Ossica

Package leaflet: Information for the patient

Ossica, 150 mg, film-coated tablets
acidum ibandronicum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ossica, 150 mg, film-coated tablets are and what they are used for
2. Important information before taking Ossica, 150 mg, film-coated tablets
3. How to take Ossica, 150 mg, film-coated tablets
4. Possible side effects
5. How to store Ossica, 150 mg, film-coated tablets
6. Contents of the pack and other information

1. What Ossica, 150 mg, film-coated tablets are and what they are used for

Ossica, 150 mg, film-coated tablets belong to a group of medicines called bisphosphonates.
It contains the active substance ibandronic acid.
Ossica can reverse bone loss by inhibiting bone loss and increasing bone mass in most women taking this medicine, even if they themselves are unable to notice or feel this difference. Ossica may help reduce the likelihood of bone fractures. Reduction in fracture incidence has been demonstrated for vertebral fractures, but not for fractures of the femoral neck.
Ossica, 150 mg, film-coated tablets have been prescribed for the treatment of
postmenopausal osteoporosis with 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 helps maintain normal bone structure.
The earlier menopause occurs in a woman, the greater her risk of fractures related to osteoporosis. 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 or other intense exercise;
• family history of osteoporosis.

A healthy lifestyle will also help you achieve the maximum benefit from treatment. This means:

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

2. Important information before using Ossica 150 mg film-coated tablets

When not to use Ossica 150 mg film-coated tablets:

• If the patient has a known allergy to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If the patient has oesophageal problems such as narrowing of the oesophagus or difficulty swallowing.
• If the patient is unable to remain upright in an upright or sitting position continuously for at least one hour (60 minutes).
• If the patient currently has or has previously had low levels of calcium in the blood. Consult a doctor.

Warnings and precautions

Osteonecrosis of the jaw (damage to the jawbone) has very rarely been reported after marketing of ibandronic acid-containing medicines in patients treated for osteoporosis. Osteonecrosis of the jaw may also occur after stopping treatment.

It is important to take preventive measures to reduce the risk of developing osteonecrosis of the jaw, as it may be a painful and difficult-to-treat condition. To reduce the risk of osteonecrosis of the jaw, appropriate precautions should be taken.

Atypical fractures of long bones, such as the forearm (ulna) and tibia, have also been reported in patients receiving long-term treatment with ibandronate. These fractures may occur following minimal trauma or even without trauma, and some patients may experience pain at the fracture site before a complete fracture occurs.

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

• if she has any oral or dental conditions, such as poor dental hygiene, gum disease, or planned tooth extraction,
• if she does not receive routine dental care or has not had a dental check-up for a long time,
• if she smokes (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 cancer diagnosis.

The doctor may recommend that the patient undergo a dental examination before starting treatment with Ossica.

During treatment, proper oral hygiene (including regular tooth brushing) should be maintained, and routine dental check-ups should be attended. If the patient wears dentures, they should be properly fitted. Patients undergoing dental treatment or prior to dental procedures (e.g. tooth extraction) should inform their doctor and dentist that they are taking Ossica.

If the patient experiences any oral or dental symptoms such as loose teeth, pain or swelling, non-healing ulcers or presence of discharge, she should contact her doctor and dentist immediately, as these may be signs of osteonecrosis of the jaw.

Special caution is required when using Ossica in certain patients. Before starting treatment with Ossica, discuss the following with the doctor or pharmacist:

• If the patient has any disorders of mineral metabolism (e.g. vitamin D deficiency).
• If the patient’s kidneys are not functioning properly.
• If the patient has any problems with swallowing or digestion.

Irritation, inflammation or ulceration of the oesophagus, often with symptoms of acute chest pain, severe pain after swallowing food or drink, acute nausea or vomiting, may occur, especially if the patient did not drink a full glass of plain water and/or lies down within one hour after taking Ossica 150 mg film-coated tablets. If such symptoms develop, stop taking Ossica 150 mg film-coated tablets immediately and contact a doctor without delay (see section 3).

Children and adolescents

Ossica 150 mg film-coated tablets must not be used in children and adolescents under 18 years of age.

Ossica 150 mg film-coated tablets and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use. In particular:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may affect the effectiveness of Ossica.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen), which may irritate the stomach and intestines. Ossica 150 mg may have a similar effect. Therefore, particular caution is advised when taking analgesic or anti-inflammatory medicines during treatment with Ossica 150 mg.

After swallowing the monthly Ossica tablet, do not take any other medicines for 1 hour, including antacids, calcium supplements or vitamins.

Ossica with food and drink:

Do not take Ossica with food. Taking Ossica with food reduces its effectiveness.

Plain water may be consumed, but no other drinks should be consumed.

After taking Ossica, wait 1 hour before eating the first meal or drinking other beverages (see section 3 “How to use Ossica 150 mg film-coated tablets”).

Pregnancy and breastfeeding

Ossica 150 mg film-coated tablets should only be used in postmenopausal women and must not be used by women of reproductive age.

Do not take Ossica 150 mg during pregnancy or breastfeeding.

Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Driving and operating machinery are permitted, as Ossica has no or negligible influence on the ability to drive and operate machinery.

Ossica 150 mg film-coated tablets contain lactose and sodium

Ossica 150 mg film-coated tablets contain 294.69 mg of monohydrated lactose. If the patient has been advised by a doctor that she has an intolerance to certain sugars, she should consult the doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered “sodium-free”.

3. How to use Ossica 150 mg, coated tablets

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.

The recommended dose of Ossica 150 mg is one tablet once a month.

Taking the tablet once a month
It is important to carefully follow the instructions below. These recommendations are designed to ensure that the Ossica tablet reaches the stomach quickly, thereby reducing the likelihood of irritation.

• Ossica 150 mg tablet should be taken once a month.
• Choose a specific day of the month that will be easy to remember. For taking the Ossica 150 mg tablet, you may select the same date (e.g., the first day of each month) or the same day of the week (e.g., the first Sunday of each month). Choose the schedule that best fits your routine.
• Ossica 150 mg should be taken at least 6 hours after consuming any food or drink, except plain water.
• The Ossica 150 mg tablet should be taken:
• in the morning upon first rising from 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 take the tablet with water containing high levels of calcium, fruit juice, or any other beverage. If there is concern about potentially high calcium levels 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 dissolve in the mouth.
• For the next hour (60 minutes) after taking the tablet:
• do not lie down – if you do not remain upright (standing or sitting), some of the medicine may flow back into the oesophagus;
• do not eat anything;
• do not drink anything (except plain water, if needed);
• do not take any other medicines.
• After one hour has passed, you may take your first meal and drink of the day. After eating, you may lie down and take other medicines, if necessary.

Continuation of treatment with Ossica 150 mg, coated tablets
It is important to take Ossica every month for as long as your doctor recommends. After 3 to 5 years of treatment with Ossica, you should consult your doctor to determine whether you should continue taking Ossica.

Taking more than the recommended dose of Ossica 150 mg, coated tablets
If you accidentally take more than one tablet, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting and do not lie down – this may cause irritation of the oesophagus by Ossica.

Missed dose of Ossica

• If you forget to take the tablet in the morning on the planned day, do not take the tablet later on the same day. In this case, check when the next scheduled dose is due.
• If you forget to take the tablet on the planned day and the next scheduled dose is due in only 1 to 7 days, never take two Ossica tablets within the same week. Wait until the next scheduled dose day and take the tablet according to your regular schedule, then resume taking tablets on the previously planned dates marked on your calendar.
• If you forget to take the tablet on the planned day and the next scheduled dose is due more than 7 days later, take one tablet in the morning on the following day (the day after you remember the missed dose), then resume taking tablets on the previously planned dates marked on your calendar.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your nurse or doctor if any of the following serious adverse reactions occur,
as immediate medical intervention may be required:

Not very common (may affect up to 1 in 100 patients)

• severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. The patient may develop severe esophagitis, possibly with esophageal ulcers or strictures,
• symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and (or) tingling sensations in the fingers or around the mouth.

Rare (may affect up to 1 in 1000 patients)

• itching, swelling of the face, lips, tongue, and throat with breathing difficulties,
• chronic eye pain and inflammation,
• new pain, weakness, or discomfort in the groin, hip, or thigh area. The patient may experience early signs of a potential atypical femoral fracture.

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

• pain or ulceration in the mouth or jaw. The patient may show early signs of serious jaw bone problems (osteonecrosis of the jaw (dead bone tissue)),
• severe, potentially life-threatening allergic reaction,
• serious skin-related adverse reactions,
• ear pain, ear discharge, and (or) ear infection. These may be symptoms of bone tissue damage in the ear.

Other possible adverse reactions
Common (may affect up to 1 in 10 patients)

• headache,
• heartburn, difficulty swallowing, stomach or abdominal pain (may occur due to gastritis), indigestion, nausea, diarrhea (loose stools),
• muscle cramps, joint or limb stiffness,
• flu-like symptoms, including fever, chills and shivering, general discomfort, bone pain, and muscle and joint aches. If any of these symptoms become bothersome or last longer than a few days, consult your nurse or doctor,
• rash.

Not very common (may affect up to 1 in 100 patients)

• dizziness,
• bloating with gas release,
• back pain,
• feeling of fatigue and exhaustion,
• asthma attacks.

Rare (may affect up to 1 in 1000 patients)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. 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.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ossica 150 mg, coated tablets

Keep this medicine out of sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the blister and carton following the word "EXP:". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Ossica 150 mg film-coated tablets contain

• The active substance is ibandronic acid. Each tablet contains 168.81 mg of ibandronic acid monosodium monohydrate, equivalent 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, containing polyvinyl alcohol, titanium dioxide (E171), talc, macrogol (3350).

What Ossica 150 mg film-coated tablets look like and contents of the pack

Ossica 150 mg film-coated tablets are white to almost white, oval, biconvex, with the imprint “M24” on one side, the other side being blank.
The tablets are supplied in white PVC/PE/PVDC/aluminum blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21.
Hungary

For further information about this medicinal product and its names in other European Economic Area countries, please contact the representative of the Marketing Authorisation 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]