Patient Information Leaflet

Calcium/Vitamin D3Sandoz 1000 mg/880 UI Chewable Tablets

calcium/colecalciferol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Calcio/Vitamina D3Sandoz contains the active principles calcium and vitamin D3and is a calcium-vitamin D3supplement.

Calcio/Vitamina D3Sandoz is used

-to prevent and treat calcium and vitamin D deficiency states in elderly individuals.

-to provide vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones).

Do not take Calcio/ Vitamin D3Sandoz

• if you are allergic to calcium, vitamin D3, or any of the other ingredients of this medication (listed in section 6),
• if you have high levels of calcium in your blood (hypercalcemia),
• if you have high levels of calcium in your urine (hypercalciuria),
• if you have hyperparathyroidism (overactive parathyroid glands),
• if you have multiple myeloma (bone cancer),
• if you have bone metastases (cancer that has spread to the bones),
• if you have prolonged immobility 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 vitamin D toxicity (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 Calcio/VitaminD3Sandoz if any of the following points affect you:

• Prolonged treatment

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

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

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

• Kidney problems

If you have kidney problems, you should take Calcio/ Vitamina D3Sandoz with special care. Especially if you are receiving other medications containing aluminum, as the citric acid present in Calcio/VitaminaD3Sandoz 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.

• Additional calcium and vitamin D supplements

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

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

You should take special care when taking Calcio/Vitamina D3Sandoz if you have sarcoidosis. There is a risk that the effect of this medication will become too strong, leading to a calcium overdose in the body. Your calcium levels in the blood and urine should be monitored.

• Immobility and osteoporosis

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

Children and adolescents

Calcio/VitaminaD3Sandoz is not indicated for use in children or adolescents under 18 years of age, see section 2 “Do not take Calcio/VitaminaD3Sandoz”.

Taking Calcio/Vitamina D3Sandoz with other medications

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

• In the case of simultaneous treatment withdigitalis glycosides(digitalis cardiac glycosides derived from the plant digitalis), arrhythmias may occur. Therefore, strict medical monitoring is required, including an ECG and determination of calcium levels in the blood.
• In the case of simultaneous administration ofthiazide diuretics (also known as medications that increase urine excretion), your calcium levels in the blood should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• The absorption and, therefore, the effectiveness ofcertain antibiotics (designated tetracyclines)are reduced with simultaneous administration of Calcio/VitaminaD3Sandoz. These medications should be taken at least 2 hours before or 4-6 hours after Calcio/VitaminaD3Sandoz.
• Additionally, other medications such assodium fluoride(used to strengthen tooth enamel or to treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medications should be taken at least 3 hours before Calcio/VitaminaD3Sandoz.
• You should leave the widest possible interval between the administration ofcolestiramine(a medication to reduce high cholesterol levels) orlaxativessuch as liquid paraffin and Calcio/VitaminaD3Sandoz, as otherwise, vitamin D will not be absorbed properly.
• Orlistat (a medication used to treat obesity) may affect vitamin D absorption. Take Calcio/Vitamina D3 Sandoz at least 2 hours before or after taking Orlistat.
• The simultaneous administration of Calcio/Vitamina D3Sandoz andrifampicin(an antibiotic),phenytoin(a medication for the treatment of epilepsy) orbarbiturates(hypnotics) may lead to a reduction in the effect of vitamin D.

• The simultaneous administration of Calcio/VitaminaD3Sandoz 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.
• Onlyadditional 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 oflevothyroxine(used to treat hypothyroidism). Therefore, levothyroxine should be taken at least four hours before or four hours after Calcio/VitaminaD3Sandoz.
• There may be a reduction in the effect ofquinolone antibioticsif taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking Calcio/VitaminaD3Sandoz.
• Calcium may reduce the absorption ofranelate ofiron, zinc or strontium. Take these medications at least two hours before or after taking Calcio/Vitamina D3 Sandoz.
• Calcium may reduce the absorption ofestramustine(a medication used in chemotherapy). Take this medication at least two hours before or after taking Calcio/Vitamina D3Sandoz.

Taking Calcio/Vitamina 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) may 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 containing calcium.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you may take Calcio/VitaminaD3Sandoz 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 vitaminD3should not exceed 600 IU (International Units).

Prolonged calcium and vitamin D overdose during pregnancy may lead to high calcium levels in the blood and may have a negative effect on the fetus.

Breastfeeding

Calcio/VitaminaD3Sandoz can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor before using this medication if your child is receiving other products containing vitamin D.

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

Driving and operating machines

Calcio/VitaminaD3Sandoz has a negligible or insignificant effect on your ability to drive and operate machines.

Calcio/Vitamina 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 that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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 him before taking this medication.

It may cause tooth decay.

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 adverse reactions.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 may take only half a chewable tablet per day (corresponding to 500 mg of calcium and 440 IU [International Units] of vitamin D3). The daily dose should not exceed half a tablet.

Use in children and adolescents

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

Administration form

Oral route

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

Treatment duration

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

If you take more Calcio/Vitamin D3 Sandoz than you should

Consult your doctor or pharmacist immediately if you suspect you have taken an overdose. Have the packaging and any remaining chewable tablets available.

An overdose of Calcio/Vitamin D3 Sandoz may produce symptoms such as feeling dizzy (nausea), vomiting, excessive thirst, increased urine output, dehydration, or constipation.

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

If you forgot to take Calcio/Vitamin D3 Sandoz

If you forgot to take Calcio/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 compensate for the missed doses.

If you interrupt the treatment with Calcio/Vitamin D3 Sandoz

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Stop taking Calcio/Vitamina D 3 Sandoz and contact a doctor immediately if you experience any of the following severe adverse effects:

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

• Increased urination, persistent headache, prolonged 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).

Adverse effects rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction: facial swelling, lip, tongue, or throat swelling with sudden difficulty breathing and severe skin rash.

Other reported adverse effects are:

Adverse effects infrequent (may affect up to 1 in 100 people):

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

Adverse effects rare (may affect up to 1 in 1,000 people):

• Feeling unwell (nausea), vomiting, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension),
• Skin rash, itching, urticaria.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and in 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 through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Calcium/Vitamin D Composition3Sandoz

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

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

Appearance of the product and contents of the package

Round, white tablets with a smooth surface and a groove to break the tablet.

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

Package sizes:

Tubes: 30, 90 chewable tablets.

Strips: 30, 90 chewable tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturerandresponsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 with the following names:

CountryMedicinal product name

Last review date 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 Medical Devices (AEMPS) http://www.aemps.gob.es/