Osagrand

Package leaflet: Information for the patient

Osagrand, 3 mg, solution for injection
Acidum ibandronicum
Please read this leaflet carefully before using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Osagrand is and what it is used for

Osagrand belongs to a group of medicines called bisphosphonates. It contains the active substance – ibandronic acid.
Osagrand can reverse bone loss by inhibiting bone loss and increasing bone mass in most women taking this medicine, even if they are unable to notice or feel this improvement themselves.
Osagrand may help reduce the likelihood of bone fractures. A reduction in fracture rates has been demonstrated for vertebral fractures, but not for hip fractures.
Osagrand, 3 mg, solution for injection in an ampoule is a solution intended for intravenous injection administered by a doctor or nurse. Do not self-administer Osagrand injections.
Osagrand has been prescribed for the treatment of postmenopausal osteoporosis due to an increased risk of fractures. Osteoporosis is a disease characterized by reduced bone density and weakened bones, which commonly occurs in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which plays a key role in maintaining normal bone structure. The earlier menopause occurs in a woman, the higher her risk of osteoporosis-related fractures. Other factors that may increase the risk of fractures include:

• inadequate dietary intake of calcium and vitamin D;
• smoking or excessive alcohol consumption;
• lack of physical activity (e.g. walking) or other weight-bearing exercises;
• a family history of osteoporosis.

A healthy lifestyle will also help maximize the benefits of treatment. This means:

• maintaining a balanced diet rich in calcium and vitamin D;
• regular walking or other weight-bearing exercises;
• not smoking and limiting excessive alcohol consumption.

2. Important information before using Osagrand

When not to use Osagrand

• If the patient currently has or has previously had low blood calcium levels. In such cases, consult a doctor.
• If the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
A rare adverse effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bones) has been reported very rarely following post-marketing use of Osagrand in patients treated with this medicine for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after discontinuation of treatment.
It is important to take preventive measures against developing osteonecrosis of the jaw and (or) mandible, as it may be a painful and difficult-to-treat condition. To reduce the risk of osteonecrosis of the jaw and (or) mandible, appropriate precautions should be taken.
In patients receiving long-term ibandronate therapy, atypical fractures of long bones, such as the forearm (ulna) and tibia, have also been reported.
These fractures occur following minimal trauma or even without trauma, and some patients experience pain at the fracture site prior to a complete fracture occurring.

Before starting treatment, the patient should inform the doctor or nurse (healthcare professional):

• If she has any oral or dental conditions, such as poor dental health, gum disease, or planned tooth extraction;
• If she does not receive routine dental care or has not had regular dental check-ups for a long time;
• If she smokes tobacco (this may increase the risk of dental problems);
• If she has previously been treated with a bisphosphonate (used in the treatment or prevention of bone diseases);
• If she is taking corticosteroids (e.g. prednisolone or dexamethasone);
• If she has a diagnosis of cancer.

The doctor may recommend a dental examination before starting treatment with Osagrand.
During treatment, proper oral hygiene (including regular tooth brushing) should be maintained, and routine dental check-ups should be attended. If dental prostheses are used, their proper fit should be ensured. During dental treatment or before any dental procedures (e.g. tooth extractions), the patient should inform her treating physician and dentist that she is taking Osagrand.
If any symptoms in the mouth or teeth occur, such as loose teeth, pain or swelling, non-healing ulcers, or presence of discharge, the patient should immediately contact her treating physician and dentist, as these may be signs of osteonecrosis of the jaw and (or) mandible.

Special caution should be taken in certain patients during treatment with Osagrand. Before starting Osagrand, the patient should inform the doctor:

• If she currently has or has ever had kidney diseases, kidney failure, required dialysis, or if she has any other conditions that may affect the kidneys.
• If she has any disturbances in mineral metabolism (such as vitamin D deficiency).
• During treatment with Osagrand, calcium and vitamin D supplements should be taken. If this is not possible, the doctor should be informed.
• If she has heart conditions and the doctor has advised limiting fluid intake.

In patients treated with intravenous ibandronic acid, cases of severe, sometimes fatal, allergic reactions have been observed. If the patient experiences any of the following symptoms, such as shortness of breath or difficulty breathing, throat tightness, tongue swelling, dizziness, feeling faint, facial redness or swelling, skin rash, nausea, or vomiting, medical help should be sought immediately (see section 4).

Children and adolescents
Do not use Osagrand in children and adolescents under 18 years of age.

Osagrand and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.

Pregnancy, breastfeeding and fertility
Osagrand is intended for postmenopausal women and must not be used in women of reproductive age.
Do not use Osagrand if the patient is pregnant or breastfeeding. Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Patients may drive and operate machinery, as Osagrand is considered to have no or negligible effect on the ability to drive and operate machinery.

Osagrand contains less than 1 mmol of sodium (23 mg) per dose (3 ml) and is therefore considered a "sodium-free" medicine.

3. How to use Osagrand

The recommended dose of Osagrand for intravenous injections is 3 mg (1 vial) every 3 months.
The intravenous injection should be administered by a doctor or by qualified/trained medical personnel.
Do not administer the injections yourself.
The solution for injection must be given exclusively intravenously and must not be used in any other way.

Continuation of Osagrand treatment
To achieve the maximum benefit from treatment, it is important that the patient receives injections every 3 months, for as long as the doctor recommends. The therapeutic effect of Osagrand in osteoporosis occurs only while the treatment is ongoing, even though the patient may not notice or feel this difference. The need for continuing treatment with Osagrand should be reviewed with the doctor after 3–5 years of treatment.

Calcium and vitamin D supplements should also be taken as recommended by the doctor.

Use of a higher than recommended dose of Osagrand
This may lead to decreased levels of calcium, phosphorus, or magnesium in the blood. The doctor may take actions to correct these changes and may administer an injection containing these mineral substances.

Missed dose of Osagrand
Schedule an appointment to receive the next injection as soon as possible. Then resume receiving injections every 3 months from the date of the last injection received.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should immediately inform a nurse or doctor if any of the following serious adverse reactions occur,
as immediate medical help may be required:
Uncommon (may occur in fewer than 1 in 100 people):

• symptoms of low blood calcium levels (hypocalcaemia), including muscle cramps or spasms and (or) tingling in the fingers or around the mouth.

Rare (may occur in fewer than 1 in 1,000 people):

• itching, swelling of the face, lips, tongue and throat, with difficulty breathing.
• persistent pain and inflammation of the eyes (if long-lasting).
• new pain, weakness or discomfort in the groin, hip or thigh area. These may be early signs indicating a possible risk of atypical femoral fractures.

Very rare (may occur in fewer than 1 in 10,000 people):

• pain or ulceration in the mouth or jaw. These may be early signs of severe jaw problems (osteonecrosis [dead bone tissue] of the jaw).
• If the patient experiences ear pain, ear discharge and (or) ear infection, inform the doctor. These may be symptoms of damage to the bone tissue in the ear.
• serious, potentially life-threatening allergic reactions (see section 2).
• severe skin reactions.

Other possible adverse reactions
Common (may occur in fewer than 1 in 10 people):

• headache.
• stomach pain (which may be due to inflammation of the stomach) or abdominal pain, indigestion, nausea, diarrhoea (loose stools) or constipation.
• muscle, joint or back pain.
• feeling tired and exhausted.
• flu-like symptoms, including fever, chills and shivering, feeling unwell, fatigue, bone pain, and muscle and joint aches. Talk to a nurse or doctor if any of these symptoms become troublesome or last longer than a few days.
• rash.

Uncommon (may occur in fewer than 1 in 100 people):

• inflammation of a vein.
• pain or soreness at the injection site.
• bone pain.
• feeling weak.
• asthma attacks.

Rare (may occur in fewer than 1 in 1,000 people):

• urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw.
Tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Osagrand

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and ampoule
after: "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
The person administering the injection should dispose of any unused portions of the solution and discard
the used ampoule in an appropriate container for such waste.

6. Contents of the package and other information

What Osagrand, 3 mg, solution for injection in ampoule contains

• The active substance is ibandronic acid. One ampoule contains 3 mg of ibandronic acid in 3 ml of solution (as 3.375 mg of monohydrate sodium ibandronate).
• The other ingredients are: sodium chloride, glacial acetic acid, trihydrate sodium acetate, water for injections.

What Osagrand, 3 mg, solution for injection in ampoule looks like and contents of the pack
Osagrand, 3 mg, solution for injection is a clear, particle-free solution in an ampoule made of colorless glass (Type I). The pH value of the solution is between 3.465 and 4.235, and osmolality ranges from 270 to 310 mosmol/kg.
Each ampoule contains 3 ml of solution.
Pack sizes: 1 or 4 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, 102 37 Prague 10 Dolní Měcholupy, Czech Republic

Manufacturer:
Zentiva k.s., U kabelovny 130, 102 37 Prague 10 Dolní Měcholupy, Czech Republic
S.C. Zentiva, S.A, B-dul Theodor Pallady no. 50, sector 3, 032266 Bucureşti, Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Poland: Osagrand
Romania, Lithuania, Latvia: Osagrand 3 mg

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

INFORMATION INTENDED EXCLUSIVELY FOR MEDICAL PROFESSIONALS

For detailed information, please refer to the Summary of Product Characteristics.
Administration method of Osagrand 3 mg solution for injection in ampoule:
Osagrand 3 mg solution for injection in ampoule should be administered as an intravenous injection over 15–30 seconds.
The solution is irritant; therefore, it must be administered intravenously only. In case of accidental extravasation into surrounding tissues, local irritation, pain, and inflammation at the injection site may occur in the patient.
Osagrand 3 mg solution for injection in ampoule must not be mixed with calcium-containing solutions (e.g., Ringer's lactate solution, calcium salt of heparin) or with other medicinal products administered intravenously. When Osagrand is administered via an existing intravenous infusion line, only 0.9% sodium chloride solution or 50 mg/ml (5%) glucose solution may be used as preceding infusion fluids.
Missed dose:
If a dose is missed, the injection should be administered as soon as possible. Subsequent injections should be scheduled every 3 months from the date of the last injection.
Overdose:
There is no detailed information available on the treatment of ibandronic acid overdose. Based on knowledge of compounds in this class, intravenous overdose may be expected to cause hypocalcemia, hypophosphatemia, and hypomagnesemia, which may lead to paresthesia. In severe cases, administration of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate via intravenous infusion may be necessary.
General information:
Osagrand 3 mg solution for injection in ampoule, like other intravenously administered bisphosphonates, may cause transient reduction in serum calcium concentration.
Before initiating treatment with Osagrand, hypocalcemia and other disorders of bone and mineral metabolism should be assessed and effectively treated. All patients should receive adequate intake of calcium and vitamin D. All patients must be supplemented with calcium and vitamin D.
Patients with concomitant diseases or those taking other medicinal products that may adversely affect renal function should undergo regular monitoring during treatment, in accordance with best medical practice.
Any unused portions of the solution for injection, as well as used ampoules, must be disposed of in accordance with local regulations.