CALDEOS 1,000 MG/880 IU CHEWABLE TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Caldeos 1,000 mg / 880 IU chewable tablets EFG

Read the entire 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Caldeos is and what it is used for

2. What you need to know before taking Caldeos

3. How to take Caldeos

4. Possible side effects

5. Storage of Caldeos

6. Contents of the pack and other information

1. What Caldeos is and what it is used for

Caldeos is a calcium and vitamin D3 supplement.

It is used:

• to prevent and treat calcium and vitamin D deficiency states in elderly people.
• to provide vitamin D and calcium as complementary therapy for osteoporosis (fragile bones).

2. What you need to know before taking Caldeos

Do not take Caldeos

• If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia),
• if you excrete too much calcium in your urine (hypercalciuria),
• if you have overactivity of the parathyroid glands (hyperparathyroidism),
• if you have bone marrow cancer (myeloma),
• if you have cancer that has spread to the bones (bone metastases),
• if you have limited limb movement (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

Talk to your doctor or pharmacist before taking this medicine if any of the following apply to you:

• Long-term treatment

During long-term treatment, calcium levels in 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 stop treatment.

• If you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems.

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

• Kidney problems

If you have kidney problems, you should take this medicine with special caution. Especially if you are taking other medicines containing aluminium, as the citric acid present in this medicine may increase aluminium absorption. Your calcium levels in 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 need frequent monitoring of calcium levels in blood and urine.

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

Take special care when taking this medicine if you have sarcoidosis. There is a risk that the effect of this medicine may become too strong, which could lead to calcium overdose in the body. Calcium levels in blood and urine should be monitored.

• Immobilization and osteoporosis

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

Children and adolescents

This medicine is not indicated for use in children or adolescents under 18 years of age. See section “Do not take Caldeos”.

Taking Caldeos with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• When taken together with digitalis glycosides (cardiac glycosides derived from the foxglove plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring including ECG and determination of blood calcium levels is necessary.
• If taken together with diuretics of the thiazide class (also known as medicines that increase urine excretion), blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption and, therefore, the effectiveness of certain antibiotics (called tetracyclines) decrease when taken simultaneously with Calcium/Vitamin D3. These medicines should be taken at least 2 hours before or 4–6 hours after Calcium/Vitamin D3.
• In addition, other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medicines should be taken at least 3 hours before Calcium/Vitamin D3.
• The longest possible interval should be maintained between the administration of cholestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and Calcium/Vitamin D3, as otherwise vitamin D may not be adequately absorbed.
• Simultaneous administration of Calcium/Vitamin D3 and phenytoin (a medicine for the treatment of epilepsy) or barbiturates (hypnotics) may lead to a reduction in the effect of vitamin D.
• Simultaneous administration of this medicine and glucocorticoids (e.g.: cortisone) may lead to a reduction in the effect of vitamin D and a decrease in blood calcium levels.
• Additional calcium and vitamin D supplements should only be taken under medical supervision, and frequent monitoring of calcium levels in blood and urine is required.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid insufficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after this medicine.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics at least two hours before or six hours after taking this medicine.

Taking Caldeos with food, drinks and alcohol

You may take the medicine at any time, with or without food.

Please note that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) may reduce the amount of calcium absorbed in the intestine. Patients should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

If you are pregnant, you may take this medicine if you have a deficiency of calcium and vitamin D.

The daily dose should not exceed 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 cause high calcium levels in the blood and may have a negative effect on the fetus.

This medicine may be used during breast-feeding. Since calcium and vitamin D pass into breast milk, consult your doctor beforehand if your child is receiving other products containing vitamin D.

Driving and using machines

There are insufficient data on the effects of this medicine on the ability to drive and use machines. However, any influence seems unlikely.

Caldeos contains aspartame (E-951), isomalt (E-953), sorbitol (E-420) and sucrose.

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

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

3. How to take Caldeos

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Unless otherwise directed by your doctor, the recommended dose is:

Adults and elderly patients: 1 chewable tablet per day (corresponds to 1,000 mg of calcium and 800 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 of half a tablet must not be exceeded.

Use in children and adolescents

This medicine is not indicated for use in children or adolescents under 18 years of age. See section “Do not take Caldeos”.

Method of administration

Oral use.

The tablet may be divided into equal doses.

The tablet must be chewed before swallowing. It can be taken at any time of day, with or without food.

Duration of treatment

This medicine should be taken as a long-term treatment. Speak with your doctor about the duration of treatment with Calcium/Vitamin D3 (see also section 2, Warnings and precautions).

If you take more Caldeos than you should

An overdose of Calcium/Vitamin D3 may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, dehydration, or constipation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Caldeos

If you forget to take your Calcium/Vitamin D3 tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Caldeos

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Caldeos and contact a doctor immediately if you experience any of the following adverse effects:

Very rare: May affect up to 1 in 10,000 people

• Allergic reaction.
• Swelling of the face, lips, tongue, or throat with sudden breathing difficulty and severe skin rash.

Other reported adverse effects are:

Rare adverse effects: May affect up to 1 in 1,000 people

• Nausea, vomiting, diarrhoea, abdominal pain, constipation, flatulence, bloating (abdominal distension).
• Skin rash, itching, urticaria.
• Allergy.

Uncommon adverse effects: May affect up to 1 in 100 people

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

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Caldeos

Keep this medicine out of sight and reach of children.

For tubes:

Keep the container tightly closed to protect it from moisture.

For aluminium strips:

Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Caldeos

• The active substances are calcium and colecalciferol. Each chewable tablet contains 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium) and 8.8 mg of concentrated colecalciferol (in powder form), equivalent to 880 IU of vitamin D3.
• The other components are: isomalt (E-953), xylitol (E-967), sorbitol (E-420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, carmellose sodium, orange flavour (CPB-239), orange flavour (CVT-255) (both flavours contain sorbitol E-420 and corn maltodextrin), aspartame (E-951), acesulfame potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the pack

Caldeos are round, white tablets with a smooth surface and a break line.

The chewable tablets are supplied in polypropylene tubes with polyethylene caps containing a desiccant, in the following pack size:

30 chewable tablets.

The chewable tablets are also supplied in aluminium/paper heat-sealed blisters in the following pack size:

30 chewable tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Procare Health Iberia, S.L.

Avda. Miguel Hernández 21, Bajo

46450 Benifaió (Valencia), Spain

Manufacturer

Hermes Arzneimittel GmbH

Georg-Kalb-Straße 5-8

82049 Pullach i. Isartal

Germany

Date of the most recent revision of this leaflet: March 2017

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