500 mg, 1000 mg effervescent tablet is 
calcium

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse.

In this leaflet: 
1. What Calcium-Sandoz is and what it is used for 
2. What you need to know before you use Calcium-Sandoz 
3. How to take Calcium-Sandoz 
4. Possible side effects 
5. How Calcium-Sandoz to be stored 
6. Contents of the packaging and other information 

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

Calcium-Sandoz contains calcium which is a vital mineral needed for skeletal formation and strength.

Calcium-Sandoz is used to prevent and treat calcium deficiency and can be used with other medicines to prevent and treat a condition called osteoporosis (weakening of the skeleton). Calcium-Sandoz is used with vitamin D3 to treat rickets (skeletal disease in children) and osteomalacia (bone softening in adults)

Calcium is absorbed from the intestines and distributed through the body by the blood. Calcium also plays an important role in the function of the nerves, muscles, and heart, as well as in the coagulation of the blood. It is also necessary for the function of many hormones. In order for calcium to play these different roles, it must be available in the right concentration in the various tissues .

2. What you need to know before you use Calcium-Sandoz

Do not use Calcium-Sandoz

  • if you are allergic to calcium or any of the other ingredients of this medicine (listed in section 6)
  • if you have high levels of calcium in your blood ( hypercalcaemia )
  • if you have increased excretion of calcium in the urine ( hypercalciuria )
  • if you have kidney problems such as kidney stones ( nephrolithiasis ) or calcium deposits in the kidney tissue ( nephrocalcinosis ).

Warnings and cautions

If you have any kidney disease, especially if you are taking preparations containing aluminum, you should consult a doctor before using this product.

Do not take products containing vitamin D with Calcium-Sandoz without consulting a doctor.

Other drugs and Calcium-Sandoz

Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription, as kalicum may affect or be affected by certain medicines.

If you are taking or have recently taken cardiac glycosides, thiazide diuretics, or corticosteroids, you must follow your doctor’s instructions carefully.

Calcium-Sandoz should be taken at least 3 hours after oral bisphosphonates or sodium fluoride.

Calcium-Sandoz should be taken at least 2 hours after or alternatively 4-6 hours before taking tetracycline ( antibiotics ).

Calcium-Sandoz with food and drink

Calcium-Sandoz should not be taken within 2 hours after eating foods that are high in oxalic acid or phytic acids, such as spinach, rhubarb, and whole grains.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, talk to your doctor or pharmacist beforehand

you take Calcium-Sandoz.

Calcium-Sandoz effervescent tablets can be used during pregnancy and lactation in case of calcium deficiency.

During pregnancy, the daily intake of calcium should be between 1000 – 1300 mg of calcium and should not exceed 1500 mg.

Calcium passes into breast milk without any adverse effects on the infant.

Driving and using machines

Calcium-Sandoz effervescent tablets have no known effect on the ability to drive or use machines.

Calcium-Sandoz contains aspartame, sodium, sorbitol, benzyl alcohol, sulfur dioxide, and glucose

  • Calcium-Sandoz is suitable for diabetics (1 effervescent tablet with 500 mg or 1000 mg contains 0.002 carbohydrate units).
  • 500 mg: This medicine contains 68.45 mg sodium (the main ingredient in table salt / table salt) per effervescent tablet . This corresponds to 3.4% of the maximum recommended daily intake of sodium for adults.
  • 1000 mg: This medicine contains 136.90 mg sodium (the main ingredient in table salt / table salt) per effervescent tablet . This corresponds to 6.9% of the maximum recommended daily sodium intake for adults.
  • This medicine contains 180 nanograms of benzyl alcohol per effervescent tablet . Benzyl alcohol can cause allergic reactions.Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing (gasping syndrome) in young children. Do not give this medicine to newborns (up to 4 weeks of age) unless your doctor tells you to.Do not use this medicine for more than 1 week in newborns (younger than 3 years) unless your doctor or pharmacist has recommended it. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. If you have had liver or kidney problems, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
  • This medicine contains 210 nanograms of sulfur dioxide which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea.
  • This medicine contains 30 mg aspartame (E 951) per effervescent tablet . Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
  • This medicine contains 630 micrograms sorbitol per effervescent tablet .
  • This medicine contains glucose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. May be harmful to teeth.

3. How to take Calcium-Sandoz

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Ask your doctor or pharmacist if you are unsure.

  • Calcium-Sandoz 500 mg effervescent tablet:- Children: 1 effervescent tablet 1-2 times daily (equivalent to 500-1000 mg calcium per day).- Adults: 1 effervescent tablet 1-3 times daily (equivalent to 500-1500 mg calciumper day).
  • Calcium-Sandoz 1000 mg effervescent tablet: Children and adults: 1 effervescent tablet once daily (equivalent to 1000 mg calcium per day).

Dissolve effervescent tablet one in a glass of water (about 2 dl) and drink it immediately. Do not swallow or chew the tablet. Calcium-Sandoz can be taken with or without food.

How long to take Calcium-Sandoz

Take Calcium-Sandoz at the dose and for the time recommended by your doctor. Because Calcium-Sandoz is used prophylactically in the treatment of calcium deficiency, and in combination with other medicines to prevent and treat oesteoporosis (weakness of the skeleton), it is likely to be a long-term treatment.

If you forget to take Calcium-Sandoz

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

4. Possible side effects

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

Very rare side effects (may affect up to 1 in 10,000 people):

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

Stop taking Calcium-Sandoz and contact a doctor immediately if swelling of e.g. face, tongue, and/or throat and/or difficulty swallowing or hives with difficulty breathing occurs.

Uncommon side effects (may affect up to 1 in 100 people):

  • increased amount of calcium in the blood ( hypercalcemia ) or increased excretion of calcium in the urine ( hypercalciuria ).

Rare side effects (may affect up to 1 in 1,000 people):

  • nausea, diarrhea, abdominal pain, constipation, flatulence, vomiting, hypersensitivity such as itching , rash and / or hives.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Calcium-Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the bottom of the tube after EXP. or EXP. The expiration date is the last day of the specified month.

Store in the original package. Close the tube tightly.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • Each 500 mg effervescent tablet contains 1132 mg of calcium lactate gluconate and 875 mg of calcium carbonate (equivalent to 500 mg or 12.5 mmol of calcium).
  • Each effervescent tablet of 1000 mg contains 2263 mg of calcium lactate 1750 mg of calcium carbonate (equivalent to 1000 mg or 25 mM calcium ).

The other ingredients are: anhydrous citric acid, orange flavoring (contains: benzyl alcohol, sorbitol (E 420), glucose and sulfur dioxide (E 220)), aspartame (E 951), macrogol 6000 and sodium bicarbonate.

What the medicine looks like and contents of the pack

Effervescent tablet one is white and round with a characteristic orange scent.

Calcium-Sandoz 500 mg effervescent tablets are packaged in tubes containing 10 or 20 effervescent tablets . The tubes are packed in cartons containing 10, 20, 30, 40, 60, 80, 100 or 600 effervescent tablets .

Calcium-Sandoz 1000 mg effervescent tablets are packaged in tubes containing 10 or 20 effervescent tablets . The tubes are packed in cartons containing 10, 20, 30, 40, 60, 80 or 100 effervescent tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer:

GLAXOSMITHKLINE SANTE GRAND PUBLIC; 23 Rue Francois Jacob, 92500 Rueil Malmaison, France

or

Delpharm Orleans, 5, Avenue de Concyr, F-45071 Orleans La Source Cedex 02, France

or

Salutas Pharma GmbH, Otto-von-Guericke Allee, 1, D-39179 Barleben, Germany

Muhammad Nadeem

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