Ibandronic acid STADA 150 mg film-coated tablets EFG

Package Leaflet: Information for the User

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, as 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 and must not be given to other people, 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 these adverse effects are not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Ibandronic Acid STADA is 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 adverse effects
5. How to store 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 by preventing further bone loss and increasing bone mass in most women who take it, even if they are unable to see or feel the 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 commonly occurs in women after menopause. During menopause, the ovaries stop producing the female hormone—estrogen—that helps maintain skeletal health.

The earlier a woman enters menopause, the higher her risk of osteoporotic fractures.

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 other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habits can also enhance 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 avoiding excessive alcohol consumption

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

Do NOT take ibandronic acid:

• 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 cannot 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, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

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 medications 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 Stada.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo 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 mouth or dental problems, such as tooth loss, pain or swelling, or delayed healing of 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 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 to children or adolescents under 18 years of age.

Other medicines and ibandronic acid

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

• Supplements containing calcium, magnesium, iron, or aluminium, as they 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 intestines, similar to bisphosphonates (like ibandronic acid). Therefore, take extra care 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 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.

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

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

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

Pregnancy and breastfeeding

Ibandronic acid is intended 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. 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 may drive and use machines, as ibandronic acid is not expected to have any effect or only a negligible effect on your ability to drive and use machines.

Ibandronic Acid Stada contains lactose and sodium

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 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Ibandronic Acid Stada

Follow exactly the instructions given by your doctor for taking this medicine. 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 important that you carefully follow these instructions. They are designed to ensure that ibandronic acid 150 mg reaches the stomach quickly and causes less irritation.

• Take one tablet of ibandronic acid once a month.

• Choose the 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 (e.g. the first Sunday of each month) to take your ibandronic acid tablet. Choose whichever best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours have passed since your last food or drink, except water.

• Take the ibandronic acid tablet

• first thing in the morning, 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 that has a high calcium concentration, fruit juice, or other beverages. If you are unsure about potentially high calcium levels in your 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.

• During the hour following tablet ingestion (60 minutes):

• Do not lie down; if you do not remain upright (standing or sitting), part of the medicine could 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 may eat breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medicines you require.

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

Continuation of treatment with ibandronic acid

It is important that you take ibandronic acid every month, as directed by your doctor. After 5 years of taking ibandronic acid, consult your doctor about whether you should continue treatment.

If you take more ibandronic acid than you should

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

If you have accidentally taken an extra tablet, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie down, as ibandronic acid could irritate your esophagus.

If you forget to take ibandronic acid

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

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

Wait until your next scheduled dose and take it as usual. Then return to taking one tablet per month according to the dates marked on your calendar.

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

Take one tablet the morning after you remember missing the dose. Then return to taking one tablet per month according to the dates marked on your calendar.

Never take two ibandronic acid tablets within the same week.

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

4. Possible adverse effects

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

Tell your doctor or nurse immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have severe inflammation, possibly with pain or tightness, 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 signs of an unusual femur (thigh bone) fracture.

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

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

Other possible adverse effects

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

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
• muscle cramps, stiffness of joints and limbs
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a few days.
• skin rash

Uncommon (may affect up to 1 in 100 people)

• dizziness
• flatulence (wind, bloating)
• back pain
• feeling of fatigue and exhaustion
  • asthma attacks
  • symptoms of low calcium levels in the blood (hypocalcaemia), 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
• urticaria

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them 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 Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid Stada

• The active substance is ibandronic acid.

Each tablet contains 150 mg of ibandronic acid (as sodium monohydrate).

• The other components are: monohydrate lactose, 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).

Appearance of the medicinal product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

Synthon BV

Microweg 22,

6545CM Nijmegen (The 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

1020 Brussels,

Belgium

or

STADA Arzneimittel GmbH,

Muthgasse 36,

1190 Wien,

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

Date of the most recent review of this leaflet: November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es