CALCIAL D 600 mg/400 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Calcial D 600 mg/400 UIchewable tablets

calcium / colecalciferol (vitamin D3)

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 signs of illness 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 Calcial D is and what it is used for
2. What you need to know before you take Calcial D
3. How to take Calcial D
4. Possible side effects
5. Storage of Calcial D
6. Contents of the pack and other information

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

Calcial D is a calcium and vitamin D supplement.

Calcial 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 its occurrence.

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

Do not takeCalcial D:

• If you are allergic to calcium carbonate, vitamin D3, or any of the other ingredients of this medicine (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 taking Calcial D.

If you suffer from any of the following diseases, remember to inform your doctor before taking this medicine:

• If you are taking other products containing vitamin D, you should inform your doctor as you should stop taking them.
• If you suffer from sarcoidosis (a granulomatous disease that affects different organs, including the skin, and can be associated with high blood calcium levels).
• 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 Calcial D have not been established in children, so its use is not recommended in this age group.

Other medicines and Calcial D

Taking Calcial D with other medicines.

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

Calcial D may interact with the following medicines:

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

TakingCalcial Dwith food, drinks, and alcohol

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

During treatment with Calcial D, do not take foods that may be "fortified" with vitamin D.

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.

Consult your doctor or pharmacist before taking any medicine.

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

The use of Calcial 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.

Calcial D containsaspartame. This medicine contains 5 mg of aspartame per unit dose. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

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

Calcial D contains sorbitol. This medicine contains 600 mg of sorbitol per unit dose. 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 disorder in which the patient cannot break down fructose, consult with your doctor before taking this medicine.

3. How to take Calcial D

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Adults and elderly patients

The recommended dose is 1 to 2 tablets per day.

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

Method of administration:

Calcial 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 action of Calcial D is too strong or too weak, tell your doctor or pharmacist.

If you take moreCalcial Dthan you should

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

In case of overdose, you may experience a feeling 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 takeCalcial 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 stop taking Calcial D

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 case of prolonged administration at high doses, high levels of calcium 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 notice any other reaction not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcial D

Do not store above 25°C. Store in the original package.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry 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 medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calcial 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 ingredients are: sodium saccharin, sorbitol (E-420), pregelatinized corn starch, magnesium stearate (E-572), sodium croscarmellose, aspartame (E-951), anhydrous lactose, anise flavor, peppermint flavor, and milk flavor.

Appearance of the product and pack contents

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

They come in polyethylene bottles containing 60 chewable tablets.

Marketing authorization holder and manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Date of last revision of this leaflet:11/2020

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