CALCIUM SANDOZ

CALCIUM SANDOZ forte Brausetabletten

Important notes (mandatory information)

Calcium-Sandoz Forte 500 mg effervescent tablets. Areas of application: for the prevention and treatment of calcium deficiency; to support a special therapy for the prevention and treatment of osteoporosis (bone loss); in addition to vitamin D3 for the treatment of rickets (softening of growing bones in children) and osteomalacia (softening of bones in adults).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcium-Sandoz Forte 500 mg effervescent tablets
Active ingredient: Calcium (as calcium D-gluconate - calcium lactate (2:3) 2 H2O and 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 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.

What this package leaflet contains

1. WHAT IS CALCIUM-SANDOZ FORTE 500 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM-SANDOZ FORTE 500 MG?
3. HOW TO TAKE CALCIUM-SANDOZ FORTE 500 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CALCIUM-SANDOZ FORTE 500 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CALCIUM-SANDOZ FORTE 500 MG AND WHAT IS IT USED FOR?

Calcium-Sandoz Forte 500 mg is a mineral supplement.

Calcium-Sandoz Forte 500 mg is used:

• for the prevention and treatment of calcium deficiency.
• to support a special therapy for the prevention and treatment of osteoporosis (bone loss).

Calcium-Sandoz Forte 500 mg is also used in addition to vitamin D3 for the treatment of rickets (softening of growing bones in children) and osteomalacia (softening of bones in adults).

How does Calcium-Sandoz Forte 300 mg work?
Calcium is an essential mineral that is necessary for bone formation and maintenance. It is absorbed in the small intestine and distributed throughout the body via the blood. Calcium plays an important role in some bodily functions. It is essential for nerve, muscle and heart function as well as for blood clotting. It also mediates the effects of many hormones. In order to meet all these tasks, calcium must be present in the appropriate tissues in the required concentration.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIUM-SANDOZ FORTE 500 MG?

Calcium-Sandoz Forte 500 mg must not be taken:

• if you are allergic to the active substance, sulfur dioxide or any of the other ingredients of this medicine listed in section 6.
• if you have elevated calcium levels in your blood (hypercalcemia).
• if you have increased calcium excretion in your urine (hypercalciuria).
• if you have certain kidney disorders, including: kidney stones (nephrolithiasis), calcium deposits in the kidney tissue (nephrocalcinosis).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Calcium-Sandoz Forte 500 mg. If you have kidney disease, you should only use this product after consulting your doctor. This is especially important if you are taking aluminum-containing preparations. Do not take vitamin D supplements together with Calcium-Sandoz Forte 500 mg without medical advice. Calcium-Sandoz Forte 500 mg may be taken at the earliest 3 hours after taking oral bisphosphonates or sodium fluoride and at least 2 hours after or 4 to 6 hours before taking tetracycline, as calcium reduces the absorption of these active ingredients.

Taking Calcium-Sandoz Forte 500 mg 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. Please consult your doctor or pharmacist if you are taking or have recently taken a medicine containing any of the following active ingredients:

• Thiazide diuretics,
• Tetracyclines,
• Sodium fluoride,
• Bisphosphonates,
• Corticosteroids.

If you are taking cardiac glycosides at the same time, please follow your doctor's instructions carefully.

Taking Calcium-Sandoz Forte 500 mg with food and drink

If you eat foods that are rich in oxalic acid or phytic acid, such as spinach, rhubarb and whole grains, Calcium-Sandoz Forte 500 mg should not be taken until at least 2 hours later.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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. Calcium-Sandoz Forte 500 mg can be taken during pregnancy and breast-feeding if there is a calcium deficiency. The appropriate daily intake for pregnant and breast-feeding women (including food and supplements) is generally 1,000 - 1,300 mg of calcium. During pregnancy and breast-feeding, the total daily intake should not exceed 1,500 mg of calcium. Calcium passes into breast milk without having any harmful effects on the newborn child.

Driving and using machines

Taking Calcium-Sandoz Forte 500 mg does not affect the ability to drive and use machines.

Calcium-Sandoz Forte 500 mg contains sodium, sorbitol and glucose

Calcium-Sandoz Forte 500 mg contains 288.3 mg (12.5 mmol) of sodium (main component of cooking salt/table salt) per effervescent tablet. This corresponds to 14.4% of the maximum recommended daily intake of sodium with food for an adult. The maximum recommended daily dose of this medicine contains 864.9 mg of sodium. This corresponds to 43.2% of the maximum recommended daily intake of sodium with food for an adult. Talk to your doctor or pharmacist if you need to take 2 or more effervescent tablets daily for a longer period of time, especially if you are on a low-sodium (low-salt) diet. This medicine contains 0.65 g of sorbitol per effervescent tablet. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or receive) this medicine if your doctor has told you (or your child) 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. This medicine contains glucose. Please take Calcium-Sandoz Forte 500 mg only after consulting your doctor if you are known to have a sugar intolerance.

3. HOW TO TAKE CALCIUM-SANDOZ FORTE 500 MG?

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 for adults is 1 effervescent tablet (as a single dose) 1, 2 or 3 times daily (corresponding to 500 - 1,500 mg of calcium).

Use in children

1 effervescent tablet (as a single dose) 1 or 2 times daily (corresponding to 500 - 1,000 mg of calcium).

Method of administration

For oral use after dissolving in water. Dissolve Calcium-Sandoz Forte 500 mg in a glass of water (approximately 200 ml) and drink the contents immediately after the effervescent tablet has dissolved. Calcium-Sandoz Forte 500 mg can be taken with or without food.

Duration of use

Take Calcium-Sandoz Forte 500 mg in the dosage recommended to relieve symptoms and complaints according to the recommended duration of use of your doctor or pharmacist.

If you have taken more Calcium-Sandoz Forte 500 mg than you should

An overdose of Calcium-Sandoz Forte 500 mg leads to elevated 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 an overdose is suspected, please contact your doctor immediately.

If you forget to take Calcium-Sandoz Forte 500 mg

Do not take twice the amount if you have forgotten to take the previous 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.

The following frequency information is used to evaluate 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.

Immune system disorders:

• Rare: hypersensitivity, such as redness and/or burning of the skin, itching.
• Very rare: severe allergic reactions such as swelling of the face, lips, tongue and/or throat, which can lead to difficulty swallowing and breathing.

Metabolic and nutritional disorders:

• Uncommon: excessively high calcium levels in the blood (hypercalcemia) or excessively high calcium excretion in the urine (hypercalciuria).

Gastrointestinal disorders:

• Rare: nausea, diarrhea, abdominal pain, constipation, flatulence, vomiting.

Other possible side effects

Sulfur dioxide can in rare cases cause severe hypersensitivity reactions and bronchial spasms (bronchospasms).

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 TO STORE CALCIUM-SANDOZ FORTE 500 MG?

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 bottom after "use by". The expiry date refers to the last day of the month indicated. Store in the original package. Keep the tube tightly closed to protect the contents from moisture. Do not store above 30°C. Never 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-Sandoz Forte 500 mg contains

The active substance is: Calcium (as calcium D-gluconate - calcium lactate (2:3) 2 H2O and calcium carbonate). 1 effervescent tablet contains 500 mg (12.5 mmol) of calcium (corresponding to 2,940 mg of calcium D-gluconate - calcium lactate (2:3) 2 H2O and 300 mg of calcium carbonate). The other ingredients are: citric acid, macrogol 4000, sodium cyclamate, sodium hydrogen carbonate, sorbitol (Ph.Eur.), orange flavor (contains glucose, sorbitol [Ph.Eur.], sulfur dioxide).

What Calcium-Sandoz Forte 500 mg looks like and contents of the pack

Calcium-Sandoz Forte 500 mg are white, round, flat effervescent tablets with a beveled edge and an orange smell. The effervescent tablets are packed in polypropylene tubes with a polyethylene stopper, which is filled with silica gel as a desiccant. Calcium-Sandoz Forte 500 mg is available in packs of 20, 40 and 100 effervescent tablets and hospital packs of 600 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 April 2020.

Source: Information from the package leaflet
Status: 09/2021
Areas of application: for the prevention and treatment of calcium deficiency; to support a special therapy for the prevention and treatment of osteoporosis (bone loss); in addition to vitamin D3 for the treatment of rickets (softening of growing bones in children) and osteomalacia (softening of bones in adults).