Leaflet: information for the user

OSTEOPOR 830 mg film-coated tablets

Osteocalcin-hydroxyapatite complex

Read this leaflet carefully before you start taking the medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Osteopor and what is it used for

2. What you need to know before starting to take Osteopor

3. How to take Osteopor

4. Possible side effects

5. Storage of Osteopor

6. Contents of the pack and additional information

Osteopor contains organic elements of bone material (ossein) and mineral bone elements (microcrystalline hydroxyapatite) that contain calcium and phosphorus in natural proportion.

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

Do not take Osteopor:

- if you are allergic to the calcium complex-hydroxyapatite or to any of the other components of this medication (listed in section 6),

- if you have excessive levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria),

- if you need a system to artificially remove substances that your kidneys cannot filter (hemodialysis),

- if you have severe kidney disorders (severe renal insufficiency),

- if you currently have kidney stones (containing calcium) in your kidneys (acute calcium nephrolithiasis),

- if you are under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Osteopor.

Consult your doctor if:

- if you are taking vitamin D concomitantly, your doctor will monitor your calcium levels in blood and urine periodically,

- if you are undergoing prolonged treatment and/or have renal insufficiency, your doctor will monitor your phosphate and calcium levels periodically.

In the case of an increase in 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 essential to follow usual dietary prevention measures, limit 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.

Taking Osteopor with other medications

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

Combinations that require special precautions:

• If you are taking the following medications: levothyroxine (for thyroid diseases); bisphosphonates (for the treatment of some bone diseases); quinolones except moxifloxacin, tetracyclines, fosfomycin (different antibiotics); phenytoin (mainly used for treating seizures), medications containing zinc, strontium, estramustine, or iron supplements, it is recommended to space the administration of Osteopor at least 2 hours.

• If you are taking thiazide diuretics or calcium antagonists (for hypertension); cardiac glycosides (heart medications); glucocorticoids (anti-inflammatory and immunosuppressive agents) or aminoglycosides (antibiotics), you should follow your doctor's instructions carefully.

Taking Osteopor with food and beverages

The absorption of calcium can 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.

This medication may be used during pregnancy and breastfeeding.

Driving and operating machinery

Not applicable.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationin case of doubt, consult your doctor or pharmacist again.

Adults and the elderly

Take2 to4 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 at the discretion of a healthcare professional.

Children and adolescents under 18 years

No recommended dose can be established for children and adolescents.

If you take more Osteopor than you should

A Osteopor overdose could cause the following symptoms: increased thirst, excessive urination, nausea, vomiting, dehydration, increased blood pressure, alterations in blood flow, constipation, loss of appetite, changes in normal heart rhythm, weakness, increased levels of calcium in the kidneys, kidney stones, bone pain, or mental changes.

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

If you forgot to take Osteopor

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Osteopor

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Rare(may occur in fewer than 1 in 100 patients):

Excessive calcium levels in the blood (hypercalcemia) or excessive calcium excretion in the urine

(hypercalciuria).

Uncommon (may occur in fewer than 1 in 1,000 patients):

Abdominal pain, constipation, nausea,itching on the skin (pruritus), redness and/or burning sensation on the skin(urticaria), skin rash (exanthema).

You should stop taking Osteopor and consult your doctor immediately if you experience severe allergic reaction symptoms, such as:

• Swelling of the face, lips, tongue, or throat.
• Difficulty swallowing.
• Urticaria and difficulty breathing.

Reporting Adverse Effects:

If you experienceany type of adverse effect, consult your doctor or pharmacist even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directly tothrough 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 on the safety of this medication.

Keepthis medicationout of the reach of children.

No special storage conditions are required.

Do not usethis medicationafter the expiration date shown onthe box. Theexpiration date is the last day of the month indicated.

Dispose of unused medications and packaging through the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Osteopor Composition

- The active principle is thecalcium hydroxyapatite complex (COH) 830 mg, composed of:

75 mg of non-collagenous peptides and proteins?

?Correspondingapprox. to 291 mg ofosteocalcin

216 mg of collagen?

178 mg of calcium?

?Corresponding approx. to 444 mg of hydroxyapatite

82 mg of phosphorus?

• The other components are microcrystalline cellulose, potato starch, colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E-171), macrogol 6000, talc, yellow iron oxide (E-172).

Appearance of the product and content of the container

The Osteopor coated tablets are pale yellow, oblong, and biconvex.

Container with 40 coated tablets.

Marketing Authorization Holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Responsible for manufacturing

PIERRE FABRE MÉDICAMENT PRODUCTION

Rue du Lycee,

Zone Industrielle de Cuiry

Gien F-45500

France

Last review date of this leaflet: September 2018.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es”