CALCIO/VITAMIN D3 SANDOZ 1000 MG/ 880 IU CHEWABLE TABLETS

2. What you need to know before taking Calcium/Vitamin D3 Sandoz

Do not take Calcium/Vitamin D3Sandoz

• if you are allergic to calcium, vitamin D3, or any of the other components of this medication (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 hyperparathyroidism (overactivity of the parathyroid glands),
• if you have bone marrow cancer (myeloma),
• if you have cancer that has affected the bones (bone metastases),
• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria,
• if you have kidney stones (nephrolithiasis),
• if you have calcium deposits in the kidneys (nephrocalcinosis),
• if you have an excess of vitamin D (hypervitaminosis D),
• if you have severe kidney problems,
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calcium/Vitamin D3 Sandoz if any of the following points apply to you:

• Prolonged treatment

During prolonged treatment, calcium levels in the blood and urine and kidney function should be monitored periodically. This is especially important if you have a tendency to develop kidney stones. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.

• If you are receiving simultaneous treatment with digitalis glycosides or thiazide diuretics (medications that increase urine excretion)for heart problems

In this case, calcium levels in the blood and urine and kidney function should be monitored periodically, especially if you are an elderly patient. Depending on blood levels, your doctor may reduce the dose or discontinue treatment.

• Kidney problems

If you have kidney problems, you should take Calcium/Vitamin D3 Sandoz with special care. Especially if you are receiving other medications that contain aluminum, as the citric acid present in Calcium/Vitamin D3 Sandoz may increase aluminum absorption. Your calcium levels in the blood and urine should be monitored. If you have severe kidney problems, use other forms of vitamin D that are not colecalciferol.

• Taking additional calcium and vitamin D supplements

Medical supervision is required, and your doctor will require frequent monitoring of calcium levels in your blood and urine.

• Sarcoidosis(an immune disorder that can affect the liver, lungs, skin, or lymph nodes)

Be careful when taking Calcium/Vitamin D3 Sandoz if you have sarcoidosis. There is a risk that the effect of this medication may become too strong, which can lead to an overdose of calcium in the body. Calcium levels in the blood and urine should be monitored.

• Immobilization and osteoporosis

In these cases, this medication should be used with special care, as it may increase calcium levels in the blood.

Children and adolescents

Calcium/Vitamin D3 Sandoz is not indicated for use in children or adolescents under 18 years of age, see section 2 "Do not take Calcium/Vitamin D3 Sandoz".

Taking Calcium/Vitamin D3Sandoz with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication

• In case of simultaneous treatment with digitalis glycosides(cardiac glycosides derived from the digitalis plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring is necessary, including an ECG and determination of calcium levels in the blood.
• In case of simultaneous administration of thiazide diuretics(also known as medications to increase urine excretion), calcium levels in the blood should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption and, therefore, the efficacy of certain antibiotics (called tetracyclines)decrease with simultaneous administration of Calcium/Vitamin D3 Sandoz. These medications should be taken at least 2 hours before or 4-6 hours after Calcium/Vitamin D3 Sandoz.
• Additionally, other medications such as sodium fluoride(used to strengthen tooth enamel or treat osteoporosis) and bisphosphonate medications (used to treat osteoporosis) are affected by interactions. Therefore, these medications should be taken at least 3 hours before Calcium/Vitamin D3 Sandoz.
• You should leave the widest possible interval between the administration of cholestyramine(a medication to reduce high cholesterol levels) or laxativessuch as liquid paraffin and Calcium/Vitamin D3 Sandoz, as otherwise, vitamin D may not be absorbed properly.
• Orlistat (a medication used to treat obesity) may affect vitamin D absorption. Take Calcium/Vitamin D3 Sandoz at least 2 hours before or after taking Orlistat.
• Simultaneous administration of Calcium/Vitamin D3 Sandoz and rifampicin(an antibiotic), phenytoin(a medication for the treatment of epilepsy), or barbiturates(hypnotics) may lead to a reduction in the effect of vitamin D.

• Simultaneous administration of Calcium/Vitamin D3 Sandoz and glucocorticoids (e.g., cortisone) may lead to a reduction in the effect of vitamin D and a reduction in calcium levels in the blood.
• Only additional calcium and vitamin D supplementsshould be administered under medical supervision, and frequent monitoring of calcium levels in the blood and urine is required.
• Calcium may reduce the effect of levothyroxine(used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after Calcium/Vitamin D3 Sandoz.
• There may be a reduction in the effect of quinolone antibioticsif taken at the same time as calcium. Quinolone antibiotics should be taken at least two hours before or six hours after taking Calcium/Vitamin D3 Sandoz.
• Calcium may reduce the absorption of iron, zinc, or strontium ranelate. These medications should be taken at least two hours before or after taking Calcium/Vitamin D3 Sandoz.
• Calcium may reduce the absorption of estramustine(a medication used in chemotherapy). This medication should be taken at least two hours before or after taking Calcium/Vitamin D3 Sandoz.

Taking Calcium/Vitamin D3Sandoz with food, drinks, and alcohol

You should be aware that oxalic acid (e.g., present in spinach and rhubarb) and phytic acid (e.g., present in whole grains) can reduce the amount of calcium absorbed in the intestine.

In the 2 hours before or after eating foods high in oxalic acid or phytic acid, you should not take medications that contain calcium.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you can take Calcium/Vitamin D3 Sandoz in case of calcium and vitamin D deficiency.

Do not exceed the daily dose of half a tablet. During pregnancy, the total daily amount of calcium should not exceed 1,500 mg, and the total daily amount of vitamin D3 should not exceed 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy should be avoided, as it may lead to high levels of calcium in the blood and may have a negative effect on the fetus.

Breastfeeding

Calcium/Vitamin D3 Sandoz can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before giving your child other products that contain vitamin D.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Calcium/Vitamin D3 Sandoz has a negligible influence on the ability to drive and use machines.

Calcium/Vitamin D3Sandoz contains aspartame, sorbitol, isomalt, sucrose, sodium, and benzyl alcohol.

This medication contains 1.00 mg of aspartame in each chewable tablet. Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medication contains 119.32 mg of sorbitol in each chewable tablet.

This medication contains isomalt and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause cavities.

This medication contains less than 23 mg of sodium (1 mmol) per chewable tablet; this is, essentially "sodium-free".

This medication contains 0.02 mg of benzyl alcohol in each chewable tablet. Benzyl alcohol may cause allergic reactions.

3. How to take Calcium/Vitamin D3 Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and elderly patients: 1 chewable tablet per day (corresponding to 1,000 mg of calcium and 880 IU [International Units] of vitamin D3).

Pregnant women can take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU [International Units] of vitamin D3). Do not exceed the daily dose of half a tablet.

Use in children and adolescents

Calcium/Vitamin D3 Sandoz is not indicated for use in children or adolescents under 18 years of age, see section 2 "Do not take Calcium/Vitamin D3 Sandoz".

Method of administration

Oral

The chewable tablet should be chewed before swallowing. You can take Calcium/Vitamin D3 Sandoz at any time, with or without food.

Duration of treatment

Calcium/Vitamin D3 Sandoz should be taken as prolonged treatment. Talk to your doctor about the duration of treatment with Calcium/Vitamin D3 Sandoz (see also section 2 "Warnings and precautions").

If you take more Calcium/Vitamin D3Sandoz than you should

Consult your doctor or pharmacist immediately if you suspect that you are suffering from an overdose. Have the package and any remaining chewable tablets available.

Overdose of Calcium/Vitamin D3 Sandoz may cause symptoms such as feeling dizzy (nausea), vomiting, thirst or excessive thirst, increased urine production, dehydration, or constipation.

If you have taken more Calcium/Vitamin D3 Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Calcium/Vitamin D3Sandoz

If you forget to take Calcium/Vitamin D3 Sandoz, take it as soon as you remember, unless it is time to take the next dose. In that case, take the next dose as usual. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Calcium/Vitamin D3Sandoz

If you want to interrupt or prematurely discontinue treatment, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking Calcium/Vitamin D3Sandoz and contact a doctor immediately if you experience any of the following serious side effects:

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

• frequent urination, persistent headache, lasting loss of appetite, nausea or vomiting, unusual fatigue or weakness along with elevated calcium levels in the blood and kidney problems that usually occur after excessive calcium intake (milk-alkali syndrome).

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

• severe allergic reaction: swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.

Other reported side effects are:

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

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

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

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

If you have kidney failure, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Calcium/Vitamin D3 Sandoz

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

Do not use this medication after the expiration date stated on the carton and on the tube or on the aluminum foil strips. The expiration date is the last day of the month indicated.

For the tube: Keep the container perfectly closed to protect it from moisture.

For the strips: This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Calcium/Vitamin D3 Sandoz Composition3Sandoz

• The active ingredients are calcium and colecalciferol (vitamin D3). Each chewable tablet contains 1,000 mg of calcium (as carbonate) and 880 IU of colecalciferol (vitamin D3) (equivalent to 22 micrograms of colecalciferol (vitamin D3)).

• The other components are isomalt (E 953), xylitol, sorbitol (E 420), citric acid, anhydrous, sodium dihydrogen citrate, magnesium stearate, sodium croscarmellose, orange flavor "CPB" and orange flavor "CVT" [both flavors contain sorbitol (E 420)], aspartame (E 951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide. Orange flavor "CPB" also contains benzyl alcohol as part of the natural/identical to nature mandarin oil.

Product Appearance and Container Content

Round, white tablets with a smooth surface and a score line for breaking the tablet.

The chewable tablets are presented in polypropylene tubes with polyethylene caps containing a desiccant, or in aluminum foil strips inserted into a cardboard box.

Container sizes:

Tubes: 30, 90 chewable tablets.

Strips: 30, 90 chewable tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Hermes Pharma GmbH

Hans-Urmiller-Ring, 52

D-82515 Wolfrathausen

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country Medicinal Product Name

Date of the Last Revision of this Leaflet:September 2020.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/