Calcium D3 Biomo 1000 mg / 880 I.E. Effervescent tablets, 120 pcs

Instructions for use for Calcium D3 Biomo 1000 mg / 880 I.E. Effervescent tablets, 120 pcs

Important notes (compulsory information):

CALCIUM-D3-BIOMO 1000 mg / 880 I.E. Effervescent tablets. Areas of application: For supportive treatment of osteoporosis (Disease of the skeleton with reduction of bone mass) in patients with simultaneous calcium and vitamin D deficiency and to compensate for simultaneous calcium and vitamin D deficiency in older people.

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


LEAFLET: INFORMATION FOR THE USER

CALCIUM-D3-BIOMO 1000 mg / 880 I.E. Effervescent tablets for application in adults
Active substances: Calcium carbonate and 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 your complaints worse or no improvement occurs, you must definitely visit a doctor.

What is in this leaflet:

1. What are CALCIUM-D3-BIOMO 1000 mg / 880 I.E. Effervescent tablets and what are you used for?
2. What should you take before taking Calcium-D3-Biomo 1000 MG / 880 I.E. Note effervescent tablets?
3. How are calcium-d3-biomo 1000 mg / 880 i.e. take effervescent tablets?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How are calcium-d3-biomo 1000 mg / 880 i.e. keep effervescent tablets?
6. Content of the pack and more information

1. What are calcium-d3-biomo 1000 mg / 880 i.e. effervescent tablets and what are they used for?

CALCIUM-D3-BIOMO 1000 mg / 880 I.E. is a mineral vitamin combination preparation for the treatment of calcium and vitamin D deficiency states.

It is applied:

• for the supportive treatment of osteoporosis (disease of skeleton with reduction of bone mass) in patients with simultaneous calcium and vitamin D deficiency
• to compensate for simultaneous calcium and vitamin D-deficiency in older people.

2. What should you take place before taking Calcium D3-Biomo 1000 MG / 880 I.E. Note effervescent tablets?

CALCIUM-D3-BIOMO 1000 mg / 880 I.e. may not be taken:

• if you are allergic to one of the active ingredients, soy, peanut or one of the other ingredients of calcium-d3-biomo 1000 mg / 880 i.e,
• if you have too high calcium concentrations in the blood or urine,
• if you have calcium-containing kidney stones or a calcification of the kidney,
• if you can not move your limbs longer or quiet (immobilization).

Warnings and Precautions:
Please talk to your doctor or pharmacist before you take Calcium-D3-Biomo 1000 mg / 880 I.e. If one of the listed points should apply to you:

• if you tend to form kidney stones and kidney calcification, or if calcium-containing kidney stones have occurred in your family. By taking CALCIUM-D3-BIOMO 1000 MG / 880 I.e. Increases the excretion of calcium in the urine. Dadu
• if you suffer from restricted renal function. You should then calcium-d3-biomo 1000 mg / 880 i.e. Only under regular monitoring of calcium and phosphate concentrations in the blood and apply urine.
• if you have a reduced phosphate concentration in the blood. Calcium salts reduce the absorption of phosphates.
• if you additionally take other vitamin D-containing medicines. The dose of vitamin D in Calcium-D3-Biomo 1000 mg / 880 I.e. must be considered. If you additionally take vitamin D or Calcium, you should only under medical
• if you suffer from a disruption of the parathyroidal (the Parathormone regulates the calcium concentration in the blood). Your vitamin D3 needs can then be reduced. To avoid overdose, you should use a smaller effective spot vitamin compartments
• if you are CALCIUM-D3-BIOMO 1000 MG / 880 I.E. Take over a long time. In this case, the calcium levels in the blood and urine as well as renal function should be monitored regularly. This is especially important in older patients and
• if you have increased calcium concentration in the blood or there are signs of reduced kidney function. The dose of calcium-d3-biomo 1000 mg / 880 i.e. must then be reduced or the treatment is interrupted.
• if you disturb the excretion of calcium and phosphate over the kidney. The calcium levels in the blood and urine should then be monitored regularly with them.
• if you are using certain dewatering medicines (Benzothiadiazin derivatives) are treated. The calcium levels in the blood and urine should then be monitored regularly with them.
• if you could hardly move for a long time. The calcium levels in the blood and urine should then be monitored regularly with them.
• if you are suffering from sarcoidosis, an autoimmune disease that is mainly lungs and lymph nodes. The calcium levels in the blood and urine should then be monitored regularly with them.
• if you have calcium and alkalis (like carbonates) from other sources (other medicines, but also foods, eg. B. Dairy products) to take. The calcium levels in the blood and urine should then be monitored regularly with them. In symptoms

Taking Calcium-D3-Biomo 1000 mg / 880 I.e. Together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / use other medicines. Certain medicines may affect the effect of calcium-d3-biomo 1000 mg / 880 I.e., and vice versa, calcium-d3-biomo 1000 mg / 880 i.e may affect the effect of other medicines. It can come to interactions. This must be observed if you take one of the following medicines:

• Vitamin D: The effect of calcium is increased.
• Diuretics from the thiazide type (certain urinary drugs): The calcium excretion is reduced. While taking these medicines and calcium-d3-biomo 1000 mg / 880 i.e. Therefore, serum calcium levels should be over regularly
• Incessive glycosides (medicines for heart failure): The risk of cardiac arrhythmias can be increased. If they are treated simultaneously with heart-like glycosides and calcium, they should use ECG and control of serum calcium spike
• Corticosteroids (medicinal products for treating rheumatism, asthma and inflammatory diseases): When they take corticosteroids, this can reduce the recording of calcium and impair the effect of vitamin D. The dose of Calcium D3-Bio

The effectiveness of these preparations is reduced by simultaneous use of calcium-d3-biomo 1000 mg / 880 i.e. Between the intake of calcium-d3-biomo 1000 mg / 880 I.e. and taking one of these preparations should therefore be a distance of at least 2 Hours are met:

• Antibiotics (eg. B tetracycline, quinolones, some Cefalosporine)
• Ketoconazole (medicines for the treatment of fungal infections)
• Iron preparations (for the treatment of anemia)
• Sodium fluoride preparations (eg for the treatment of osteoporosis)
• Estramustin (medicines for the treatment of prostate cancer)
• Bisphosphonate preparations (for treatmentg of osteoporosis).

These medicines can affect the effect of vitamin D:

• Barbiturates (treatment of epilepsy, sleep disorders and anesthesia)
• Phenytoin (medicine for the treatment of epilepsy).

Taking Calcium-D3-Biomo 1000 mg / 880 I.e. Together with food and beverages:
Please note that dairy products have a high calcium content. You have to consider this if you calcium-d3-biomo 1000 mg / 880 i.e. Take. One liter of milk can z. B up to 1200 Mg calcium included. This makes the effect of calcium-d3 biomo 1000 mg / 880 I.e. reinforced. Talk to your doctor or pharmacist if you take dairy products in large quantities. Interactions with food may occur which contain oxalic acid, phytic acid or phosphates. These include z. B spinach, rhubarb and cereal products. If you take such foods, you should calcium-d3-biomo 1000 MG / 880 I.e. Only take two hours after the food.

Pregnancy, breastfeeding and procilability:
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 this medicine.

Pregnancy:
During pregnancy you should calcium-d3-biomo 1000 MG / 880 I.E. only take with absolute necessity, and only as dosed as it is necessary to resolve the deficiency of calcium and vitamin D. Vitamin D overdoses in pregnancy must be prevented because a long-lasting increased calcium concentration in the blood can lead to physical and intellectual disability and innate heart and eye diseases of the child. If you are pregnant, you should contact your doctor before taking Calcium-D3-Biomo 1000 mg / 880 I.e.

Latving:
CALCIUM-D3-BIOMO 1000 mg / 880 I. E. Should only be taken during breastfeeding when there is a lack of calcium and vitamin D. Vitamin D and its metabolic products go into breast milk. So far it has not been observed that infants have received too much calcium and vitamin D3 in this way. If you breastfeed your child, you should take place before taking Calcium D3-Biomo 1000 mg / 880 I.e. talking to your doctor.

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

CALCIUM-D3-BIOMO 1000 mg / 880 I.e. Contains soy oil, sucrose (sugar), Lactose and sodium compounds:
CALCIUM-D3-BIOMO 1000 mg / 880 I.e. Contains soy oil. Soy oil can cause severe allergic reactions in rare cases. If you are hypersensitive to soybean oil, you may not take CALCIUM-D3-BIOMO 1000 mg / 880 I.e. Do not take. This also applies if you know that they react hypersensitive to peanuts, as soybeans and peanuts are related sleeve fruits. (see section 2. Under "Calcium-D3-Biomo 1000 mg / 880 I.e. may not be taken"). This medicine contains milk sugar (Lactose) and sugar (sucrose). Please take Calcium-D3-Biomo 1000 mg / 880 I.e. Therefore only after consulting with your doctor if you know that you can not tolerate certain sugar species. CALCIUM-D3-BIOMO 1000 mg / 880 I.e. Contains sugar. This can be harmful to the teeth (caries). A Calcium D3-Biomo 1000 MG / 880 I.E. Escort tablet contains 94.5 mg of sodium. If you need to meet a saline diet, you should consider this.

Note for diabetics:
An effervescent tablet contains 3.7 g of sugar (sucrose), accordingly 0.31 BE.

3. How are Calcium D3-Biomo 1000 mg / 880 I.E. take effervescent tablets?

Always take this medicine as described in this leaflet or just according to the agreement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: once a day 1 effervescent tablet (corresponding to 1000 Mg Calcium and 880 I.e. Vitamin D).

Note to take the effervescent tablets:
Loosen the effervescent tablet in a glass of water (about 200 ml) and drink the solution immediately. You can eat the effervescent tablet for food or also take between meals.

Duration of treatment:
The treatment of calcium deficiency and osteoporosis is usually a long term treatment. About the necessary duration of the application please contact your doctor!

If you are a larger amount of calcium-d3-biomo 1000 mg / 880 i.e. have taken than you should:
If you have taken more calcium-d3-biomo 1000 mg / 880 I.e. as you should, or if children accidentally take the medicine, please contact your doctor immediately. He will then decide on the further procedure. Signs of overdose may be: nausea, vomiting, initially often diarrhea, later constipation, loss of appetite, mattedness, headache, muscle and joint pain, muscle weakness and stubborn drowsiness, increased thirst, elevated urinary edge and in the final phase dehydration. Please consult your doctor about the symptoms of overdose vitamin D.

If you are taking CALCIUM-D3-BIOMO 1000 mg / 880 I.E. have forgotten:
Do not take the double amount when you forget the previous taking.

If you are taking CALCIUM-D3-BIOMO 1000 mg / 880 I.E. abort:
Please talk to your doctor if you want to interrupt the treatment or end prematurely. If you cancel or interrupt the treatment too early, the treatment success is called into question. Your complaints can deteriorate or occur again.

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

4. Which side effects are possible?

Like all medicines, this medicine can also. Have side effects, which do not have to occur with everyone. 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.

Possible side effects:
Diseases of the immune system:
Very rare: soybean oil, another ingredient of Calcium-D3-Biomo 1000 mg / 880 I.e., can cause allergic reactions.

Metabolic and nutritional disorders:
Rarely: increase the calcium concentration in the blood (hypercalcaemia); increased calcium excretion in urine (hypercalcuria). In severe and long-lasting hypercalcaemia, acute cardiac arrhythmias, nausea, vomiting, mental symptoms and awareness may occur as well as chronic consequences such as e.g. Intermediate urinary urgency, reinforced thirst feeling, loss of loss, weight loss, renal stone formation, renal calcification and calcification in tissues outside the bone. Deadly courses have been described in individual cases (see section 3. below "If you are a larger amount of calcium D3-Biomo 1000 mg / 880 I.e. have taken than they should").

Stomach and bowel diseases:
Rare: constipation, bloating, nausea, abdominal pain and diarrhea.

Diseases of the skin and subcutaneous tissue:
Rare: itching, hives and rash.

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 safety of this medicinebe elt.

5. What are calcium D3-Biomo 1000 mg / 880 I.E. keep effervescent tablets?

Keep this medicine for children inaccessible to you, this medicine may be based on the container (Ver. To) Do not use the specified expiry date. The expiry date is indicated on the bottom of the tube and the folding box and refers to the last day of the specified month. No over Store 25 ° C! The tube must be sealed tight and stored dry. Stable after a breakdown of the container 1 month. You must not use this medicine if you notice the following: Significant changes in shape and color. 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 Calcium-D3-Biomo 1000 mg / 880 I.e. Contains:
The active ingredients are: calcium carbonate and vitamin D3 (Colecalciferol). An effervescent tablet contains: 2500 mg of calcium carbonate, corresponding to 1000 mg of calcium and 22 μg colecalciferol, corresponding to 880 i.e. Vitamin D3. The other ingredients are: alpha-tocopherol, hydrogenated soybean oil (pH. EUR.), Gelatine, sucrose (pH. EUR.), Corn starch, citric acid, sodium bicarbonate, lactose monohydrate (pH. EUR.), Povidone K25, Saccharin sodium, sodium cyclamate, Macrogol 6000, Simeticon, methylcellulose, orange juice aroma.

Like Calcium D3-Biomo 1000 mg / 880 I.e. looks and content of the pack:
CALCIUM-D3-BIOMO 1000 mg / 880 I.E. Effervescent tablets are white to almost white, round and beveled on the sides. Calcium D3 biomo 1000 mg / 880 I.e. is in original packages with 10, 20, 40, 100 and 120 effervescent tablets available. Not all pack sizes may be placed on the market.

Pharmaceutical entrepreneur and manufacturer
biomo pharma GmbH
Josef-Dietzgen-Straße 3
53773 Hennef
Tel.: 02242 / 8740-0
Fax: 02242 / 8740-499
E-Mail: [email protected]

This leaflet was recently revised in February 2014.

Source: Information of the leaflet
Status: 05/2016