Leaflet: information for the user

Ibandronic Acid STADA 150 mg film-coated tablets EFG

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 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.

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

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

3. How to take Ibandronic Acid Stada

4. Possible side effects

5. Storage of Ibandronic Acid Stada

6. Contents of the pack and additional information

Ibandronic acid belongs to a group of medications called bisphosphonates. It contains the active ingredient ibandronic acid. Ibandronic acid may reverse bone loss by preventing further bone loss and increasing bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronic acid may help reduce the number of bone 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 consists of a thinning and weakening of the bones, a common condition among 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 suffering 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

A healthy lifestyle also facilitates 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 ibandronate:

• if you are allergic to ibandronate 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 (60 minutes) at a time.
• if you have or have had low calcium levels 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 ibandronate 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 corticosteroid medications (such as prednisolone or dexamethasone)

•ifyou have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronate Stada.

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 ibandronate.

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 ibandronate. Consult your doctor before taking ibandronate:

• 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.

Esophageal irritation, inflammation, or ulceration may occur, often with severe 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 one hour after taking ibandronate. If you develop these symptoms, stop taking ibandronate and inform your doctor immediately (see section 3).

Children and adolescents

Do not administer ibandronate to children or adolescents under 18 years of age.

Other medicines and ibandronate

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

• Calcium, magnesium, iron, or aluminum supplements, as they may affect the effects of ibandronate.
• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen), which may irritate the stomach and intestines, just like bisphosphonates (such as ibandronate). Be careful when taking painkillers or anti-inflammatory medications at the same time as ibandronate.

After taking the monthly ibandronate tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements, and vitamins.

Ibandronate with food and drinks:

Do not take ibandronate with food. Ibandronate loses its effectiveness if taken with food.

You may drink water, but not other liquids.

Do not take water with high calcium levels. If you suspect that tap water may contain high levels of calcium (hard water), it is recommended that you use bottled water with low mineral content (see section 3).

Take ibandronate at least 6 hours after eating, drinking, or taking any other medicine or supplement (e.g., products containing calcium (milk), aluminum, magnesium, and iron) except water.

After taking ibandronate, wait 1 hour before eating your first meal and other drinks (see point 3 How to take Ibandronate Stada).

Pregnancy and breastfeeding

Ibandronate is only for use in postmenopausal women and should not be taken by women of childbearing age.

Do not take ibandronate if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop it to take ibandronate.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

You may drive and operate machines as ibandronate is expected to have no effect or a negligible effect on your ability to drive and operate machines.

Ibandronate Stada contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it 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 ibandronate acid is one tablet per month.

Administration Form

It is essential to follow these instructions carefully. They are designed to ensure that ibandronate acid 150 mg reaches the stomach immediately and causes less irritation.

• Take one ibandronate acid tablet once a month.
• Choose the day of the month that 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) to take your ibandronate acid tablet. Choose what best fits your routine.
• Take the ibandronate acid tablet after a minimum of 6 hours after the last meal or drink, except for water

• Take the ibandronate 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 not take the tablet with water with a high concentration of calcium, fruit juice, 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 ingesting 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.

Do not take this medication at bedtime or before getting up.

Continuation of treatment with ibandronate acid

It is essential to take ibandronate acid every month until your doctor tells you to stop. After 5 years of taking ibandronate acid, consult with your doctor if you should continue taking ibandronate acid.

If you take more ibandronate acid than you should

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 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 down because ibandronate acid could irritate your esophagus.

If you forgot to take ibandronate acid

Do not take a double dose to compensate for the missed doses.

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

If your next dose is within 1 to 7 days...

Wait until it is time to take the next dose and take it as usual, then go back to taking one tablet per month according to the marked days on your calendar.

If your next dose is more than 7 days...

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

Never take two ibandronate acid tablets within the same week.

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 severe 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.

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.

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 (necrosis (bone tissue death) 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 ear bones.

•Severe allergic reaction that may be life-threatening.

•Severe adverse reactions in the skin.

Other possible side effects

Frequent (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 and limb stiffness

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

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 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 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.

This medication does not require special storage conditions.

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 Stada

• The active ingredient is ibandronic acid.

Each tablet contains 150 mg of ibandronic acid (in the form of sodium monohydrate).

• The other components are: lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), sodium stearate fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).

Appearance of the product and contents of the package

Ibandronic Acid Stada tablets are white or off-white, oval-shaped and marked with the inscription “19BE” on one side and “150” on the other.

They are available in blister packs of 1, 3, 6, 9 or 12 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

Synthon BV

Microweg 22,

6545CM Nijmegen (Netherlands)

or

Synthon Hispania,S.L.

C/ Castelló 1,

08830 Sant Boi de Llobregat (Spain)

or

STADA Arzneimittel AG,

Stadastrasse 2 – 18,

61118 Bad Vilbel,

Germany

or

Eurogenerics N.V.,

Heizel Esplanade B22, 1

020 Brussels,

Belgium

or

STADA Arzneimittel GmbH,

Muthgasse 36,

1190 Vienna,

Austria

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

BE:Ibandronate EG 150mg filmomhulde tabletten

BG:Ibandronic acid STADA 150 mg filmcoated tablets

CZ:Ibandronic acid STADA 150 mg potahované tablety

DE:Ibandronsäure AL 150 mg Filmtabletten

DK:Ibandronat STADA

ES:Ácido Ibandrónico STADA 150 mg comprimidos recubiertos con película EFG

FI:Ibandronat STADA 150 mg tabletti, kalvopäällysteinen

FR:ACIDE IBANDRONIQUE EG 150 mg, comprimé pelliculé

HU:Ibandronsav Stada 150 mg filmtabletta

IE:Ibandronic acid Clonmel 150 mg film-coated tablets

IT:ACIDO IBANDRONICO EG 150 mg compresse rivestite con film

LU:Ibandronate EG 150mg comprimés pelliculés

NL:Ibandroninezuur STADA 150 mg filmomhulde tabletten

PL:Ibandronic acid STADA

PT:Ácido Ibandrónico Stada

RO:Acid Ibandronic STADA, comprimate filmate, 150 mg

SI:Ibandronska kislina STADA 150 mg filmsko obložene tablete

SK:Ibandronic acid STADA

Last review date of this leaflet:November 2022

Detailed and updated information on this medicinal product is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es