Patient Information Leaflet: Product Information

Ibandronic Acid Sandoz 150 mg 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 give it to others even if they have similar symptoms, 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.

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

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

3.How to take Ibandronic Acid Sandoz

4.Possible side effects

5.Storage of Ibandronic Acid Sandoz

6. Contents of the pack and additional information

Sandoz Ibandronic Acid belongs to a group of medicines called bisphosphonates.

It contains the active substance ibandronic acid. Ibandronic acid can reverse bone loss by preventing further loss and increasing bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronic acid can 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 to 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, which is common in 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 suffering fractures include:

• insufficient intake of calcium and vitamin D in the diet,
• smoking or excessive alcohol consumption,
• lack of physical activity or weight-bearing exercise,
• family history of osteoporosis.

Healthy lifestyle habits also facilitate the favorable effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D,
• physical activity or weight-bearing exercise,

not smoking, and moderate alcohol consumption.

Do not take Sandoz Ibandronic Acid

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (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 in a row (60 minutes),
• if you have or have had low levels of calcium in your blood.Please consult your doctor.

Warnings and precautions

A very rare adverse reaction 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 appear 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,
• 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 medications called corticosteroids (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 fixed. 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.

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. Consult your doctor:

• 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 frequently 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 Sandoz Ibandronic Acid to children or adolescents under 18 years of age.

Use of Sandoz Ibandronic Acid with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. Especially if you are taking:

• Calcium, magnesium, iron, or aluminum supplementsas 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; just like ibandronic acid. Therefore, be careful when taking painkillers or anti-inflammatory medications at the same time as ibandronic acid.

After taking the monthly ibandronic acid tablet,wait 1 hour to take any other medicine, even antacids, calcium supplements, or vitamins.

Taking Sandoz Ibandronic Acid with food and drinks

Do not takeibandronic acidwith food. Ibandronic acid loses its effectiveness if taken with food.

You may drink water but not other liquids.

After taking Sandoz Ibandronic Acid, please wait 1 hour before taking the first meal and drink (see section 3 “How to take Sandoz Ibandronic Acid”).

Pregnancy and breastfeeding

Sandoz Ibandronic Acid is only for use in postmenopausal women and should not be taken by women of childbearing age. Do not take ibandronic acid if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

You may drive and operate machines as ibandronic acid is expected to have an insignificant or no effect on your ability to drive and operate machines.

Sandoz Ibandronic Acid contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

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

Follow exactly the administration instructions for ibandronic acid indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose of ibandronic acid is 1 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 tablet of Ibandronic Acid Sandoz 150 mg 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 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 high in calcium, fruit juice, or other beverages. If there is a concern regarding potentially high levels of calcium in the 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 you need it),
• 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 with Ibandronic Acid Sandoz

It is essential to take ibandronic acid every month until your doctor tells you to stop. After 5 years of treatment with Ibandronic Acid Sandoz, contact your doctor to find out if you should continue treatment with Ibandronic Acid Sandoz.

If you take more Ibandronic Acid Sandoz than you should

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

Do not induce vomiting or lie downas this could cause ibandronic acid to irritate your esophagus.

If you forget to take Ibandronic Acid Sandoz

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

• Do not take two tablets of Ibandronic Acid 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 your dose on the designated day and your next dose is within 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.

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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Rare(may affect up to 1 in 100 people):

• Severe chest pain, strong pain after eating or drinking, intense nausea or vomiting, difficulty swallowing. You may have a severe inflammation of the

throat/esophagus, possibly with sores or constriction of the throat or esophagus.

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. You may be experiencing the first signs of an unusual fracture of the thigh bone.

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

• Pain or ulcers in the mouth or jaw. They may be early signs of serious jaw problems (necrosis (bone tissue death) of the jawbone),
• Severe or potentially fatal allergic reaction,
• Severe adverse reactions in the skin,
• Consult your doctor if you have ear pain, the ear is discharging and/or you have an ear infection. These may be signs of damage to the ear bones.

Other possible side effects

Common(may affect up to 1 in 10 people):

• Headache,
• Heartburn, swallowing difficulties, stomach pain or abdominal pain (may be 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, bone, muscle, and joint pain. Talk to a doctor or nurse if the effects worsen or last more than a couple of days,
• Rash.

Uncommon(may affect up to 1 in 100 people):

• Dizziness,
• Flatulence (gas, feeling bloated)
• Back pain,
• Feeling tired and exhausted,
• 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) causing stomach pain,
• Urticaria.

Reporting of 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 the 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 blister and packaging after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Ibandronic Acid Sandoz

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

Core: povidone, microcrystalline cellulose, pregelatinized maize starch, crospovidone, anhydrous colloidal silica, glycerol dibehenate.

Coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Appearance of the product and contents of the package

White, round, biconvex film-coated tablets.

Ibandronic Acid Sandoz is presented in a carton containing an appropriate number of blisters of (1, 3 or 6 tablets) PA/Aluminum/PVC-Aluminum (Alu-Alu blister) and a leaflet.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

LEK S.A.

ul. Domaniewska 50 C,

PL-02-672 Warszawa

Poland

or

Pharmathen S.A.

6 Dervenakion Str.,

153 51 Pallini, Attiki,

Greece

or

Lek pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7ª

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Pharmathen International, S.A.

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

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

Bélgica:Ibandronic acid Sandoz 150 mg film-coated tablets

Italy:Ibandronic acid Sandoz 150 mg film-coated tablets

Netherlands:Ibandronic acid Sandoz 150 mg film-coated tablets

Portugal:Ibandronic acid Sandoz 150 mg film-coated tablets

Romania:Ibandronic acid Sandoz 150 mg film-coated tablets

Slovak Republic:Ibandronic acid Sandoz 150 mg film-coated tablets

Northern Ireland:Ibandronic acid Sandoz 150mg Film-coated Tablets

Last review date of this leaflet:December 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/