Ibandronic acid Sandoz 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibandronic Acid Sandoz 150 mg film-coated tablets EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ibandronic Acid Sandoz is 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. How to store Ibandronic Acid Sandoz
6. Contents of the pack and other information

1. What is Ibandronic Acid Sandoz and what is it 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 by preventing further bone loss and increasing bone mass in most women who take it, even when they are unable to see or feel a difference. Ibandronic acid can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for 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 characterized by thinning and weakening of the bones, which is common among women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis.

Other factors that increase the risk of fractures include:

• inadequate dietary intake of calcium and vitamin D,
• smoking or excessive alcohol consumption,
• lack of walking or weight-bearing exercise,
• family history of osteoporosis.

Healthy lifestyle habits also support 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
• moderate alcohol consumption.

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

Do not take Ibandronic Acid Sandoz

• if you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6),
• if you have certain problems with your throat/food pipe (oesophagus), such as narrowing or difficulty swallowing,
• if you are unable to remain upright, either standing or sitting, for at least one continuous hour (60 minutes),
• if you have or have had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

Very rarely, a serious 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 occur after stopping treatment.

It is important to try to prevent ONJ from developing, 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.

Atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (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 starting treatment, inform your doctor/nurse (healthcare professional) if:

• you have any mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction,
• you do not receive 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 previously been treated with a bisphosphonate (used to treat or prevent bone disorders),
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone),
• you have cancer.

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

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for 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 healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people may require special care during treatment with ibandronic acid. Consult your doctor:

• if you have a mineral metabolism disorder (e.g. vitamin D deficiency),
• if you have kidney problems,
• if you have any difficulty swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/food pipe (oesophagus) may occur, often with symptoms such as 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 lie down before one 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 give Ibandronic Acid Sandoz to children or adolescents under 18 years of age.

Taking Ibandronic Acid Sandoz with other medicines

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

• Supplements containing calcium, magnesium, iron, or aluminium, as these may interfere with the effects of ibandronic acid.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestine, just like ibandronic acid. Therefore, be very careful when taking painkillers or anti-inflammatory medicines at the same time as ibandronic acid.

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

Taking Ibandronic Acid Sandoz with food and drink

Do not take ibandronic acid with food. Ibandronic acid becomes less effective if taken with food.

You may 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 intended for use only 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 may drive and use machines, as ibandronic acid is expected to have no 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 informed you that you have an intolerance to certain sugars, consult him 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 exactly the dosing instructions for ibandronic acid as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose of ibandronic acid is 1 tablet once a month.

How to take the monthly tablet

It is important that you carefully follow these instructions. They are designed to ensure that ibandronic acid reaches the stomach quickly and causes less irritation.

• Take 1 tablet of Ibandronic Acid Sandoz 150 mg once a month.

• Choose a day of the month that is easiest for you to remember. You may choose the same date (e.g., the first day of each month) or the same day of the week (e.g., the first Sunday of each month). Choose the option that best fits your routine.

• Take the ibandronic acid tablet at least 6 hours after your last meal or drink, except water.

• Take the ibandronic acid tablet

• immediately upon waking up, and

• before breakfast or drinking any liquids (on an empty stomach).

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

Do not take the tablet with water high in calcium, fruit juice, or other beverages. If there is concern about potentially high calcium levels 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 the mouth.

• During 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 may flow back into 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 may eat breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medications you require, if desired.

Continuation of treatment with Ibandronic Acid Sandoz

It is important that you take ibandronic acid every month, as directed by your doctor. After 5 years of treatment with Ibandronic Acid Sandoz, contact your doctor to determine whether 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 down, as 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 your chosen day, do not take the tablet later in the day. Instead, check your calendar to determine when your next dose is due:

• If you miss your dose on the scheduled day and your next dose is due in 1 to 7 days

Never take two tablets of Ibandronic Acid Sandoz 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 dates marked on your calendar.

• If you miss your dose on the scheduled day and your next dose is due in more than 7 days

Take one tablet the morning after the day you remember you missed the dose, then resume taking one tablet per month according to the dates marked on your calendar.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Severe chest pain, severe pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. You may have a serious inflammation of the throat/esophagus, possibly with sores 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 early signs of an unusual femur (thigh bone) fracture.

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

• Pain or ulcers in the mouth or jaw. These may be early symptoms of serious jaw problems (osteonecrosis (bone tissue death) of the jaw bone),
• Severe or potentially life-threatening allergic reaction,
• Serious skin adverse reactions,
• Consult your doctor if you have ear pain, ear discharge, and/or suffer an ear infection. These could be symptoms of damage to the ear bones.

Other possible adverse effects

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

• Headache,
• Acid reflux, discomfort when swallowing, stomach or abdominal pain (may be due to stomach inflammation), indigestion, nausea, diarrhea, bowel leakage,
• Muscle cramps, stiffness in joints and limbs,
• Flu-like symptoms, including fever, shivering, and chills, bone, muscle, and joint pain. Speak to a doctor or nurse if symptoms worsen or last longer than a few days,
• Rash.

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

• Dizziness,
• Flatulence (gas, bloating),
• 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 part of the intestine) causing stomach pain,
• Hives.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister and packaging after EXP/CAD. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Package contents and other information

Composition of Ibandronic Acid Sandoz

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

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

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

Appearance of the product and package contents

White, round, biconvex film-coated tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
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

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 filmomhulde tabletten
Italy: Acido Ibandronico Sandoz 150 mg compresse rivestite con film
Netherlands: Ibandroninezuur Sandoz 150 mg, filmomhulde tabletten
Portugal: Ácido Ibandrónico Sandoz 150 mg comprimidos revestidos por película
Romania: Ibandronic Acid Sandoz 150 mg comprimate filmate
Slovakia: Kyselina ibandrónová Sandoz 150mg filmom obalené tablety
Northern Ireland: Ibandronic acid Sandoz 150mg Film-coated Tablets

Date of the most recent review 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/