CALCIUM

CALCIUM D3 beta effervescent tablets

Important notes (mandatory information)

Calcium D3 beta 1000 mg/880 IU, effervescent tablets. Areas of application: used to compensate for a simultaneous calcium and vitamin D deficiency in elderly people and to support specific osteoporosis treatment in patients with proven or high risk of a simultaneous calcium and vitamin D deficiency.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcium D3 beta 1000 mg/880 IU, effervescent tablets
Active ingredients: Calcium (as carbonate) and cholecalciferol (vitamin D3)

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

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

What is in this package leaflet

1. WHAT IS CALCIUM D3 BETA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM D3?
3. HOW SHOULD CALCIUM D3 BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CALCIUM D3 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CALCIUM D3 AND WHAT IS IT USED FOR?

Calcium D3 beta is a mineral and vitamin combination preparation. Calcium D3 beta is used to compensate for a simultaneous calcium and vitamin D deficiency in elderly people and to support specific osteoporosis treatment in patients with proven or high risk of a simultaneous calcium and vitamin D deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM D3 BETA?

Calcium D3 beta must not be taken:

• if you are allergic to calcium carbonate, vitamin D3, soy, peanuts or any of the other ingredients of this medicine listed in section 6.
• in case of excessively high calcium concentrations in the blood, which may occur in the following cases:
• in case of hyperfunction of the parathyroid glands
• in case of vitamin D overdose
• in case of certain tumours, such as lung cancer, breast cancer, kidney cancer, certain forms of blood cancer and in case of bone metastases
• in case of certain lung diseases (sarcoidosis, Morbus Boeck)
• in case of immobilisation of limbs.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Calcium D3 beta if you:

• have or have had impaired kidney function
• have or have had kidney stones and kidney calcification
• have or have had increased calcium excretion in the urine
• have or have had decreased phosphate concentration in the blood
• take calcium or alkaline substances from other sources (milk, food, fortified foods or other medicines, such as carbonates or antacids for stomach hyperacidity). This can lead to a calcium metabolism disorder (milk-alkali syndrome, also: Burnett syndrome) with calcium salt deposits in soft tissues and kidneys up to kidney failure. Therefore, when taking high amounts, the calcium level in blood and urine should be monitored.
• if calcium-containing kidney stones have occurred in your family.

Taking Calcium D3 beta increases the excretion of calcium in the urine. In the first months of taking it, the risk of calcium salts and kidney and urinary stones forming is therefore increased. This can be avoided by drinking plenty of fluids. Additional intake of vitamin D or calcium should only be taken under strict medical supervision.

Taking Calcium D3 beta together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

• Vitamin D enhances the effect of Calcium D3 beta.
• Certain diuretics (thiazide diuretics) reduce calcium excretion. The calcium blood level should therefore be monitored.
• Phenytoin (a medicine for epilepsy and certain heart rhythm disorders), barbiturates (sleeping pills) accelerate the breakdown and reduce the effect of vitamin D.
• Glucocorticoids (medicines for suppressing the immune system and for certain inflammations) reduce the effect of vitamin D.
• Digitalis glycosides (heart-strengthening medicines) increase the risk of heart rhythm disorders. Strict medical supervision and, if necessary, ECG examination and monitoring of the blood calcium level are required.
• Bisphosphonates, sodium fluoride (medicines for osteoporosis): Calcium D3 beta reduces the absorption of these active ingredients into the blood. Therefore, at least 2 hours should be waited with taking Calcium D3 beta.
• Tetracycline (antibiotic): Calcium reduces the absorption of this active ingredient into the blood. It is therefore recommended to take Calcium D3 beta at least 3 hours later than tetracycline.
• Calcium salts can reduce the absorption of iron, zinc and strontium ranelates. Therefore, iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcium D3 beta.

Taking Calcium D3 beta together with food and drink

Dairy products have a high calcium content and therefore enhance the effect of Calcium D3 beta. One litre of milk contains 1200 mg of calcium. Interactions with certain foods (e.g. foods containing oxalic acid, phosphates or phytic acid) are possible.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Calcium D3 beta should not be used during pregnancy and breast-feeding because of the high dosage of vitamin D. Overdoses of vitamin D must be avoided during pregnancy, as a long-lasting increase in the calcium level in the blood can lead to physical and mental developmental delay, special forms of aortic stenosis and retinal diseases in the child. In animal studies, an overdose of vitamin D during pregnancy led to malformations. Vitamin D and its metabolites pass into breast milk.

Driving and using machines

No special features need to be considered. Calcium D3 beta contains sucrose (sugar) and lactose. Therefore, please only take Calcium D3 beta after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW SHOULD CALCIUM D3 BETA BE TAKEN?

Always take this medicine exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1000 mg of calcium and 880 IU of vitamin D3 daily, corresponding to 1 effervescent tablet once a day. The effervescent tablets are taken dissolved in a glass of water. The duration of treatment should be decided individually.

If you have taken more Calcium D3 beta than you should

Increased calcium excretion in the urine and an increase in the calcium concentration in the blood with the following symptoms may occur: nausea, vomiting, thirst and increased thirst, increased urination, constipation. Chronic overdose with the resulting increased blood calcium level can lead to vascular and organ calcification. Please contact your doctor immediately if the above symptoms occur.

If you forget to take Calcium D3 beta

Do not take double the amount to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Constipation, flatulence, nausea, stomach pain and diarrhoea may occur. In the first months of taking it, there is increased calcium excretion in the urine, which can promote stone formation. In case of renal insufficiency and long-term intake of high doses, an increase in the calcium concentration in the blood and increased calcium excretion in the urine may occur. Taking calcium salts leads to a reduction in phosphate absorption into the blood due to the formation of poorly soluble calcium phosphate. Hypersensitivity reactions such as swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal oedema) may occur. If your kidney function is impaired, there is a risk that you will have too much phosphate in your blood, that kidney stones will form and that too much calcium will be in your kidneys. Soya oil can very rarely cause allergic reactions.

Reporting of side effects
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, website: www.bfarm.de, by reporting side effects you can help to provide more information on the safety of this medicine.

5. HOW SHOULD CALCIUM D3 BETA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by". The expiry date refers to the last day of the month indicated. Keep the tube tightly closed to protect the contents from moisture. The shelf life after opening a tube is 4 weeks. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcium D3 beta contains

The active ingredients are: Calcium (as carbonate) and cholecalciferol (vitamin D3). 1 effervescent tablet contains 1000 mg of calcium (as calcium carbonate) and 880 IU of vitamin D3 (corresponding to 22 µg of cholecalciferol). The other ingredients are: RRR-alpha-tocopherol, hydrogenated soya oil (Ph.Eur.), gelatine, sucrose (sugar), maize starch, citric acid, sodium hydrogen carbonate, lactose monohydrate, povidone K 25, saccharin sodium, sodium cyclamate, macrogol 6000, dimethicone, highly dispersed silicon dioxide, methylcellulose, orange juice flavouring.

What Calcium D3 beta looks like and contents of the pack

Round, white to cream-coloured, smooth tablet with bevelled edges on both sides. Diameter: approx. 29.8 mm - 30.3 mm. Packs of 20, 40 and 100 effervescent tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Telephone 08 21/74 88 10
Telefax 08 21/74 88 14 20

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 06/2016
Areas of application: used to compensate for a simultaneous calcium and vitamin D deficiency in elderly people and to support specific osteoporosis treatment in patients with proven or high risk of a simultaneous calcium and vitamin D deficiency.