Package Insert: Information for the Patient

Bonesil D Flas 1.500 mg/400 IU Chewable Tablets

(Calcium Carbonate/Vitamin D3)

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• 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.

This medication is a combination of calcium and vitamin D.

Bonesil D Flas is indicated for the treatment of vitamin D deficiency states in patients who require calcium supplementation, as well as a vitamin D and calcium supplement associated with certain osteoporosis treatments.

Do not take Bonesil D Flas

• if you are allergic to calcium, vitamin D, 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.
• this medication contains soy oil. Do not use in case of allergy to peanuts or soy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Bonesil D Flas:

• during prolonged treatment with this medication, your doctor will monitor your urine calcium levels and adjust the dose.
• if your kidneys do not function well or you are prone to forming kidney stones.
• in elderly patients, it is recommended to regularly monitor kidney function.
• if you have sarcoidosis (a disease in which the lymph nodes, lungs, liver, eyes, skin, and other tissues become inflamed).

Other medications and Bonesil D Flas

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

Certain medications may interact with this medication; in these cases, it may be necessary to change the dose, discontinue treatment with one of them, or wait at least a few hours between administration of both.

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 (certain antibiotics), wait at least 3 hours.
• Thiazide diuretics (medications that increase the elimination of water and sodium).
• Anticonvulsants (medications to treat seizures).
• Systemic corticosteroids (medications used as anti-inflammatory agents in various diseases).
• Bisphosphonates and sodium fluoride (medications to treat osteoporosis), wait at least 3 hours.
• Barbiturates (medications that induce sleep) or phenytoin (medication to treat epilepsy).

Taking Bonesil D Flas with food, drinks, and alcohol

If you take this medication with foods and drinks 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.

The consumption of medications during pregnancy can be hazardous to the embryo and fetus.

During pregnancy and breastfeeding, the daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D3.

In pregnant women, excessive doses of vitamin D should be avoided, as prolonged maintenance of high blood calcium levels could produce alterations in the fetus.

Driving and operating machinery

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

Bonesil D Flas contains aspartame, lactose, and saccharose

This medication contains 8.672 mg of aspartame in each 4.124 mg/g equivalent tablet.

Aspartame contains a source of phenylalanine that may be detrimental 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 have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

Interactions with diagnostic tests

If you are to undergo any diagnostic test (blood, urine, etc.), inform your doctor that you are being treated with Bonesil D Flas, as it may alter the results.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication. The recommended dose is:

Adults: 1-2 buccal tablets per day, preferably after meals

Use in children and adolescents

Consult your doctor to individualize the dose.

To properly administer the medication, allow the tablet to dissolve in the mouth, then drink a glass of water.

If you estimate that the action of this medication 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, 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 Bonesil D Flas than you should, consult your doctor or pharmacist immediately.

Intentional or accidental overdose with buccal tablets is unlikely.

In case of overdose, you may experience a sensation of thirst, increased levels of calcium in the blood, increased levels of calcium in urine, anorexia, nausea, vomiting, abnormal emission of large amounts of urine, and calcium deposits in soft tissues.

If you forgot to take Bonesil D Flas

Do not take a double dose to compensate for the missed dose, simply take the missed dose as soon as possible and take the next doses with the indicated interval (12 – 24 hours).

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:

Rare(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.

Mild digestive changes may occasionally occur. Bonesil D Flas may stimulate the formation of kidney stones in patients with altered renal function.

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 or pharmacist.

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.

Do not store at a temperature above 86°F (30°C). Store in the original packaging.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bonesil D Flas

• The active principles are calcium carbonate and colecalciferol (vitamin D 3 ). Each tablet contains 1,500 mg of calcium carbonate equivalent to 600 mg of calcium and 400 UI of colecalciferol (vitamin D 3 ) (equivalent to 0.01 mg).
• The other components (excipients) are: anhydrous citric acid, maltodextrin, hydroxypropylcellulose, lactose monohydrate, stearic acid, aspartame (E951), orange aroma, gelatin, sucrose, cornstarch, partially hydrogenated soybean oil, all-rac-α-tocopherol, and silicon dioxide.

Appearance of the product and content of the packaging

Bonesil D Flas is presented in the form of buccodispersable tablets for oral administration in containers of 60 tablets.

Holder of the marketing authorization

ITF Medilab Farma, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Last review date of this prospectus: April 2021 .

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