Leaflet: information for the user

ibandronic acid cinfa 150 mg film-coated tabletsEFG

ibandronate sodium monohydrate

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

ibandronate sodium belongs to a group of medicines calledbisphosphonateswhich contains ibandronate.

ibandronate sodium may reverse bone loss as it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronate sodium may help reduce the likelihood of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed ibandronate sodium to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, a common occurrence in women after menopause. During menopause, the ovaries stop producing the female hormone —estrogens— 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 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 not drinking too much alcohol.

Do not take ibandronic acid cinfa

• If you are allergic to ibandronic acid or any of the other components 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 straight (60 minutes).
• If you have or have had low levels of calcium 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 ibandronic acid for osteoporosis. ONJ can 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):

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

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 secured. 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 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 ibandronic acid. Consult your doctor or pharmacist before starting to take ibandronic acid cinfa:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If your kidneys do not function normally.
• If you have any swallowing or digestive problems.

Esophageal irritation, inflammation, or ulceration may occur, often with symptoms of intense chest pain, intense pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before an 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 administer ibandronic acid to children or adolescents under 18 years old.

Other medicines and ibandronic acid cinfa

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

• Calcium, magnesium, iron, or aluminum supplementsas they may affect the effects of ibandronic acid cinfa.
• Acetylsalicylic acidand other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like bisphosphonates (such as ibandronic acid cinfa). Be careful when takinganalgesics or anti-inflammatoryat the same time as ibandronic acid.

After taking the monthly ibandronic acid cinfa tablet, wait 1 hour to take any other medicine, including antacids, calcium supplements, or vitamins.

Taking ibandronic acid cinfa with food and drinks

Do not take ibandronic acid cinfa with food.

Ibandronic acid loses its effectiveness if taken with food.

You may drink water but not other liquids(see section 3 How to take ibandronic acid cinfa).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Ibandronic acid is 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.

Driving and operating machines

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

Ibandronic acid cinfa contains lactose.

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Ibandronic acid cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of ibandronate cinfa is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to facilitate the immediate arrival of ibandronate in the stomach and cause less irritation.

• Take one ibandronate cinfa 150 mg tablet once a month.
• Choose the day of the monththat 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 tablet. Choose what best suits your routine.
• Take the ibandronate tabletat least 6 hours after the last meal or drink (except water).
• Take the ibandronate tabletimmediately upon waking, andbefore consuming any food or liquids(with an empty stomach).
• Swallow the tablet with a full glass of water(at least 180 ml).Do nottake the tablet with water with high calcium levels, 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 leave it to dissolve in the mouth.
• During 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 you wish, lie down and take any other medications you need.

Continuation of treatment with ibandronate cinfa

It is essential to take ibandronate every month, for the duration prescribed by your doctor. After 5 years of taking ibandronate, consult your doctor to determine if you should continue taking ibandronate.

If you take more ibandronate cinfa than you should

If you have taken, by mistake, one or more tablets in excess,drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause you could irritate the esophagus.

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 forgot to take ibandronate cinfa

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

If you forgot to take the tablet on your chosen day and your next dose is within 1 to 7 days.

Never take two ibandronate tablets within the same week.Wait until it is time to take the next dose and take it as usual, then return to taking one tablet per month according to the marked days on your calendar.

If you forgot to take the tablet on your chosen day and your next dose is more than 7 days away.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following serious 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.
• Symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and/or a tingling sensation in the fingers or around the mouth.

Uncommon(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 a sensation of pain in the mouth or jaw. These may be early symptoms of severe jaw problems [jaw 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 may be symptoms of damage to the ear bones.
• Severe allergic reaction that may pose a life-threatening risk.
• Severe adverse reactions in the skin.

Other possible side effects

Common(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).
• Skin rash.
• Muscle cramps, joint stiffness and extremities.
• Flu-like symptoms (including fever, chills, and shivering, feeling unwell, pain in bones and muscles and joints. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days).

Rare(may affect up to 1 in 100 people)

• Back pain.
• Sensation of fatigue and exhaustion.
• Dizziness.
• Flatulence (ventoseo, feeling bloated).
• Asthma attacks.

Uncommon(may affect up to 1 in 1,000 people)

• Inflammation of the duodenum (first section of the intestine) that causes stomach pain.
• Urticaria.

Reporting of 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 directly 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.

This medication does not require special conditions for conservation.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your 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 cinfa

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

Tablet core: lactose monohydrate, crospovidone (Type A) (E-1202), microcrystalline cellulose (E-460), anhydrous colloidal silica, sodium stearate fumarate.

Tablet coating:polyvinyl alcohol, macrogol/PEG 3350, talc, titanium dioxide (E-171).

Appearance of the product and contents of the package

Ibandronic acid cinfa 150 mg tablets are white or off-white, oblong in shape, marked with the inscription “I9BE” on one face and “150” on the other.

Ibandronic acid cinfa 150 mg is presented in blisters (Aluminum/aluminum and PVC-PVDC/aluminum) with 1 or 3 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Synthon Hispania S.L.

Castelló 1

Las Salinas Industrial Estate

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22

6545CM Nijmegen

Netherlands

Last review date of this leaflet:June 2022

For detailed and updated information on this medicine, please visit the website oftheSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74407/P_74407.html

QR code to:https://cima.aemps.es/cima/dochtml/p/74407/P_74407.html