BONESIL D FLAS 1500 mg/400 IU ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Bonesil D Flas 1,500 mg/400 UI Oral Dispersible Tablets

(calcium carbonate/colecalciferol)

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What Bonesil D Flas is and what it is used for
2. What you need to know before taking Bonesil D Flas
3. How to take Bonesil D Flas
4. Possible side effects
5. Storage of Bonesil D Flas
6. Package Contents and Additional Information

1. What Bonesil D Flas is and what it is used for

This medication is an association of calcium and vitamin D.

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

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 components of this medication (listed in section 6).
• if you have kidney stones.
• if you have high levels of calcium in the blood or urine.
• this medication contains soybean oil. It should not be used in case of peanut or soy allergy.

Warnings and Precautions

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

• during prolonged treatments with this medication, so your doctor can monitor your urine calcium levels and adjust the dose.
• if your kidneys do not function properly or you have a tendency to form kidney stones.
• in elderly patients, it is recommended to regularly monitor kidney function.
• if you have sarcoidosis (a disease that causes inflammation of the lymph nodes, lungs, liver, eyes, skin, and other tissues).

Other Medications and Bonesil D Flas

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

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

It is essential that you inform your doctor if you are taking or have recently taken any of the following medications:

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

Taking Bonesil D Flas with Food, Drinks, and Alcohol

If you take this medication with foods and drinks that contain oxalic acid (found in spinach and rhubarb) or phytic acid (found 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 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.

Taking 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 UI of vitamin D3.

In pregnant women, vitamin D overdoses should be avoided, as maintaining high blood calcium levels for prolonged periods could cause alterations in the fetus.

Driving and Using Machines

No effects on the ability to drive and use machines have been observed.

Bonesil D Flas contains aspartame, lactose, and sucrose

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

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains sucrose. If your doctor has told you 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 going to undergo any diagnostic tests (blood tests, urine tests, ...), inform your doctor that you are being treated with Bonesil D Flas, as it may alter the results.

3. How to take Bonesil D Flas

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication. The recommended dose is:

Adults: 1-2 oral dispersible tablets per day, preferably after meals.

Use in Children and Adolescents

Consult your doctor to individualize the dose.

To administer the medication correctly, let the tablet dissolve in your mouth, then swallow a glass of water.

If you think the effect of this medication is too strong or too weak, tell 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 Toxicology 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.

Deliberate or accidental poisoning with oral dispersible tablets is unlikely.

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

If you forget to take Bonesil D Flas

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose as soon as possible and take the next doses with the indicated interval (12-24 hours).

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed:

Uncommon(may affect up to 1 in 100 people): hypercalcemia (high calcium levels in the blood) and hypercalciuria (high calcium levels in the urine).

Rare(may affect up to 1 in 1,000 people): constipation, gas, nausea, abdominal pain, and diarrhea.

Occasional mild digestive disorders. Bonesil D Flas may stimulate the formation of kidney stones in patients with altered renal function.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bonesil D Flas

Keep this medication out of the sight and reach of children.

Do not store above 30°C. Store in the original package.

Do not use this medication after the expiration date shown on the package, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Bonesil D Flas Composition

• The active ingredients are calcium carbonate and colecalciferol (vitamin D3). Each tablet contains 1,500 mg of calcium carbonate equivalent to 600 mg of calcium and 400 UI of colecalciferol (vitamin D3) (equivalent to 0.01 mg).
• The other ingredients (excipients) are: anhydrous citric acid, maltodextrin, hydroxypropylcellulose, lactose monohydrate, stearic acid, aspartame (E951), orange flavor, gelatin, sucrose, corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol, and silicon dioxide.

Product Appearance and Package Contents

Bonesil D Flas is presented in the form of oral dispersible tablets for oral administration in packages 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

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

Italfarmaco, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Date of the last revision of this package leaflet:April 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).