OSAGRAND 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Osagrand, 150 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Osagrand and what is it used for
   1. Osagrand has been prescribed to treat postmenopausal osteoporosis
4. Important information before taking Osagrand
   1. When not to take Osagrand
   2. Warnings and precautions
   3. Children and adolescents
   4. Osagrand and other medicines
   5. Osagrand with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Osagrand contains lactose.
5. How to take Osagrand
   1. The usual dose of Osagrand is one tablet once a month.
   2. Taking the tablet once a month
   3. Continuing Osagrand treatment
   4. Taking more Osagrand than recommended
   5. Missing a dose of Osagrand
6. Possible side effects
   1. Immediately inform your nurse or doctor if you experience any of the following serious side effects, as you may need urgent medical attention:
   2. Other possible side effects
   3. Reporting side effects
7. How to store Osagrand
8. Contents of the pack and other information
   1. What Osagrand contains
   2. What Osagrand looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information about Osagrand, contact the representative of the marketing authorization holder in Poland:

Package Leaflet: Information for the Patient

Osagrand, 150 mg, coated tablets

Ibandronic acid

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

• Keep the package leaflet, so you can read it again if needed.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Osagrand and what is it 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 do not notice or feel the difference.
Osagrand may help reduce the risk of bone fractures.
The reduction in the number of fractures has been demonstrated for vertebral fractures, but not for hip fractures.

Osagrand has been prescribed to treat postmenopausal osteoporosis

due to an increased risk of fractures.Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones, which often occurs in women after menopause. During menopause, the female ovaries stop producing the female hormone estrogen, which helps maintain normal bone structure.
The earlier menopause occurs in a woman, the higher her risk of fractures related to osteoporosis. Other factors that may increase the risk of fractures include:

• insufficient calcium and vitamin D in the diet;
• smoking or excessive alcohol consumption;
• insufficient physical activity (walking) or other intense exercise;
• a family history of osteoporosis.

A healthy lifestylewill also help achieve the greatest benefits from treatment. This means:

• following a balanced diet rich in calcium and vitamin D,
• walking or other intense exercise,
• not smoking and limiting excessive alcohol consumption.

2. Important information before taking Osagrand

When not to take Osagrand

• If the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If the patient has problems with the esophagus, such as esophageal narrowing or difficulty swallowing.
• If the patient cannot stand or sit upright for at least one hour (60 minutes).
• If the patient currently has or has had low calcium levels in the blood.In this case, consult a doctor.

Warnings and precautions

A side effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bone) has been very rarely reported after the marketing of Osagrand in patients treated with this medicine for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after treatment has ended.
It is essential to take steps to prevent the development of osteonecrosis of the jaw and (or) mandible, as it can be a painful and difficult condition to treat. To reduce the risk of osteonecrosis of the jaw and (or) mandible, appropriate precautions should be taken.
In patients receiving long-term ibandronate treatment, unusual fractures of long bones, such as the forearm (ulna) and shinbone, have also been reported. These fractures occur with minimal trauma or without trauma, and some patients experience pain at the fracture site before the fracture occurs.
Before starting treatment, the patient should inform their doctor or nurse (healthcare professional):

• if they have any oral or dental problems, such as poor dental condition, gum disease, or planned tooth extraction;
• if they do not receive routine dental care or have not had dental check-ups for a long time;
• if they smoke (which may increase the risk of dental problems);
• if they have been previously treated with bisphosphonates (used to treat or prevent bone diseases);
• if they are taking corticosteroids (e.g., prednisolone or dexamethasone);
• if they have been diagnosed with cancer.

The doctor may recommend a dental examination before starting Osagrand treatment.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If dental prostheses are used, ensure they fit properly. During dental treatment or before dental procedures (e.g., tooth extraction), inform the doctor and dentist that Osagrand is being taken.
If any oral or dental problems occur, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, contact the doctor and dentist immediately, as these may be symptoms of osteonecrosis of the jaw and (or) mandible.
Some patients should be cautious when taking Osagrand.
Before starting Osagrand treatment, discuss the following with your doctor:

• If there are any mineral metabolism disorders (such as vitamin D deficiency).
• If the kidneys are not functioning properly.
• If there are any problems with swallowing or digestion.

After taking Osagrand, irritation, inflammation, or esophageal ulcers may occur, often with symptoms of severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, especially if the patient does not drink a full glass of plain water and (or) lies down within an hour of taking Osagrand. If such symptoms occur, stop taking Osagrand and consult a doctor immediately (see section 3).

Children and adolescents

Do not give Osagrand to children and adolescents under 18 years of age.

Osagrand and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the action of Osagrand.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)(including ibuprofen, diclofenac sodium, and naproxen) may irritate the stomach and intestines. Osagrand may have a similar effect. Therefore, be cautious when taking painkillers or anti-inflammatory drugswhile taking Osagrand.

After swallowing the Osagrand tablet, which is taken once a month, wait 1 hourbefore taking any other medicines, including antacids, calcium supplements, or vitamins.

Osagrand with food, drink, and alcohol

Do not take Osagrand with food.Osagrand taken with food is less effective.
You can drink water, but do not drink any other beverages.After taking Osagrand, wait 1 hour before eating or drinking other beverages (see section 3 "How to take Osagrand").

Pregnancy, breastfeeding, and fertility

Osagrand is intended for postmenopausal women and should not be taken by women of childbearing age.
Do not take Osagrand if you are pregnant or breastfeeding.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines, as Osagrand is not expected to affect your ability to drive or use machines.

Osagrand contains lactose.

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking Osagrand.

3. How to take Osagrand

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

The usual dose of Osagrand is one tablet once a month.

Taking the tablet once a month

It is essential to carefully follow the instructions below. These instructions have been developed to help the Osagrand tablet reach the stomach quickly, reducing the risk of irritation.

• Take one Osagrand 150 mg tablet once a month.
• Choose a specific day of the monththat is easy to remember. You can choose the same date (e.g., the first day of each month) or the same day (e.g., the first Sunday of each month). Choose a time that best suits your habits.
• Take the Osagrand tablet at least 6 hours after eating or drinking anything, except water.
• Take the Osagrand tablet:
• in the morning after getting upand
• before eating or drinking anything("on an empty stomach").
• Swallow the tablet with a full glass of water(at least 180 ml). Do notswallow the tablet with water containing high levels of calcium, fruit juice, or any other beverage. If you are concerned that the tap water contains high levels of calcium (hard water), use bottled water with low mineral content.
• Swallow the tablet whole- do not chew, crush, or let it dissolve in your mouth.
• For the next hour (60 minutes)after taking the tablet:
• do not lie down; if you do not maintain an upright position (standing or sitting), part of the medicine may flow back into the esophagus,
• do not eat,
• do not drink(except water, if needed),
• do not take any other medicines.
• After 1 hour, you can take your first meal and drink of the day. After eating, you can lie down and take other medicines if needed.

Continuing Osagrand treatment

It is essential to take Osagrand every month, as long as your doctor recommends.
Consult your doctor about the need to continue Osagrand treatment after 5 years of taking the medicine.

Taking more Osagrand than recommended

If you accidentally take more than one tablet, drink a full glass of milkand immediately contact your doctor.
Do not induce vomiting and do not lie down- this may cause Osagrand to irritate the esophagus.

Missing a dose of Osagrand

• If you forget to take a tablet in the morning on the scheduled day, do not take the tablet later that day. Check when the next scheduled dose is due:
• If the next scheduled dose is due in 1 to 7 days…

Never take two Osagrand tablets in the same week.Wait until the next scheduled dose and take the tablet according to the established schedule, then return to taking the tablets on the previously planned days marked in your calendar.

• If you forget to take a tablet on the scheduled day and the next scheduled dose is due in more than 7 days…Take one tablet the next morning (after the day you remembered the missed dose), and then return to taking the tablets on the previously planned days marked in your calendar.

4. Possible side effects

Like all medicines, Osagrand can cause side effects, although not everybody gets them.

Immediately inform your nurse or doctor if you experience any of the following serious side effects, as you may need urgent medical attention:

Uncommon(may affect up to 1 in 100 people):

• severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, difficulty swallowing. Severe esophageal inflammation, as well as esophageal ulcers or narrowing, may occur.
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and (or) tingling in the fingers or around the mouth.

Rare(may affect up to 1 in 1,000 people):

• itching, swelling of the face, lips, tongue, and throat, with difficulty breathing.
• persistent eye pain and inflammation.
• new pain, weakness, or discomfort in the thigh, hip, or groin area. These may be early signs of atypical fractures of the thigh bone.

Very rare(may affect up to 1 in 10,000 people):

• mouth or jaw pain or ulcers. These may be early signs of severe jaw problems (necrosis [dead bone tissue] in the jaw).
• If you experience ear pain, discharge from the ear, and (or) ear infection, inform your doctor. These may be symptoms of bone damage in the ear.
• severe, potentially life-threatening allergic reactions.
• severe skin reactions.

Other possible side effects

Common(may affect up to 1 in 10 people):

• headache
• heartburn, uncomfortable swallowing, stomach pain (may be caused by stomach inflammation) or abdominal pain, indigestion, nausea, diarrhea (loose stools).
• muscle cramps, joint stiffness and pain.
• flu-like symptoms, including fever, chills, and shivering, discomfort, fatigue, bone pain, and muscle and joint pain. Talk to your nurse or doctor if any of these symptoms become troublesome or last more than a few days.
• rash.

Uncommon(may affect up to 1 in 100 people):

• dizziness.
• bloating (gas, feeling bloated).
• back pain.
• feeling tired and weak.
• asthma attacks.

Rare(may affect up to 1 in 1,000 people):

• duodenitis (inflammation of the duodenum, the first part of the small intestine) causing abdominal pain.
• hives.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Osagrand

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicinal product.
Do not use this medicine after the expiry date stated on the carton after "EXP". 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 Osagrand contains

• The active substance of Osagrand is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other ingredients are:
• in the tablet core:Ludipress (lactose, povidone K-30, crospovidone type A), magnesium stearate;
• in the tablet coating:Opadry II 85F18422 White (macrogol 3350, titanium dioxide [E 171], talc, and polyvinyl alcohol).

What Osagrand looks like and contents of the pack

Osagrand is a white, elongated, biconvex, film-coated tablet, approximately 14.1 x 7.0 mm in size.
Pack sizes: 1, 3, or 6 film-coated tablets in blisters (OPA/Aluminum/PVC/Aluminum) in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Dolní Měcholupy, Czech Republic
This medicine is authorized in the Member States of the European Economic Area under the following names:
Slovakia, Romania : Osagrand 150 mg
Czech Republic, Poland : Osagrand

For more information about Osagrand, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the package leaflet:August 2024