Leaflet: information for the user

Caosina 1.000 mg powder for oral suspension

Calcium carbonate

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

• Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
• Keep this leaflet, as you may need to read 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 not listed in this leaflet. See section 4.

1. What Caosina is and for what it is used

2. What you need to know before starting to take Caosina

3. How to take Caosina

4. Possible adverse effects

5. Storage of Caosina

6. Contents of the pack and additional information

Caosina is a medication that is presented in the form of a powder for oral suspension, and is used as:

- prevention and treatment of calcium deficiency,

- calcium supplement for the prevention and treatment of osteoporosis,

- treatment of elevated levels of phosphate in the blood (Hyperphosphatemia).

Do not take Caosina:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have diseases or conditions that lead to hypercalcemia (elevated calcium levels in the blood) and/or hypercalciuria (elevated calcium levels in the urine).
• If you have nephrolithiasis (kidney stones).
• If you have ventricular fibrillation (a heart rhythm disorder).

Warnings and precautions

• If you have renal insufficiency, Caosina should only be administered in conditions where hyperphosphatemia is controlled.
• If you have a history of kidney stones.
• During high-dose treatment and especially during concomitant treatment with vitamin D and/or medications or foods containing calcium (such as milk), there may be a risk of hypercalcemia with subsequent renal function alteration. Your doctor should monitor your serum calcium levels and renal function.

Other medications and Caosina

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

Be aware that these instructions may also apply to medications taken before or that may be taken after.

Thiazide diuretics (medications used to treat edema and hypertension) reduce urinary calcium excretion. Due to the increased risk of hypercalcemia, serum calcium levels should be regularly monitored during concomitant use with thiazide diuretics.

Systemic corticosteroids (medications used for their anti-inflammatory and immunosuppressive activity) reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Caosina. It is recommended to space the administration 2 hours apart.

Calcium carbonate may interfere with the absorption of tetracycline preparations (antibiotics) administered concomitantly. Therefore, tetracycline preparations should be administered at least 2 hours before or 4 to 6 hours after oral calcium intake.

Hypercalcemia may increase the toxicity of cardiac glycosides (medications used to treat heart diseases) during calcium treatment.

It should be monitored by electrocardiogram (ECG) and serum calcium levels.

If you are taking a bisphosphonate (medications for the prevention and treatment of bone resorption) concomitantly, this preparation should be administered at least 3 hours before Caosina intake, as it may reduce gastrointestinal absorption.

The efficacy of levothyroxine (thyroid hormone) may be reduced if used simultaneously with calcium, due to a decrease in levothyroxine absorption. Calcium and levothyroxine administration should be separated by at least 4 hours.

The absorption of quinolones (antimicrobials) may be impaired if administered concomitantly with calcium. Quinolones should be taken 2 hours before or 6 hours after calcium intake.

Calcium salts may decrease the absorption of iron, zinc, and strontium ranelate (medication for the treatment of osteoporosis). Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after calcium carbonate.

Some medications may also reduce their absorption by forming chelates, such as:phenytoin(antiarrhythmic),fosfomycin(antibiotic),iron saltsanddoxycycline(antibiotic).

Concomitant administration with gentamicin (antibiotic) may potentiate its nephrotoxicity (toxicity to the kidneys).

Concomitant administration with verapamil may attenuate its antihypertensive effects.

Caosina intake with food, drinks, and alcohol

Acid oxalate (present in spinach and rhubarb) and phytic acid (present in whole grains) may inhibit calcium absorption by forming insoluble compounds with calcium. Do not take products containing calcium within 2 hours of consuming foods high in acid oxalate and phytic acid.

Phosphorus present in milk or other products may also cause a decrease in calcium absorption.

Pregnancy, lactation, and fertility

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

The recommended daily intake (including foods and supplements) during pregnancy and lactation is 1,000 – 1,300 mg of calcium.

During pregnancy, the daily intake of calcium should not exceed 1,500 mg.

In cases of calcium deficiency, Caosina may be used during pregnancy and lactation, as it passes into breast milk, but at therapeutic doses, no effects are expected in newborns.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery. However, it is unlikely that effects on driving and operating machinery will occur.

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:

Prevention and treatment of calcium deficiency

Adults: 500 – 1,500 mg of calcium per day.

Children: 500 – 1,000 mg of calcium per day.

Treatment for osteoporosis

Adults: 500 – 1,500 mg of calcium per day.

Hyperphosphatemia (elevated levels of phosphate in the blood)

Individual dosing. Usually, 2 - 6 grams of calcium (2 to 6 Caosina packets) per day are required, divided into 2 – 4 doses.

Caosina is administered orally. Pour the contents of one or several packets, depending on the indication, into a medium-sized glass of water (100 ml). Shake until a homogeneous suspension is formed.

If only 500 mg is needed, dilute one packet homogeneously in a medium-sized glass of water, and discard approximately half, in order to take only the remaining amount.

Caosina should be taken with meals in order to combine with the phosphate of the food.

If you take more Caosina than you should

If you have taken more Caosina than you should or in case of accidental overdose, consult your doctor or pharmacist immediately, or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Overdose may lead to hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental alterations, thirst, excessive urine production, bone pain, nephrocalcinosis (calcium deposits in the kidney), kidney stones, and in severe cases, cardiac arrhythmias. Extreme hypercalcemia may cause coma and death. Persistently elevated calcium levels may lead to irreversible kidney damage and calcifications in certain tissues.

A milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkaline substances, causing a metabolic imbalance due to increased calcium in the body, which may lead to a loss of renal function.

If you forget to take Caosina

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

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at its usual time.

If you interrupt the treatment with Caosina

Remember to take your medication. Your doctor will indicate the duration of your treatment with this medication. Avoid suspending treatment without consulting your doctor first.

If you have any other doubts 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.

The following adverse reactions are classified by organs and systems and by frequencies. Frequencies are defined as: infrequent (between 1 and 100 per 1,000 patients), rare (between 1 and 1,000 per 10,000 patients), or very rare (up to 1 in 10,000 people).

Metabolic and Nutritional Disorders

Infrequent: hypercalcemia, hypercalciuria, and metabolic alkalosis (elevated blood bicarbonate levels).

Very rare: milk-alkali syndrome (urgent need to urinate frequently, continuous headache, continuous loss of appetite, nausea or vomiting, excessive fatigue or weakness, hypercalcemia, alkalosis, and renal insufficiency). It usually only appears in cases of overdose.

Gastrointestinal Disorders

Rare: constipation, flatulence, anorexia, nausea, vomiting, abdominal pain, dry mouth, heartburn (if taken on an empty stomach, not recommended) and diarrhea.

Unknown frequency: Dyspepsia (abdominal pain or discomfort).

Nervous System Disorders

Very Rare: confusion, irritability, delirium, stupor, and coma (high doses).

Renal and Urinary Tract Disorders

Rare: polyuria (elevated urine excretion), renal failure, kidney stones.

Skin and Subcutaneous Tissue Disorders

Rare: pruritus, rashes, and urticaria.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for 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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Caosina

• The active principle is calcium carbonate. Each sachet contains 2,500 mg of calcium carbonate, equivalent to 1,000 mg or 25 mmol of calcium.
• The other components are: Sodium saccharin and ethylvanillin.

Appearance of the product and content of the packaging

Caosina is a medication that is presented in the form of an oral suspension powder. Each box contains 24 or 60 sachets of paper/aluminum/polyethylene.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona. Spain.

Manufacturing responsible parties

Laboratorios ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

Last review date of this leaflet: October 2018.

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