Leaflet: information for the user

Ibandronic Acid Alter 150 mg film-coated tablets

Read this leaflet carefully before you start to take 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ibandronic Acid Alter belongs to a group of medications known asbisphosphonates.It contains the active ingredient ibandronic acid.

Ibandronic Acid Alter 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. Ibandronic Acid Alter 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 prescribed Ibandronic Acid Alter to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is characterized by a thinning and weakening of the bones, a common condition among 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 greater her risk of suffering fractures due to osteoporosis. Other factors that increase the risk of fractures include:

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

Healthy lifestyle habitsalso facilitate 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 Ibandronic Acid Alter

• If you are allergic to ibandronic acid or any of the other components of this medication (listed in section 6).
• If you have certain problems with your throat/food pipe (esophagus) such as narrowing or difficulty swallowing.
• If you cannot remain upright, both standing and sitting, for at least one hour straight (60 minutes).
• If you have or have had low calcium levels in your blood. Please consult your doctor.

Warnings and precautions

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

A very rare adverse reaction called osteonecrosis of the jaw (ONJ) (death of jawbone tissue) has been reported in patients treated with ibandronic acid for osteoporosis during post-marketing experience. ONJ may also appear after interrupting treatment.

It is essential to prevent the development of ONJ as it is 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 professional) if:

• You have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction.
• If you do not receive regular dental care or if you have not had a dental check-up for a long time.
• If you are a smoker (as this may increase the risk of dental problems).
• If you have been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• If you are taking corticosteroid medications (such as prednisolone or dexamethasone).
• If you have cancer.

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

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

Some people require special care during treatment with ibandronic acid. Consult your doctor before taking ibandronic acid.

• 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/food pipe (esophagus) 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 glass of water and/or if they lie down before an 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 administer ibandronic acid to children or adolescents under 18 years old.

Taking Ibandronic Acid Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially:

• Supplements containing calcium, magnesium, iron, or aluminumas they may influence the effects of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like bisphosphonates (ibandronic acid). Therefore, be careful when takinganalgesics or anti-inflammatory medicationsat the same time as ibandronic acid.

After taking the monthly ibandronic acid tablet,wait 1 hour before taking any other medication,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 effectiveness if taken with food.You may drink water, but not other liquids..

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

Pregnancy and breastfeeding

Ibandronic acid is only for use in postmenopausal women, and they should not take it while fertile.

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

Consult your doctor or pharmacist before using this medication.

Driving and using machines

You may drive and use machines as ibandronic acid is expected to have no effect or a negligible effect on your ability to drive and use machines.

Ibandronic Acid Alter contains lactose.

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Ibandronic Acid Alter contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, 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 essential to follow these instructions carefully. 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 the 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 fits your routine.

• Take the ibandronic acid tabletat least 6 hours after the last meal or drink, except for water.

• Take the ibandronic acid tablet

• immediately upon waking, and
• before breakfast or consuming liquids(with an empty stomach).

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

Do nottake the tablet with water with a high calcium concentration, fruit juice, or other beverages. If you are unsure about the potential high calcium levels of 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 remain upright (standing or sitting), part of the medication could return to the esophagus

• do not eat anything

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

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

Continuation of treatment with Ibandronic Acid Alter

It is essential to take ibandronic acid every month until your doctor tells you to stop. Ibandronic acid only treats osteoporosis while you are taking this medication.

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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have taken, by mistake, one or more extra tablets,drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause you could irritate your esophagus.

If you forget to take Ibandronic Acid Alter

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

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

Never take two ibandronic acid tablets within the same week.

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 marked days on your calendar.

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

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Rare(may affect up to 1 in 100 people)

• Severe chest pain, intense pain when swallowing food or drink, intense nausea or vomiting, difficulty swallowing. You may have a severe inflammation possibly with a sensation of pain or constriction, in the throat/ tube through which food passes.

Very 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 may be early symptoms of an unusual fracture of the thigh bone.

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

• Pain or sensation of pain in the mouth or jaw. These may be early symptoms of serious jaw problems [jaw necrosis (bone tissue death) of the jawbone].
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be symptoms of damage to the ear bones.
• Severe allergic reaction that may pose a life-threatening threat.
• Severe adverse reactions in the skin.

Other possible side effects

Common(may affect up to 1 in 10 people)

• Headache.
• Heartburn, discomfort when swallowing, stomach pain or cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses).
• Muscle cramps, joint stiffness and extremities.
• Symptoms similar to the flu, including fever, chills, and shivering, feeling unwell, bone and muscle pain, and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than two days.
• Skin rash.

Rare(may affect up to 1 in 100 people)

• Dizziness.
• Flatulence (gas, feeling bloated).
• Back pain.
• Sensation of fatigue and exhaustion.
• 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.

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

• Inflammation of the duodenum (first section of the intestine) that causes stomach pain
• Urticaria.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibandronic Acid Alter

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

tablet core: povidone K30, microcrystalline cellulose, pregelatinized cornstarch, 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 contents of the package

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

Ibandronic Acid Alter 150 mg film-coated tablets are presented in cartons containing the appropriate number of PA/Aluminio/PVC-Aluminio (alu-alu blister) blisters containing 1 or 3 units.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter. S.A

C/ Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen.S.A

6 Dervenakion Str.

153 51 Pallini, Attiki

Greece

O

Pharmathen International SA,

Sapes Industrial Park, Block 5

69300Rodopi

Greece

O

Laboratorios Alter. S.A

C/ Mateo Inurria, 30

28036 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: March 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.