CARBOCAL 600 MG TABLETS

Introduction

Patient Information Leaflet

Carbocal600 mg tablets

Calcium carbonate

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

Follow the instructions for taking the medicine exactly as stated in this leaflet or as directed 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 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 your condition worsens or does not improve.

Contents of the Leaflet

1. What is Carbocal and what is it used for
2. What you need to know before taking Carbocal
3. How to take Carbocal
4. Possible side effects
5. Storage of Carbocal
6. Package contents and additional information

1. What is Carbocal and what is it used for

Carbocal is a calcium supplement.

It is indicated:

• To prevent and treat calcium deficiency or lack of calcium.
• As a supplement in the prevention and treatment of osteoporosis (fragile and brittle bones).
• To treat hyperphosphatemia (high levels of phosphate in the blood).

2. What you need to know before taking Carbocal

Do not take Carbocal

• If you are allergic to calcium or any of the other components 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

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

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

Other medicines and Carbocal

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

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

• Cardiac glycosides (heart medicines)
• Levothyroxine (thyroid hormone)
• Iron, zinc, and strontium ranelate preparations
• Tetracyclines and quinolones
• Thiazide diuretics (medicines that increase urine elimination)
• Systemic corticosteroids (anti-inflammatory medicines derived from steroids)
• Bisphosphonates (medicines for the treatment and prevention of osteoporosis: fragile and brittle bones)
• Sodium fluoride (to stimulate the remineralization of decalcified enamel)

Taking Carbocal with food and drinks

If you take Carbocal with foods that contain oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole wheat bread and whole grain cereals), interactions may occur, so it is recommended not to take Carbocal during the two hours following consumption of foods high in oxalic acid and phytic acid.

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. Your doctor will assess the suitability of the 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 case of calcium deficiency.

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

Driving and using machines

No effects on the ability to drive and use machines have been observed.

3. How to take Carbocal

Follow the instructions for taking the medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. Remember to take your medicine.

Carbocal tablets are for oral use. You should swallow the Carbocal tablets whole or broken, and then drink a little water if you wish.

The recommended dose is:

Calcium deficiency

Adults: the usual recommended dose is 1 to 2 tablets per day.

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

Osteoporosis

Adults: the usual recommended dose is 1 to 2 tablets per day.

Hyperphosphatemia (high levels of phosphate in the blood)

Your doctor will indicate the dose individually. The usual dose is 3 to 13 tablets per day, divided into 2-4 doses. The tablets should be taken with meals to bind to the phosphate in food.

Your doctor will indicate the duration of your treatment with Carbocal. Do not stop treatment before; otherwise, the desired effect will not be achieved.

If you think the effect of Carbocal is too strong or too weak, tell 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 Toxicology Information Service, phone 91-562-04-20, indicating the medicine and the amount taken.

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

If you forget to take Carbocal

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

4. Possible side effects

Like all medicines, Carbocal can cause side effects, although not everyone gets them.

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

Metabolic and nutritional disorders

Uncommon: hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).

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 (see section 4.9).

Gastrointestinal disorders

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

Dyspepsia has occurred with an unknown frequency (cannot be estimated from available data).

Skin and subcutaneous tissue disorders

Very rare: itching, exanthema (skin rash), and urticaria (hives).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carbocal

Keep this medicine out of the sight and reach of children. This medicine does not require special storage conditions. Keep the bottle tightly closed to protect it from moisture.

Do not use Carbocal after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Carbocal

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

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

Appearance of the product and package contents

Carbocal is presented in the form of white tablets.

Plastic bottle: 20 and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Farmasierra Laboratorios S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes (Madrid)

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes (Madrid)

Date of the last revision of this leaflet: April 2023

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