Abrion 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ABRION 150 mg film-coated tablets EFG

Ibandronic acid

Contents of the leaflet:

1. What ABRION is and what it is used for
2. Before you take ABRION
3. How to take ABRION
4. Possible side effects
5. How to store ABRION
6. Further information

1. What ABRION is and what it is used for

ABRION belongs to a group of medicines called bisphosphonates and contains the active substance ibandronic acid. It does not contain hormones.

ABRION can reverse bone loss by preventing further bone loss and increasing bone mass in most women who take it, even if they are unable to see or feel a difference. ABRION can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed ABRION to treat your osteoporosis because you are at high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common among women after menopause. During menopause, the ovaries stop producing the female hormone—estrogen—that helps maintain skeletal health.

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

• inadequate dietary intake of calcium and vitamin D
• smoking or excessive alcohol consumption
• lack of walking or other weight-bearing exercises
• family history of osteoporosis

Many people with osteoporosis do not experience symptoms. If you have no symptoms, it may be difficult to know whether you have the condition. However, osteoporosis increases the likelihood of bone fractures following a fall or injury. Any bone fracture occurring after age 50 may be a sign of osteoporosis. Osteoporosis may also cause back pain, loss of height, and kyphosis (stooped posture).

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

Healthy lifestyle habits also support the beneficial effects of treatment. These include a balanced diet rich in calcium and vitamin D; walking or other weight-bearing exercises; not smoking; and moderate alcohol consumption.

2. BEFORE TAKING ABRION

Do not take ABRION:

• If you are allergic (hypersensitive) to ibandronic acid or to any of the other components of ABRION.

• If you have certain oesophageal problems (the oesophagus is the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.

• If you are unable to remain upright, either standing or sitting, for at least one continuous hour (60 minutes).

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

Do not administer ABRION to children or adolescents.

Take special care with ABRION:

Some people require special precautions during treatment with ABRION.

Consult your doctor:

• If you have any mineral metabolism disorders (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 dental surgery planned, inform your dentist that you are being treated with ABRION.

Irritation, inflammation, or ulceration of the oesophagus (the oesophagus is the tube connecting your mouth to your stomach) may occur, often accompanied by symptoms such as severe chest pain, intense pain after swallowing food and/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 ABRION. If you develop these symptoms, stop taking ABRION and inform your doctor immediately.

Very rarely, an adverse reaction known as 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 discontinuation of 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 starting treatment, inform your doctor/nurse (healthcare professional) if:

• You have mouth or dental problems, such as poor dental health, gum disease, or 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 previously been 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 ABRION.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for 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 mouth or dental problems, such as tooth loss, pain or swelling, or difficulty healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Use of other medicines:

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

• Supplements containing calcium, magnesium, iron, or aluminium, as they may possibly interfere with the effects of ABRION.

• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestines; similar to bisphosphonates (like ABRION 150). Therefore, be very careful when taking painkillers or anti-inflammatory drugs 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 becomes less effective if taken with food.

You may drink tap water but no other liquids (see section 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 in order to take ABRION.

Driving and use of machines

It is highly unlikely that ABRION will affect your ability to drive or use machinery.

Important information about some of the components of ABRION

ABRION contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. HOW TO TAKE ABRION

Follow exactly the 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 important that you carefully follow these instructions. They are designed to ensure that ABRION reaches the stomach quickly and causes less irritation.

• Take one ABRION tablet once a month.

• Choose the day of the month that is easiest for you to remember. You may choose the same date (such as the first day of each month) or always the same day (such as the first Sunday of each month). Choose whichever best fits your routine.

• Take the ABRION tablet after at least 6 hours without food or drink (except water). You may only drink water during this period.

• Take the ABRION tablet

• immediately after waking up, and

• before breakfast or consuming any liquids (on an empty stomach)

• Swallow the tablet whole 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 following hour (60 minutes) after taking the tablet:

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

• do not eat anything

• do not drink anything (except tap water, if needed)

• do not take any other medication

• After waiting for 1 hour, you may eat breakfast and drink the first beverage of the day. Once you have eaten, you may, if desired, lie down and take any other medications you need.

Do not take this medicine at bedtime or just before getting up.

Continuation of ABRION treatment

It is important that you take ABRION every month, for as long as your doctor instructs. ABRION treats osteoporosis only while you are taking the medication.

If you take more ABRION than you should:

If you accidentally take more tablets than prescribed, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie down, as this could irritate the esophagus.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take ABRION:

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

If your next dose is due in 1 to 7 days...

Wait until your next scheduled dose and take it as usual. Then continue taking one tablet per month according to the dates marked on your calendar.

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

Take one tablet on the morning after the day you remembered you missed the dose. Then continue taking one tablet per month according to the dates marked on your calendar.

Never take two ABRION tablets within the same week.

4. Possible adverse effects

Like all medicines, ABRION may have adverse effects, although not everyone experiences them.

These side effects may occur with certain frequencies, defined as follows:

• Very common: affects more than 1 in 10 people
• Common: affects between 1 and 10 in every 100 people
• Uncommon: affects between 1 and 10 in every 1,000 people
• Rare: affects between 1 and 10 in every 10,000 people
• Very rare: affects fewer than 1 in every 10,000 people
• Not known: frequency cannot be estimated from available data.

Common side effects include pyrosis (a burning sensation rising from the stomach to the mouth), indigestion, diarrhoea, stomach pain, and nausea.

ABRION may also irritate the oesophagus, although this reaction can usually be avoided if the dose is taken as directed in the leaflet. 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 may also include flu-like symptoms (such as pain, malaise, fatigue), which are usually mild, short-lived, and disappear shortly after taking the first dose. You are very likely to tolerate these symptoms and continue treatment with ABRION. However, speak to your doctor if the symptoms worsen or persist for a long time.

Uncommon side effects include symptoms of low calcium levels in the blood (hypocalcaemia), such as muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth, dizziness, back pain, and flatulence.

Rare side effects that may occur include swelling and itching of the face, lips, and mouth.

Atypical femoral fractures (thigh bone fractures) may occur rarely, particularly in patients undergoing long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early warning signs indicating a possible femoral fracture.

Very rare (may affect up to 1 in 10,000 people).

Consult your doctor if you experience ear pain, ear discharge, or an ear infection. These could be symptoms of damage to the ear bones.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of ABRION

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use ABRION after the expiry date stated on the container after “EXP:”. The expiry date is the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of ABRION:

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic acid.

• The other components are:

Tablet core: Povidone, microcrystalline cellulose (E460), corn starch, crospovidone (E1202), colloidal silicon dioxide, glycerol dibehenate

Tablet coating: Titanium dioxide (E171), lactose monohydrate, hypromellose (E464)/macrogol/polyethylene glycol 4000

Appearance of the product and contents of the container:

The film-coated tablets are white or almost white, round biconvex in shape.

ABRION 150 mg tablets are available in "aluminum-aluminum" blisters (PA/AL/PVC-Aluminium), containing one or three units.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.
C/Sagitario 14
03006 Alicante (Spain)
Telephone: 965 28 67 00
Fax: 965 28 64 34

Manufacturer

Pharmathen, S.A.
6, Dervenakion Str – GR-16351 (Pallini Attikis), Greece

or

Pharmathen International, S.A.
Shapes Industrial Park, Block 5 – 69300 (Rodopi), Greece

Date of the most recent revision of this leaflet: April 2022.