IBANDRONIC ACID ALTER 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Alter 150 mg film-coated tablets EFG

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.

Contents of the pack and other information:

1. What is Ibandronic Acid Alter and what is it used for
2. What you need to know before you take Ibandronic Acid Alter
3. How to take Ibandronic Acid Alter
4. Possible side effects
5. Storing 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 cannot see or feel the difference. Ibandronic Acid Alter may help reduce the risk of broken bones (fractures). This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed Ibandronic Acid Alter to treat your postmenopausal osteoporosis because you are at high risk of fractures.Osteoporosis is a condition where bones become thinner and weaker, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep the bones healthy.

The earlier a woman reaches the menopause, the greater her risk of 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 weight-bearing exercise, such as walking
• a family history of osteoporosis.

Healthy lifestyle habitscan also help 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 not drinking too much alcohol

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

Do not take Ibandronic Acid Alter

• Please consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Ibandronic Acid Alter.

A rare side effect has been reported with ibandronic acid called osteonecrosis of the jaw (ONJ) (bone damage in the jaw). This has been reported mostly in patients taking ibandronic acid for osteoporosis who have had dental procedures such as tooth extraction or who have poor dental health.

It is important to try to prevent ONJ as it can be a painful condition that can 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 provider) if:

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

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

While you are being treated with ibandronic acid, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should make sure they fit properly. If you are having dental treatment or are about to have a tooth extracted, 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 loose teeth, pain or swelling, or difficulty healing after dental procedures, as these could be signs of osteonecrosis of the jaw.

Some people need special care when taking ibandronic acid. Consult your doctor before taking ibandronic acid.

Irritation, inflammation or ulceration of the gullet (oesophagus) 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 if they lie down less than 60 minutes after taking ibandronic acid. If you develop these symptoms, stop taking ibandronic acid and tell 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 take any other medicines. Especially:

• supplements containing calcium, magnesium, iron or aluminiumas they may interfere with the effects of ibandronic acid.
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium and naproxen) which may irritate the stomach and intestines, as do bisphosphonates (ibandronic acid). Therefore, be careful when taking analgesics or anti-inflammatory drugsat 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 loses its effect if taken with food. You can drink water, but not other drinks.

After taking ibandronic acid, wait 1 hour before taking your first food and other drinks (see section 3 “How to take Ibandronic Acid Alter”).

Pregnancy and breast-feeding

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

Do not take Ibandronic Acid Alter if you are pregnant or breast-feeding. If you are breast-feeding, you may need to stop doing so to take ibandronic acid.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines as ibandronic acid is not expected to affect your ability to drive or use machines.

Ibandronic Acid Alter contains lactose.

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

Ibandronic Acid Alter contains sodium

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

3. How to take Ibandronic Acid Alter

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended dose of Ibandronic Acid Alter is one tablet once a month.

How to take the monthly tablet

It is important that you follow these instructions carefully. They are designed to help ibandronic acid reach the stomach quickly and cause less irritation.

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

• Choose a day of the monththat you can easily 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 tablet after an interval of at least 6 hours after the last food or drink except water.

• Take the ibandronic acid tablet

• immediately after waking up, and
• before breakfast or drinking (on an empty stomach).

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

Do nottake the tablet with water with a high concentration of calcium, fruit juice or other drinks. If you are unsure about the 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.

• For the next hour (60 minutes)after taking the tablet

• do not lie down; if you do not stay upright (standing or sitting), part of the medicine could come back up into your gullet (oesophagus)

• do not eat anything

• do not drink anything(except water, if needed)
• do not take any 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.

Continuation of treatment with Ibandronic Acid Alter

It is important that you take ibandronic acid every month, until your doctor tells you to stop. Ibandronic acid only works for osteoporosis while you are taking it.

After 5 years of taking ibandronic acid, consult your doctor to see if you should continue taking Ibandronic Acid Alter.

If you take more Ibandronic Acid Alter than you should

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

If you have taken, by mistake, one more tablet than prescribed, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downas this could irritate your gullet (oesophagus).

If you forget to take Ibandronic Acid Alter

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 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 a month on the days 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 a tablet the next morning after the day you remember you forgot the dose, then continue taking one tablet a month on the days marked on your calendar.

If you have any other questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need 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 severe inflammation possibly with a feeling of pain or constriction in the gullet (oesophagus).

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 inflammation.
• new pain, weakness or discomfort in the thigh, hip or groin. These can be early signs of a possible 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 can be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone].
• tell your doctor if you have ear pain, discharge from the ear or an ear infection. These could be signs of damage to the bones of the ear.
• severe allergic reaction that can be life-threatening.
• severe skin reactions.

Other possible side effects

Common(may affect up to 1 in 10 people)

• headache.
• heartburn, difficulty swallowing, stomach pain or discomfort (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 of illness, pain in bones, muscles and joints. Consult your doctor or nurse if any effect becomes troublesome or lasts more than a couple of days.
• skin rash.

Uncommon(may affect up to 1 in 100 people)

• dizziness.
• flatulence (bloating, feeling of being bloated).
• back pain.
• feeling tired or weak.
• asthma attacks.
• symptoms of low blood calcium levels (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 section of the intestine) that causes stomach pain
• hives.

Reporting of side effects

If you get any 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ibandronic Acid Alter

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ibandronic Acid Alter

• The active ingredient 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, anhydrous colloidal silica, glycerol dibehenate.

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

Appearance of the Product and Container Content

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 presented in cardboard boxes containing the appropriate number of PA/Aluminum/PVC-Aluminum (alu-alu blister) packs containing 1 or 3 units.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Alter Laboratories, S.A.

Mateo Inurria Street, 30

28036 Madrid

Spain

Manufacturer

Pharmathen S.A.

6 Dervenakion Street

153 51 Pallini, Attiki

Greece

Or

Pharmathen International S.A.,

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

Or

Alter Laboratories, S.A.

Mateo Inurria Street, 30

28036 Madrid

Spain

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

Date of the Last Revision of this Leaflet: March 2023

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/.