NATECAL 600 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Natecal 600 mg Chewable Tablets

Calcium Carbonate

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult your doctor if you get worse or do not improve.

Contents of the Package Leaflet

1. What is Natecal and what is it used for
2. What you need to know before taking Natecal
3. How to take Natecal
4. Possible side effects
5. Storage of Natecal
6. Contents of the pack and further information

1. What is Natecal and what is it used for

Natecal is a calcium supplement.

Natecal is indicated:

• For the prevention and treatment of calcium deficiency.
• As a supplement in the prevention and treatment of osteoporosis.

2. What you need to know before taking Natecal

Do not take Natecal

• If you are allergic to calcium 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.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medicine.

If you have kidney failure or a tendency to form kidney stones, consult your doctor before starting to take this medicine.

Other medicines and Natecal

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

Certain medicines may interact with Natecal. In these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• Cardiac glycosides (heart medicines)
• Tetracyclines (antibiotics)
• Thiazide diuretics (medicines that increase urine elimination)
• Systemic corticosteroids
• Bisphosphonate
• Sodium fluoride

Taking Natecal with food and drinks

If you take Natecal with foods 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 advised not to take this medicine during the two hours following the consumption of foods with high content of oxalic acid and phytic acid.

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.

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

Natecal can be used during pregnancy in case of calcium deficiency.

Driving and using machines

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

Natecal contains sorbitol, aspartame, lactose, and sodium

This medicine contains 566.00 mg of sorbitol in each tablet, equivalent to 232.35 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 correctly.

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

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

3. How to take Natecal

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Remember to take your medicine. The recommended dose is:

Calcium deficiency

Adults: 1-2 chewable tablets per day.

Children and adolescents

The usual recommended dose is 1 tablet per day.

Osteoporosis

Adults: 1-2 tablets per day.

Your doctor will indicate the duration of your treatment with Natecal. Do not stop treatment before, as the desired effect will not be achieved.

To carry out a correct administration of the medicine, chew or suck the tablets before swallowing, then drink a little water.

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

If you take more Natecal 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 ingested.

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

Deliberate or accidental intoxication with chewable tablets is unlikely.

In case of overdose, you may experience a sensation of thirst, nausea, vomiting, constipation, anorexia, abdominal pain, muscle weakness, fatigue, mental changes, polydipsia (excessive thirst), polyuria (increased frequency of urination), bone pain, nephrocalcinosis, kidney stones, and in severe cases, cardiac arrhythmias.

If you forget to take Natecal

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 have any other doubts 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; itching, rash, and urticaria.

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 package leaflet, inform your doctor, pharmacist, or nurse.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Natecal

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date 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 medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Natecal

• The active ingredient is calcium carbonate. Each tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium).
• The other ingredients (excipients) are: sorbitol (E420), maltodextrin, lactose monohydrate, magnesium stearate, sodium croscarmellose, anise essence, peppermint essence, molasses essence, aspartame (E951), sodium saccharin.

Appearance of the product and contents of the pack

Natecal is presented in the form of white chewable tablets. Each pack contains 20 or 60 chewable tablets.

Marketing authorization 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 package leaflet: May 2021

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