CARBOCAL D 600 MG/400 IU TABLETS

Introduction

Package Leaflet: Information for the User

Carbocal D600 mg/400 UItablets

calcium/colecalciferol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Carbocal D and what is it used for
2. What you need to know before you take Carbocal D
3. How to take Carbocal D
4. Possible side effects

5 Conservation of Carbocal D

1. Contents of the pack and further information

1. What is Carbocal D and what is it used for

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

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

2. What you need to know before you take Carbocal D

Do not take Carbocal D

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

Warnings and precautions

Consult your doctor or pharmacist before taking Carbocal D.

Tell your doctor if you have any of the following conditions before taking Carbocal D:

• if you are taking other medicines that contain vitamin D. In this case, the amount of vitamin D you take daily should be calculated,
• if you have a disease called sarcoidosis, as you should take this medicine with caution due to a possible increase in vitamin D metabolism,
• if you have kidney disease, as it may cause an alteration in vitamin D metabolism,
• when treatment with Carbocal D is very prolonged, as your calcium levels in the urine should be monitored,
• if you are receiving treatment with vitamin D, as it is essential to monitor your calcium and phosphorus levels in the blood.

Children

Carbocal D should not be used in children.

Other medicines and Carbocal D

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

Carbocal D may interfere with other medicines, such as:

• oral tetracyclines, as their effects may be reduced if taken with Carbocal D, and an interval of at least three hours should be respected,
• bisphosphonates or sodium fluoride, as their effects may be reduced if taken with Carbocal D, and an interval of at least two hours should be respected,
• anticonvulsants and barbiturates, as they may make vitamin D less effective,
• cardiac glycosides, as their combination with Carbocal D may pose a risk of cardiac arrhythmias,
• thiazide diuretics, as they may increase calcium levels in the blood if taken with Carbocal D,
• levothyroxine, as calcium may decrease its absorption, and an interval of at least four hours should be respected,
• quinolone antibiotics, as calcium may alter their absorption, and these medicines should be taken two hours before or six hours after taking Carbocal D.

Taking Carbocal D with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Carbocal D has no or negligible influence on the ability to drive and use machines.

During treatment with this medicine, you can drive and use machinery safely.

3. How to take Carbocal D

Follow exactly the administration instructions of this medicine 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 UI of vitamin D) per day, preferably after meals.

The tablets should be swallowed with a glass of water, whole or broken. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Remember to take your medicine.

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

If you think the action of Carbocal D is too strong or too weak, tell 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 Toxicology Information Service, phone 91 562.04.20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Carbocal D

If you forget to take the tablets, take the forgotten 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 forgotten dose, just take the next dose normally.

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

If you stop taking Carbocal D

Take Carbocal D as prescribed. Do not stop treatment with this medicine 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 possible side effects are listed below, grouped by frequency:

Uncommon(may affect up to 1 in 100 people):

• increased levels of calcium in the blood and urine.

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

• constipation, flatulence, nausea, diarrhea, and abdominal pain,
• itching, redness, or abnormal skin texture.

If you think any of the side effects are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

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

5. Conservation of Carbocal D

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicines to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packages and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Carbocal D

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

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

Appearance and packaging of the product

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

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

They are available in packs of 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmasierra Laboratorios, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes

Madrid, Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. de Irún, km 26,200

28709, San Sebastián de los Reyes

Madrid, Spain

Date of last revision of this leaflet: June 2024

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