InfoCons Consumer Protection informs you – Iasibon – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor , pharmacist or nurse .
• If you get any side effects , talk to your doctor , pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See section 4

ℹ️ 1. What Iasibon is and what it is used for

Iasibon contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Iasibon is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases ’).

• It helps to prevent your bones from breaking (fractures).
• It also helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronate works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

⚠️ 2. What you need to know before you take Iasibon

Do not take Iasibon

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• if you have problems with your food pipe /gullet (oesophagus ) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes ) at a time
• if you have or ever had low calcium in your blood.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Iasibon.

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronate for cancer -related conditions. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.

In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• you don’t receive routine dental care or have not had a dental check up for a long time
• you are a smoker (as this may increase the risk of dental problems)
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with Iasibon .

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check -ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Iasibon.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non -healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Atypical fractures of the long bones, such as in the forearm bone (ulna) and the shinbone (tibia), have also been reported in patients receiving long -term treatment with Ibandronate. These fractures occur after minimal, or no trauma and some patients experience pain in the area of the fracture prior to presenting with a completed fracture.

Talk to your doctor or pharmacist before taking Iasibon:

• if you are allergic to any other bisphosphonates
• if you have any swallowing or digestion problems
• if you have high or low blood levels of vitamin D or any other minerals
• if you have kidney problems Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Iasibon . If you develop these symptoms, stop taking Iasibon and tell your doctor straight away (see sections 3 and 4).

Children and adolescents

Iasibon should not be used in children and adolescents below the age of 18 years.

Other medicines and Iasibon

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines .

This is because Iasibon can affect the way some other medicines work. Also , some other medicines can affect the way Iasibon works.

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

• supplements containing calcium, magnesium, iron or aluminium
• acetylsalicylic acid and non-steroidal anti -inflammatory medicines called “NSAIDs” , such as, ibuprofen or naproxen. This is because NSAIDs and Iasibon can both irritate your stomach and gut
• a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Iasibon can both lower the amount of calcium in your blood Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Iasibon.

Iasibon with food and drink Do not take Iasibon with food or any other drinks except plain water as Iasibon is less effective if it is taken with food or drink (see section 3).

Take Iasibon at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), alumin ium, magnesium and iron) except water.

After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements (see section 3).

Pregnancy and breast feeding Do not take Iasibon if you are pregnant , planning to get pregnant or if you are breast -feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Iasibon has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machine s or tools.

Iasibon contains lactose .

If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

💊 3. How to take Iasibon

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.

Your doctor may do regular blood tests while you are taking Iasibon. This is to check that you are being given the right amount of medicine.

Taking this medicine It is important that you take Iasibon at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe /gullet (oesophagus).

You can help stop this happening by doing the following:

• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
• Take your tablet with a full glass of water only (about 200 mL). Do not take your tablet with any drink other than water
• Swallow the tablet whole. Do not chew, suck or crush the tablet . Do not let the tablet dissolve in your mouth
• After taking your tablet, wait at least 30 minutes . Then you can have your first food and drink and take any medicines or supplements
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).

Otherwise, some of the medicine could leak back into your food pipe /gullet (oesophagus) How much to take The usual dose of Iasibon is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.

If you take more Iasibon than you should

If you take too many tablets talk to a doctor or go to hospital straight away . Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.

If you forget to take Iasibon

Do not take a double dose to make up for a forgotten dose . If you are taking a tablet each day, skip the missed dose completely. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.

If you stop taking Iasibon

Keep taking Iasibon for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.

If you have any further questions on the use of this medicine , ask your doctor or pharmacist.

❗ 4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects , you may need urgent medical treatment:

Common (may affect up to 1 in 10 people)

• feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)

Uncommon (may affect less than 1 in 100 people)

• severe stomach pain. This could be a sign of an ulcer of the first section of the bowel (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)

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

• persistent eye pain and inflammation
• new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone

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

• pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone )
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction
• severe adverse skin reactions
• ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)

• asthma attack Other possible side effects

Common ( may affect up to 1 in 10 people)

• tummy pain, indigestion
• low calcium levels in your blood
• weakness

Uncommon (may affect less than 1 in 100 people)

• chest pain
• itching or tingling skin (paraesthesia)
• flu-like symptoms, feeling generally unwell or in pain
• dry mouth, strange taste in your mouth or difficulty swallowing
• anaemia (bloodlessness)
• high levels of urea or high levels of parathyroid hormone in your blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Iasibon

• Keep this medicine out of the sight and reach of children .
• Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.

The expiry date refers to the last day of that month .

• Store in the original package in order to protect from moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment .

📦 6. Contents of the pack and other information

What Iasibon contains

• The active substance is ibandronic acid. Each film -coated table t contains 50 mg of ibandronic acid (as sodium monohydrate) The other ingredients are:
• tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
• tablet coat: titanium dioxide (E 171), lactose monohydrate, hypromellose (E 464), macrogol 4 000

What Iasibon looks like and contents of the pack

The film -coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC – Aluminum foil blister. They are available in packs of 3, 6, 9, 28 and 84 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pharmathen S.A.

Dervenakion 6 Pallini 15351 Attiki Greece

Manufacturer

Pharmathen S.A.

Dervenakion 6 Pallini 15351 Attiki Greece And Pharmathen International S.A.

Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Pharmathen S.A.

Tél/Tel: +30 210 66 04 300 Lietuva Pharmathen S.A.

Tel: +30 210 66 04 300 България Alvogen Pharma Bulgaria Ltd Teл.: + 359 2 441 7136 Luxembourg/Luxemburg Pharmathen S.A.

Tél/Tel: +30 210 66 04 300 Česká republika PHARMAGEN CZ s.r.o.

Tel: +420 721 137 749 Magyarország Pharmathen S.A.

Tel.: +30 210 66 04 300 Danmark Bluefish Pharmaceuticals AB Tlf: +46 8 51911600 Malta Pharmathen S.A.

Tel: +30 210 66 04 300 Deutschland Pharmathen S.A.

Tel: +30 210 66 04 300 Nederland Pharmathen S.A.

Tel: +30 210 66 04 300 Eesti (Estonia) Pharmathen S.A.

Tel: +30 210 66 04 300 Norge Pharmathen S.A.

Tlf: +30 210 66 04 300 Ελλάδα INNOVIS PHARMA AEBE Τηλ: +30 210 6664805 -806 Österreich Pharmathen S.A.

Tel: +30 210 66 04 300 España Pharmathen S.A.

Tel: +30 210 66 04 300 Polska Pharmathen S.A.

Tel.: +30 210 66 04 300 France Pharmathen S.A.

Tél: +30 210 66 04 300 Portugal Pharmathen S.A.

Tel: +30 210 66 04 300 Hrvatska România 102 PROXIMUM d.o.o.

Tel: +385 1 30 111 28 Labormed Pharma Trading SRL Tel: +(40) 21 304 7597 Ireland Pharmathen S.A.

Tel: +30 210 66 04 300 Slovenija Pharmathen S.A.

Tel: +30 210 66 04 300 Ísland Alvogen ehf.

Sími: +354 522 2900 Slovenská republika PHARMAGEN CZ s.r.o.

Tel: +420 721 137 749 Italia Pharmathen S.A.

Tel: +30 210 66 04 300 Suomi/Finland Pharmathen S.A.

Puh/Tel: +30 210 66 04 300 Κύπρος The Star Medicines Importers Co. Ltd Τηλ: +357 25371056 Sverige Pharmathen S.A.

Tel: +30 210 66 04 300 Latvija SIA ELVIM Tel: +371 67808450 United Kingdom (Northern Ireland) Pharmathen S.A.

Tel: +30 210 66 04 300

This leaflet was last revised in {MM/YYYY }

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Iasibon (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/10/659).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.