Bonesil D Flas 1500 mg/400 IU buccodispersible tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bonesil D Flas 1.500 mg/400 IU orodispersible 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, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, since it may 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 Bonesil D Flas is and what it is used for
- What you need to know before taking Bonesil D Flas
- How to take Bonesil D Flas
- Possible adverse effects
- How to store Bonesil D Flas
- Contents of the pack and other information
1. What Bonesil D Flas is and what it is used for
This medicine is a combination of calcium and vitamin D.
Bonesil D Flas is indicated for the treatment of vitamin D deficiency states in patients requiring calcium supplementation, as well as for vitamin D and calcium supplementation associated with certain osteoporosis treatments.
2. What you need to know before taking Bonesil D Flas
Do not take Bonesil 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
Talk to your doctor, pharmacist, or nurse before taking Bonesil D Flas:
- during prolonged treatment with this medicine, your doctor will monitor your calcium levels in 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 Bonesil 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 a few hours between administrations.
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 (certain antibiotics); wait an interval of at least 3 hours.
- Thiazide diuretics (medicines that increase the elimination 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 used to treat osteoporosis); wait an interval of 3 hours.
- Barbiturates (medicines that induce sleep) or phenytoin (a medicine used to treat epilepsy).
Taking Bonesil 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 whole-grain 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, 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 may 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.
Vitamin D overdose should be avoided in pregnant women, as maintaining high levels of calcium in the blood over a prolonged period may cause abnormalities in the fetus.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Bonesil 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 patients 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 informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains sucrose. If your doctor has informed you that you have 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 tests, urine tests, etc.), inform your doctor that you are being treated with Bonesil D Flas, as it may alter test results.
3. How to take Bonesil D Flas
Follow exactly the administration instructions for this medicine as indicated 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 the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Bonesil D Flas than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
If you have taken more Bonesil 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 calcium levels in blood, increased calcium levels in urine, anorexia, nausea, vomiting, abnormally increased urine output, and calcium deposits in soft tissues.
If you forget to take Bonesil D Flas
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as possible, and take the following doses at the recommended intervals (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 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.
Occasionally, mild gastrointestinal disturbances. Bonesil D Flas 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 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 may also report them directly via 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 Bonesil D Flas
Keep this medicine out of the 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, following “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 in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bonesil 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-α-tocopherol and silicon dioxide.
Appearance of the product and contents of the pack
Bonesil D Flas is presented as orally disintegrating tablets in packs of 60 tablets.
Marketing Authorization Holder
ITF Medilab Farma, S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain
Manufacturer
ITALFARMACO S.p.A.
Viale Fulvio Testi, 330
20126 Milan
Italy
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder
Italfarmaco, S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: April 2021.
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).