Natecal 600 mg chewable tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Natecal 600 mg chewable tablets
Calcium carbonate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
- You should consult your doctor if you get worse or do not improve.
Contents of the leaflet
- What Natecal is and what it is used for
- What you need to know before taking Natecal
- How to take Natecal
- Possible adverse effects
- How to store Natecal
- Contents of the pack and other information
1. What Natecal is and what it is 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 to any of the other ingredients of this medicine (listed in section 6).
- If you have kidney stones (calculi).
- If you have high levels of calcium in your blood or in your urine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take this medicine.
If you have renal insufficiency or a tendency to form kidney stones (calculi), consult your doctor before starting to take this medicine.
Other medicines and Natecal
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Natecal. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:
- Cardiac glycosides (medicines for the heart)
- Tetracyclines (antibiotics)
- Thiazide diuretics (medicines that increase urine elimination)
- Systemic corticosteroids
- Bisphosphonates
- Sodium fluoride
Taking Natecal with food and drinks
If you take Natecal together with foods containing oxalic acid (found in spinach and rhubarb) or phytic acid (found in wholemeal bread and whole grains), interactions may occur. Therefore, it is recommended not to take this medicine within two hours after consuming foods high in oxalic acid or phytic acid.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Your doctor will assess whether treatment is appropriate for you.
Natecal may be used during pregnancy in cases of calcium deficiency.
Driving and using machines:
No effects on the ability to drive or use machines have been observed.
Natecal contains sorbitol, aspartame, lactose, and sodium
This medicine contains 566.00 mg of sorbitol per tablet, equivalent to 232.35 mg/g.
Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.
This medicine contains 5.00 mg of aspartame per tablet, equivalent to 2.05 mg/g.
Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take Natecal
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult 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 determine the duration of your treatment with Natecal. Do not stop the treatment earlier, as the desired effect will not be achieved.
To properly administer the medicine, chew or suck the tablets before swallowing, then drink a small amount of water.
If you think that the effect 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 at: 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 preparations is unlikely.
In case of overdose, you may experience thirst, nausea, vomiting, constipation, anorexia, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia (excessive thirst), polyuria (increased frequency of urination), bone pain, nephrocalcinosis, kidney stones (renal calculi), and in severe cases, cardiac arrhythmias.
If you forget to take Natecal
Do not take a double dose to make up for 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed:
Uncommon (may affect up to 1 in 100 people): hypercalcemia (high levels of calcium in blood) and hypercalciuria (high levels of calcium in urine)
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain and diarrhoea; itching, rash and urticaria.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 any 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. Return any unused medicines and empty containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Natecal
- The active substance 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, monohydrate lactose, magnesium stearate, sodium croscarmellose, anise flavour, mint flavour, molasses flavour, aspartame (E951), sodium saccharin.
Appearance of the product and contents of the pack
Natecal is presented as 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 most recent review of this leaflet: May 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.