Ibandronic acid synthon

Package leaflet: Information for the user

Ibandronic acid Synthon, 50 mg film-coated tablets
Acidum ibandronicum
Read this entire leaflet carefully before using this medicine,
because it contains important information for the patient.

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

Table of contents:

1. What Ibandronic acid Synthon 50 mg is and what it is used for
2. What you need to know before taking Ibandronic acid Synthon 50 mg
3. How to take Ibandronic acid Synthon 50 mg
4. Possible side effects
5. How to store Ibandronic acid Synthon 50 mg
6. Contents of the pack and other information

1 What Ibandronic acid Synthon 50 mg is and what it is used for
Ibandronic acid Synthon 50 mg contains the active substance ibandronic acid. Ibandronic acid Synthon belongs to a group of medicines called bisphosphonates.
Ibandronic acid Synthon 50 mg is used in adults who have breast cancer that has spread to the bones (so-called bone metastases).

• It helps prevent bone fractures.
• It helps prevent bone complications requiring surgical or radiation treatment.

The action of Ibandronic acid Synthon 50 mg involves inhibiting increased calcium loss from bones. This helps prevent weakening of the bones.
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2 What you need to know before taking Ibandronic acid Synthon 50 mg
When not to take Ibandronic acid Synthon 50 mg:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have disorders of the oesophagus (the tube connecting the mouth to the stomach), such as narrowing or difficulty swallowing
• if you are unable to remain upright (sitting or standing) continuously for at least one hour (60 minutes)
• if you have low blood calcium levels currently or have ever had them.

Do not take this medicine if any of the above conditions apply. If you are unsure, consult your doctor or pharmacist before taking Ibandronic acid Synthon 50 mg.

Warnings and precautions
A rare adverse effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bone) has been very rarely reported in patients treated with Ibandronic acid Synthon for tumour-related conditions after its market introduction.
Osteonecrosis of the jaw or mandible may also occur after treatment has ended.
It is important to take preventive measures against developing osteonecrosis of the jaw 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.
Before starting treatment, the patient should inform the doctor/nurse (healthcare professional):

• if they have any oral or dental conditions, such as poor dental health, gum disease, or planned tooth extraction
• if they do not receive routine dental care or have not had a dental check-up for a long time
• if they smoke (this may increase the risk of dental problems)
• if they have previously been treated with a bisphosphonate (used in the treatment or prevention of bone diseases)
• if they are taking medicines called corticosteroids (e.g. prednisolone or dexamethasone)
• if they have a diagnosis of cancer.

Your doctor may recommend a dental examination before starting treatment with Ibandronic acid Synthon.
During treatment, maintain proper oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If you wear dentures, ensure they are properly fitted. Patients undergoing dental treatment or those scheduled for dental procedures (e.g. tooth extraction) should inform their treating doctor and dentist that they are taking Ibandronic acid Synthon.
If you experience any symptoms in the mouth or teeth, such as loose teeth, pain or swelling, non-healing sores or discharge, contact your treating doctor and dentist immediately, as these may be signs of osteonecrosis of the jaw and (or) mandible.
In patients receiving long-term ibandronate treatment, atypical fractures of long bones such as the forearm (ulna) and tibia have also been reported. These fractures occur after minimal trauma or without trauma, and some patients experience pain at the fracture site before a complete fracture occurs.
Before starting Ibandronic acid Synthon, discuss the following with your doctor or pharmacist:

• if you are allergic to other bisphosphonates
• if you have any swallowing or digestive disorders
• if you have high or low vitamin D levels or any other mineral metabolism disorder
• if you have kidney disease

Irritation, inflammation or ulceration of the oesophagus may occur, often manifesting as severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, especially if the patient did not drink a full glass of water and (or) lies down within one hour after taking Ibandronic acid Synthon. If these symptoms occur, stop taking Ibandronic acid Synthon and contact your doctor immediately (see sections 3 and 4).

Children and adolescents
Ibandronic acid Synthon must not be used in children and adolescents under 18 years of age.

Ibandronic acid Synthon and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Ibandronic acid Synthon may affect the action of other medicines. Likewise, other medicines may alter the effect of Ibandronic acid Synthon.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• calcium, magnesium, iron or aluminium supplements

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• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, ibuprofen or naproxen. NSAIDs and Ibandronic acid Synthon may cause irritation of the stomach and intestines
• aminoglycoside antibiotics administered by injection, e.g. gentamicin. Concurrent use of aminoglycosides and Ibandronic acid Synthon 50 mg may lead to decreased serum calcium levels.

Taking medicines that reduce gastric acidity, such as cimetidine and ranitidine, may slightly enhance the effect of Ibandronic acid Synthon 50 mg.

Ibandronic acid Synthon with food and drink
Do not take Ibandronic acid Synthon with food or any other drink except water, as Ibandronic acid Synthon is less effective when taken with food or drinks (see section 3).
Ibandronic acid Synthon should be taken at least 6 hours after the last meal, drink, other medicine or supplement (e.g. a product containing calcium (milk), aluminium, magnesium or iron), except water. After taking the tablet, wait at least 30 minutes before consuming the first meal or drink, or taking other medicines or supplements (see section 3).

Pregnancy and breastfeeding
Do not use Ibandronic acid Synthon 50 mg in pregnant women, women planning to become pregnant, or women who are breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines
You may drive and operate machinery, as Ibandronic acid Synthon has no effect or negligible effect on the ability to drive and operate mechanical devices. Inform your doctor if you intend to drive, operate machinery or equipment in motion.

Ibandronic acid Synthon contains lactose and sodium
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3 How to take Ibandronic acid Synthon 50 mg
Always take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Ibandronic acid Synthon should be taken at least 6 hours after the last meal, drink, other medicine or supplement, except water. Water with high calcium content should not be used. If you suspect that tap water has high calcium content (so-called hard water), use water with low mineral content.
Your doctor may recommend regular blood tests during treatment with Ibandronic acid Synthon 50 mg. These tests are performed to ensure the dose being taken is appropriate.

How to take this medicine
It is important to take Ibandronic acid Synthon 50 mg at the correct time and in the correct manner due to the risk of irritation, inflammation or ulceration of the oesophagus.
To reduce this risk, follow these instructions:

• Take the tablet immediately after getting up in the morning, before taking your first meal, drink, or other medicine or dietary supplement of the day.
• Take the tablet with a full glass of water only (approximately 200 ml). Do not take the tablet with any drink other than water.
• Swallow the tablet whole. Do not chew, suck, crush, or allow the tablet to dissolve in the mouth.
• After taking the tablet, wait at least 30 minutes before taking your first meal, drink, or other medicine or dietary supplement.
• When taking the tablet, remain in an upright position (sitting or standing) and stay upright for at least one hour (60 minutes) after taking the tablet. Otherwise, some of the medicine may reflux back into the oesophagus.

How much medicine to take
Usually, one tablet of Ibandronic acid Synthon 50 mg is taken daily. In cases of moderate renal impairment, your doctor may reduce the dose to one tablet every other day. In cases of severe kidney disease, your doctor may reduce the dose to one tablet per week.

Taking more Ibandronic acid Synthon 50 mg than prescribed
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
Before leaving, drink a full glass of milk. Do not induce vomiting. Do not lie down.

Missed dose of Ibandronic acid Synthon 50 mg
Do not take a double dose to make up for a missed dose.
If you take one tablet daily, simply skip the missed dose and take the next dose as usual the following day. If you take the medicine every other day or once a week, consult your doctor or pharmacist.
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Stopping Ibandronic acid Synthon 50 mg
Continue taking Ibandronic acid Synthon 50 mg for as long as your doctor recommends. The medicine is effective only when taken regularly.

Continuing Ibandronic acid Synthon 50 mg
It is important to continue taking Ibandronic acid Synthon 50 mg monthly as long as your doctor recommends. After 3–5 years of treatment with Ibandronic acid Synthon 50 mg, consult your doctor about whether to continue taking Ibandronic acid Synthon 50 mg.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.

Immediately inform your nurse or doctor if you experience any of the following serious adverse events, as immediate medical attention may be required:

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

• nausea, heartburn and discomfort when swallowing (inflammation of the oesophagus/food passage)

Uncommon (may affect less than 1 in 100 people):

• severe abdominal pain. This may be a sign of ulceration in the initial part of the intestine (duodenum) with bleeding or inflammation of the stomach

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

• chronic pain and inflammation of the eyes
• new pain, weakness or discomfort in the hip, thigh or groin area. These may be early signs indicating possible atypical fractures of the femur

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

• pain or sores in the mouth, jaw or mandible. These may be early signs of serious conditions in the jaw or mandible (necrosis (dead bone tissue) in the jaw or mandible bone)
• If you experience ear pain, ear discharge and (or) ear infection, inform your doctor. These may be signs of bone tissue damage in the ear.
• itching, swelling of the face, lips, tongue and throat, with difficulty breathing. This may indicate a severe, potentially life-threatening allergic reaction
• severe skin reactions

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Frequency not known (frequency cannot be estimated from available data):

• asthma attack

Other possible side effects

Common (may affect 1 in 10 people):

• abdominal pain, indigestion
• low blood calcium levels
• fatigue

Uncommon (may affect less than 1 in 100 people):

• chest pain
• skin itching or tingling sensation (paresthesia)
• flu-like symptoms, malaise and pain
• dry mouth, taste disturbances or difficulty swallowing
• anaemia (low red blood cell count)
• high blood urea levels and high parathyroid hormone activity in the blood.

Reporting of side effects
If you experience any adverse effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5 How to store Ibandronic acid Synthon 50 mg
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the specified month.
No special storage instructions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
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6 Contents of the pack and other information

What Ibandronic acid Synthon 50 mg contains

• The active substance is 50 mg of ibandronic acid in the form of 56.25 mg of monohydrate sodium ibandronate.
• Other ingredients are monohydrate lactose, crospovidone (E1202), microcrystalline cellulose (E460), anhydrous colloidal silicon dioxide (E551), sodium stearyl fumarate; polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).

What Ibandronic acid Synthon 50 mg looks like and contents of the pack
Ibandronic acid Synthon tablets are white or almost white, oblong tablets with the imprint “I9BE” on one side and “50” on the other side.
Tablets in blisters of 1, 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 60, 84, 90, 100, 126, 168 and 210 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Synthon BV, Microweg 22, 6545 CM, Nijmegen, The Netherlands
Manufacturers:
Synthon BV, Microweg 22, 6545 CM, Nijmegen, The Netherlands
Synthon Hispania S.L., castello 1, Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia Ibandronic acid Synthon 50 mg
Hungary Ibandronsav Synthon 50 mg
Latvia Ibandronic acid Synthon 50 mg apvalkotās tabletes
Netherlands Ibandroninezuur Synthon 50 mg, filmohulde tabletten
Poland Ibandronic acid Synthon
Slovenia Ibandronska kislina Synthon 50 mg filmsko obložene tablete

Date of latest revision of the leaflet: 25/06/2025
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