Calcium-20 oral emulsion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
CALCIO-20 oral emulsion
Tricalcium phosphate
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to refer to it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult your doctor if you worsen or do not improve after 3 days.
Leaflet Contents
- What Calcio-20 is and what it is used for
- What you need to know before taking Calcio-20
- How to take Calcio-20
- Possible adverse effects
- Storage of Calcio-20
- Contents of the pack and other information
1. What Calcio-20 is and what it is used for
Calcio-20 is a calcium supplement. It is indicated for: calcium deficiency states and situations where additional amounts of this mineral are required. You should consult a 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 ingredients of this medicine (listed in section 6).
- If you have kidney stones.
- If you have high levels of calcium in your blood or urine.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Calcio-20:
If you have renal insufficiency (kidney problems) or are prone to developing kidney stones, make sure to inform your doctor before taking this medicine.
Other medicines and Calcio-20
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Especially if you are taking any of the following medicines:
- Cardiac glycosides (heart medications)
- Tetracyclines (antibiotics)
- Thiazide diuretics (medicines that increase urine elimination)
- Systemic corticosteroids (steroid-derived anti-inflammatory drugs)
- Bisphosphonates (medicines for the treatment and prevention of osteoporosis: fragile and brittle bones)
- Sodium fluoride (a bone growth stimulant in patients with osteoporosis)
Taking Calcio-20 with food and drinks
If you take Calcio-20 together with foods containing oxalic acid (found in spinach and rhubarb) or phytic acid (found in wholemeal bread and whole grains), interactions may occur. Therefore, it is recommended not to take Calcio-20 within two hours after consuming foods high in oxalic acid or phytic acid.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Calcio-20 may be used during pregnancy in cases of calcium deficiency.
Driving and use of machines
No effects on the ability to drive or operate machinery have been observed.
Calcio-20 contains methylparahydroxybenzoate sodium salt (E-219).
This medicine may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate sodium salt (E-219).
Calcio-20 contains sodium benzoate.
This medicine contains 1.15 mg of sodium benzoic acid salt (E-211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
3. How to take Calcio-20
Follow exactly the administration instructions provided 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) during the three main meals of the day.
Children: 2 teaspoonfuls (10 ml) during the three main meals of the day.
1 tablespoon = 15 ml = 125 mg of elemental calcium.
2 teaspoonfuls = 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 or pharmacist immediately or call the Toxicology Information Service at telephone number 91-562-04-20, indicating the medication and amount taken.
In case of overdose, you may experience thirst, nausea, vomiting, constipation, loss of appetite, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia (excessive thirst), polyuria (increased frequency of urination), bone pain, nephrocalcinosis (high calcium levels 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 missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Uncommon adverse effects, may affect 1 in 100 people:
- hypercalcaemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine)
Rare adverse effects, may affect 1 in 1,000 people:
- constipation, flatulence, nausea, abdominal pain and diarrhoea
- itching, rash (skin eruption) and urticaria (hives)
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Calcio-20
Keep this medicine out of sight and reach of children.
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.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Calcio-20
The active substance 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, methylparahydroxybenzoate (sodium salt), sodium cyclamate, sodium saccharin, curaçao essence, lemon essence, pineapple essence, and purified water.
Appearance of the product and contents of the container
Calcio-20 is supplied in a transparent PET bottle containing 300 ml of white 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 most recent revision of this package leaflet: March 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es