OSTEOPOR 830 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

OSTEOPOR 830 mg film-coated tablets

Oseine-hydroxyapatite complex

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 or pharmacist.
• This medication has been prescribed to you only, and you should 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 or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Osteopor and what is it used for
2. What you need to know before taking Osteopor
3. How to take Osteopor
4. Possible side effects
5. Storage of Osteopor
6. Package contents and additional information

1. What is Osteopor and what is it used for

Osteopor contains the active ingredient oseine-hydroxyapatite complex.

It belongs to the group of medications called treatments for the alimentary tract and metabolism.

Osteopor is indicated for the prevention and as a complementary aid to the main treatment of processes that involve decalcification: prevention of bone mass loss, adjuvant treatment of osteoporosis, prevention and treatment of calcium deficiency.

2. What you need to know before taking Osteopor

Do not take Osteopor:

• if you are allergic to oseine-hydroxyapatite complex or any of the other components of this medication (listed in section 6),
• if you have excessive levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria),
• if you need an artificial system to remove substances that the kidneys cannot filter (hemodialysis),
• if you have severe kidney disorders (severe renal insufficiency),
• if you currently have kidney stones (nephrolithiasis) containing calcium in the kidneys,
• if you are under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Osteopor.

Consult your doctor if:

• you are taking vitamin D concomitantly, your doctor will periodically check your blood and urine calcium levels,
• you are undergoing prolonged treatment and/or have renal insufficiency, as long-term elevated calcium levels in the blood (hypercalcemia) can induce calcium deposits in soft tissues (such as the kidneys) and irreversible renal insufficiency.
• you are taking concomitantly preparations/foods that contain alkaline compounds (such as absorbable anti-acid medications (e.g., sodium bicarbonate) and high doses of calcium), as there is a risk of excessive calcium levels in the blood (hypercalcemia) or a risk of milk-alkali syndrome (i.e., excessive calcium levels in the blood (hypercalcemia), increased blood pH (alkalosis), and renal disorder (renal insufficiency)).
• you are over 65 years old and taking thiazide diuretics (medications used to treat hypertension) or cardiac glycosides (medications used to treat heart rhythm disorders).

Your doctor will periodically check your blood and urine phosphorus and calcium levels.

In case of increased phosphorus/calcium levels in blood or urine, you should consult your doctor, who will adjust the dose as necessary.

In cases with a history of kidney stone formation, it is necessary to follow usual dietary prevention measures, respect the dose of this medication, adapt calcium intake according to diet, and avoid vitamin D supplements.

Children and adolescents

Do not administer to children under 6 years old.

Other medications and Osteopor

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication:

• thiazide diuretics (medication used to treat hypertension), as they may increase calcium levels in the blood.
• cardiac glycosides (medications used to treat heart rhythm disorders), as they may increase side effects.
• certain antibiotics (cyclines), medications containing iron and zinc, bisphosphonates (medications used to treat bone weakness), quinolones, and strontium (medication used to treat severe osteoporosis), thyroid hormones (medications used to treat thyroid disorders), or estramustine (medication used to treat certain types of cancer), as Osteopor may decrease their absorption. An interval of at least 2 hours is required between their respective administrations.
• glucocorticoids (anti-allergic and anti-inflammatory medications), as they may reduce calcium absorption.
• integrase inhibitors (dolutegravir, bictegravir, elvitegravir, medications used to treat HIV), as Osteopor may decrease their digestive absorption. Calcium and integrase inhibitors can be administered together if taken with a meal. On an empty stomach, the integrase inhibitor should be administered 2 hours before or 6 hours after calcium salts.
• fluoride (medication used to prevent tooth decay). As a precautionary measure, an interval of at least 2 hours can be observed between fluoride intake and oseine hydroxyapatite compound.

Taking Osteopor with food and drinks

Calcium absorption may be inhibited by foods containing oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains). You should wait at least two hours before taking Osteopor if you have consumed foods with high levels of oxalic acid or phytic acid.

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.

Osteopor can be used during pregnancy when clinically indicated.

Osteopor can be used during breastfeeding.

Driving and using machines

No data are available on the impact of oseine-hydroxyapatite complex on the ability to drive or use machines.

3. How to take Osteopor

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

Adults and elderly

2 to 4 film-coated tablets per day, divided into two daily doses, taken with a little liquid. In cases of advanced osteoporosis, the dosage may be increased, always according to medical criteria.

Children and adolescents under 18 years

A recommended dose cannot be established for children and adolescents.

If you take more Osteopor than you should

An overdose of Osteopor could cause the following symptoms: increased thirst, increased urination, nausea, vomiting, dehydration, increased blood pressure, alterations in blood flow, constipation, loss of appetite, abnormal or irregular heartbeats, weakness, increased calcium levels in the kidneys, kidney stones, bone pain, or mental disorders.

Severe hypercalcemia (excessive calcium levels in the blood) can cause coma and death.

If you suspect you have taken an overdose, contact your doctor or pharmacist immediately.

In addition, prolonged excessive calcium levels in the blood can cause calcium deposits in soft tissues (such as the kidneys) and irreversible renal insufficiency.

If you suspect you have taken more Osteopor than you should, stop treatment and contact your doctor or pharmacist immediately or call the Toxicology Information Service. Phone (91) 562 04 20.

If you forget to take Osteopor

Do not take a double dose to make up for forgotten doses.

If you stop taking Osteopor

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects are of unknown frequency (cannot be estimated from available data):

• Prolonged treatment and/or high doses of the product may increase calcium levels in the blood and/or urine (hypercalcemia and hypercalciuria).
• Abdominal pain, constipation, nausea, vomiting.
• Itching (pruritus), skin rash.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 contribute to providing more information on the safety of this medication.

5. Storage of Osteopor

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the box. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Osteopor composition

The active ingredient is:

oseine-hydroxyapatite complex (COH) ………… 830 mg*

• i.e., 444 mg of hydroxyapatite equivalent to 178 mg or 4.44 mmol of calcium

The other ingredients are:

Core:microcrystalline cellulose (E460), potato starch, colloidal anhydrous silica (E551), magnesium stearate (470b).

Coating:hypromellose (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of the product and package contents

Osteopor film-coated tablets are pale yellow, regular in color, oblong, and biconvex.

Package with 40 film-coated tablets.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Manufacturer

PIERRE FABRE MÉDICAMENT PRODUCTION

Site PROGIPHARM

Rue du Lycee

45500 Gien

France

Date of the last revision of this package leaflet: February 2025.

"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"