Ibandronic acid Alter 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibandronic Acid Alter 150 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ibandronic Acid Alter is and what it is used for
2. What you need to know before taking Ibandronic Acid Alter
3. How to take Ibandronic Acid Alter
4. Possible side effects
5. How to store Ibandronic Acid Alter
6. Contents of the pack and other information

1. What is Ibandronic Acid Alter and what is it used for?

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

Ibandronic Acid Alter can reverse bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they are unable to see or feel the difference. Ibandronic Acid Alter can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

Your doctor has prescribed Ibandronic Acid Alter to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

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

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. What you need to know before starting to take Ibandronic Acid Alter

Do not take Ibandronic Acid Alter

• If you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems with your throat/food pipe (oesophagus), such as narrowing or difficulty swallowing.
• If you are unable to remain upright, either standing or sitting, for at least one hour (60 minutes) continuously.
• If you have or have had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ibandronic Acid Alter.

Very rarely, a side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with ibandronic acid for osteoporosis. ONJ may also occur after stopping 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 problems with your mouth or teeth, 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 medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer

Your doctor may ask you to have a dental examination before starting treatment with ibandronic acid.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If you wear dentures, make sure they fit properly. 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 ibandronic acid.

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

Some people may require special care during treatment with ibandronic acid. Talk to your doctor before taking ibandronic acid if:

• you have a mineral metabolism disorder (e.g. vitamin D deficiency)
• you have kidney problems
• you have difficulty swallowing or digestive problems

Irritation, inflammation, or ulceration of the throat/food pipe (oesophagus) may occur, often with symptoms such as 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. If you develop these symptoms, stop taking ibandronic acid and inform your doctor immediately (see section 3).

Children and adolescents

Do not give ibandronic acid to children or adolescents under 18 years of age.

Taking Ibandronic Acid Alter with other medicines

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

• Calcium, magnesium, iron, or aluminium-containing supplements, as they may interfere with the effects of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestine, just like bisphosphonates (ibandronic acid). Therefore, be very careful when taking painkillers or anti-inflammatory medicines at the same time as ibandronic acid.

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

Taking Ibandronic Acid Alter with food and drinks

Do not take ibandronic acid with food. Ibandronic acid becomes less effective if taken with food. You may drink water, but no other liquids.

After taking ibandronic acid, wait 1 hour before eating your first meal or drinking other beverages (see section 3 “How to take Ibandronic Acid Alter”).

Pregnancy and breastfeeding

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

Do not take Ibandronic Acid Alter if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop breastfeeding while taking ibandronic acid.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and use machines, as ibandronic acid is not expected to have any effect or its effect is negligible on your ability to drive and use machines.

Ibandronic Acid Alter contains lactose

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

Ibandronic Acid Alter 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 Alter

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual dose of Ibandronic Acid Alter 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 ibandronic acid reaches the stomach quickly and causes less irritation.

• Take one 150 mg ibandronic acid tablet once a month.

• Choose a 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 the same day of the week (such as the first Sunday of each month). Choose whichever best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours without food or drink, except water.

• Take the ibandronic acid tablet

• immediately after waking up, and

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

• Swallow the tablet with a full glass of water (at least 180 ml).

Do not take the tablet with water that has a high calcium concentration, fruit juice, or other beverages. If you are unsure about 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 following 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 eat anything

• Do not drink anything (except water, if needed)

• Do not take any other medication

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

Continuation of treatment with Ibandronic Acid Alter

It is important that you take ibandronic acid every month, as directed by your doctor. Ibandronic acid helps treat osteoporosis only while you are taking the medicine.

After 5 years of taking ibandronic acid, consult your doctor to determine whether you should continue treatment with Ibandronic Acid Alter.

If you take more Ibandronic Acid Alter than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you have accidentally taken extra tablets, drink a full glass of milk and inform your doctor immediately.

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

If you forget to take Ibandronic Acid Alter

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 you missed your dose and your next dose is due in 1 to 7 days...

Never take two ibandronic acid 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 dates marked on your calendar.

If you forgot to take the tablet on your chosen day and your next dose is due in more than 7 days...

Take one tablet on the morning after you remember missing the dose, then resume your regular monthly schedule according to the dates marked on your calendar.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have a serious swelling possibly with pain or tightness in the throat/food pipe.

Rare (may affect up to 1 in 1,000 people)

• itching, swelling of the face, lips, tongue and throat, with difficulty breathing, persistent eye pain and swelling.
• new pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an unusual fracture of the thigh bone.

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

• pain or discomfort in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone].
• consult your doctor if you have ear pain, discharge from the ear, or suffer from an ear infection. These could be symptoms of damage to the ear bones.
• severe allergic reaction which may be life-threatening.
• serious skin reactions.

Other possible adverse effects

Common (may affect up to 1 in 10 people)

• headache.
• heartburn, discomfort when swallowing, stomach or abdominal pain (due to inflammation of the stomach), indigestion, nausea, diarrhoea (loose stools).
• muscle cramps, stiffness in joints and limbs.
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• dizziness.
• flatulence (gas, bloated feeling).
• back pain.
• feeling of fatigue and exhaustion.
• asthma attacks.
• symptoms of low calcium levels in the blood (hypocalcaemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

Rare (may affect up to 1 in 1,000 people)

• inflammation of the duodenum (first part of the intestine) causing stomach pain.
• hives.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Alter

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ibandronic Acid Alter

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
• The other components are:

tablet core: povidone K30, microcrystalline cellulose, pregelatinized corn starch, crospovidone, colloidal anhydrous silica, glycerol dibehenate.

coating of the tablet: Opadry OY-LS-28908 (white II) composed of: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Appearance of the product and contents of the container

The film-coated tablets of Ibandronic Acid Alter 150 mg are white, round, and biconvex.

The film-coated tablets of Ibandronic Acid Alter 150 mg are supplied in cardboard boxes containing the appropriate number of PA/Aluminum/PVC-Aluminum blisters (alu-alu blisters) with 1 or 3 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain

Manufacturer

Pharmathen S.A.
6 Dervenakion Str.
153 51 Pallini, Attiki
Greece

Or

Pharmathen International SA
Sapes Industrial Park, Block 5
69300 Rodopi
Greece

Or

Laboratorios Alter, S.A.
C/ Mateo Inurria, 30
28036 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.