CALCIO-20 ORAL EMULSION

Introduction

Package Leaflet: Information for the Patient

CALCIO-20 Oral Emulsion

Tricalcium Phosphate

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What is Calcio-20 and what is it used for
2. What you need to know before taking Calcio-20
3. How to take Calcio-20
4. Possible side effects
5. Storage of Calcio-20
6. Package contents and additional information

1. What is Calcio-20 and what is it used for

Calcio-20 is a calcium supplement. It is indicated in: calcium deficiency states and situations where supplemental amounts of this mineral are required. You should consult your doctor if your condition worsens or does not improve after 3 days.

2. What you need to know before starting to take Calcio-20

Do not take Calcio-20

• If you are allergic to tricalcium phosphate or any of the other components of this medication (listed in section 6).
• If you have kidney stones.
• If you have high levels of calcium in the blood or urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calcio-20:

If you have kidney problems or a tendency to form kidney stones, remember to inform your doctor before taking this medication.

Other medications and Calcio-20

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Especially if you are using any of the following medications:

• Cardiac glycosides (heart medications)
• Tetracyclines (antibiotics)
• Thiazide diuretics (medications that increase urine elimination)
• Systemic corticosteroids (anti-inflammatory medications derived from the steroid group)
• Bisphosphonate (medications for the treatment and prevention of osteoporosis: fragile and brittle bones)
• Sodium fluoride (bone growth stimulant in patients with osteoporosis)

Taking Calcio-20 with food and beverages

If you take Calcio-20 with foods that contain oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole wheat bread and whole grain cereals), interactions may occur, so it is recommended not to take Calcio-20 during the two hours following the consumption of foods with high oxalic acid and phytic acid content.

Pregnancy, breastfeeding, and fertility

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.

Calcio-20 can be used during pregnancy in case of a calcium deficiency.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

Calcio-20 containsmethyl parahydroxybenzoate, sodium salt (E-219).

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219).

Calcio-20 containssodium benzoate.

This medication contains 1.15 mg of sodium benzoate (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

3. How to take Calcio-20

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablespoon (15 ml) at the 3 main meals of the day

Children: 2 teaspoons (10 ml) at the 3 main meals of the day

1 tablespoon = 15 ml = 125 mg of elemental calcium.

2 teaspoons = 10 ml = 83.3 mg of elemental calcium.

Shake the bottle before each intake

If you take more Calcio-20 than you should

If you have taken more Calcio-20 than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562-04-20, indicating the medication and the amount taken.

In case of overdose, you may experience thirst, nausea, vomiting, constipation, loss of appetite, abdominal pain, muscle weakness, fatigue, mental changes, polydipsia (excessive thirst), polyuria (increased frequency of urination), bone pain, nephrocalcinosis (high levels of calcium in the kidneys), kidney stones, and in severe cases, cardiac arrhythmias (abnormal heart rate).

If you forget to take Calcio-20

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

4. Possible side effects

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

Uncommon side effects, may affect 1 in 100 people:

• Hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine)

Rare side effects, may affect 1 in 1000 people:

• Constipation, gas, nausea, abdominal pain, and diarrhea.
• Itching, exanthema (skin rash), and urticaria (hives)

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting side effects

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

5. Storage of Calcio-20

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Calcio-20

The active ingredient is tricalcium phosphate. Each ml of oral emulsion contains 20.88 mg tricalcium phosphate (equivalent to 8.12 mg of calcium).

The other components (excipients) are: liquid paraffin, sodium carboxymethylcellulose, sodium benzoate, potassium sorbate, methyl parahydroxybenzoate (sodium salt), sodium cyclamate, sodium saccharin, curaçao essence, lemon essence, pineapple essence, and purified water.

Appearance of the product and package contents

Calcio-20 is presented in a transparent PET bottle containing 300 ml of white-colored emulsion.

Marketing authorization holder

Farmasierra Laboratorios, S.L.

Ctra. de Irún, km 26,200

San Sebastián de los Reyes. 28709 (Madrid)

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

San Sebastián de los Reyes. 28709 (Madrid)

Date of the last revision of this package leaflet: March 2021

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