IBANDRONIC ACID SANDOZ 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibandronic Acid Sandoz 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

1. What Ibandronic Acid Sandoz is and what it is used for
2. What you need to know before you take 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 other information

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

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

It contains the active substance ibandronic acid. Ibandronic acid 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 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 to treat your postmenopausal osteoporosis because you are at high risk of fractures.Osteoporosis is a condition where your bones become thin and weak, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone, estrogen, which helps to keep your skeleton 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,
• lack of weight-bearing exercise,
• family history of osteoporosis.

Healthy lifestyle habitsalso help the beneficial effects of treatment. These include:

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

not smoking, and moderate alcohol consumption.

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

Do not take Ibandronic Acid Sandoz

• 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 stand or sit upright for at least one hour (60 minutes),
• if you have or have had low blood calcium levels.Please consult your doctor.

Warnings and precautions

A very rare side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with ibandronic acid for osteoporosis. ONJ can also occur after stopping treatment.

It is important to try to prevent ONJ from developing 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 need to be taken.

Atypical fractures of long bones, such as the forearm (ulna) and lower leg (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma and some patients experience pain in the area of the fracture before a complete fracture occurs.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• you have dental problems or are about to undergo dental surgery,
• you do not receive regular dental check-ups 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 medicines called 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, 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 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 with your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty healing of mouth ulcers or discharge, as these could be signs of osteonecrosis of the jaw.

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

• 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.

Irritation, inflammation, or ulcers of the throat/food pipe (esophagus) may occur, often with symptoms of severe chest pain, severe pain after swallowing food and/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 inform your doctor immediately (see section 3).

Children and adolescents

Do not give Ibandronic Acid Sandoz to children or adolescents under 18 years of age.

Using Ibandronic Acid Sandoz with other medicines

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

• Supplements containing calcium, magnesium, iron, or aluminumas 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) as they may irritate the stomach and intestines, as does ibandronic acid. Therefore, be careful when taking painkillers or anti-inflammatory drugs at the same time as ibandronic acid.

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

Taking Ibandronic Acid Sandoz with food and drinks

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

You can drink water but no other liquids.

After taking Ibandronic Acid Sandoz, please wait 1 hour before taking your first food and drink (see section 3 "How to take Ibandronic Acid Sandoz").

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines as ibandronic acid is not expected to have a significant or negligible effect on the ability to drive and use machines.

Ibandronic Acid Sandoz contains lactose and sodium

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

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

3. How to take Ibandronic Acid Sandoz

Follow the instructions for administration of ibandronic acid exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose of ibandronic acid 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 Ibandronic Acid Sandoz 150 mg 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 at least 6 hours after your 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 that has a high calcium content, fruit juice, or other drinks. If there is concern about potentially high calcium levels in the water (hard water), it is recommended to use bottled water with a low mineral content.

• Swallow the tablet whole, do not chew, crush, or dissolve it in your mouth.

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

• do not lie down; if you do not remain upright (standing or sitting), some of the medicine could come back up into your esophagus,

• 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 your 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 Sandoz

It is important that you 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 contact 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 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 forget your dose on the scheduled day and your next dose is within 1 to 7 days

Never take two Ibandronic Acid Sandoz 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 days marked on your calendar.

• If you forget your dose on the scheduled day and your next dose is more than 7 days away

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

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

4. Possible side effects

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

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

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

• Severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. You may have severe inflammation of the throat/esophagus, possibly with ulcers or narrowing of the throat or esophagus.

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. You may be experiencing the first signs of a possible 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. These can be early symptoms of serious jaw problems (necrosis (death of bone tissue) of the jawbone),
• severe allergic reaction or potentially life-threatening allergic reaction,
• severe skin reactions,
• consult your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be symptoms of damage to the bones of the ear.

Other possible side effects

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

• headache,
• heartburn, difficulty swallowing, stomach pain or discomfort (may be due to stomach inflammation), indigestion, nausea, diarrhea, bowel movements
• muscle cramps, stiffness in the joints and limbs.
• flu-like symptoms, including fever, chills, and shivers, 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,
• bloating (gas, feeling bloated)
• back pain,
• feeling tired and weak,
• 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,
• hives.

Reporting of side effects:

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

5. Storage of Ibandronic Acid Sandoz

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 blister and carton after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Acid Ibandronic Sandoz

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

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

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

Appearance and Packaging of the Product

White, round, and biconvex film-coated tablets.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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

Belgium: Ibandronic acid Sandoz 150 mg film-coated tablets

Italy: Acido Ibandronico Sandoz 150 mg coated tablets

Netherlands: Ibandroninezuur Sandoz 150 mg, film-coated tablets

Portugal: Ácido Ibandrónico Sandoz 150 mg film-coated tablets

Romania: Ibandronic Acid Sandoz 150 mg film-coated tablets

Slovak Republic: Kyselina ibandrónová Sandoz 150mg film-coated tablets

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

Date of the last revision of this leaflet:January 2025

Detailed 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/