Package Leaflet: Information for the User

Ibandronic Acid Aristo 150mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Ibandronic Acid Aristo and what it is used for

2.What you need to know before taking Ibandronic Acid Aristo

3.How to take Ibandronic Acid Aristo

4.Possible side effects

5.Storage of Ibandronic Acid Aristo

6.Contents of the pack and additional information

This medicationbelongs to a group of medications called bisphosphonates. It contains the active ingredient ibandronate.

Ibandronate Aristomay 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.Ibandronate Aristomay help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribedIbandronate Aristoto treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is a condition characterized by a thinning and weakening of the bones, a common occurrence in women after menopause. During menopause, the ovaries stop producing the female hormone —estrogen— 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 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 takeIbandronic Acid Aristo:

-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/esophagus (the tube through which food passes), such as narrowing or difficulty swallowing.

-If you are unable to remain upright, both standing and sitting, for at least one hour (60 minutes) at a time.

-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 Aristo.

A rare side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients receiving ibandronic acid for osteoporosis. ONJ can also occur after stopping 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,
• You do not receive regular dental care or have not had a dental check-up for a long time,
• You are a smoker (as this can 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 Ibandronic Acid Aristo.

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 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 Aristo.

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.

Some people require special care during treatment with Ibandronic Acid Aristo. Consult your doctor before taking Ibandronic Acid Aristo:

-If you have any mineral metabolism disorders (e.g., vitamin D deficiency).

-If you have any kidney problems.

-If you have any swallowing or digestive problems.

-

Esophageal irritation, inflammation, or ulceration may occur, often with 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 Aristo. If you develop these symptoms, stop taking Ibandronic Acid Aristo and inform your doctor immediately (see section 3).

Children and adolescents

Do not administer Ibandronic Acid Aristo to children or adolescents under 18 years old.

Other medications and Ibandronic Acid Aristo

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

-Calcium, magnesium, iron, or aluminum supplementsas they may affect the effects of Ibandronic Acid Aristo.

-Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like Ibandronic Acid Aristo. Therefore, be careful when taking pain relievers or anti-inflammatory medications at the same time as Ibandronic Acid Aristo.

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

Administration of Ibandronic Acid Aristo with food and drinks

Do not take Ibandronic Acid Aristo with food.Ibandronic Acid Aristo loses its effectiveness if taken with food.

You may drink water but not other liquids.

After taking Ibandronic Acid Aristo, wait 1 hour before taking your first meal and other drinks (see section 3).

Pregnancy and breastfeeding

Ibandronic Acid Aristo is only for use in postmenopausal women, and they should not take it if they are fertile.

Do not take Ibandronic Acid Aristo if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medication.

Driving and operating machines

You may drive and operate machines as it is expected that Ibandronic Acid Aristo will have no effect or a negligible effect on your ability to drive and operate machines.

This medication contains lactose.

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

Ibandronic Acid Aristo contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free"..

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult with your doctor or pharmacist.

The recommended dose of the medication 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 theibandronatetablet reaches the stomach quickly and causes less irritation.

-Take oneibandronate Aristo150mg 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 theibandronatetablet after a minimum of 6 hours after the last meal or drink,except for water.

-Take the tablet:

• nothing more than upon waking, and
• before breakfast or before consuming liquids(with an empty stomach).

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

Do not takethe tablet with high calcium water, fruit juices, or other beverages. If you have any doubt 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 hour following (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 you wish, lie down and take any other medications you need.

Continuation of treatment withibandronate Aristo

It is essential to takeibandronate Aristoevery month, until your doctor tells you otherwise.

After 5 years of takingibandronateconsult with your doctor if you should continue takingthe medication.

If you take moreibandronate Aristothan you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeibandronate Aristo

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

Never take twoibandronate Aristotablets within the same week. Wait until it is time to take the 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 forgot 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine 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):

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

Uncommon(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 a possible unusual fracture of the thigh bone.

Very 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[bone necrosis (death of bone tissue) of the jawbone].

• Consult your doctor if you have ear pain, your ear is discharging, or you have an ear infection. These may be symptoms of damage to the bones of the ear.

?severe allergic reaction that may pose a life-threatening risk.

• severe skin adverse reactions.

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

?flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone, muscle, and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days

?skin rash.

Uncommon(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.

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 of side effects:

If you experience any type of side effect, consult your doctor or nurse, 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 of 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 medicine.

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 after CAD.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications.This will help protect the environment.

Composition of Aristo Ibandronic Acid

-The active ingredient is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (in the form of sodium monohydrate).

-The other components are:

Tablet core: Povidone, microcrystalline cellulose, pregelatinized cornstarch, crospovidone, anhydrous colloidal silica, glicerol 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

Aristo Ibandronic Acid tablets are white or off-white, round, and biconvex.

They are presented in carton containers containing 1 or 3 tablets conditioned in PA/Aluminum/PVC-aluminum laminate (alu-alu blister).

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible manufacturer

Pharmathen S.A.

6 Dervenakion Str.

153 51 Pallini, Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

693 00 Rodopi

Greece

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

Last review date of this leaflet: July 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