IBANDRONIC ACID CINFA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Acid Ibandronic Cinfa 150 mg film-coated tablets EFG

Ibandronate sodium monohydrate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Acid Ibandronic Cinfa and what is it used for
2. What you need to know before you take Acid Ibandronic Cinfa
3. How to take Acid Ibandronic Cinfa
4. Possible side effects
5. Storage of Acid Ibandronic Cinfa
6. Contents of the pack and further information

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

Acid Ibandronic Cinfa belongs to a group of medicines called bisphosphonates, which contains ibandronic acid.

Acid Ibandronic Cinfa can 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. Acid Ibandronic Cinfa can help reduce the likelihood of bone fractures. This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed Acid Ibandronic Cinfa to treat your postmenopausal osteoporosis because you are at high risk of suffering fractures.Osteoporosis is a condition where bones become thinner and weaker, which is common 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 fractures include:

• 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 habitsalso 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 not drinking too much alcohol.

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

Do not take Acid Ibandronic Cinfa

• 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 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 occur after stopping treatment.

It is essential to try to prevent the development of ONJ, as it is a painful condition that can be challenging 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.
• If you do not receive routine dental care or if you have not had a dental check-up for a long time.
• If you are a smoker (as this can 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 medications called corticosteroids (such as prednisolone or dexamethasone).
• If you have cancer.

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

While you are being treated, you must maintain good oral hygiene (including regular toothbrushing) and undergo routine dental check-ups. If you wear dentures, ensure they fit properly. 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 Acid Ibandronic Cinfa.

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 can be signs of osteonecrosis of the jaw.

Some people require special care during treatment with Acid Ibandronic Cinfa. Consult your doctor or pharmacist before starting Acid Ibandronic 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.

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 full glass of water and/or if they lie down before one hour has passed after taking Acid Ibandronic Cinfa. If you develop these symptoms, stop taking Acid Ibandronic Cinfa and inform your doctor immediately (see section 3).

Children and adolescents

Do not give Acid Ibandronic Cinfa to children or adolescents under 18 years of age.

Other medicines and Acid Ibandronic Cinfa

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

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the effects of Acid Ibandronic Cinfa.
• 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 Acid Ibandronic Cinfa.

After taking the monthly tablet of Acid Ibandronic Cinfa, wait 1 hour before taking any other medicine,including antacids, calcium supplements, or vitamins.

Taking Acid Ibandronic Cinfa with food and drinks

Do not take Acid Ibandronic Cinfa with food.

Ibandronic acid loses its effectiveness if taken with food.

You can drink water, but not other liquids(see section 3 How to take Acid Ibandronic Cinfa).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Ibandronic acid is for use in postmenopausal women only and should not be taken by women of childbearing age. Do not take Acid Ibandronic Cinfa if you are pregnant or breastfeeding.

Driving and using machines

You can drive and use machines, as Acid Ibandronic Cinfa is not expected to have a significant effect on your ability to drive and use machines.

Acid Ibandronic Cinfa contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Acid Ibandronic Cinfa contains sodium.

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

3. How to take Acid Ibandronic Cinfa

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

The recommended dose of Acid Ibandronic Cinfa is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to help ibandronic acid reach the stomach quickly and cause less irritation.

• Take one 150 mg tablet of Acid Ibandronic Cinfa once a month.
• Choose the day of the monththat 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 Acid Ibandronic Cinfa tablet. Choose what best fits your routine.
• Take the Acid Ibandronic Cinfa tablet after a minimum of 6 hours after your last meal or drink (except water).
• Take the Acid Ibandronic Cinfa tablet as soon as you get up, and before taking any food or drink(on 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 concentration, fruit juice, or other drinks. If you are unsure about the 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 let it dissolve in your mouth.
• During 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.

Continuation of treatment with Acid Ibandronic Cinfa

It is essential to take Acid Ibandronic Cinfa every month, for as long as your doctor prescribes it. After 5 years of taking Acid Ibandronic Cinfa, consult your doctor to see if you should continue taking Acid Ibandronic Cinfa.

If you take more Acid Ibandronic Cinfa than you should

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

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

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 forget to take Acid Ibandronic Cinfa

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

Never take two Acid Ibandronic Cinfa tablets 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 days marked on your calendar.

If you forget 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 you missed the dose, then continue taking one tablet per month according to the days marked on your calendar.

4. Possible side effects

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

Tell your doctor 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 when 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.
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or a feeling of tingling in the fingers or around the mouth.

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 can 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 discomfort in the mouth or jaw. These can be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jawbone].
• Tell 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, difficulty swallowing, stomach pain or discomfort (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses).
• Rash.
• Muscle cramps, joint stiffness, and limb pain.
• Flu-like symptoms (including fever, chills, and sweating, feeling unwell, pain in bones, muscles, and joints. Consult your nurse or doctor if any effect becomes troublesome or lasts more than a couple of days).

Uncommon(may affect up to 1 in 100 people)

• Back pain.
• Feeling tired and weak.
• Dizziness.
• Flatulence (bloating, feeling bloated).
• Asthma attacks.

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 package leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance 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 Acid Ibandronic Cinfa

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

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ibandronic Acid Cinfa

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

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

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

Appearance of the Product and Container Content

Ibandronic acid cinfa tablets are white or almost white, oblong in shape, marked with the inscription "I9BE" on one side and "150" on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22

6545CM Nijmegen

Netherlands

Date of the Last Revision of this Prospectus:June 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/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the prospectus and packaging with your mobile phone (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