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Package Leaflet: Information for the user

Ibandronate Bluefish 150 mg film-coated tablets

Ibandronic acid

Read all of this leaflet carefully before you start taking 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 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

Planning when to take Ibandronate Bluefish with peel-off stickers for your personal calendar

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. Content of the pack and other information

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

Ibandronate Bluefish belongs to a group of medicines called bisphosphonates.It contains the active substance ibandronic acid.

Ibandronate Bluefish may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won´t be able to see or feel a difference. Ibandronate Bluefish may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronate Bluefish is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

• not enough calcium and vitamin D in the diet

• smoking, or drinking too much alcohol

• not enough walking or other weight-bearing exercise

• a family history of osteoporosis

A healthy lifestyle will also help you to get the most benefit from your treatment. This includes:

• eating a balanced diet rich in calcium and vitamin D

• walking or any other weight-bearing exercise

• not smoking; and not drinking too much alcohol.

2. 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 certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.

• If you can´t stand or sit upright for at least one hour (60 minutes) at a time.

• If you have, or had in the past low blood calcium. Please consult your doctor.

Warnings and precautions

Some people need to be especially careful while they’re taking Ibandronate Bluefish. Talk to your doctor before taking Ibandronate Bluefish:

• If you have any disturbances of mineral metabolism (such as vitamin D deficiency).

• If your kidneys are not functioning normally.

• If you have any swallowing or digestive problems

• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronate Bluefish. When you have cancer, tell your dentist as well.

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 plain 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 section 3).

Children and adolescents

Do not give Ibandronat Bluefish to children or adolescents below 18 years.

Other medicines and Ibandronat Bluefish

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

Ibandronate Bluefish may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Ibandronate Bluefish.

After swallowing your monthly Ibandronate Bluefish tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

Ibandronate Bluefish with food and drink:

Do not take Ibandronate Bluefish with food.

Ibandronate Bluefish is less effective if it’s taken with food.

You can drink water but no other drinks.

After you have taken Ibandronate Bluefish, please wait for 1 hour before you can have your first food and further drinks.(see section 3. How to take Ibandronate bluefish).

Pregnancy and breast feeding

Ibandronate Bluefish is for use only by postmenopausal women and must not be taken by women who could still have a baby.

Do not take Ibandronate Bluefish if you are pregnant or 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.

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.

3. 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.

The usual dose of Ibandronate Bluefish is one tablet once a month.

Taking your monthly tablet

It’s important to follow these instructions carefully. They are designed to help your Ibandronate Bluefish tablet reach your stomach quickly, so it’s less likely to cause irritation.

• Take one Ibandronate Bluefish 150 mg tablet once a month.

• Choose one day of the month that will be easy to remember. You can choose either the same date (such as the 1^st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronate Bluefish tablet. Choose the date that best fits your routine.

• Take your Ibandronate Bluefish tablet at least 6 hours after you last had anything to eat or drink except water.

Take your Ibandronate Bluefish tablet

- after you first get up for the day, and

- before you have anything else to eat or drink(on an empty stomach)

Do nottake your tablet with water with a high concentration of calcium, (e.g mineral water) fruit juice or any other drinks. If there is a 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.

For the next hour (60 minutes) after you’ve taken your tablet

- do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus

- do not eat anything

- do not drink anything (except water if you need it)

- do not takeany other medicines

Continuing to take Ibandronate Bluefish

It´s important to keep taking Ibandronate Bluefish every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronate Bluefish, please consult with your doctor whether you should continue to take Ibandronate Bluefish.

If you take more Ibandronate Bluefish than you should

If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.

Do not make yourself vomit, and do not lie down— this could cause Ibandronate Bluefish to irritate your oesophagus.

If you forget to take Ibandronate Bluefish

Instead, consult your calendar and find out when your next scheduled dose is.

Never take two Ibandronate Bluefish tablets within the same week. You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you´ve marked on your calendar.

You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you´ve marked on your calendar.

4. 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 (rare, may affect 1 in 1,000 people). You may be having a serious, potentially life-threatening allergic reaction (very rare, may affect 1 in 10,000 people).

• severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing. You may have severe inflammation of your gullet/food pipe, possibly with sores or constriction of gullet/food pipe (uncommon, may affect up to 1 in 100 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:

• persistent eye pain and inflammation (rare, may affect 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 1 in 1,000 people).

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 1 in 10,000 people)

Other possible side effects

Common (may affect up to1 in 10 people):

• headache

• heartburn, discomfort in swallowing, indigestion, having diarrhoea (loose bowels), stomach or tummy pain (maybe due to an inflammation of the stomach), nausea

• muscle cramps, stiffness of your muscles joints and limbs

• flu-like symptoms, including fever , shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. Talk to nurse or doctor if any effects become troublesome or last more than a couple of days.

• rash

Uncommon(may affect up to 1 in 100 people):

• dizziness

• flatulence (farting, feeling bloated).

• Back pain

• Feeling tired and exhausted

• Asthma attacks

Rare(may affect up to 1 in 1000 people):

• Inflammation of duodenum (first section of the bowel) causing stomach pain

• hives

Reporting of side effects

If you get any of the 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 Ibandronate Bluefish

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the 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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibandronate Bluefish contains

• The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).

• The other ingredients are:

Tablet core:Povidone, microcrystalline cellulose, starch pregelantinized (maize), crospovidone, silica colloidal anhydrous, glycerol dibehenate

Tablet coat:Opadry OY-LS-28908 (white II) consisting of: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol.

What Ibandronate Bluefish looks like and contents of the pack

Ibandronate Bluefish 150 mg film-coated tablets are white, round biconvex tablets with dimensions: 11.2mm±0.1mm in diameter.

Ibandronate Bluefish 150 mg film-coated tablets are available in packs containing 1 or 3 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 150 mg Filmtabletten
Italy	Acido Ibandronico Bluefish 150 mg compresse rivestite con film
Portugal	Ibandronate Bluefish
Spain	Ibandronate Bluefish 150 mg Comprimidos recubiertos con película
Sweden	Ibandronate Bluefish

This leaflet was last revised in 2016-03-16