CARBOCAL D 600 MG/400 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Carbocal D 600 mg/400 UI Chewable Tablets

Calcium / Colecalciferol (Vitamin D3)

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

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

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

Carbocal D is a calcium and vitamin D supplement.

Carbocal D is indicated for the treatment of calcium and vitamin D deficiency states. It can also be used as a supplement in the treatment of osteoporosis in patients with manifest calcium and vitamin D deficiency or at high risk of developing it.

2. What you need to know before taking Carbocal D

Do not take Carbocal D:

• If you are allergic to calcium carbonate, vitamin D3, or any of the other components of this medication (listed in section 6).
• If you have kidney stones.
• If you have severe kidney failure.
• If you have high levels of calcium in the blood or urine.

Warnings and Precautions

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

• If you suffer from any of the following diseases, remember to inform your doctor before taking this medication:
• If you are taking other products that contain vitamin D, you should inform your doctor, as you should stop taking them.
• If you have sarcoidosis (a granulomatous disease that affects various organs, including the skin, and can be associated with elevated calcium levels in the blood).
• If you have kidney failure or a tendency to form kidney stones.
• If you have any heart disease.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Children

The safety and efficacy of Carbocal D have not been established in children, so its use is not recommended in this age group.

Other Medications and Carbocal D

Taking Carbocal D with other medications.

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

Carbocal D may interact with the following medications:

• Cardiac glycosides, such as digoxin.
• The following antibiotics: tetracyclines, penicillin, neomycin, chloramphenicol
• Certain diuretics: loop diuretics (furosemide, ethacrynic acid) and thiazide diuretics (hydrochlorothiazide)
• Antacids that contain aluminum salts
• Thyroid hormones
• Colestyramine
• Corticosteroids
• Mineral oils
• Phenytoin
• Barbiturates
• Bisphosphonate
• Sodium fluoride

Taking Carbocal D with Food, Beverages, and Alcohol

If you take Carbocal D chewable tablets with foods that contain oxalates (beets, spinach, chocolate), phosphates (red meat), or phytic acid (whole wheat bread, cereals), interactions may occur, so it is recommended not to take Carbocal D with meals.

During treatment with Carbocal D, you should not take foods that may be "fortified" with vitamin D.

Pregnancy, Breastfeeding, and Fertility

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

Consult your doctor or pharmacist before taking any medication.

Your doctor will assess the suitability of the treatment for you.

The use of Carbocal D is not recommended during pregnancy or breastfeeding.

Driving and Using Machines

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

Important Information about Some Components of Carbocal D

This medication contains 5 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 600 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor before taking this medication.

3. How to Take Carbocal D

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

Remember to take your medication.

Adults and Elderly Patients

The recommended dose is 1 to 2 tablets per day.

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

Method of Administration:

Carbocal D chewable tablets are for oral use. Chew the tablets, then drink a little water if desired.

They can also be dispersed in half a glass of water and taken afterwards.

If you think the effect of Carbocal D is too strong or too weak, inform your doctor or pharmacist.

If You Take More Carbocal D Than You Should

If you have taken more Carbocal D than you should, consult your doctor or pharmacist immediately.

In case of overdose, you may experience a sensation of thirst, nausea, vomiting, dehydration, increased frequency of urination, and constipation.

In case of overdose or accidental ingestion, consult the Toxicology Information Service: Telephone 91 562 04 20.

If You Forget to Take Carbocal D

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.

If You Interrupt Treatment with Carbocal D

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed:

Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, and diarrhea.

In cases of prolonged administration at high doses, elevated calcium levels in the blood and urine may appear, with symptoms such as loss of appetite, vomiting, nausea, headache, weakness, apathy, and somnolence. Other more serious symptoms are thirst, dehydration, increased frequency of urination, abdominal pain, and irregular heartbeat.

If you observe any other reaction not described in this package leaflet, consult your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Carbocal D

Do not store above 30°C. Keep in the original package.

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

Do not use this medication after the expiration date stated on the package, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Carbocal D

• The active ingredients are calcium (carbonate) and colecalciferol (vitamin D3). Each chewable tablet contains 600 mg of calcium and 400 UI of colecalciferol.
• The other components are: sodium saccharin, sorbitol (E-420), pregelatinized corn starch, magnesium stearate (E-572), sodium croscarmellose, aspartame (E-951), anhydrous lactose, anise flavor, mint flavor, and milk flavor.

Appearance of the Product and Package Contents

Carbocal D are white, anise-menthol flavored chewable tablets.

They come in polyethylene bottles containing 60 chewable tablets.

Marketing Authorization Holder

Farmasierra Laboratorios SL

Ctra de Irún km 26,200 San Sebastián de los Reyes

28709 Madrid, Spain

Manufacturer

Farmasierra Manufacturing SL

Ctra de Irún km 26,200 San Sebastián de los Reyes

28709 Madrid, Spain

Date of the Last Revision of this Package Leaflet:July 2018

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