?
3. How to take Calciaaps D3?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Calciaaps D3?
6. Content of the pack and more information

1. What is CALCI APS D3 and what is it used for?

Calciaaps D3 is a mineral preparation with calcium and vitamin D3. CalciaS D3 is used to compensate for simultaneous calcium and vitamin D-deficiency in older people as well as supportive treatment of osteoporosis in patients with proven or high risk of simultaneous calcium and vitamin D-deficiency.

2. What should you consider before taking Calci APS D3?

Calciaaps D3 may not be taken:

• if they are allergic to calcium carbonate or colecalciferol or soy, peanut or one of the other ingredients of this medicine referred to in section 6,
• if you have an increased calcium content in the blood (Hypercalcaemia) was found,
• if you have an increased calcium excretion in the urine (Hypercalciurie) was found,
• if you have a transfer of the side thyroid gland (Hyperparathyroidism) was found,
• if you have a vitamin D overdose,
• if you suffer from one of the following tumors: lung cancer (Bronchial cancer), breast cancer (mammary cancer), kidney cancer (Hyporephroma), certain forms of blood cancer (plasmocytoma), Multiple bone market tumor (myeloma) and subsidiaries in the bone (bone metastases), as these diseases can cause increased calcium levels in the blood,
• if you suffer from one of the following pulmonary diseases (sarcoidosis, boeck's disease,
• if a immobilization of limbs (immobilization) is necessary with you.

Please talk to your doctor or pharmacist before taking Calciaaps D3.

Warnings and Precautions:
Take special care with CALCIAPS D3 is required:

• if you have limited kidney function (Renal insufficiency,
• if renal escalates have occurred with you or in your family,
• if you suffer from kidney calculation (nephrocalcinose,
• if you have a degraded Phosphate concentration in the blood (Hypophosphatemia) was detected.

During long term treatment with Calcias D3, the blood calcium mirror is to be controlled and the kidney values are monitored by measuring the serum creatinine values. The monitoring is particularly important in older patients and in patients who receive heart glycosides and diuretics as accompanying medication. When an excessive calcium mirror in the blood or signs of a kidney function disorder, the dose must be reduced or cancel the therapy. By taking Calcias D3, the elimination of calcium in the urine increases. In the first few months after the degree of income, this also increases the tendency to precipitate calcium salts and under certain circumstances to form stones in kidney and urinary bubble. This can be avoided by a plentiful supply of liquid. Since CALCIAPS D3 already contains vitamin D, additional use of vitamin D or calcium may only be carried out under strict medical control. Calcium and alkali recording from other sources (foodstuffs, enriched foods or other medicines) should be considered when CalciaPs D3 is taken. When high doses of calcium together with alkaline agents (such as carbonates) be given, this can lead to a milk alkaline syndrome (Burnett's syndrome) with hypercalcaemia, metabolic alkalosis, kidney failure and soft tissue clarification. At administration of high doses, the calcium level should be checked in serum and urine.

Children and adolescents:
There is no relevant use of Calciaaps D3 in children and adolescents in the field of application. The safety and efficacy of Calcias D3 in children and adolescents has not yet been proven. No data is available. Therefore, a dosage recommendation can not be given.

Taking Calcias D3 together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / use other medicines.

• Vitamin D increases the effect of calciaaps D3 (Resorption increase).
• Certain urinary driven agents (diuretics from the thiazide type) Reduce the calcium excretion. With simultaneous use of Calcias D3 and such medicines, the calcium blood mirror should be monitored.
• With simultaneous treatment with cardiac medications of the type of digitalislycosides, cardiac arrhythmias can occur. Strict medical control including ECG examinations and control of the calcium blood mirror is therefore required.
• The recording and thus the effectiveness of different antibiotics (tetracyclines, quinolons, some cephalosporines) and other medicines (e.g., the fungus ketoconazole, means against osteoporosis (sodium fluoride, biphosphonate preparations), Eisen or Estramustinparaten) is reduced by the simultaneous application of Calcias D3. Between the intake of these preparations and taking Calcias D3, a distance of at least 2-3 hours should be adhered to.
• The simultaneous intake of phenytoin (agent against epilepsy and against certain cardiac arrhythmias), rifampicin or barbiturates (sleep aid) with calciaaps D3 can lead to accelerated degradation and thus to reduce the effect of vitamin D.
• The simultaneous intake of glucocorticoids (means for suppressing immune defense and at certain infections) or Colestyramine and Calcias D3 can lead to a reduction in the effect of vitamin D.

Taking Calcias D3 together with food and beverages:
Oxalic acid (included in spinach and rhubarb) and phytic acid (included in wholemeal) can inhibit the calcium uptake by forming insoluble compounds with calcium ions. You should wait for at least 2 hours between the consumption of spinach, rhubarb or wholegrain products and taking Calciaaps D3. Please note that dairy products have a high calcium content and thus the effect of calciaaps is enhanced. One liter of milk contains 1200 mg of calcium.

Pregnancy and breast feeding period:
If you are pregnant or silence, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Calciaaps D3 should not be used because of the high dosage of vitamin D during pregnancy and lactation. In pregnancy, overdose with Calcias D3 is to be avoided, as a long-lasting increase in the blood (hypercalcaemia) calcium mirror (hypercalcaemia) is a physical and mental development delay, special forms of aortic narrowing (Supravalvular aortic stenosis) and non-inflammatory network high diseases (retinopathy) can lead to the child. However, there are also individual case reports, which demonstrate that despite highly dosed gifts of vitamin D for the therapy of a subfunction of the parathyroid gland (hypoparathyroidism) of the mother, healthy children were born. In animal experiments, an overdose with vitamin D led to malformations during pregnancy (Teratogenic effect). However, there is no evidence that vitamin D is teratogenic in therapeutic doses. Calcium, vitamin D and its metabolic products go into breast milk. Calciaaps D3 should not be taken due to the high dosage of vitamin D during lactation. Ask your doctor or pharmacist for advice before taking all medicines.

Driving and ability to operate machines:
There are no special precautions required.

Calciaaps D3 contains lactose, sucrose and sodium compounds:
Please take CALCIAPS D3 only after consulting with your doctor if you are known to suffer from any intolerance to certain sugars. Calciaaps D3 Can be harmful to the teeth (caries). An effervescent tablet contains 4.2 mmol (96 mg) sodium. If you need to meet a saline diet, you should consider this.

3. How to take Calci APS D3?

Always take Calciaaps D3 exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: 1-time daily 1 effervescent tablet CalciaS D3. Please loose the effervescent tablet in a glass of drinking water 200 ml and fully drink the contents of the glass. You can take Calcias D3 for food or between meals. About the duration of the treatment can be decided individually from your doctor. In general, the treatment should be done in the long term. Please talk to your doctor or pharmacist if you have the impression that the effect of Calciaaps D3 is too strong or too weak.

If you take a larger amount of Calcias D3 than you should:
An overdose leads to increased calcium excretion in urine and increasing the calcium concentration in the blood with the following symptoms: nausea, vomiting, thirst and increased dur stagn, increased urination or constipation. If there is suspected overdose, set Calcias D3 and contact your doctor immediately. This may take necessary measures if necessary. Chronic overdose leads to increased blood calcium levels and can lead to vascular and organ valve.

If you forget to take Calcias D3:
Do not take the double amount when you forget the previous taking.

If you cancel the taking Calcias D3:
CALCIAPS D3 can only work if you take the effervescent tablets regularly. If you interrupt or terminate the treatment for a longer time or prematurely, the desired treatment success does not occur.

If you have further questions about taking the medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. The assessment of side effects is based on the following frequency information:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Diseases of the gastrointestinal tract:
Occasionally: nausea, diarrhea, abdominal pain, constipation, flatulence.

Diseases of the kidney and urinary tract:
Rarely: In the first few months of the administration an increased calcium excretion in urine that can favor a stone formation, increased calcium blood levels.
Not known: In the case of a renal function and long-term taking of high doses, increased calcium mirrors in the blood and urine can come. The intake of calcium salts leads to a reduction in phosphate resorption by forming difficult soluble calcium phosphate.

Diseases of the immune system:
Very rare: allergic reactions.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Calci APS D3?

Keep this medicine inaccessible to children. You must not use the drug after the expiry date specified on the carton and on the tablet tube after "usable until". The expiry date refers to the last day of the specified month. Do not store more than 25 ° C. Store dry and close the tube close to use. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist How to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What CALCIAPS D3 contains:
Active ingredients: 1 effervescent tablet contains: 2500 mg of calcium carbonate (corresponding to 1000 mg calcium) 22 μg colecalciferol (corresponding to 880 I. E. Vitamin D3). The other ingredients are: Alpha-tocopherol, hydrogenated soybean oil, gelatin, sucrose, corn starch, anhydrous citric acid, sodium bicarbonate, lactose monohydrate, povidone k25, saccharin sodium, sodium cyclamate, macrogol 6000, orange juice aroma, simethicon, methyl cellulose.

How CALCIAPS D3 looks like and content of the pack:
Calciaaps D3 are white, round, smooth, non-curved effervescent tablets. There are Calcias D3 in the following packing sizes: Original pack with 20 effervescent tablets, original pack with 40 Effervescent tablets and original packaging with 100 effervescent tablets. There may not be all pack sizes on the market.

Pharmaceutical entrepreneur and manufacturer:
Cheplapharm Arzneimittel GmbH
Bahnhofstr. 1A
17498 Mesekenhagen
Telephone (038351) 5369-0
Fax (038351) 5369-25
E Mail: [email protected]
Internet: www.cheplapharm.de

This information information was last revised in August 2014.

Source: Information of the leaflet
Status: 09/2016