Ibandronate Bluefish

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PACKAGE LEAFLET

Package Leaflet: Information for the user

Ibandronate Bluefish 50 mg film-coated tablets

ibandronic acid

Read all of this leaflet carefully before you start taking this medicinebecause 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 or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet .See section 4.

What is in this leaflet:

1. What Ibandronate Bluefish is and what it is used for.

2. What you need to know before you take Ibandronate Bluefish.

3. How to take Ibandronate Bluefish.

4. Possible side effects.

5. How to store Ibandronate Bluefish.

6. Contents of the pack and other information.

What Ibandronate Bluefish is and what it is used for

Ibandronate Bluefish contains the active substance ibandronic acid. This belongs to the group of medicines called bisphosphonates. Ibandronate Bluefish works by reducing the amount of calcium that is lost from the bones. This helps to stop your bone from getting weaker. Ibandronate Bluefish is used in adults and prescribed to you if you have breast cancer that has spread to your bone (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.

What you need to know before you take Ibandronate Bluefish

Do not take Ibandronate Bluefish:

if you are allergic to ibandronic acid or any of the other ingredients of this medicine (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 Ibandronate Bluefish.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibandronate Bluefish

if you are allergic to any other bisphosphonates
if you have high or low blood level of vitamin D or any other minerals.
if you have kidney problems
if you have any swallowing or digestive problems
if you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronate Bluefish for cancer.

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 Ibandronate Bluefish. If you develop these symptoms, stop taking Ibandronate Bluefish and tell your doctor straight away (see sections 3 and 4).

Children and adolescents

Ibandronate Bluefish should not be used in children and adolescents below age 18 years.

Othermedicines and Ibandronate Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines .This is because Ibandronate Bluefish can affect the way some other medicines work. Also some other medicines can affect the way Ibandronate Bluefish works.

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

supplements containing calcium, magnesium, iron or aluminium.
acetylsalicyclic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen. This is because NSAIDs, and Ibandronate Bluefish can both irritate your stomach and gut
a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronate Bluefish can both lower the amount of calcium in your blood.

Talking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronate Bluefish.

Ibandronate Bluefish with food and drink

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

Take Ibandronate Bluefish at least 6 hours after you had last had anything to eat, drink or any other medications or supplements (e.g. products containing calcium (milk), aluminium, 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 Ibandronate Bluefish if you are pregnant, planning to get pregnant or if you are breast-feeding.

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

Driving and using machines

You can drive and use machines as it’s expected that Ibandronate Bluefish 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 or tools.

Ibandronate Bluefish contains lactose

If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.

How to take Ibandronate Bluefish

Always take this medicine exactly as your doctor has told you. 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 (e.g. mineral water) 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 Ibandronate Bluefish. This is to check that you are being given the right amount of medicine

How much to take

The usual dose of Ibandronate Bluefish 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 problem, your doctor may reduce your dose to one tablet each week.

Taking this medicine

It is important that you take Ibandronate Bluefish 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, 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).

If you take more Ibandronate Bluefish 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 Ibandronate Bluefish:

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 Ibandronate Bluefish

Keep taking Ibandronate Bluefish 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.

Possible side effects

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

Stop taking Ibandronate Bluefish and seek medical help immediately if you experience any of the following serious side effects:

itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction (very rare, may affect up to 1 in 10,000 people).
feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe) (common, may affect up to 1 in 10 people).

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

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) (uncommon, may affect less than 1 in 100 people).

Persistent eye pain and inflammation (rare may affect up to 1 in 1,000 people).
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 (rare may, affect up to 1 in 1,000 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) (very rare may affect up to 1 in 10,000 people).

asthma attack (frequency not known, cannot be estimated from the available data
Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear (very rare, may affect up to 1 in 10,000 people).

Other possible side effects

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

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

Uncommon (may affectless than 1 in 100 people):

dry mouth, strange taste in your mouth, difficulty swallowing
itching or tingling skin (paraesthesia).
chest pain
flu-like symptoms, feeling generally unwell, or in pain.
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.

How to store Ibandronate Bluefish

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from moisture.

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.

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 to protect the environment.

Contents of the pack and other information

What Ibandronate Bluefish contains

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

The other ingredients are:

- tablet core: povidone, microcrystalline cellulose, crospovidone, starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.

- tablet coat: Opadry OY-LS-28908(White II)[consisting of:lactose monohydrate, macrogol, hypromellos (E464), titanium dioxide (E171)]

What Ibandronate Bluefish looks like and contents of the pack

The film-coated tablets are white, round biconvex tablets. They are available in packs of 28 and 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany	Ibandronate Bluefish 50 mg Filmtabletten
Sweden	Ibandronate Bluefish

This leaflet was last approved in 2016-03-16