IBANDRONIC ACID STADA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Ibandronic acid 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 number of bone fractures (fractures). This reduction has been shown in vertebral fractures but not in hip fractures.

You have been prescribed ibandronic acid to treat your postmenopausal osteoporosis because you are at high risk of suffering fractures. Osteoporosis is a condition where bones become thinner and weaker, a common condition 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 higher the risk of suffering fractures due to osteoporosis.

Other factors that increase the risk of suffering fractures are:

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habits also facilitate the beneficial 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

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

Do not take Ibandronic Acid Stada:

• 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 calcium levels in your blood. Please consult your doctor.

Warnings and precautions

A 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 can also occur after stopping treatment.

It is essential to try 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 must be taken.

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

• you have dental problems or teeth, such as poor dental health, gum disease, or a 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 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 medications called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer

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

While you are being treated, you must maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, you must ensure they fit properly. If you are undergoing dental treatment or are going 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 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 before taking ibandronic acid:

• 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, 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 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 to children or adolescents under 18 years of age.

Other medicines and ibandronic acid

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

• supplements containing calcium, magnesium, iron, or aluminum, as they may affect the effects of ibandronic acid.
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen), which can irritate the stomach and intestine, as well as bisphosphonates (such as ibandronic acid). Therefore, be very 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, including antacids, calcium supplements, and vitamins.

Ibandronic acid with food and drinks:

Do not take ibandronic acid with food. Ibandronic acid loses effectiveness if taken with food.

You can drink water, but not other liquids.

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

Take ibandronic acid at least 6 hours after you have eaten, drunk, or taken any other medicine or supplement (e.g., products containing calcium, aluminum, magnesium, and iron), except for water.

After taking ibandronic acid, wait 1 hour before taking your first meal and other drinks (see section 3, How to take Ibandronic Acid Stada).

Pregnancy and breastfeeding

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

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

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 effect on your ability to drive and use machines.

Ibandronic Acid Stada contains lactose and sodium

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 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Ibandronic Acid Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist.

The recommended dose of ibandronic acid is one tablet per month.

Method of administration

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

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

• take the ibandronic acid tablet

• as soon as you get up, and
• before breakfast or drinking (on an empty stomach).

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

Do not take the tablet with water that has a high concentration of calcium, fruit juice, or other drinks. If you are unsure about the potentially high calcium levels in your tap water (hard water), it is recommended that you 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 medicine may return to the 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 breakfast and your first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medicines you need.

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

Continuation of treatment with ibandronic acid

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

If you take more Ibandronic Acid Stada than you should

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

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 down, as ibandronic acid may irritate your esophagus.

If you forget to take Ibandronic Acid Stada

Do not take a double dose to make up for forgotten doses.

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

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

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

Never take two ibandronic acid tablets within the same week.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as 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, possibly with a feeling of pain or constriction, in the throat/food pipe.

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 a possible unusual fracture of the thigh bone.

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

• pain or feeling of pain in the mouth or jaw. These may be early symptoms of serious jaw problems (necrosis (death of bone tissue) of the jawbone).
• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.
• severe allergic reaction that can be life-threatening.
• severe skin reactions.

Other possible side effects

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

• headache
• heartburn, discomfort when swallowing, stomach pain or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses)
• muscle cramps, joint stiffness, and limb stiffness
• flu-like symptoms, including fever, chills, and sweating, feeling unwell, bone pain, and muscle and joint pain. Consult your nurse or doctor if any effect becomes troublesome or lasts more than a couple of days.
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• dizziness
• flatulence (bloating, feeling of bloating)
• back pain
• feeling 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.
• 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 Information 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 Stada

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Container Content and Additional Information

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 stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b), and titanium dioxide (E171) (tablet coating).

Product Appearance and Container Content

Ibandronic Acid Stada tablets are white or off-white, oblong, 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

info@stada.es

Manufacturer

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 film-coated tablets

BG: Ibandronic acid STADA 150 mg film-coated tablets

CZ: Ibandronic acid STADA 150 mg coated tablets

DE: Ibandronsäure AL 150 mg Filmtabletten

DK: Ibandronat STADA

ES: Ácido Ibandrónico STADA 150 mg film-coated tablets EFG

FI: Ibandronat STADA 150 mg tablet, film-coated

FR: ACIDE IBANDRONIQUE EG 150 mg, film-coated tablet

HU: Ibandronsav Stada 150 mg film tablet

IE: Ibandronic acid Clonmel 150 mg film-coated tablets

IT: ACIDO IBANDRONICO EG 150 mg film-coated tablets

LU: Ibandronate EG 150mg film-coated tablets

NL: Ibandroninezuur STADA 150 mg film-coated tablets

PL: Ibandronic acid STADA

PT: Ácido Ibandrónico Stada

RO: Acid Ibandronic STADA, film-coated tablets, 150 mg

SI: Ibandronska kislina STADA 150 mg film-coated tablets

SK: Ibandronic acid STADA

Date of the Last Revision of this Leaflet:November 2022

Detailed and updated 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