IBANDRONIC ACID BLUEFISH 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the PatientIbandronic Acid Bluefish 150 mg Film-Coated Tablets EFG

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.

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

Contents of thepackage leaflet:

1. What is Ibandronic Acid Bluefish and what is it used for
2. What you need to know before you take Ibandronic Acid Bluefish
3. How to take Ibandronic Acid Bluefish
4. Possible side effects
5. Storage of Ibandronic Acid Bluefish

1. Contents of the pack and further information

1. What is Ibandronic Acid Bluefish and what is it used for

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

Ibandronic Acid Bluefish can reverse bone loss, as it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronic Acid Bluefish may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures, but not in hip fractures.

You have been prescribedIbandronic Acid Bluefish to treat your postmenopausal osteoporosis because you are at high risk of suffering fractures.Osteoporosis is a condition where bones become thinner and weaker, often occurring in women after menopause. During menopause, the ovaries stop producing the female hormone — estrogen — which helps maintain bone health.

The earlier a woman reaches menopause, the higher the risk of suffering fractures due to osteoporosis. Other factors that increase the risk of fractures include:

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habitsalso facilitate the beneficial effects of treatment. These include a balanced diet rich in calcium and vitamin D; walking or any other weight-bearing exercise; not smoking; and moderate alcohol consumption.

2. What you need to know before you take Ibandronic Acid Bluefish

Do not take Ibandronic Acid 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 throat/esophagus, 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 have had low calcium levels in your blood. Please consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Ibandronic Acid Bluefish.

A rare adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with Ibandronic Acid Bluefish for osteoporosis. ONJ may also occur after treatment is discontinued.

It is essential to try to prevent the development of ONJ, as it is a painful condition that can be challenging to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• you have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction
• you do not 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 been previously treated with a bisphosphonate (used to treat or prevent bone disorders)
• you are taking medications called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Bluefish.

While you are being treated, you must maintain good oral hygiene (including regular toothbrushing) and undergo routine dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are about to undergo dental surgery (e.g., tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with Ibandronic Acid Bluefish.

Contact your doctor and dentist immediately if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Atypical fractures of the long bones, such as the forearm (ulna) and tibia, have also been reported in patients receiving long-term treatment with ibandronic acid. These fractures occur after minimal or no trauma, and some patients experience pain in the area of the fracture before a complete fracture occurs.

Some people require special care during treatment with Ibandronic Acid Bluefish. Consult your doctor before taking Ibandronic Acid Bluefish:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If you have any kidney problems.
• If you have any swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/esophagus may occur, often with symptoms of severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting, especially if patients do not drink a full glass of water and/or lie down before one hour has passed after taking Ibandronic Acid Bluefish. If you develop these symptoms, stop taking Ibandronic Acid Bluefish and inform your doctor immediately (see section 3).

Children and adolescents

Do not give Ibandronic Acid Bluefish to children or adolescents under 18 years of age.

Othermedicines and Ibandronic Acid Bluefish

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

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the action of Ibandronic Acid Bluefish.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen), which may irritate the stomach and intestines, just like Ibandronic Acid Bluefish. Therefore, be very careful when taking painkillers or anti-inflammatory drugs at the same time as Ibandronic Acid Bluefish.

After taking the monthly Ibandronic Acid Bluefish tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements, and vitamins.

Ibandronic Acid Bluefish with food and drinks

Do not take Ibandronic Acid Bluefish with food. Ibandronic Acid Bluefish loses its effectiveness if taken with food.

You can drink water, but not other liquids

After taking Ibandronic Acid Bluefish, wait 1 hour before taking your first meal and other drinks (see the point 3. How to take Ibandronic Acid Bluefish)

Pregnancy and breastfeeding

Ibandronic Acid Bluefish is only for use in postmenopausal women and should not be taken by women of childbearing age.

Do not take Ibandronic Acid Bluefish if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines, as Ibandronic Acid Bluefish is not expected to have a significant effect on your ability to drive and use machines.

Ibandronic Acid Bluefish contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ibandronic Acid Bluefish contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet;this is, essentially “sodium-free”.

3. How to take Ibandronic Acid Bluefish

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The usual dose of Ibandronic Acid Bluefish is one tablet per month.

How to take the monthly tablet

It is essential that you follow these instructions carefully. They are designed to ensure that Ibandronic Acid Bluefish reaches the stomach quickly and causes less irritation.

• Take one 150 mg Ibandronic Acid Bluefish tablet once a month.
• Choose a day of the monththat is easy for you to remember. You can choose the same date (e.g., the first day of each month) or always the same day (e.g., the first Sunday of each month). Choose what best fits your routine.
• Take the Ibandronic Acid Bluefish tablet after a minimum of 6 hours after your last meal or drink(except water).

Take the Ibandronic Acid Bluefish tablet

• as soon as you get up, and
• before breakfast or drinking(on an empty stomach)
• Swallow the tablet with a glass of water(at least 180 ml).

Do nottake the tablet with water that has a high concentration of calcium, fruit juice, or other drinks. If you are unsure about the potentially high calcium levels in your tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole- do not chew, crush, or dissolve it in your mouth.

During the next hour (60 minutes)after taking the tablet

• do not lie down; if you do not remain upright (standing or sitting), part of the medicine may return to the esophagus

• do not eatanything

• do not drinkanything (except water, if needed)
• do not takeany other medicine
• After waiting 1 hour, you can have breakfast and your first drink of the day. Once you have eaten, you can lie down and take any other medicines you need.

Continuationof treatment with Ibandronic Acid Bluefish

It is essential that you take Ibandronic Acid Bluefish every month, until your doctor tells you to stop. Ibandronic Acid Bluefish only works to treat osteoporosis while you are taking this medicine. After 5 years of taking Ibandronic Acid Bluefish, consult your doctor to see if you should continue taking Ibandronic Acid Bluefish.

If you take more Ibandronic Acid Bluefishthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have taken an extra tablet by mistake, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause it could irritate the esophagus.

It is recommended to bring the package leaflet and the medicine packaging to the healthcare professional.

If you forget to take Ibandronic Acid Bluefish

• If you forget to take the tablet on the morning of the day you have chosen, do not take the tablet later.

Instead, consult your calendar to see when your next dose is due:

• If you forgot to take the tablet on your chosen day and your next dose is within 1 to 7 days

Never take two Ibandronic Acid Bluefish tablets within the same week. Wait until your next scheduled dose and take it as usual, then continue taking one tablet per month according to the days marked on your calendar.

• If you forgot to take the tablet on your chosen day and your next dose is more than 7 days away:Take a tablet the next morning after the day you remembered you missed the dose, then continue taking one tablet per month according to the days marked on your calendar.

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

4. Possible side effects

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

Stop taking Ibandronic Acid Bluefish and inform your doctor immediately if you experience any of the following serious side effects

• Itching, swelling of the face, lips, tongue, and throat, with difficulty breathing (rare, may affect up to 1 in 1000 people). You may have a severe allergic reaction that can be life-threatening (very rare, may affect up to 1 in 10,000 people)
• severe chest pain, severe pain when swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. You may have severe inflammation, possibly with a feeling of pain or constriction, in the throat/esophagus (uncommon, may affect up to 1 in 100 people)

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• persistent eye pain and inflammation (rare, may affect up to 1 in 1000 people)
• new pain, weakness, or discomfort in the thigh, hip, or groin. These may be early symptoms of a possible unusual fracture of the thigh bone (rare, may affect up to 1 in 1000 people)
• pain or sensation of pain in the mouth or jaw. These may be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jawbone] (very rare, may affect up to 1 in 10,000 people)
• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear (very rare, may affect up to 1 in 10,000 people)
• serious skin reactions (very rare, may affect up to 1 in 10,000 people)

Other possible side effects

Common (may affect up to 1 in 10 people)

• headache
• heartburn, discomfort when swallowing, indigestion, diarrhea (intestinal losses), stomach pain or abdominal pain (due to inflammation of the stomach, such as “gastroenteritis” or “gastritis”), and nausea
• muscle cramps, stiffness of joints and limbs
• flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone pain, and muscle and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days
• skin rash

Uncommon (may affect up to 1 in 100 people)

• dizziness
• flatulence (bloating, feeling bloated)
• back pain
• feeling tired and exhausted
• asthma attacks
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

Rare (may affect up to 1 in 1000 people)

• inflammation of the duodenum (first section of the intestine) that causes stomach pain
• hives

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

• unusual fracture in places other than the thigh bone.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Bluefish

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after “EXP.” The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ibandronic Acid Bluefish

• The active ingredient is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).
• The other components (excipients) are:

Core of the tablet: povidone, microcrystalline cellulose, pregelatinized corn starch, crospovidone, anhydrous colloidal silica, glycerol dibehenate;

Coating of the tabletcomposed of Opadry OY-LS-28908 (White II) which contains hypromellose (E464), lactose monohydrate, titanium dioxide (E171), macrogol.

Appearance of the Product and Container Content

Ibandronic Acid Bluefish 150 mg film-coated tablets, white, biconvex, 11.2±0.1mm in diameter.

Package sizes: 1 and 3 tablets

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

Pharmathen S.A.

Dervenakion 6, Pallini Attiki, 15351,

Greece

Pharmathen International S.A

Industrial Park Sapes Rodopi Prefecture,

Block No 5, Rodopi, 693 00,

Greece

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder

Bluefish Pharma S.L.U., AP 36007

2832094 Madrid, Branch 36

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

Germany Ibandronate Bluefish 150 mg Filmtabletten

Portugal Ibandronic Acid Bluefish 150 mg film-coated tablets

Sweden Ibandronate Bluefish 150 mg film-coated tablets

Date of the last revision of this leaflet:October 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/