Iasibon 50 mg Film Coated Tablets

The active substance of Iasibon, ibandronic acid, belongs to the group of medicines known as bisphosphonates. It inhibits increased loss of calcium from the bones (bone resorption), and prevents bone complications and fractures related to the spread of cancer cells into bone.

Iasibon tablets are indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases(neoplasms)..

Do not take Iasibon:

• if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients
• abnormalities (change from normal) of the oesophagus which delay oesophageal emptying such as stricture or achalasia (difficulty swallowing, regurgitation)
• if you are unable to stand or sit upright for at least 60 minutes
• if you have low calcium levels in your blood (hypocalcaemia).

During treatment your blood may be monitored to ensure that you are receiving the correct dose of Iasibon.

If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Iasibon

Iasibon should not be used in children below 18 years old..

Take special care with Iasibon:
if you know or believe that you may have:

• hypersensitivity to other bisphosphonates
• low blood calcium
• other disturbances of mineral metabolism (such as vitamin D deficiency)
• moderate or severe kidney disease (renal insufficiency)

or when

• you have had problems in the past with your oesophagus (the tube that connects your mouth to your stomach) or any digestive problem
• you become aware of any signs or symptoms suggesting a possible reaction of the oesophagus (this may include: pain in the chest, heartburn, pain after swallowing drink and / or food). If this is the case, you should stop taking this medicine and speak to your doctor without delay.

Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription,

After taking your Iasibon tablet, wait at least 30 minutes before taking any other medicines of the day, including indigestion tablets/medicine, supplements containing calcium, magnesium, iron or aluminium and vitamins.

When administered with H2-antagonists or other drugs that increase gastric pH Iasibon absorption may be slightly increased but no dose adjustment is needed.

If you are also taking non-steroidal anti-inflammatory drugs (NSAIDs), please note that both types of medicinal products (NSAIDs and bisphosphonates) may cause irritation to the stomach and intestine.

Caution is advised when bisphosphonates are administered with aminoglycosides(antibacterial medicines) since both agents can lower serum calcium levels for prolonged periods. Caution should also be paid to the possible existence of simultaneous reduced magnesium levels (hypomagnesaemia).

Taking Iasibon with food and drink:
Your Iasibon tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Iasibon tablets. Fasting, including avoiding other medication and supplements should be continued for at least 30 minutes after taking the tablet. Plain water may be taken at any time during the course of Iasibon treatment. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.

Pregnancy and breast feeding:
You should not take Iasibon if you are pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines:
No studies on the effects on the ability to drive and use machines have been performed

Important information about some of the ingredients of Iasibon
Iasibon tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Iasibon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of Iasibon is one tablet per day.
If you have severe kidney problems, your doctor may reduce your dose to one tablet per week. If you have moderate renal impairment a dosage adjustment to one 50 mg film-coated tablet every second day is recommended.

To reduce possible irritation, it is important that you follow the instructions below:

• BEFORE taking your first food, drink or other medicinal products of the day, take your Iasibon

tablet with a full glass of plain water only (about 200 mL). Do not take your tablet with any drink other than plain water. Some mineral waters may have a higher concentration of calcium and therefore should not be used.

• Do not chew, suck, crush or allow the tablet to dissolve in your mouth.
• After taking your Iasibon tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day.
• You should remain in an upright (sitting or standing) position while taking Iasibon tablets and remain upright for the next hour (60 minutes) after taking your tablet.
• It is important to continue taking Iasibon for as long as your doctor prescribes the medicine. Iasibon can help with your condition only if you continue to take the tablets.

If you take more Iasibon than you should:

Overdose may result in upset stomach, heartburn, inflammation of the gullet (oesophagitis), inflammation of the stomach (gastritis) or ulcer.

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take Iasibon:
Do not take a double dose to make up for a forgotten dose. Return to taking one tablet per day the following day, as usual.

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

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

Common side effects affects 1 to 10 users in 100 indigestion, nausea, stomach pain, inflammation of the gullet oesophagitis, tiredness, low calcium levels in the blood.

Uncommon side effects affects 1 to 10 users in 1,000 strange taste, tingling sensation paraesthesia, dry mouth, bleeding gastrointestinal ulcer, haemorrhage, difficulty swallowing, inflammation of the stomach gastritis, itching, chest pain, flu-like symptoms, feeling unwell, pain. low hemoglobin, high levels of urea and parathyroid hormone.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Iasibon 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Iasibon contains

• The active substance is ibandronic acid. Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronic sodium monohydrate).

The other ingredients are:

• tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
• tablet coat: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000

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

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.

BelgiëBelgiqueBelgien Pharmathen S.A. TélTel 30 210 66 65 067 LuxembourgLuxemburg Portfarma ehf. TélTel 354 534 4030

Alvogen Pharma Bulgaria Ltd Te. 359 2 400 555 2 Magyarország Pharmathen S.A. Tel. 30 210 66 65 067

eská republika Pharmathen S.A. Tel 30 210 66 65 067 Malta Pharmathen S.A. Tel 30 210 66 65 067

Danmark Pharmathen S.A. Tlf 30 210 66 65 067 Nederland Pharmathen S.A. Tel 30 210 66 65 067

Deutschland Pharmathen S.A. Tel 30 210 66 65 067 Norge Pharmathen S.A. Tlf 30 210 66 65 067

Eesti Estonia Portfarma ehf. Tel 354 534 4030 Österreich Pharmathen S.A. Tel 30 210 66 65 067

Pharmathen S.A. 30 210 66 65 067 Polska Pharmathen S.A. Tel. 30 210 66 65 067

España Pharmathen S.A. Tel 30 210 66 65 067 Portugal Pharmathen S.A. Tel 30 210 66 65 067

France Pharmathen S.A. Tél 30 210 66 65 067 România Alvogen Pharma SRL Romania Tel 40 744 543249

Ireland Aspire Pharma Ltd Tel 44 1730 234527 Slovenija Pharmathen S.A. Tel 30 210 66 65 067

Ísland Portfarma ehf. Sími 354 534 4030 Slovenská republika Pharmathen S.A. Tel 30 210 66 65 067

Italia Pharmathen S.A. Tel 30 210 66 65 067 SuomiFinland Pharmathen S.A. PuhTel 30 210 66 65 067

P.T. Hagjigeorgiou Co Ltd 357 25372425 Sverige Pharmathen S.A. Tel 30 210 66 65 067

Latvija United Kingdom

Portfarma ehf. Tel 354 534 4030 Aspire Pharma Ltd Tel 44 1730 234527

Lietuva

Portfarma ehf.
Tel: +354 534 4030

This leaflet was last approved in {MM/YYYY }