Osteogenon

Package Leaflet: Information for the Patient

Osteogenon, 830 mg, Coated Tablets

Ossein and hydroxyapatite complex

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Osteogenon and what is it used for
• 2. Important information before taking Osteogenon
• 3. How to take Osteogenon
• 4. Possible side effects
• 5. How to store Osteogenon
• 6. Contents of the pack and other information

1. What is Osteogenon and what is it used for

The active substance of Osteogenon is an ossein and hydroxyapatite complex.
Osteogenon belongs to the group of medicines in the category "gastrointestinal tract and metabolism".
The medicine is used in osteoporosis of various origins (in the elderly, after menopause,
after steroid use) and in the regulation of calcium-phosphorus balance during pregnancy
and breastfeeding, as well as auxiliary after bone fractures.

2. Important information before taking Osteogenon

When not to take Osteogenon

if you are allergic to the active substances or any of the other ingredients of this
medicine (listed in section 6),
if you have hypercalcemia, hypercalciuria, kidney stones of calcium origin or soft tissue calcification,
if you have severe kidney failure,
if you are on dialysis.
in children under 6 years of age.

Warnings and precautions

Before taking Osteogenon, discuss it with your doctor or pharmacist.
Consult your doctor if:

• you are taking vitamin D at the same time; your doctor will regularly check your blood and urine calcium levels;
• you are taking the medicine for a long time and (or) you have kidney function disorders, as prolonged high calcium levels in the blood (hypercalcemia) can cause calcium deposits in soft tissues (such as kidneys) and irreversible kidney failure (kidney dysfunction);
• you are taking high doses of calcium and products or foods containing alkaline substances (such as antacids) at the same time, as there is a risk of developing the so-called milk-alkali syndrome (with excessive calcium levels in the blood, increased blood pH, and kidney function disorders);
• you are over 65 years old and taking thiazide diuretics (medicines used to treat high blood pressure) or cardiac glycosides (medicines used to treat heart rhythm disorders).

Your doctor will regularly check your blood and urine calcium and phosphorus levels. If
these levels are elevated, your doctor will adjust the dose of Osteogenon.
If you have had kidney stones in the past, you should follow preventive dietary recommendations,
follow the dosing of Osteogenon, adjust the amount of calcium taken with food, and avoid vitamin D supplementation. In case of doubts, consult your doctor.

Children and adolescents

Do not use the medicine in children under 6 years of age.

Osteogenon and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently,
as well as any medicines you plan to take:

• thiazide diuretics (used to treat high blood pressure) - as they may increase calcium levels in the blood;
• cardiac glycosides (medicines used to treat heart rhythm disorders) - as they may contribute to the occurrence of toxic side effects;
• certain antibiotics (tetracyclines), iron and zinc-containing medicines, bisphosphonates (medicines used to treat bone weakness), quinolones, and strontium (a medicine used to treat severe osteoporosis), thyroid hormones (medicines used to treat thyroid disorders), or estramustine (a medicine used to treat certain cancers), as Osteogenon may reduce the absorption of these medicines. It is necessary to maintain a 2-hour interval between taking these medicines and Osteogenon.
• glucocorticoids (medicines with anti-allergic and anti-inflammatory effects) - as they may reduce calcium absorption;
• integrase inhibitors (dolutegravir, bictegravir, elvitegravir - medicines used to treat HIV infection), as Osteogenon may reduce their absorption from the gastrointestinal tract. Calcium can be taken with integrase inhibitors if taken with a meal. If the integrase inhibitor is taken on an empty stomach, it should be administered 2 hours before or 6 hours after calcium administration;
• fluoride (used to prevent tooth decay) - as a precaution, maintain a 2-hour interval between Osteogenon and fluoride administration.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child,
consult your doctor or pharmacist before taking this medicine.
Osteogenon can be used during pregnancy if clinically necessary.
Osteogenon can be used during breastfeeding.

Driving and using machines

No data are available on the effects of Osteogenon on the ability to drive and use machines.

3. How to take Osteogenon

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

Osteoporosis: 2 to 4 tablets 2 times a day
Other indications: 1 or 2 tablets per day

Method of administration

Swallow the tablets with a small amount of water, preferably during meals.
The medicine is intended for adults.

Taking a higher dose of Osteogenon than recommended

Taking too much Osteogenon may cause the following symptoms: excessive thirst,
increased urine production, nausea, vomiting, dehydration, high blood pressure,
circulatory disorders, constipation, loss of appetite, abnormal or irregular heart rhythm,
weakness, increased calcium levels in the kidneys, and kidney stones, bone pain, or mental disorders.
Severe hypercalcemia (excessive calcium levels in the blood) can lead to coma and death. If
you suspect an overdose of calcium, contact your doctor or pharmacist immediately.
Furthermore, prolonged high calcium levels in the blood may cause calcium deposits in soft tissues (such as kidneys) and irreversible kidney failure (kidney dysfunction).
Consult your doctor or pharmacist.

Missing a dose of Osteogenon

Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Osteogenon can cause side effects, although not everybody gets them.
The following side effects have an unknown frequency (frequency cannot be estimated from the available data):

• increased calcium levels in the blood and (or) urine (hypercalcemia and hypercalciuria) in case of long-term treatment and (or) high doses of the medicine;
• abdominal pain, constipation, nausea, vomiting;
• skin itching (pruritus), rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Osteogenon

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25 ° C.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Osteogenon contains

• The active substance is an ossein and hydroxyapatite complex (830 mg), including 444 mg of hydroxyapatite, which corresponds to 178 mg or 4.44 mmol of calcium in one coated tablet.
• The other ingredients are: core: potato starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica; coating: hypromellose, talc, macrogol 6000, yellow iron oxide (E 172), titanium dioxide (E 171).

What Osteogenon looks like and contents of the pack

The coated tablets are uniformly light yellow, elongated, and biconvex.
Osteogenon is available in packs containing 40 coated tablets.

Marketing authorization holder

Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw

Manufacturer

Pierre Fabre Medicament Production site Progipharm
Rue du Lycée
45500 Gien
France
To obtain more detailed information, contact the local representative of the marketing authorization holder
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel.: 22 559 63 00

Date of last revision of the leaflet: