NATECAL D 1500 mg/400 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Natecal D1,500 mg/400 UI Chewable Tablets

(Calcium Carbonate/Cholecalciferol)

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. Storage of Natecal D
2. Contents of the Pack and Further Information

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

This medicinal product is an association of calcium and vitamin D.

Natecal 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 of osteoporosis.

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

Do not take Natecal D

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before taking Natecal D

• during prolonged treatments with this medicinal product; 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 in which the lymph nodes, lungs, liver, eyes, skin, and other tissues become inflamed).

Other Medicines and Natecal D

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

Certain medicines may interfere with this medicinal product; 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 of both.

It is important 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 the elimination of water and sodium).
• Anticonvulsants (medicines used to treat convulsions).
• Systemic Corticosteroids (medicines used as anti-inflammatory in various diseases).
• Bisphosphonates and Sodium Fluoride (medicines used to treat osteoporosis), wait for an interval of 3 hours.
• Barbiturates (medicines that induce sleep) or Phenytoin (medicine used to treat epilepsy).

Taking Natecal D with Food, Drinks, and Alcohol

If you take this medicinal product together with food and drinks containing oxalic acid (present in spinach and rhubarb) or phytic acid (present in wholemeal bread and whole grain cereals), interactions may occur, so it is advised not to take this medicinal product during the two hours following the intake of foods with high content of oxalic acid and phytic acid.

Pregnancy, Breast-feeding, and Fertility

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

Taking medicines during pregnancy can be dangerous for the embryo and fetus.

During pregnancy and breast-feeding, 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.

Natecal D contains Sorbitol, Aspartame, Lactose, Sucrose, and Sodium

This medicinal product 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 some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicinal product.

This medicinal product 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 disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

This medicinal product contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicinal product. It may cause tooth decay.

This medicinal product 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 have any diagnostic tests (blood tests, urine tests...), inform your doctor that you are being treated with Natecal D, as it may alter the results.

3. How to Take Natecal D

Follow exactly the administration instructions of this medicinal product given 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 medicinal product, chew the tablets well before swallowing, then drink a glass of water.

If you think the action of this medicinal product is too strong or too weak, tell your doctor or pharmacist.

If you Take More Natecal 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 medicinal product and the amount ingested.

If you have taken more Natecal 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 a sensation of 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 Natecal 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 between administrations (12-24 hours).

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

4. Possible Side Effects

Like all medicines, this medicinal product 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.

Occasional mild gastrointestinal disturbances. Natecal D may stimulate the formation of kidney stones in patients with altered renal function.

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Natecal D

Keep this medicinal product out of the sight and reach of children.

Store in the original packaging to protect from moisture.

Do not use this medicinal product after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Natecal D

The active substances are calcium carbonate and cholecalciferol (vitamin D3).

Each tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 400 UI of cholecalciferol (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 Contents of the Pack

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

Each pack contains 60 chewable tablets.

Marketing Authorisation Holder

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan

Italy

Date of the Last Revision of this Leaflet:August 2024

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