CALCIUM 1000 HEXAL effervescent tablets

Important notes (mandatory information)

Calcium 1000 mg HEXAL. Active ingredient: Calcium carbonate. Areas of application: For the prevention of calcium deficiency in cases of increased demand (e.g. during growth, pregnancy, breastfeeding). For the supportive treatment of osteoporosis.

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


Patient information: Information for users
Calcium 1000 mg HEXAL effervescent tablets
Active ingredient: Calcium carbonate

Read the entire package leaflet carefully before you start taking this medicine, as 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, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
. If you do not feel better or even worse, contact your doctor.

What is in this package leaflet
1. WHAT IS CALCIUM 1000 MG HEXAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM 1000 MG HEXAL?
3. HOW TO TAKE CALCIUM 1000 MG HEXAL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CALCIUM 1000 MG HEXAL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CALCIUM 1000 MG HEXAL AND WHAT IS IT USED FOR?

Calcium 1000 mg HEXAL is a mineral supplement.

Calcium 1000 mg HEXAL is used
. for the prevention of calcium deficiency in cases of increased demand (e.g. during growth, pregnancy, breastfeeding)
. for the supportive treatment of osteoporosis.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM 1000 MG HEXAL?

Calcium 1000 mg HEXAL must not be taken
. if you are allergic to calcium carbonate or any of the other ingredients of this medicine listed in section 6
. in case of excessively high calcium concentrations in the blood or urine
. in case of prolonged immobilisation of limbs
. in case of calcium-containing kidney stones (nephrolithiasis) or calcification of the kidney (nephrocalcinosis).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Calcium 1000 mg HEXAL

. in case of impaired kidney function, especially if you are taking aluminium-containing preparations
. in case of reduced phosphate concentration in the blood (hypophosphataemia)

Also ask your doctor for advice if calcium-containing kidney stones have occurred in your family.
Taking Calcium 1000 mg HEXAL increases the excretion of calcium in the urine. In the first few months after the start of intake, this also increases the tendency for calcium salts to precipitate and, under certain circumstances, for stones to form in the kidneys and bladder. Therefore, an increased fluid intake is recommended for patients who tend to form stones in the urinary tract. In case of renal insufficiency, Calcium 1000 mg HEXAL should only be used under continuous monitoring of the calcium and phosphate concentrations in the blood and urine. During therapy with high doses of Calcium 1000 mg HEXAL, especially if vitamin D is also used, there is a risk of hypercalcaemia, which can be followed by impaired kidney function. In such patients, the serum calcium level and kidney function should be monitored.

Taking Calcium 1000 mg HEXAL 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 increases the effect of Calcium 1000 mg HEXAL (increased absorption). Certain diuretics (thiazide-type diuretics) reduce calcium excretion. Therefore, if Calcium 1000 mg HEXAL and such medicines are taken at the same time, the serum calcium level should be monitored regularly. If the calcium blood level rises due to taking Calcium 1000 mg HEXAL, the sensitivity to certain medicines that increase the force of the heart (cardiac glycosides) is increased and the risk of cardiac arrhythmias is increased. Patients receiving concomitant treatment with cardiac glycosides and calcium should be monitored by means of an ECG and monitoring of the serum calcium levels. The absorption and thus also the effectiveness of various antibiotics, such as tetracyclines, quinolones, some cephalosporins, as well as many other medicines (e.g. the antifungal ketoconazole, iron, sodium fluoride, etamustine, bisphosphonate preparations) is reduced by the simultaneous intake of Calcium 1000 mg HEXAL. The absorption of aluminium and bismuth salts and thus also their toxicity is increased by the citric acid contained in Calcium 1000 mg HEXAL. Therefore, an interval of at least 2 hours should generally be maintained between taking Calcium 1000 mg HEXAL and taking other preparations. In the case of tetracycline preparations, a time interval of at least 2 hours before or 4-6 hours after taking calcium should be observed. Bisphosphonates or sodium fluoride should be taken at least 3 hours before taking Calcium 1000 mg HEXAL. If you are taking corticosteroids, this can reduce the absorption of calcium and it may be necessary to increase the dose of Calcium 1000 mg HEXAL. Calcium salts reduce the absorption of phosphate by forming poorly soluble salts.

Taking Calcium 1000 mg HEXAL together with food and drink
Please note that dairy products have a high calcium content. 1 litre of milk can contain up to 1200 mg of calcium. This should be taken into account when taking Calcium 1000 mg HEXAL. Interactions can also occur with foods that contain oxalic acid, phytic acid or phosphates, such as spinach, rhubarb, cereal products. No calcium supplements should be taken within 2 hours of consuming foods with a high content of oxalic acid and phytic acid.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Calcium 1000 mg HEXAL should only be taken during pregnancy if there is a calcium deficiency.

Breastfeeding
Calcium 1000 mg HEXAL should only be taken during breastfeeding if there is a calcium deficiency. Calcium passes into breast milk. In pregnant and breastfeeding women, the adequate daily intake (including food and supplementary intake) is generally 1000-1300 mg of calcium. During pregnancy and breastfeeding, the total daily intake should not exceed 1500 mg of calcium.

Driving and using machines
Calcium HEXAL has no or negligible influence on the ability to drive and use machines.

3. HOW TO TAKE CALCIUM 1000 MG HEXAL?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 500-1000 mg of calcium daily, corresponding to 1 effervescent tablet once a day.

Method of administration
The effervescent tablets are dissolved in 1 glass of water and drunk immediately after dissolving. Any possible clouding of the solution has no influence on the effectiveness. You can take Calcium 1000 mg HEXAL with or between meals.

Duration of use
The treatment of calcium deficiency and osteoporosis is intended to be long-term. Its duration depends on the desired therapeutic goal. Talk to your doctor about how long you should take Calcium 1000 mg HEXAL. Please talk to your doctor or pharmacist if you have the impression that the effect of Calcium 1000 mg HEXAL is too strong or too weak.

If you have taken more Calcium 1000 mg HEXAL than you should
A single overdose is usually without consequences. If symptoms occur, please contact your doctor. 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.

The following categories are used to classify the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Uncommon
In case of renal insufficiency and long-term use, an increase in the calcium concentration in the blood (hypercalcaemia), an increased excretion of calcium in the urine (hypercalciuria) and an undersupply of acid in the blood (metabolic alkalosis) can occur.

Rare
Constipation, flatulence, nausea, vomiting, abdominal pain, diarrhoea, itching, hives, rash

Very rare
allergic reactions such as swelling of the face, lips, tongue and/or throat (may lead to difficulty swallowing) In the first months of calcium administration, there is an increased excretion of calcium in the urine, which can promote stone formation.

Reporting of side effects
If you notice any side effects, talk to 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, D-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 TO STORE CALCIUM 1000 MG HEXAL?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the tube after "use by". The expiry date refers to the last day of the month indicated.

Storage conditions
Store in the original package. Keep the tube tightly closed in order to protect the contents from moisture.
Do not store above 30 °C.

Note on shelf life after opening
Shelf life after opening: 1 year.

Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcium 1000 mg HEXAL contains
The active ingredient is calcium carbonate.
1 effervescent tablet contains 2500 mg calcium carbonate, corresponding to 1000 mg calcium as dissolved calcium citrate in the finished solution.

The other ingredients are:
Citric acid, sodium cyclamate, saccharin sodium, flavourings (lemon)

What Calcium 1000 mg HEXAL looks like and contents of the pack
Calcium 1000 mg HEXAL are white, round effervescent tablets. Calcium 1000 mg HEXAL is available in packs of 20, 40 and 100 effervescent tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur
Hexal AG
Industriestraße 25
83607 Holzkirchen
Phone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: service@hexal.com

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in June 2013.

Source: Information from the package leaflet
Status: 07/2014
Active ingredient: Calcium carbonate. Areas of application: For the prevention of calcium deficiency in cases of increased demand (e.g. during growth, pregnancy, breastfeeding). For the supportive treatment of osteoporosis.