VERISCAL D 1.500 MG/400 IU CHEWABLE TABLETS

Introduction

Leaflet: information for the patient

Veriscal D1,500 mg/400 UI chewable tablets

(calcium carbonate/colecalciferol)

Read this leaflet carefully before starting to take 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, ask your doctor, pharmacist, or nurse.
• This medicine 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. Storage of Veriscal D
2. Package contents and additional information

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

This medicine is an association of calcium and vitamin D.

Veriscal D is indicated for the treatment of vitamin D deficiency states in patients who require calcium intake, as well as a supplement of vitamin D and calcium associated with certain treatments for osteoporosis.

2. What you need to know before taking Veriscal D

Do not take Veriscal D

• if you are allergic to calcium, vitamin D, or any of the other components of this medicine (listed in section 6).
• if you have kidney stones.
• if you have high levels of calcium in the blood or urine.
• this medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Veriscal D

• during prolonged treatments with this medicine; your doctor will monitor your urine calcium levels and adjust the dose.
• if your kidneys do not function properly or you have a tendency to form kidney stones.
• in elderly patients, it is recommended to regularly monitor kidney function.
• if you suffer from sarcoidosis (a disease that causes inflammation of the lymph nodes, lungs, liver, eyes, skin, and other tissues).

Other medicines and Veriscal D

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

Certain medicines may interfere with this medicine; in these cases, it may be necessary to change the dose, interrupt treatment with one of them, or wait at least a few hours between administration.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Cardiac glycosides (heart medicines).
• Tetracyclines (certain antibiotics), wait for an interval of at least 3 hours.
• Thiazide diuretics (medicines that increase water and sodium elimination).
• Anticonvulsants (medicines for treating convulsions).
• Systemic corticosteroids (medicines used as anti-inflammatory agents in various diseases).
• Bisphosphonates and sodium fluoride (medicines for treating osteoporosis), wait for an interval of 3 hours.
• Barbiturates (sleep-inducing medicines) or phenytoin (a medicine for treating epilepsy).

Taking Veriscal D with food, drinks, and alcohol

If you take this medicine with foods and drinks that contain oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole wheat bread and whole grain cereals), interactions may occur, so it is recommended not to take this medicine during the two hours following consumption of foods with high oxalic acid and phytic acid content.

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.

Taking medicines during pregnancy can be hazardous to the embryo and fetus.

During pregnancy and breastfeeding, the daily intake should not exceed 1,500 mg of calcium and 600 UI of vitamin D3.

In pregnant women, vitamin D overdoses should be avoided, as maintaining high blood calcium levels for a prolonged period could cause alterations in the fetus.

Driving and using machines

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

Veriscal D contains sorbitol, aspartame, lactose, sucrose, and sodium

This medicine contains 565.25 mg of sorbitol in each tablet, equivalent to 232.04 mg/g.

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 your doctor before taking this medicine.

This medicine contains 5.00 mg of aspartame in each tablet, equivalent to 2.05 mg/g.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. It may cause tooth decay.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Interactions with diagnostic tests

If you are going to undergo any diagnostic tests (blood or urine tests...), inform your doctor that you are being treated with Veriscal D, as it may alter the results.

3. How to take Veriscal 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. The recommended dose is:

Adults: 1-2 chewable tablets per day, preferably after meals.

Use in children and adolescents

Consult your doctor to individualize the dose.

To ensure proper administration of the medicine, chew the tablets well before swallowing, followed by a glass of water.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Veriscal 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 taken.

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

Deliberate or accidental overdose with chewable tablets is unlikely.

In case of overdose, you may experience thirst, increased calcium levels in the blood, increased calcium levels in the urine, anorexia, nausea, vomiting, abnormal emission of large amounts of urine, and calcium deposits in soft tissues.

If you forget to take Veriscal D

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember and take the next doses with the indicated interval (12-24 hours).

If you have any further questions about 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 following side effects have been observed:

Uncommon(may affect up to 1 in 100 people): hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).

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

Occasionally, mild digestive disorders. Veriscal D may stimulate the formation of kidney stones in patients with altered renal function.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Veriscal D

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

Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration 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 medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Veriscal 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: sorbitol (E420), maltodextrin, lactose monohydrate, magnesium stearate, sodium croscarmellose, anise essence, peppermint essence, molasses essence, aspartame (E951), sodium saccharin, sucrose, gelatin, corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol, and silicon dioxide.

Appearance of the product and package contents

Veriscal D is presented in the form of white or almost white chewable tablets, marked with a "D" on one of their faces.

Each package contains 60 chewable tablets.

Marketing authorization holder

Laboratorios Farmacéuticos VALOMED, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Date of the last revision of this leaflet:August 2024

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