Ossica

Leaflet accompanying the packaging: patient information

Ossica, 150 mg, coated tablets

Ibandronic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ossica, 150 mg, coated tablets and what is it used for
• 2. Important information before taking Ossica, 150 mg, coated tablets
• 3. How to take Ossica, 150 mg, coated tablets
• 4. Possible side effects
• 5. How to store Ossica, 150 mg, coated tablets
• 6. Contents of the packaging and other information

1. What is Ossica, 150 mg, coated tablets and what is it used for

Ossica, 150 mg, coated tablets belong to a group of medicines called bisphosphonates.
It contains the active substance ibandronic acid.
Ossica may reverse bone loss by inhibiting bone loss and increasing bone mass in most women who take this medicine, even if they do not notice or feel the difference. Ossica may help reduce the risk of bone fractures. A reduction in the number of fractures has been demonstrated in the case of vertebral fractures, but not in the case of hip fractures.

Ossica, 150 mg, coated tablets have 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 the normal structure of the bones.
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;
• lack of exercise or other intense exercise;
• 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 Ossica, 150 mg, coated tablets

When not to take Ossica, 150 mg, coated tablets:

• If the patient is hypersensitive 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 narrowing or difficulty swallowing.
• If the patient is unable to stand or sit upright for at least one hour (60 minutes).
• If the patient has or has had a decrease in calcium levels in the blood. Consult a doctor.

Warnings and precautions

A side effect called jaw bone necrosis (damage to the jaw bone) has been very rarely reported in patients treated with ibandronic acid for osteoporosis. Jaw bone necrosis may also occur after treatment has ended.
It is essential to take steps to prevent the development of jaw bone necrosis, as it can be a painful and difficult condition to treat. To reduce the risk of jaw bone necrosis, appropriate precautions should be taken.
In addition, atypical fractures of long bones, such as the forearm (ulna) and shin bone, have been reported in patients receiving long-term ibandronic acid treatment. 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 the doctor and/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 regular 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 that the patient undergo a dental examination before starting Ossica treatment.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend regular dental check-ups. If the patient wears dentures, they should ensure a proper fit. Patients undergoing dental treatment or procedures (e.g., tooth extraction) should inform their doctor and dentist that they are taking Ossica.
If the patient experiences any oral or dental problems, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, they should immediately contact their doctor and dentist, as these may be symptoms of jaw bone necrosis.
Some people need to be particularly careful when taking Ossica. Before starting Ossica treatment, they should discuss this with their doctor or pharmacist:

• If the patient has any mineral metabolism disorders (such as vitamin D deficiency).
• If the patient's kidneys do not function properly.
• If the patient has any swallowing or digestive problems.

Irritation, inflammation, or ulceration of the esophagus, often with symptoms of acute chest pain, acute pain after swallowing food or drink, acute nausea, or vomiting, may occur, especially if the patient does not drink a full glass of plain water or lies down within an hour of taking Ossica, 150 mg, coated tablets. If such symptoms develop, the patient should stop taking Ossica, 150 mg, coated tablets and immediately consult their doctor (see section 3).

Children and adolescents

Ossica, 150 mg, coated tablets should not be used in children and adolescents under 18 years of age.

Ossica, 150 mg, coated tablets and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the efficacy of Ossica.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs)(including ibuprofen, diclofenac sodium, and naproxen), which may irritate the stomach and intestines. Ossica, 150 mg, may have a similar effect. Therefore, the patient should be particularly careful when taking painkillers or anti-inflammatory drugsduring Ossica treatment.

After swallowing the monthly tablet of Ossica, the patient should wait 1 hour before taking any other medicines, including antacids, calcium supplements, or vitamins.

Ossica with food and drink:

Do not take Ossica with food.Ossica taken with food is less effective.

It is possible to drink plain water, but the patient should not drink any other beverages.

After taking Ossica, the patient should wait 1 hour before having their first meal and drinking other beverages (see section 3 "How to take Ossica, 150 mg, coated tablets").

Pregnancy and breastfeeding

Ossica, 150 mg, coated tablets should only be used in postmenopausal women and should not be taken by women of childbearing age.
Do not take Ossica, 150 mgduring pregnancy or breastfeeding.
Before taking this medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

The patient can drive and use machines, as Ossica has no or negligible influence on the ability to drive and use machines.

Ossica, 150 mg, coated tablets contain lactose and sodium

Ossica, 150 mg, coated tablets contain 294.69 mg of lactose monohydrate. If the patient has been informed by their doctor that they do not tolerate some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Ossica, 150 mg, coated tablets

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Ossica, 150 mg, 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 ensure that the Ossica tablet quickly reaches the stomach, reducing the risk of irritation.

• The Ossica, 150 mg, tablet should be taken once a month.
• Choose a specific day of the monththat is easy to remember. To take the Ossica, 150 mg, tablet, the patient 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). The patient should choose a date that best suits their habits.
• Ossica, 150 mg, should be taken at least 6 hours after eating any food or drinking any beverages, except for plain water.
• The Ossica, 150 mg, tablet should be taken:
• in the morning after getting upfrom bed and
• before eating or drinking anything("on an empty stomach").
• The tablet should be swallowed with a full glass of plain water(at least 180 ml). Do not swallow the tablet with water containing high levels of calcium, fruit juice, or any other beverage.If there is a concern about the potentially high level of calcium in tap water (hard water), it is recommended to use bottled water with low mineral content.
• Swallow the tablet whole - do not chew, crush, or allow it to dissolvein the mouth.
• For the next hour (60 minutes) after taking the tablet:
• do not lie down; if the patient does not maintain an upright position (standing or sitting), part of the medicine may flow back into the esophagus;
• do not eat anything;
• do not drink anything (except plain water, if needed);
• do not take any other medicines.
• After an hour, the patient can have their first meal and drink of the day. After eating, they can lie down and take other medicines if needed.

Continuing treatment with Ossica, 150 mg, coated tablets

It is essential to take Ossica every month, as long as the doctor recommends. After 3-5 years of Ossica treatment, the patient should consult their doctor to assess whether they should continue taking Ossica.

Taking more than the recommended dose of Ossica, 150 mg, coated tablets

If the patient accidentally takes more than one tablet, they should drink a full glass of milk and immediately contact their doctor.
Do not induce vomiting and do not lie down- this may cause irritation of the esophagus by Ossica.

Missing a dose of Ossica

• If the patient forgets to take the tablet in the morning on the planned day , they should not take the tablet later that day.In this case, the patient should check when the next planned dose is due.
• If the patient forgets to take the tablet on the planned day and the next planned dose is due in 1 to 7 days

Never take two Ossica tablets in the same week.

The patient should wait until the next planned dose and take the tablet according to the established schedule, then return to taking the tablets on the previously planned days marked in the calendar.

• If the patient forgets to take the tablet on the planned day and the next planned dose is due in more than 7 daysThe patient should take one tablet the next morning (after the day they remembered the missed dose), then return to taking the tablets on the previously planned days marked in the calendar.

4. Possible side effects

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

The patient should immediately inform their nurse or doctor if they experience any of the following serious side effects, as they may need urgent medical attention:

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, severe pain when swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. The patient may experience severe esophagitis, possibly with ulcers or narrowing of the esophagus,
• 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,
• chronic eye pain and inflammation,
• new pain, weakness, or discomfort in the thigh, hip, or groin area. The patient may experience early symptoms of a possible atypical fracture of the thigh bone.

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

• pain or ulcers in the mouth or jaw. The patient may experience early symptoms of serious jawbone problems (jawbone necrosis),
• severe, potentially life-threatening allergic reactions,
• severe skin reactions,
• ear pain, discharge from the ear, and/or ear infection. These may be symptoms of bone damage in the ear.

Other possible side effects

Common (may affect up to 1 in 10 people)

• headache,
• heartburn, difficulty swallowing, stomach or abdominal pain (which may be due to gastritis), indigestion, nausea, diarrhea (loose stools),
• muscle cramps, stiffness of the joints or limbs,
• flu-like symptoms, including fever, chills, and shivering, discomfort, bone pain, and muscle and joint pain. If any of these symptoms become troublesome or last more than a few days, the patient should talk to their nurse or doctor,
• rash.

Uncommon (may affect up to 1 in 100 people)

• dizziness,
• bloating with gas,
• back pain,
• feeling tired and weak,
• asthma attacks.

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

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ossica, 150 mg, coated tablets

The medicine should be stored out of sight and reach of children.
There are no special storage requirements.
Do not use this medicine after the expiry date stated on the blister pack and carton after the words "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ossica, 150 mg, coated tablets contain

• The active substance is ibandronic acid. Each tablet contains 168.81 mg of ibandronic acid monohydrate, which corresponds to 150 mg of ibandronic acid.
• Other ingredients:

tablet core: lactose monohydrate, povidone (K 30), microcrystalline cellulose 101, microcrystalline cellulose 12, crospovidone, magnesium stearate, colloidal anhydrous silica.
tablet coating: opadry II white 85F18422 contains polyvinyl alcohol, titanium dioxide (E171), talc, macrogol (3350).

What Ossica, 150 mg, coated tablets look like and what the pack contains

Ossica 150 mg coated tablets are white to almost white, oval, biconvex, with the symbol "M24" embossed on one side, and the other side without embossing.
The tablets are supplied in white PVC/PE/PVDC/Aluminum blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21.
Hungary
To obtain more detailed information about the medicine and its names in other EU member states, the patient should contact the representative of the marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet: June 2025