Natecal D Flas 1.500 mg/400 IU orodispersible tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the patient
Natecal D Flas 1.500 mg/400 IU orodispersible tablets
(calcium carbonate/colecalciferol)
Read the entire leaflet carefully before you start taking 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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Natecal D Flas is and what it is used for
- What you need to know before taking Natecal D Flas
- How to take Natecal D Flas
- Possible side effects
- How to store Natecal D Flas
- Contents of the pack and other information
1. What Natecal D Flas is and what it is used for
This medicine is a combination of calcium and vitamin D.
Natecal D Flas 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 Flas
Do not take Natecal D Flas
- 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.
- if you have high levels of calcium in your blood or urine.
- this medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Natecal D Flas:
- during long-term treatment with this medicine, your doctor will monitor calcium levels in your urine and adjust your dose accordingly.
- if you have poor kidney function or are prone to developing kidney stones.
- 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 Flas
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 adjust the dose, interrupt treatment with one of the medicines, or wait at least several 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 excretion of water and sodium).
- Anticonvulsants (medicines used to treat seizures).
- Systemic corticosteroids (medicines used as anti-inflammatory agents in various conditions).
- Bisphosphonates and sodium fluoride (medicines used to treat osteoporosis); wait a 3-hour interval.
- Barbiturates (medicines that induce sleep) or phenytoin (a medicine used to treat epilepsy).
Taking Natecal D Flas with food, drinks, and alcohol
If you take this medicine together with foods or 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 advised 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.
Taking medicines during pregnancy can be harmful to the embryo or fetus.
During pregnancy and breastfeeding, daily intake should not exceed 1500 mg of calcium and 600 IU of vitamin D3.
Vitamin D overdosage should be avoided in pregnant women, as prolonged high calcium levels 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 Flas contains aspartame, lactose, and sucrose
This medicine contains 8.672 mg of aspartame per tablet, equivalent to 4.124 mg/g.
Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine. It may cause dental caries.
Interactions with diagnostic tests
If you are scheduled for any diagnostic tests (blood or urine tests, etc.), inform your doctor that you are taking Natecal D Flas, as it may alter test results.
3. How to take Natecal D Flas
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 orodispersible tablets per day, preferably after meals.
Use in children and adolescents
Consult your doctor to individualize the dose.
To properly administer the medicine, allow the tablet to dissolve in the mouth, then swallow a glass 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 D Flas than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you have taken more Natecal D Flas than you should, contact your doctor or pharmacist immediately.
Deliberate or accidental intoxication with orodispersible preparations is unlikely.
In case of overdose, you may experience thirst, increased blood calcium levels, increased urinary calcium levels, anorexia, nausea, vomiting, abnormal excretion of large amounts of urine, and calcium deposits in soft tissues.
If you forget to take Natecal D Flas
Do not take a double dose to make up for missed doses. Simply take the missed dose when you remember, and take the following doses with the recommended interval between doses (12–24 hours).
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 can 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, gas, nausea, abdominal pain, and diarrhea.
Occasionally mild gastrointestinal disturbances. Natecal D Flas may promote 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 effects 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 Flas
Keep this medicine out of sight and reach of children.
Do not store above 30°C. Store in the original container.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the package and other information
Composition of Natecal D Flas
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: anhydrous citric acid, maltodextrin, hydroxypropylcellulose, lactose monohydrate, stearic acid, aspartame (E951), orange flavour, gelatin, sucrose, corn starch, partially hydrogenated soybean oil, all-rac-β-α-tocopherol and silicon dioxide.
Appearance of the product and contents of the pack
Natecal D Flas is presented as buccodispersible tablets for oral administration in packs of 60 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 package leaflet: May 2021.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).