Calcium Sandoz + Vitamin D3

Package Leaflet: Information for the Patient

Calcium Sandoz + Vitamin D, 1000 mg + 880 IU, Chewable Tablets

Calcium + Cholecalciferol
For use in adults

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Calcium Sandoz + Vitamin D and what is it used for
• 2. Important information before taking Calcium Sandoz + Vitamin D
• 3. How to take Calcium Sandoz + Vitamin D
• 4. Possible side effects
• 5. How to store Calcium Sandoz + Vitamin D
• 6. Contents of the pack and other information

1. What is Calcium Sandoz + Vitamin D and what is it used for

Calcium Sandoz + Vitamin D contains two active substances - calcium and vitamin D. The medicine is a calcium and vitamin D supplement.

Calcium Sandoz + Vitamin D is used:

• to prevent and treat calcium and vitamin D deficiency in the elderly;
• as a supplement to vitamin D and calcium in the supportive treatment of osteoporosis (brittle bones).

2. Important information before taking Calcium Sandoz + Vitamin D

When not to take Calcium Sandoz + Vitamin D

if you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6);
if you have high levels of calcium in the blood (hypercalcemia);
if you have high levels of calcium in the urine (hypercalciuria).
if you have been diagnosed with hyperparathyroidism;
if you have bone marrow cancer (multiple myeloma);
if you have cancer that has spread to the bones;
if you have limited mobility of the limbs (prolonged immobilization), accompanied by hypercalcemia and/or hypercalciuria;
if you have been diagnosed with kidney stones;
if calcium deposits have been found in your kidneys (nephrocalcinosis);
if you are taking too much vitamin D (hypervitaminosis D);
if you have severe kidney function disorders;
if you are under 18 years old.

Warnings and precautions

You should discuss this with your doctor or pharmacist if any of the following situations apply to you before or during the use of Calcium Sandoz + Vitamin D:
long-term treatment
During long-term treatment, you should regularly check your blood and urine calcium levels and have your kidney function tested. This is especially important for patients with a tendency to develop kidney stones. Depending on the test results, your doctor may reduce the dose of the medicine or stop the treatment.
concomitant use of digitalis glycosides or thiazide diuretics
due to heart problems
In such cases, you should regularly check your blood and urine calcium levels and have your kidney function tested, especially in the elderly. Depending on the test results, your doctor may reduce the dose of the medicine or stop the treatment.
kidney function disorders
Patients with kidney function disorders should take Calcium Sandoz + Vitamin D with caution, especially if they are also taking aluminum-containing products, as the citric acid in Calcium Sandoz + Vitamin D may increase aluminum absorption by the body. You should have your blood and urine calcium levels checked. Patients with severe kidney function disorders should take vitamin D in a form other than cholecalciferol.
additional intake of calcium and vitamin D supplements
In this case, close medical supervision is necessary, and your doctor will recommend frequent checks of your blood and urine calcium levels.
sarcoidosis(a disorder of the immune system that can affect the liver, lungs, skin, or lymph nodes)
Patients with sarcoidosis should be cautious when taking Calcium Sandoz + Vitamin D. There is a risk of excessive action of the medicine, resulting in calcium overdose. It is necessary to monitor blood and urine calcium levels.
osteoporosis in immobilized patients
In this case, you should be cautious. It is possible to increase blood calcium levels.

Children and adolescents

Calcium Sandoz + Vitamin D should not be used in children and adolescents under 18 years of age (see also "When not to take Calcium Sandoz + Vitamin D").

Calcium Sandoz + Vitamin D and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
If you are also being treated with digitalis glycosides, heart rhythm disorders may occur. Therefore, close monitoring of your condition is necessary, including ECG and blood calcium level measurements.
If you are taking thiazide diureticsat the same time, you should regularly check your blood calcium levels, as these medicines reduce calcium excretion in the urine.
Taking Calcium Sandoz + Vitamin D may reduce the absorption of certain antibiotics (such as tetracyclines)and thus their effectiveness. The antibiotic should be taken at least 2 hours before or 4 to 6 hours after taking Calcium Sandoz + Vitamin D.
The action of other medicines, such as fluoride(used to strengthen tooth enamel or treat osteoporosis), quinolone antibiotics, and bisphosphonates(used to treat osteoporosis), may change due to interactions. Therefore, these medicines should be taken at least 3 hours before taking Calcium Sandoz + Vitamin D.
You should keep the largest possible interval between taking Calcium Sandoz + Vitamin D and taking cholestyramine(a medicine used to reduce elevated cholesterol levels), orlistat(a medicine used to treat obesity), or laxatives(such as liquid paraffin), due to the possible disruption of vitamin D absorption.
Concomitant use of Calcium Sandoz + Vitamin D and rifaximin(an antibiotic used to treat traveler's diarrhea), phenytoin(used to treat epilepsy), or barbiturates(sleeping pills) may lead to a weakening of the effect of vitamin D.
Concomitant use of Calcium Sandoz + Vitamin D and glucocorticoids(such as cortisone) may lead to a weakening of the effect of vitamin D and a decrease in blood calcium levels.
Taking additional calcium and vitamin D supplementsrequires close medical supervision and regular checks of blood and urine calcium levels.
Calcium may reduce the absorption of iron, zinc, or strontium ranelate. You should take these medicines at least 2 hours before or after taking Calcium Sandoz + Vitamin D.
Calcium may reduce the absorption of estrmustine(a medicine used in chemotherapy) and thyroid hormones(used to treat hypothyroidism). You should take these medicines at least 2 hours after taking Calcium Sandoz + Vitamin D.

Calcium Sandoz + Vitamin D with food, drink, and alcohol

Remember that oxalic acid (e.g., found in spinach and rhubarb) and phytic acid (found in whole grain products) may reduce the amount of calcium absorbed in the intestine. Calcium-containing medicines should be taken with a 2-hour interval from consuming products containing oxalic acid or phytic acid.

Pregnancy and breastfeeding

Pregnancy
Calcium Sandoz + Vitamin D can be used in pregnant women with calcium and vitamin D deficiency.

• The daily dose should not exceed half a tablet. During pregnancy, the total daily amount of calcium should not exceed 1500 mg, and the total daily amount of vitamin D should not exceed 600 IU. You should avoid long-term overdose of calcium and vitamin D during pregnancy due to the possible risk of high blood calcium levels and adverse effects on the unborn child.

Breastfeeding
Calcium Sandoz + Vitamin D can be used during breastfeeding. Both calcium and vitamin D pass into breast milk, so you should ask your doctor if your child is also receiving other products containing vitamin D.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The effect of Calcium Sandoz + Vitamin D on the ability to drive and use machines is not known.

Calcium Sandoz + Vitamin D contains sodium, aspartame (E 951), sorbitol, isomalt (E 953), and

• sucrose and benzyl alcoholThis medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

This medicine contains 1.00 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains up to 152.89 mg of sorbitol (E 420) in each tablet. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.
This medicine also contains isomalt (E 953) and sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine may have a negative effect on teeth.
This medicine contains 0.02 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions.

3. How to take Calcium Sandoz + Vitamin D

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose is

Adults and the elderly take 1 tablet daily (corresponding to 1000 mg of calcium and 880 IU of vitamin D).
Pregnant women take only half a tablet daily (corresponding to 500 mg of calcium and 440 IU of vitamin D). Do not exceed the daily dose of half a tablet.

Use in children and adolescents

Calcium Sandoz + Vitamin D should not be used in children and adolescents under 18 years of age (see also "When not to take Calcium Sandoz + Vitamin D").

Method of administration

Oral use.
The tablet should be chewed and then swallowed. It can be taken at any time, regardless of meals. The tablet can be divided into equal doses.

Duration of treatment

Calcium Sandoz + Vitamin D should be taken for a longer period. Consult your doctor about this (see also section 2 "Warnings and precautions").

Use of a higher than recommended dose of Calcium Sandoz + Vitamin D

If an overdose is suspected, contact your doctor or pharmacist immediately and show them the package and any remaining tablets.
Overdose of Calcium Sandoz + Vitamin D may cause the following symptoms: nausea, vomiting, increased thirst, increased urine production, dehydration, or constipation (milk-alkali syndrome, see also section 4 "Possible side effects").

Missed dose of Calcium Sandoz + Vitamin D

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at the usual time and do not take a double dose to make up for the missed dose.

Stopping the use of Calcium Sandoz + Vitamin D

If you plan to stop or prematurely end the treatment, discuss this with your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Calcium Sandoz + Vitamin D and contact your doctor immediately:

Frequency not known (frequency cannot be estimated from the available data)

• -severe allergic reactions: facial swelling, lip, tongue, or throat swelling with sudden breathing difficulties and severe rash,
• frequent need to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis, and kidney function disorders (milk-alkali syndrome).

Other reported side effects:

Uncommon (may affect up to 1 in 100 people)

• high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).

Rare (may affect up to 1 in 1000 people)

• nausea, diarrhea, abdominal pain, constipation, gas, bloating (feeling of abdominal distension)
• skin rash, itching, hives

Frequency not known (frequency cannot be estimated from the available data)

• vomiting

In patients with kidney function disorders, there is an increased risk of high phosphate levels in the blood, increased calcium levels in the kidneys, and the formation of kidney stones.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium Sandoz + Vitamin D

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month.
Container: after first opening, keep the container tightly closed to protect from moisture.
Blister packs: no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Calcium Sandoz + Vitamin D contains

• The active substances are calcium and cholecalciferol. One tablet contains 1000 mg of calcium (in the form of calcium carbonate) and 22 micrograms of cholecalciferol (vitamin D), which corresponds to 880 IU, in the form of powder concentrate.
• The medicine also contains: isomalt (E 953), xylitol, sorbitol (E 420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmellose, orange flavor "CPB" and orange flavor "CVT" [both contain sorbitol (E 420)], aspartame (E 951), acesulfame potassium, sodium ascorbate, all-rac-α-tocopherol, modified starch (corn), sucrose, medium-chain triglycerides, and anhydrous colloidal silica. Orange flavor "CPB" also contains benzyl alcohol as a component of natural or analogous mandarin oil.

What Calcium Sandoz + Vitamin D looks like and contents of the pack

Round, white tablets with a smooth surface and a dividing line.
The tablets are available in polypropylene containers with polyethylene caps containing a desiccant or in soft blisters made of paper laminated with aluminum foil.
Pack sizes:
Packs contain 10, 20, 28, or 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Hermes Pharma GmbH
Georg-Kalb-Straße 5 - 8
82049 Pullach i.Isratal
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:11/2020
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