Natecal D 1.500 mg/400 IU chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Natecal D 1,500 mg/400 IU chewable tablets
(calcium carbonate/colecalciferol)
Read the entire leaflet carefully before starting to take this medicine, because 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 for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Natecal D is and what it is used for
- What you need to know before taking Natecal D
- How to take Natecal D
- Possible adverse effects
- How to store Natecal D
- Contents of the pack and other information
1. What Natecal D is and what it is used for
This medicine is a combination of calcium and vitamin D.
Natecal D is indicated for the treatment of vitamin D deficiency states in patients who require calcium supplementation, as well as for vitamin D and calcium supplementation associated with certain osteoporosis treatments.
2. What you need to know before taking Natecal D
Do not take Natecal D
- if you are allergic to calcium, vitamin D, or 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 urine.
- this medicine contains soybean oil. It should not be used if you are allergic to peanut or soy.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Natecal D
- during long-term treatment with this medicine; your doctor will monitor your calcium levels in urine and adjust your dose accordingly.
- if your kidneys do not function properly or if you are prone to developing kidney stones (calculi).
- in elderly patients, regular monitoring of kidney function is recommended.
- if you have sarcoidosis (a disease causing inflammation of lymph nodes, lungs, liver, eyes, skin, and other tissues).
Other medicines and Natecal D
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interfere with this medicine; in such cases, it may be necessary to change the dose, interrupt treatment with one of them, or wait at least a few hours between administrations.
It is important to inform your doctor if you are taking or have recently taken any of the following medicines:
- Cardiac glycosides (medicines for the heart).
- Tetracyclines (certain antibiotics); wait at least a 3-hour interval.
- Thiazide diuretics (medicines that increase the excretion of water and sodium).
- Anticonvulsants (medicines used to treat seizures).
- Systemic corticosteroids (medicines used as anti-inflammatory agents in various diseases).
- Bisphosphonates and sodium fluoride (medicines for treating osteoporosis); wait a 3-hour interval.
- Barbiturates (medicines that induce sleep) or phenytoin (a medicine used to treat epilepsy).
Taking Natecal D with food, drinks, and alcohol
If you take this medicine together with foods and drinks 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 2 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.
Taking medicines during pregnancy can be harmful to the embryo and fetus.
During pregnancy and breastfeeding, daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D3.
In pregnant women, vitamin D overdosage should be avoided, as prolonged high levels of calcium in the blood may cause fetal abnormalities.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Natecal D contains sorbitol, aspartame, lactose, sucrose, and sodium
This medicine contains 565.25 mg of sorbitol per tablet, equivalent to 232.04 mg/g.
Sorbitol is a source of fructose. If your doctor has told 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 contains 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 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 dental caries.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
Interactions with diagnostic tests
If you are scheduled for any diagnostic tests (blood, urine analyses, etc.), inform your doctor that you are being treated with Natecal D, as it may alter test results.
3. How to take Natecal D
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 properly administer the medicine, chew the tablets thoroughly before swallowing, and then drink a glass of water.
If you feel that the effect of this medicine is too strong or too weak, inform 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 at: 91 562 04 20, indicating the medicine and the amount ingested.
If you have taken more Natecal D 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, increased calcium levels in blood, increased calcium levels in urine, anorexia, nausea, vomiting, abnormal excretion 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 missed doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (12–24 hours apart).
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 produce 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.
Occasionally mild gastrointestinal disturbances. Natecal D may stimulate kidney stone formation in patients with impaired renal function.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of 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 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 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 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. Dispose of unused medicines and their containers at the SIGRE 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 D
The active substances are calcium carbonate and colecalciferol (vitamin D3).
Each tablet contains 1,500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 400 IU of colecalciferol (vitamin D3) (equivalent to 0.01 mg).
The other components (excipients) are: sorbitol (E420), maltodextrin, lactose monohydrate, magnesium stearate, sodium croscarmellose, anise flavour, mint flavour, molasses flavour, 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 as white or almost white chewable tablets, marked with a "D" on one side.
Each pack contains 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 revision of this leaflet: August 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).