Package Insert: Information for the Patient

Natecal 600 mg Chewable Tablets

Calcium Carbonate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor, pharmacist, or nurse.

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

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.

Do not take Natecal

• If you are allergic to calcium or any of the other components of this medication (listed in section 6).
• If you have kidney stones.
• If you have high levels of calcium in your blood or urine.

Warnings and precautions

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

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

Other medications and Natecal

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

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

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

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

Taking Natecal with food and beverages

If you takeNatecalwith foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (present in whole wheat bread and whole grain cereals), interactions may occur, so it is recommended not to take this medication during the two hours following the 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 medication.

Your doctor will assess the suitability of treatment for you.

Natecalmay be used during pregnancy in cases of calcium deficiency.

Driving and operating machinery:

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

Natecal contains sorbitol, aspartame, lactose, and sodium

This medication contains 566.00 mg of sorbitol in each 232.35 mg/g equivalent tablet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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 (or your child) before taking this medication.

This medication contains 5.00 mg of aspartame in each 2.05 mg/g equivalent tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains lactose. If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Remember to take your medication. 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 discontinue treatment before, as the desired effect will not be achieved.

To carry out proper medication administration, chew or crush the tablets before swallowing, followed by a small amount of water.

If you estimate that the action of this medication is too strong or 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 Toxicological Information Service, phone: 91 562.04.20, indicating the medication and the amount ingested.

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

Intentional or accidental overdose with chewable tablets is unlikely.

In case of overdose, you may experience dry mouth, nausea, vomiting, constipation, loss of appetite, abdominal pain, muscle weakness, fatigue, mental changes, excessive thirst, increased frequency of urination, bone pain, nephrocalcinosis, kidney stones, and in severe cases, cardiac arrhythmias.

If You Forget to TakeNatecal

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 have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been observed:

Rarely Occurring(may affect up to 1 in 100 people): hypercalcemia (elevated blood calcium levels) and hypercalciuria (elevated calcium levels in urine)

Uncommon(may affect up to 1 in 1,000 people): constipation, gas, nausea, abdominal pain, and diarrhea; itching, rash, and urticaria.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor, pharmacist, or nurse.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

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.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 components (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 content of the packaging

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

Holder of the marketing authorization

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas,

Madrid

Spain

Responsible for manufacturing

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan

Italy

Last review date of this leaflet: May 2021

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