Ibandronic acid Sinthon

Package Leaflet: Information for the User

Ibandronic Acid Synthon, Coated Tablets, 50 mg

Ibandronic Acid

Read the package 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 you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ibandronic Acid Synthon 50 mg and what is it used for.
• 2. Important information 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 is Ibandronic Acid Synthon 50 mg and what is it 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 when a patient has breast cancer that has spread to the bone (so-called bone metastases).

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

The action of Ibandronic Acid Synthon 50 mg is to inhibit the increased loss of calcium from the bones. This prevents bone weakness.
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2 Important information before taking Ibandronic Acid Synthon 50 mg

50 mg

When not to take Ibandronic Acid Synthon 50 mg:

Do not take the medicine if you have experienced any of the above symptoms. Before taking Ibandronic Acid Synthon 50 mg, consult your doctor or pharmacist if you have any doubts.

Warnings and precautions

A side effect called jawbone necrosis (death of bone tissue in the jaw) has been very rarely reported in patients taking Ibandronic Acid Synthon for cancer-related conditions, after its introduction to the market.
Jawbone necrosis may also occur after the end of treatment.
It is essential to take preventive measures to prevent the development of jawbone necrosis, as it can be a painful and difficult-to-treat condition. To reduce the risk of jawbone necrosis, appropriate precautions should be taken.
Before starting treatment, the patient should inform the doctor/nurse (healthcare professional):

The doctor may recommend that the patient undergo a dental examination before starting Ibandronic Acid Synthon treatment.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups.
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If the patient wears dentures, they should ensure a proper fit. Patients undergoing dental treatment or patients before dental procedures (e.g., tooth extraction) should inform their doctor and dentist that they are taking Ibandronic Acid Synthon.
If the patient experiences any oral or dental symptoms, such as tooth loosening, pain, or swelling, non-healing ulcers, or discharge, they should immediately contact their doctor and dentist, as these may be symptoms of jawbone necrosis.
Before starting Ibandronic Acid Synthon, discuss with your doctor or pharmacist:

Irritation, inflammation, or ulcers of the esophagus may occur, often manifesting as severe chest pain, severe pain after swallowing food and/or drink, severe nausea, or vomiting, especially if the patient does not drink a full glass of water or lies down within an hour of taking Ibandronic Acid Synthon. If these symptoms occur, stop taking Ibandronic Acid Synthon and consult your doctor immediately (see sections 3 and 4).

Children and adolescents

Ibandronic Acid Synthon should not be used in children and adolescents under 18 years of age.

Ibandronic Acid Synthon and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Ibandronic Acid Synthon may affect the action of other medicines, and other medicines may modify the action of Ibandronic Acid Synthon.
In particular, inform your doctor or pharmacistif you are taking any of the following medicines:

• supplements containing calcium, magnesium, iron, or aluminum
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, ibuprofen, or naproxen. NSAIDs and Ibandronic Acid Synthon may cause stomach and intestinal irritation
• a type of antibiotic injection from the aminoglycoside group, e.g., gentamicin. When aminoglycosides and Ibandronic Acid Synthon 50 mg are used together, a decrease in calcium levels in the blood may occur.

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Taking medicines that reduce stomach acid, such as cimetidine and ranitidine, may slightly enhance the action of Ibandronic Acid Synthon 50 mg.

Ibandronic Acid Synthon with food and drink

Do not take Ibandronic Acid Synthon with food or any other drinks, except water, as Ibandronic Acid Synthon is less effective if taken with a meal or drink (see section 3).
Ibandronic Acid Synthon should be taken at least 6 hours after the last meal, drink, or intake of another medicine or supplement (e.g., a product containing calcium, such as milk), except for water. After taking the tablet, wait at least 30 minutes. Then, you can have your first meal and drink, as well as take other medicines or supplements (see section 3).

• 3).

Pregnancy and breastfeeding

Ibandronic Acid Synthon 50 mg should not be used in pregnant or breastfeeding women, or women planning to become pregnant. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines, as Ibandronic Acid Synthon does not affect or has negligible effects on the ability to drive and use machines. Inform your doctor if you plan to drive, use machines, or operate equipment in motion.

Ibandronic Acid Synthon contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3 How to take Ibandronic Acid Synthon 50 mg

Take this medicine always as directed 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, or intake of another medicine or supplement, except for water. Water with high calcium levels should not be used. If there is a concern that the tap water has high calcium levels (so-called hard water), it is recommended to use water with low mineral content.
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Your doctor may order regular blood tests during treatment with Ibandronic Acid Synthon 50 mg. The tests are performed to ensure that the dose of the medicine is appropriate.

Taking this medicine

It is essential to take Ibandronic Acid Synthon 50 mg at the right time and in the right way. This is due to the possibility of esophageal irritation, inflammation, or ulcers.
To reduce the risk, follow the instructions below:

• Take the tablet immediately after getting up in the morning, before taking your first meal, drink, or other medicine or supplement of the day.
• Take the tablet with a full glass of water (about 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 your mouth.
• After taking the tablet, wait at least 30 minutes. Then, you can have your first meal, drink, or take other medicines or supplements.
• While taking the tablet, stay in an upright position (sitting or standing) and remain upright for at least one hour (60 minutes) after taking the tablet. Otherwise, some of the medicine may flow back into the esophagus.

How much medicine to take

Usually, one tablet of Ibandronic Acid Synthon 50 mg is taken every day. In cases of moderate kidney 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 than the recommended dose of Ibandronic Acid Synthon 50 mg

mg
In case of accidental overdose, contact your doctor or go to the emergency department immediately.
Before leaving, drink a full glass of milk. Do not induce vomiting. Do not lie down.

Missing a 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, skip the missed dose. From the next day, take the medicine as usual. If you take the medicine every other day or once a week, consult your doctor or pharmacist.

Stopping treatment with Ibandronic Acid Synthon 50 mg

Continue taking Ibandronic Acid Synthon 50 mg for as long as your doctor recommends. The medicine is effective only if taken regularly.
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If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4 Possible side effects

Like all medicines, Ibandronic Acid Synthon can cause side effects, although not everybody gets them.

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

Frequent(may affect 1 in 10 people):

• nausea, heartburn, and discomfort when swallowing (esophagitis/inflammation of the tube that food passes through)

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

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

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

• chronic 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 1 in 10,000 people):

• mouth or jaw pain or ulcers. These may be early signs of serious jawbone or tooth disease (necrosis or 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.
• 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

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

• asthma attack

Other possible side effects

Frequent(may affect 1 in 10 people):

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

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

• chest pain
• tingling or numbness of the skin (paresthesia)
• flu-like symptoms, malaise, and pain
• dry mouth, taste disturbances, or difficulty swallowing
• anemia (anemia)
• high levels of urea and high parathyroid hormone activity in the blood.

Reporting side effects

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

5 How to store Ibandronic Acid Synthon 50 mg

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the blister pack and carton after the expiration date: EXP. The expiration date refers to the last day of the specified month.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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 ibandronate sodium monohydrate.
• The other ingredients of the medicine are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal silica anhydrous (E551), sodium stearyl fumarate; polyvinyl alcohol, macrogol/PEG 3350, talc (E553b), and titanium dioxide (E171) (tablet coating).

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The appearance of Ibandronic Acid Synthon 50 mg and pack contents

The appearance of Ibandronic Acid Synthon 50 mg and pack contents

Ibandronic Acid Synthon tablets are white or almost white, elongated tablets with the inscription "I9BE" on one side and "50" on the other side.
Tablets are available 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 authorization holder and manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

European Economic Area under the following names:

Estonia
Ibandronic acid Synthon 50 mg
Hungary
Ibandronsav Synthon 50 mg
Latvia
Ibandronic acid Synthon 50 mg film-coated tablets
Lithuania
Ibandronic acid Synthon 50 mg, film-coated tablets
Netherlands
Ibandroninezuur Synthon 50 mg, film-coated tablets
Poland
Ibandronic acid Synthon
Romania Acid ibandronic Glenmark 50 mg film-coated tablets
Slovenia Ibandronska kislina Synthon 50 mg film-coated tablets
Date of last revision of the leaflet:09/2020
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