PATIENT INFORMATION LEAFLET

ABRION 150 mg Film-Coated Tablets

Ibandronic Acid

1. What ABRION is and what it is used for

2. Before taking ABRION

3. How to take ABRION

4. Possible side effects

5. Storage of ABRION

6. Additional information

ABRION belongs to a group of medications called bisphosphonates that contain ibandronate acid. It does not contain hormones.

ABRION may 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. ABRION may help reduce the number of bone fractures. This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed ABRION to treat your osteoporosis because you have a high risk of suffering fractures.Osteoporosis is a condition characterized by the thinning and weakening of bones, a common occurrence in women after menopause. During menopause, the ovaries stop producing the female hormone —estrogens— that helps maintain bone health.

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

- Insufficient calcium and vitamin D intake in the diet

- Smoking or excessive alcohol consumption

- Limited walking or other weight-bearing exercises

- Family history of osteoporosis

Many people with osteoporosis do not experience symptoms. If you do not have symptoms, it may be difficult to determine if you have the condition. However, osteoporosis increases the likelihood of bone fractures in cases of falls or injuries. Any bone fracture that occurs after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, loss of height, and kyphosis.

ABRION prevents bone loss due to osteoporosis and helps rebuild bone. Therefore, ABRION reduces the likelihood of fractures.

A healthy lifestyle also facilitates the favorable 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.

Do not take ABRION:

• If you are allergic (hypersensitive) to ibandronate acid or any of the other components of ABRION.
• If you have certain esophageal problems (the esophagus is the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you cannot remain upright, both standing and sitting, for at least one hour at a time (60 minutes).

- If you have or have had low calcium levels in your blood. Please consult your doctor.

Do not administer ABRION to children or adolescents.

Be especially careful with ABRION:

Some people require special care during treatment with ABRION.

Consult your doctor:

- If you have any mineral metabolism disorder (for example, vitamin D deficiency).

- If you have any kidney problems.

- If you have any swallowing or digestive problems.

- If you are undergoing dental treatment or have scheduled dental surgery, inform your dentist that you are being treated with ABRION.

Esophageal irritation, inflammation, or ulceration (the esophagus is the tube that connects your mouth to your stomach) may occur, often with symptoms of intense chest pain, intense pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before an hour has passed after taking ABRION. If you develop these symptoms, stop taking ABRION and inform your doctor immediately.

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 Abrion for osteoporosis. ONJ may also occur after interrupting treatment.

It is important to try to prevent the development of ONJ as it is a painful condition that may be difficult 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 planned tooth extraction.
• You do not receive regular dental care or if you 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 corticosteroid medications (such as prednisolone or dexamethasone).
• You have cancer.

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

While you are being treated, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo routine dental check-ups. If you wear dentures, make sure they are securely fixed. 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 Abrion.

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 in healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription. Especially:

- Calcium, magnesium, iron, or aluminum supplementsas they may affect the effects of ABRION.

• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) which may irritate the stomach and intestines; as well as bisphosphonates (such as ABRION 150). Be careful when taking pain relievers or anti-inflammatory medications at the same time as ABRION.

After taking the monthly ABRION tablet,wait 1 hour before taking any other medication, including antacids, calcium supplements, and vitamins.

Taking ABRION with food and drinks:

Do not take ABRION with food.ABRION loses effectiveness if taken with food.

You may drink tap water but not other liquids(see point 3 HOW TO TAKE ABRION).

Pregnancy and breastfeeding

Do not take ABRION if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop it to take ABRION.

Driving and operating machines

It is very unlikely that ABRION will affect your ability to drive and use machines.

Important information about one of the components of ABRION

ABRION contains lactose. If your doctor has told you that you have a certain sugar intolerance, contact them before taking this medication.

Follow the exact administration instructions for ABRION, as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose of ABRION is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to ensure that ABRION reaches your stomach quickly and causes less irritation.

- Take one ABRION tablet once a month.

-Choose a day of the monththat is easiest for you to remember. You can choose the same date (either the first day of each month) or always the same day (such as the first Sunday of each month). Choose what best suits your routine.

- Take the ABRION tabletafter a minimum of 6 hours from the last meal or drink (except water)you can only drink water during this period.

- Take the ABRION tablet

-nothing more than get up, and

-before breakfast or before consuming liquids(with an empty stomach)

-Swallow the tablet with a glass of tap water(at least 180 ml). Do not take the tablet with mineral water, fruit juice, or other beverages.

-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 medication could return to the esophagus

-do not eat anything

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

-do not take any other medication

• After waiting 1 hour, you will be able to take breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medications you need.

Do not take this medication at bedtime or before getting up.

Continuation of ABRION treatment

It is essential to take ABRION every month until your doctor tells you to stop. ABRION is only effective for treating osteoporosis while you are taking this medication.

If you take more ABRION than you should:

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 you could irritate your esophagus.

In case of overdose or accidental ingestion, call the Toxicological Information Service. Phone:91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take ABRION:

If you forget to take the tablet in the morning of the day you chose,do not take the tablet later. Instead, check your calendar to see when your next dose is due:

If your next dose is within1 to 7 days...

Wait until it is time to take your next dose and take it as usual, then go back to taking one tablet a month according to the days marked on your calendar.

If your next dose is more than 7 days...

Take a tablet the morning after the day you remember forgetting the dose, then go back to taking one tablet a month according to the days marked on your calendar.

Never take two ABRION tablets within the same week.

Like all medicines, ABRION may have side effects, although not everyone will experience them.

These side effects may occur at certain frequencies, which are defined as follows: - very common: affects more than 1 in 10 people

- common: affects between 1 and 10 of every 100 people

- uncommon: affects between 1 and 10 of every 1,000 people

- rare: affects between 1 and 10 of every 10,000 people

- very rare: affects fewer than 1 in 10,000 people

- unknown: the frequency cannot be estimated from the available data.

The common side effectsinclude heartburn (a burning sensation that rises from the stomach to the mouth), indigestion, diarrhea, stomach pain, and nausea.

ABRION may also irritate the esophagus, although this reaction usually occurs if you ingest the dose according to the package insert. If you experience symptoms such as severe chest pain, severe pain when swallowing after eating or drinking, nausea, or vomiting, inform your doctor immediately.

Other common side effects include rash, muscle cramps, muscle and joint pain, and headache.

They also include flu-like symptoms (such as pain, feeling unwell, fatigue) that are usually mild, short-lived, and disappear shortly after taking the first dose. It is very likely that you can tolerate them and continue treatment with ABRION. However, speak with your doctor if the side effects worsen or last a long time.

The uncommon side effects are symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or a tingling sensation in the fingers or around the mouth, dizziness, back pain, and flatulence.

The rare side effects that may appear are swelling and itching of the face, lips, and mouth.

Atypical femur fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early symptoms and indicative of a possible femur fracture.

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 may be symptoms of damage to the bones of the ear.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this package insert, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use ABRION after the expiration date appearing on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of ABRION:

- The active ingredient is ibandronate acid. Each tablet contains 150 mg of ibandronate acid.

- The other components are:

tablet core:Polividone, microcrystalline cellulose (E460), cornstarch, crospovidone (E1202), colloidal silicon dioxide, dibehenate of gicerol

tablet coating:Titanium dioxide (E171), lactose monohydrate, hypromellose (E464)/macrogol/polietilenglycol 4000

Appearance of the product and contents of the package:

The coated tablets, are white or off-white in color, with a rounded biconvex shape.

ABRION 150 mg tablets are presented in aluminum-aluminum blister strips “PA/ALL/PVC-Aluminium”, containing one or three units.

Holder of the marketing authorization and responsible for manufacturing:

Holder

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A

C/Sagitario 14

03006 Alicante (Spain)

Telephone:965 28 67 00

Fax:965 28 64 34

Responsible for manufacturing

Pharmathen, S.A.

6, Dervenakion Str – GR-16351 (Pallini Attikis), Greece

or

Pharmathen International, S.A.

Shapes Industrial Park, Block 5 – 69300 (Rodopi), Greece

Last review date of this leaflet: April 2022.