Patient Information Leaflet

Calcial D 600 mg/400 IUChewable Tablets

Calcium / Colecalciferol (Vitamin D3)

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Calcial D

4. Possible side effects

5. Storage of Calcial D

6. Contents of the pack and additional information

Calcial Dis a calcium and vitamin D supplement.

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

Do not takeCalcial D:

- If you are allergic to calcium carbonate, vitamin D3, or any of the other components of this medication (listed in section 6).3

- If you have kidney stones.

- If you have severe kidney failure.

- If you have high levels of calcium in your blood or urine.

Warnings and precautions

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

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

- If you are taking other products containing vitamin D, inform your doctor as you should stop taking them.

- If you have sarcoidosis (a granulomatous disease affecting various organs, including the skin, and which may be associated with elevated 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 aforementioned circumstances have occurred at any time.

NChildren

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

Other medications and Calcial D

Taking Calcial D with other medications.

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

Calcial D may interact with the following medications:

- Cardiac glycosides, such as digoxin.

- The following antibiotics: tetracyclines, penicillin, neomycin, chloramphenicol

- Some diuretics: loop diuretics (furosemide, etacrynic acid) and thiazide diuretics (hydrochlorothiazide)

- Antacids containing aluminum salts

- Thyroid hormones

- Cholestyramine

- Corticosteroids

- Mineral oils

- Phenobarbital

- Barbiturates

- Biphosphonate

- Sodium fluoride

Taking Calcial D with food, drinks, and alcohol

If you take Calcial D tablets with foods containing oxalates (spinach, beets, 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, or if you think you may be 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 treatment for you.

Calcial D is not recommended for use during pregnancy or breastfeeding.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

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

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

Calcial D contains sorbitol. This medication contains 600 mg of sorbitol in each dose unit. Sorbitol is a source of fructose. If your doctor has indicated 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 (or your child) before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 Calcial D. Do not discontinue treatment prematurely; as the desired effect would not be achieved.

Administration form:

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

Alternatively, you can disperse 1 or 2 tablets in a half glass of water and ingest it afterwards.

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

If you take more Calcial D than 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 sensation of thirst, nausea, vomiting, dehydration, increased urination frequency, and constipation.

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

If you forgot to take Calcial D

Do not take a double dose to compensate for the missed 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 Calcial D

If you have any other doubts 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 following adverse effects have been observed:

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

Following prolonged administration at high doses, elevated levels of calcium in the blood and urine may appear, along with symptoms such as loss of appetite, vomiting, nausea, headache, weakness, apathy, and drowsiness. Other more severe symptoms include thirst, dehydration, increased frequency of urination, abdominal pain, and irregular heart palpitations.

If any other reaction not described in this prospectus is observed, consult a doctor or pharmacist.

Reporting Adverse Effects

If any type of adverse effect is experienced, consult a doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. Adverse effects can also be reported 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 about the safety of this medication.

Do not store at a temperature above 25°C. Store in the original packaging.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Calcial D

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

Appearance of the product and contents of the packaging

Calcial Dare white, anise-mentha flavored chewable tablets.

They are presented in polyethylene bottles containing 60 chewable tablets.

Holder of the marketing authorization and responsible for manufacturing

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Date of the last review of this leaflet:11/2020

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