CAOSINA 1000 mg ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Caosina 1,000 mg Powder for Oral Suspension

Calcium Carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Caosina and what is it used for
2. What you need to know before taking Caosina
3. How to take Caosina
4. Possible side effects
5. Storage of Caosina
6. Contents of the pack and further information

1. What is Caosina and what is it used for

Caosina is a medicine that comes in the form of 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 high phosphate levels in the blood (Hyperphosphatemia).

2. What you need to know before taking Caosina

Do not take Caosina:

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

Warnings and precautions

• If you have kidney failure, Caosina should only be administered under 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 calcium-containing medications or foods (such as milk), there may be a risk of hypercalcemia with consequent impairment of renal function. Your doctor should monitor your serum calcium levels and renal function.

Other medicines and Caosina

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Note that these instructions may also apply to medicines taken before or after Caosina.

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

Systemic corticosteroids (medicines 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 out the administration by 2 hours.

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

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

Monitoring by electrocardiogram (ECG) and serum calcium levels is recommended.

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

The efficacy of levothyroxine (thyroid hormone) may be reduced if used simultaneously with calcium, due to decreased absorption of levothyroxine. The administration of calcium and levothyroxine 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 (medicine for the treatment of osteoporosis). Consequently, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after calcium carbonate.

Some medicines may also have their absorption reduced by the formation of chelates, such as phenytoin (antiarrhythmic), fosfomycin (antibiotic), iron salts, and doxycycline (antibiotic).

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

Administration with verapamil may attenuate its antihypertensive effects.

Taking Caosina with food, drinks, and alcohol

Oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) may inhibit calcium absorption through the formation of insoluble compounds with calcium. You should not take calcium products within 2 hours of consuming foods high in oxalic acid and phytic acid.

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

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 medicine.

The recommended daily intake (including food and supplements) during pregnancy and breastfeeding is 1,000-1,300 mg of calcium.

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

In case of calcium deficiency, Caosina can be used during pregnancy and breastfeeding, as although it passes into breast milk, at therapeutic doses used, no effects are expected in newborns.

Driving and using machines

No studies have been conducted on the ability to drive and use machines. However, it is unlikely that there will be effects on the ability to drive and use machines.

3. How to take Caosina

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If in 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 (high phosphate levels in the blood)

Individual dosing. Usually, 2-6 g of calcium (2-6 sachets of Caosina) per day are required, divided into 2-4 doses.

Caosina is administered orally. Pour the contents of one or more sachets, depending on the indication, into half a glass of water (100 ml). Shake until a homogeneous suspension is formed.

In case you only need 500 mg, dilute one sachet homogeneously in half a glass of water and discard approximately half, in order to take only the remaining amount.

Caosina should be taken with meals so that it binds to phosphate in 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package and the package leaflet of the medicine to the healthcare professional.

Overdose can lead to hypervitaminosis and hypercalcemia. The symptoms of hypercalcemia can be anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental changes, thirst, production of a large amount of urine, bone pain, nephrocalcinosis (calcium deposits in the kidney), kidney stones, and in severe cases, cardiac arrhythmias. Extreme hypercalcemia can produce coma and death. Persistently elevated calcium levels can lead to irreversible kidney damage and calcification in certain tissues.

Syndrome of milk and alkali can occur in patients who ingest large amounts of calcium and absorbable alkalis, causing a metabolic imbalance due to increased calcium in the body, resulting in loss of renal function.

If you forget to take Caosina

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

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

If you stop taking Caosina

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following adverse reactions are classified by organ system and frequency. Frequencies are defined as: uncommon (between 1 and 100 in every 1,000 patients), rare (between 1 and 10 in every 10,000 patients), or very rare (up to 1 in every 10,000 people).

Metabolic and nutritional disorders

Uncommon: hypercalcemia, hypercalciuria, and metabolic alkalosis (high levels of bicarbonate in the blood).

Very rare: milk-alkali syndrome (frequent need to urinate, continuous headache, loss of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis, and kidney failure). This usually occurs only in case of overdose.

Gastrointestinal disorders

Rare: constipation, flatulence, anorexia, nausea, vomiting, abdominal pain, dry mouth, and diarrhea.

Frequency not known: dyspepsia (pain or discomfort in the abdomen).

Nervous system disorders

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

Renal and urinary disorders

Rare: polyuria (excessive urine production), renal failure, kidney stones.

Skin and subcutaneous tissue disorders

Rare: itching, rash, and urticaria.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Caosina

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the package and any unused medicine to a pharmacy for proper disposal. If in doubt, consult your pharmacist on how to dispose of the package and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Caosina

• The active substance is calcium carbonate. Each sachet contains 2,500 mg of calcium carbonate, equivalent to 1,000 mg or 25 mmol of calcium.
• The other ingredients are: sodium saccharin and ethyl vanillin.

Appearance of the product and pack contents

Caosina is a medicine that comes in the form of powder for oral suspension. Each carton contains 24 or 60 sachets of complex paper/aluminum/polyethylene.

Marketing authorization holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Manufacturers

Laboratorios ERN, S.A.

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

Date of last revision of this package leaflet: October 2018.

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