Carbocal d 600 mg/400 ui comprimidos

Product Information for the User

Carbocal D600 mg/400 IUtablets

calcium/colecalciferol

Read this entire product information carefully before starting to take this medication,because it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this product information. See section 4.

1.What isCarbocal D andwhat it is used for

2.What you need to knowbeforestarting totakeCarbocal D

3.How to takeCarbocal D

4.Possible adverse effects

5Storage ofCarbocal D

6.Contents of the package and additional information

Carbocal D belongs to a group of medications known as calcium and vitamin D associations.

Carbocal D is indicated in cases of calcium and vitamin D deficiency and in the treatment of postmenopausal, senile, or corticosteroid-induced osteoporosis in adults.

Do not take Carbocal D

• if you are allergic to calcium, colecalciferol (vitamin D3), or any of the other components of this medication (listed in section 6),
• if you have high levels of calcium in your blood or calcium in your urine,
• if you have severe kidney impairment,
• if you have kidney stones,
• if you have been immobile for a long time and have high levels of calcium in your blood or calcium in your urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carbocal D.

Inform your doctor if you experience any of the following situations before taking Carbocal D:

• if you are taking other medications that contain vitamin D. In this case, they will need to calculate the amount you take daily of this vitamin,
• if you have a disease called sarcoidosis, as you will need to take this medication with caution due to a possible increase in vitamin D metabolism,
• if you have a kidney disease, as it may cause an alteration in vitamin D metabolism,
• when the treatment with Carbocal D is very prolonged, as they will need to control your calcium levels in urine,
• if you are receiving treatment with vitamin D, as in these cases it is essential to have your calcium and phosphorus levels in blood checked.

Children

Carbocal D cannot be used in children.

Other medications and Carbocal D

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

Carbocal D may interact with other medications, such as:

• oral tetracyclines, as taking them together with Carbocal D may reduce their effects, and a gap of at least three hours should be respected,
• bisphosphonates or sodium fluoride, as taking them together with Carbocal D may reduce the effect of these products, and a gap of at least two hours should be respected,
• anticonvulsants and barbiturates, as taking them together with Carbocal D may make vitamin D less effective,
• cardiotonic glucosides, as their association with Carbocal D may present a risk of cardiac arrhythmias,
• thiazide diuretics, as taking them together with Carbocal D may increase their levels of calcium in the blood,
• levotiroxine, as calcium may decrease its absorption, and a gap of at least four hours should be respected,
• quinolone antibiotics, as calcium may alter their absorption, and these medications should be taken two hours before or six hours after taking Carbocal D.

Carbocal D with food and drinks

If you take this medication concomitantly with foods and drinks that contain oxalic acid (a compound present in spinach and rhubarb), phytic acid (present in whole wheat bread and cereals) or phosphorus (present in foods such as milk), interactions may occur. Therefore, it is recommended not to take this medication during the 2 hours following the ingestion of these types of foods.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, you should consult your doctor before starting treatment with this medication, as you should not take more than one tablet per day in any case.

Driving and operating machinery

The influence of Carbocal D on the ability to drive and operate machinery is negligible or insignificant.

During treatment with this medication, you will be able to drive and operate machinery safely.

Follow exactly the administration instructions for this medication as indicated by your doctor.If in doubt, consult your doctor or pharmacist again.

Carbocal D tablets are administered orally.

The recommended dose is 1 to 2 tablets (1,500-3,000 mg of calcium carbonate, 400-800 IU of vitamin D) per day, preferably after meals.

Tablets should be swallowed with a glass of water, whole or divided. The groove is only for dividing the tablet if it is difficult to swallow whole.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Carbocal D. Do not discontinue treatment beforehand, as the expected effects will not be achieved.

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

If you take more Carbocal D than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call 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.

If you forget to take Carbocal D

If you forget to take the tablets, take the missed dose as soon as possible; then return to your regular dosing schedule.

If it is almost time for the next dose, do not take the missed dose, only take the next dose normally.

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

If you interrupt treatment with Carbocal D

Take Carbocal D as prescribed. Do not discontinue your treatment with this medication without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The possible adverse effects are detailed below, grouped by frequency of occurrence.

Rarely Occurring(may affect up to 1 in 100 people):

• Increased levels of calcium in the blood and urine.

Uncommon(may affect up to 1 in 1,000 people):

• Constipation, flatulence, nausea, diarrhea, and abdominal pain,
• Itching, redness, or abnormal texture of the skin.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears onthecontainer. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Carbocal D

• The active principles are:calcium carbonate and colecalciferol (Vitamin D3). Each tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 400 IU of colecalciferol (Vitamin D3) (equivalent to 0.01 mg).

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

Appearance of the product and contents of the packaging

Carbocal D 600 mg/400 IU tablets are presented in the form of white, oval, and scored tablets for oral administration.

The tablets are packaged in opaque white high-density polyethylene (HDPE) bottles, with a polyethylene cap and a safety seal, conditioned in a cardboard box.

It is presented in packs of 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Farmasierra Laboratorios, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes

Madrid, Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes

Madrid, Spain

Last review date of thisleaflet: June 2024

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