CALCIUM

CALCIUM 500 HEXAL effervescent tablets

Important notes (mandatory information)

Calcium 500 mg Hexal effervescent tablets. Active ingredient: Calcium (as calcium carbonate). Areas of application: for the prevention of calcium deficiency in cases of increased need (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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcium 500 mg Hexal effervescent tablets
Active ingredient: Calcium (as calcium carbonate)

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 experience 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 if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS CALCIUM 500 MG HEXAL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM 500 MG HEXAL?
3. HOW SHOULD CALCIUM 500 MG HEXAL BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CALCIUM 500 MG HEXAL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CALCIUM 500 MG HEXAL AND WHAT IS IT USED FOR?

Calcium 500 mg Hexal is a mineral supplement.

Calcium 500 mg Hexal is used:

• for the prevention of calcium deficiency in cases of increased need (e.g. during growth, pregnancy, breastfeeding).
• for the supportive treatment of osteoporosis.

If you do not feel better or if you feel worse, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM 500 MG HEXAL?

Calcium 500 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 500 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 500 mg Hexal increases the excretion of calcium in the urine. In the first months after the start of treatment, this also increases the tendency for calcium salts to precipitate and, under certain circumstances, for stones to form in the kidneys and bladder. Therefore, patients who tend to form stones in the urinary tract are recommended to increase their fluid intake. In case of renal insufficiency and hypophosphataemia, Calcium 500 mg Hexal should only be used under continuous monitoring of the calcium and phosphate concentrations in the blood and urine. During treatment with high doses of Calcium 500 mg Hexal, especially if additionally treated with vitamin D, certain diuretics (thiazide-type diuretics) and/or calcium-containing medicines or if additional food (supplements) (such as milk) is taken, there is a risk of hypercalcaemia, which can be followed by impaired kidney function. This risk also exists if you are pregnant and taking high doses of calcium or if you have impaired kidney function. In such patients, the serum calcium level and kidney function should be monitored. Calcium and alkali intake from other sources (food, fortified foods or other medicines) should be considered when taking Calcium 500 mg Hexal. If high doses of calcium are taken together with alkaline agents (such as carbonates), this can lead to milk-alkali syndrome (Burnett syndrome) with increased calcium concentration in the blood (hypercalcaemia), undersupply of acid in the blood (metabolic alkalosis), kidney failure and soft tissue calcification. When administering high doses, the calcium level in serum and urine should be monitored.

Taking Calcium 500 mg Hexal 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 500 mg Hexal (increased absorption). Certain diuretics (thiazide-type diuretics) reduce calcium excretion. Therefore, when Calcium 500 mg Hexal is taken together with such medicines, the serum calcium level should be monitored regularly. If the calcium blood level rises due to taking Calcium 500 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 ECG and monitoring of 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, estramustine, bisphosphonate and L-thyroxine-containing preparations) is reduced by the simultaneous intake of Calcium 500 mg Hexal. The absorption of aluminium and bismuth salts and thus also their toxicity is increased by the citric acid contained in Calcium 500 mg Hexal. Therefore, an interval of at least 2 hours should generally be maintained between taking Calcium 500 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 500 mg Hexal.

The bioavailability of calcium can be reduced by antacids, and the excretion via the kidneys can be prolonged by alkalisation of the urine. If you are taking corticosteroids, this can reduce the absorption of calcium and it may be necessary to increase the dose of Calcium 500 mg Hexal. Calcium salts reduce the absorption of phosphate by forming poorly soluble salts. The simultaneous intake of calcium carbonate and sodium hydrogen carbonate (contained in certain antacids) together with the intake of large amounts of milk and dairy products must be avoided, as this can lead to a serious condition (milk-alkali syndrome). See also "Warnings and precautions".

Taking Calcium 500 mg Hexal with food and drink

Please note that dairy products have a high calcium content. 1 litre of milk can contain up to 1,200 mg of calcium. This should be taken into account when taking Calcium 500 mg Hexal. The intake of large amounts of milk and dairy products together with calcium carbonate and sodium hydrogen carbonate (baking soda) must be avoided, as this can lead to a serious condition (milk-alkali syndrome). Interactions can also occur with foods that contain oxalic acid, phytic acid or phosphates, such as spinach, rhubarb, cereal products. No calcium preparations 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 500 mg Hexal should only be taken during pregnancy if there is a calcium deficiency.

Breastfeeding

Calcium 500 mg Hexal should only be taken during breastfeeding if there is a calcium deficiency. Calcium passes into breast milk, but this has no harmful effects on the infant when calcium is taken in therapeutic doses.

The appropriate daily intake (including food and supplementary intake) for pregnant and breastfeeding women is generally 1,000 - 1,300 mg of calcium. During pregnancy and breastfeeding, the total daily intake should not exceed 1,500 mg of calcium.

Driving and using machines

Calcium Hexal has no or negligible influence on the ability to drive and use machines.

Calcium 500 mg Hexal contains sodium and sorbitol

This medicine contains 56.5 mg sodium (main component of cooking salt/table salt) per effervescent tablet. This corresponds to 2.8% of the maximum recommended daily intake of sodium for an adult. This medicine contains a maximum of 50 mg sorbitol per effervescent tablet. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or are given) this medicine if you (or your child) have been told by your doctor that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which a person cannot break down fructose.

3. HOW SHOULD CALCIUM 500 MG HEXAL BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is 500 - 1,000 mg of calcium daily, corresponding to 1 to 2 effervescent tablets 1-2 times 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 does not affect the effectiveness. You can take Calcium 500 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 500 mg Hexal.

If you have taken more Calcium 500 mg Hexal than you should

A single overdose is usually without consequences. An overdose of Calcium 500 mg Hexal leads to increased calcium levels in the blood. Symptoms may include nausea, vomiting, thirst or constipation. In the long term, this can lead to calcium deposits in blood vessels and organs. If symptoms occur, please contact your doctor immediately.

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 frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Uncommon:

• increased calcium concentration in the blood (hypercalcaemia).
• increased calcium excretion in the urine (hypercalciuria).

Rare:

• constipation
• flatulence
• nausea
• vomiting
• abdominal pain
• diarrhoea
• itching
• hives
• rash

Very rare:

• severe allergic reactions such as swelling of the face, lips, tongue and/or throat (may lead to difficulty swallowing and breathing).

Not known:

• milk-alkali syndrome

In the first months of calcium administration, there is increased calcium excretion in the urine, which can promote stone formation. In case of renal insufficiency and long-term use, an increase in the calcium concentration in the blood (hypercalcaemia), an increase in calcium excretion in the urine (hypercalciuria) and undersupply of acid in the blood (metabolic alkalosis) can occur.

Reporting of side effects

If you experience 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 provide more information on the safety of this medicine.

5. HOW SHOULD CALCIUM 500 MG HEXAL 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 carton and 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.

Shelf life after first opening

Shelf life after first opening: 3 years.

Do not dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcium 500 mg Hexal contains

The active ingredient is calcium (as calcium carbonate). 1 effervescent tablet contains 500 mg calcium (as calcium carbonate). The other ingredients are: malic acid, citric acid, sodium carbonate, sodium cyclamate, sodium hydrogen carbonate, saccharin sodium, lemon flavour (contains sorbitol [Ph.Eur.]).

What Calcium 500 mg Hexal looks like and contents of the pack

Calcium 500 mg Hexal are white, round, flat on both sides, effervescent tablets with a lemon scent. The effervescent tablets are contained in a polypropylene tube with a polyethylene stopper, which is filled with silica gel as a desiccant. Calcium 500 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 September 2019.

Source: Information from the package leaflet
Status: 09/2021
Active ingredient: Calcium (as calcium carbonate). Areas of application: for the prevention of calcium deficiency in cases of increased need (e.g. during growth, pregnancy, breastfeeding); for the supportive treatment of osteoporosis.