Package leaflet: Information for the user

Calcium Sandoz 500 mg effervescent tablets, 1,000 mg effervescent tablets

calcium
Please read this leaflet carefully before you start taking this medicine because it
contains important information for you.
in Take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Calcium Sandoz is and what it is used for
What you need to know before taking Calcium Sandoz
How to take Calcium Sandoz
Possible side effects
How to store Calcium Sandoz
Contents of the pack and other information

1. What Calcium Sandoz is and what it is used for

Calcium Sandoz contains a rich source of calcium, which is an essential mineral necessary for bone formation and maintenance.
Calcium Sandoz is indicated for the prevention and treatment of calcium deficiency, and may be used, together with other medicinal products, for the prevention and treatment of a condition called osteoporosis (thinning of the bones).
Calcium Sandoz is also used, in addition to vitamin D, for the treatment of rickets (loss of bone strength in growing children) and osteomalacia (loss of bone strength in adults).
Calcium is absorbed from the intestine and distributed throughout the body via the bloodstream.
Calcium plays an important role in numerous body functions. It is essential for nerve, muscle, and heart function, as well as for blood clotting. In addition, it is necessary for many hormones to work properly in the body. In order to perform these various functions, calcium must be available in adequate concentrations.

2. What you need to know before taking Calcium Sandoz

Do not take Calcium Sandoz:

If you are allergic to calcium or to any of the excipients in Calcium Sandoz (see the list of excipients in section 6 at the end of this leaflet);
If you have high levels of calcium in your blood (hypercalcemia);
If you have increased excretion of calcium in the urine (hypercalciuria);
If you have any kidney problems, including kidney stones (nephrolithiasis), or calcium deposits in kidney tissue (nephrocalcinosis).

Warnings and precautions

If you have kidney disease, use Calcium Sandoz only after consulting your doctor, especially if you are taking products containing aluminium.
Do not take vitamin D supplements together with Calcium Sandoz without medical advice.

Other medicines and Calcium Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription, as calcium may interact with certain other
medicines when taken at the same time.

If you are taking or have recently taken cardiac glycosides, thiazide diuretics, or corticosteroids, follow your doctor’s instructions carefully;
If you are taking oral bisphosphonates or sodium fluoride, take Calcium Sandoz at least 3 hours after these medicines;
If you are taking an antibiotic from the class known as tetracyclines, take Calcium Sandoz at least 2 hours after or 4–6 hours before the tetracycline.

Calcium Sandoz with food and drink

Calcium Sandoz should not be taken within 2 hours of consuming foods rich in oxalic and phytic acid, such as spinach, rhubarb, and whole grains.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking Calcium Sandoz.
Calcium Sandoz may be used during pregnancy and breastfeeding in cases of calcium deficiency. In general, the recommended daily intake (including food and supplements) for pregnant and breastfeeding women is 1000–1300 mg of calcium. During pregnancy and breastfeeding, the total daily dose should not exceed 1500 mg of calcium.
Calcium passes into breast milk, but has no negative effect on the newborn.

Driving and using machines
There are no known effects of Calcium Sandoz on the ability to drive or operate machinery.

Calcium Sandoz contains aspartame, sodium, sorbitol, sulfur dioxide, and glucose.

Calcium Sandoz is suitable for diabetics (1 effervescent tablet of 500 mg or 1000 mg contains 0.002 carbohydrate units).
Calcium Sandoz 500 mg contains 68.45 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 3.4% of the maximum recommended daily sodium intake for an adult.
Calcium Sandoz 1000 mg contains 136.90 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to 6.9% of the maximum recommended daily sodium intake for an adult.
This medicine contains 180 nanograms of benzyl alcohol in each effervescent tablet. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (gasping syndrome), in young children.
Do not administer to neonates up to 4 weeks of age unless otherwise advised by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless advised by a doctor or pharmacist. Consult your doctor or pharmacist if you are pregnant or breastfeeding. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and may cause adverse effects (called "metabolic acidosis").
This medicine contains 210 nanograms of sulfur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 30 mg of aspartame (E 951) per effervescent tablet. Aspartame is a source of phenylalanine and may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains glucose. If you think you have an intolerance to certain sugars, consult your doctor before taking this medicine. It may be harmful to teeth.

3. How to take Calcium Sandoz

As with all medicines, follow all instructions carefully to ensure that Calcium
Sandoz works properly.

For Calcium Sandoz 500 mg:
Children should take one effervescent tablet (as a single dose) once or twice daily (equivalent to 500–1000 mg of calcium).
Adults should take one effervescent tablet (as a single dose) one, two, or three times daily (equivalent to 500–1,500 mg of calcium).
For Calcium Sandoz 1000 mg:
Children and adults should take one effervescent tablet (as a single dose) once daily.

Dissolve Calcium Sandoz in a glass of water (approximately 200 ml) and drink
immediately. Do not swallow or chew the tablet.
Calcium Sandoz may be taken with or without food (see section “Taking
Calcium Sandoz with food and drink” for further information).

How long should you take Calcium Sandoz
Take Calcium Sandoz at the recommended daily dose for as long as advised by your
doctor. Since Calcium Sandoz is indicated for the prevention and treatment of calcium
deficiency and, together with other medicines, for the prevention and treatment of a condition
called osteoporosis (thinning of the bones), it is likely to be a long-term treatment.

If you take more Calcium Sandoz than you should
An overdose of Calcium Sandoz may cause symptoms such as nausea, vomiting, thirst, or
constipation. If you suspect an overdose, contact your doctor or pharmacist immediately.

If you forget to take Calcium Sandoz
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Calcium Sandoz can cause side effects, although not everybody gets them.

Very rare side effects (occur in less than 1 in 10,000 people) include:
Severe allergic reactions, such as swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing. If any of the above-mentioned allergic reactions occur, STOP taking Calcium Sandoz and contact your doctor immediately.
Rare side effects (occur in less than 1 in 1,000 people) include:
Nausea, diarrhoea, abdominal pain, constipation, flatulence, vomiting, itching, redness and/or burning of the skin.
Uncommon side effects (occur in less than 1 in 100 people) may include:
Excessively high calcium levels in the blood (hypercalcaemia) or excessive excretion of calcium in the urine (hypercalciuria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium Sandoz

Keep out of the reach and sight of children.
Expiry date: Do not use Calcium Sandoz after the expiry date stated on the outer packaging and on the tube after "Exp". The expiry date refers to the last day of the month.
Storage conditions: Store in the original packaging and keep the tube tightly closed.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Calcium Sandoz contains
The active substances are calcium lactate gluconate and calcium carbonate.

Each 500 mg tablet contains 1,132 mg of calcium lactate gluconate and 875 mg of calcium carbonate ( equivalent to 500 mg of calcium ).
Each 1,000 mg tablet contains 2,263 mg of calcium lactate gluconate and 1,750 mg of calcium carbonate ( equivalent to 1,000 mg of calcium ).
The excipients are: anhydrous citric acid, orange flavour (containing: benzyl alcohol, sorbitol (E 420), glucose and sulfur dioxide (E-220)); aspartame (E951), macrogol 6000 and sodium bicarbonate.

Description of the appearance of Calcium Sandoz and contents of the pack
The effervescent tablet is white and round, with a characteristic orange odour.
Calcium Sandoz 500 mg is available in packs of 20 effervescent tablets.
Calcium Sandoz 1,000 mg is available in packs of 30 effervescent tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L. go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Famar Orléans, 5 Avenue de Concyr, 45071 Orléans Cedex 2, France
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany
Glaxosmithkline Sante Grand Public, 23 Rue Francois Jacob, 92500 Rueil Malmaison, France

This medicinal product is authorised in the European Economic Area countries under the following names:

For 500 mg effervescent tablets:
Austria: Calcium "Sandoz" 500 mg – Brausetabletten
Belgium: Sandoz Calcium, bruistabletten
Cyprus: Calsource 500 mg Effervescent Tablets
Czech Republic: CALCIUM-SANDOZ FORTE 500 mg
Denmark: Calcium-Sandoz, brusetabletter
France: CALCIUM SANDOZ 500 mg, comprimés effervescents
Hungary: Calcium-Sandoz 500 mg pezsgõtabletta
Iceland: Calcium-Sandoz, freyðitöflur
Italy: Calcium Sandoz 500 mg compresse effervescenti
Norway: Calcium-Sandoz 500 mg brusetabletter
Poland: CALCIUM-SANDOZ Forte
Portugal: CALCIUM-SANDOZ FORTE
Slovakia: CALCIUM-SANDOZ Forte 500 mg
Slovenia: Calcium Calvive 500 mg šumeče tablete
Spain: CalciumOsteo 500 mg comprimidos efervescentes
Sweden: Calcium-Sandoz 500 mg, brustabletter

For 1,000 mg effervescent tablets:
Finland: Mega-Calcium 1 g poretabletti
Greece: Calsource
Italy: Calcium Sandoz 1000 mg compresse effervescenti
Slovakia: CALCIUM-SANDOZ FF 1000 mg
Sweden: Calcium-Sandoz 1000 mg, brustabletter
United Kingdom: Calvive