Prospect: information for the patient

CALCIO-20 oral emulsion

Calcium phosphate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

-Keep this prospect, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

-You should consult a doctor if it worsens or does not improve after 3 days.

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

2. What you need to know before taking Calcio-20

3. How to take Calcio-20

4. Possible adverse effects

5. Storage of Calcio-20

6. Contents of the package and additional information

Calcio-20 is a calcium supplement. It is indicated in: calcium deficiency states and situations in which supplementary amounts of this mineral are required. Consult a doctor if it worsens or does not improve after 3 days.

Do not take Calcio-20

- If you are allergic to calcium 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 your 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

Inform your doctor or pharmacist if you are taking, have taken recently, 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 steroids)

- Bisphosphonates (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 drinks

If you take Calcio-20 with foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (present 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Calcio-20 may be used during pregnancy in cases of calcium deficiency.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed.

Calcio-20 containsparahydroxybenzoic acid methyl ester, sodium salt (E-219).

This medication may produce allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester, sodium salt (E-219).

Calcio-20 containssodium benzoate.

This medication contains 1.15 mg of sodium salt of benzoic acid (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks of age).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

Children: 2 teaspoons (10 ml) with 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 dose

If you take more Calcio-20 than you should

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

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

If you forgot to take Calcio-20

Do not take a double dose to compensate for the missed doses.

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

Adverse effects that are infrequent, may affect 1 in 100 people:

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

Adverse effects that are rare, may affect 1 in 1000 people:

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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 for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about 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 packaging 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 drains or trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment

Composition of Calcio-20

The active principle is tricalcium phosphate. Each ml of oral emulsion contains 20.88 mg of 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 contents of the packaging

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

Holder of the authorization

Farmasierra Laboratorios, S.L.

Ctra. de Irún, km 26,200

San Sebastián de los Reyes. 28709 (Madrid)

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

San Sebastián de los Reyes. 28709 (Madrid)

Last review date of this leaflet: March 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es