Patient Information Leaflet

Carbocal 600 mg Tablets

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 given by your doctor, pharmacist, or nurse.

• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if you get worse or do not improve

Carbocal is a calcium supplement.

It is indicated:

• For preventing and treating calcium deficiency or lack.
• As a supplement in the prevention and treatment of osteoporosis (fragile and brittle bones).
• For treating hyperphosphatemia (elevated levels of phosphate in the blood).

Do not take Carbocal

• If you are allergic to calcium 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, pharmacist, or nurse before starting to take this medication.

If you have kidney failure or a tendency to form kidney stones, consult your doctor before starting to take this medication.

Other medications and Carbocal

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. Certain medications may interact with Carbocal. In these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Cardiac glycosides (heart medications)
• Levotiroxine (thyroid hormone)
• Iron, zinc, and strontium ranelate preparations
• Tetracyclines and quinolones.
• 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 (stimulates the remineralization of decalcified enamel)

Carbocal and food, beverages

If you take Carbocal 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 Carbocal within two hours of consuming 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. Your doctor will assess the suitability of treatment for you.

During pregnancy, the daily intake of calcium should not exceed 2500 mg (including food and supplements).

Carbocal can be used during pregnancy in cases of calcium deficiency.

Carbocal can be used during breastfeeding. Calcium passes through breast milk.

Driving and operating machinery

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

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. Remember to take your medication.

Carbocal tablets are for oral use. You should swallow the Carbocal tablets whole or break them, followed by drinking a little water if desired.

The recommended dose is:

Calcium Deficiency

Adults: the usual recommended dose is1 to2 tablets per day.

Children: the usual recommended dose is 1 tablet per day.

Osteoporosis

Adults: the usual recommended dose is1 to2 tablets per day.

Hypophosphatemia (elevated levels of phosphate in the blood)

Your doctor will indicate the dose individually. The usual dose is3 to13 tablets per day divided into 2-4 doses. The tablets should be taken with meals to bind to the phosphate of the food.

Your doctor will indicate the duration of your treatment with Carbocal. Do not discontinue treatment before; as the desired effect would not be achieved.

If you estimate that the action of Carbocal is too strong or weak, inform your doctor or pharmacist.

If you take more Carbocal than you should

If you have taken more Carbocal than you should, consult your doctor, pharmacist, 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, polydipsia (excessive thirst), polyuria (increased frequency of urination), bone pain, nephrocalcinosis (high calcium levels in the kidneys), kidney stones, and in severe cases, arrhythmias (abnormal heart rate).

If you forgot to take Carbocal

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take the next one as soon as possible and continue as before.

Like all medications, Carbocal can 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 people), rare (between 1 and 1,000 per 10,000 people) or very rare (up to 1 per 10,000 people)

Metabolic and Nutritional Disorders

Infrequent: hypercalcemia (elevated blood calcium levels) and hypercalciuria (elevated urine calcium levels)

Very rare: Milk-Alkali Syndrome (urgent need to urinate frequently, continuous headache, persistent loss of appetite, nausea or vomiting, excessive fatigue or weakness, hypercalcemia, alkalosis, and renal insufficiency.). It usually only appears in cases of overdose (see section 4.9).

Gastrointestinal Disorders

Rare: constipation, gas, nausea, abdominal pain, and diarrhea.

Diarrhea has occurred with an unknown frequency (it cannot be estimated from the available data).

Skin and Subcutaneous Tissue Disorders

Very rare: pruritus, exanthema (skin eruption), and urticaria (hives)

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 Medicinal Products for Human Use: https://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.This medication does not require special storage conditions.Keep the bottle perfectly closed to preserve it from moisture.

Do not use Carbocal 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 trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carbocal

The active principle is calcium carbonate. Each tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium).

The other components (excipients) are: cornstarch, pregelatinized cornstarch, sodium starch glycolate type A (from potato), povidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the packaging

Carbocal is presented in the form of white tablets.

Plastic bottle: 20 and 60 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization

Farmasierra Laboratorios S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes (Madrid)

Responsible for manufacturing:

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes (Madrid)

Date of the last review of this leaflet: April 2023

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