Ibandronic acid CINFA 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ibandronate sodium cinfa 150 mg film-coated tablets EFG

sodium ibandronate monohydrate

Read the entire 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, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What ibandronate sodium cinfa is and what it is used for
2. What you need to know before taking ibandronate sodium cinfa
3. How to take ibandronate sodium cinfa
4. Possible side effects
5. How to store ibandronate sodium cinfa
6. Contents of the pack and other information

1. What is ibandronic acid cinfa and what is it used for

Ibandronic acid cinfa belongs to a group of medicines called bisphosphonates, and contains the active substance ibandronic acid.

Ibandronic acid cinfa 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 cinfa can help reduce the likelihood of bone breaks (fractures). This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

Your doctor has prescribed ibandronic acid cinfa to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis involves 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 skeletal health.

The earlier a woman reaches 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 also support 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 starting to take ibandronic acid cinfa

Do not take ibandronic acid cinfa

• 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 are unable to 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

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 may also occur after stopping treatment.

It is important to try to prevent the development of 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.
• If you do not receive routine dental care or 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 previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• If you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• If you have cancer.

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

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, make sure 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 problems in your mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing of sores 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 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 cinfa

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

• Calcium, magnesium, iron or aluminium-containing supplements, as they may interfere with the effects of ibandronic acid cinfa.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac and naproxen), which can irritate the stomach and intestine, just like bisphosphonates (such as ibandronic acid cinfa). Therefore, be very careful when taking analgesics or anti-inflammatory medicines at the same time as ibandronic acid.

After taking the monthly ibandronic acid cinfa tablet, wait 1 hour before taking any other medicine, including antacid tablets, calcium supplements or vitamins.

Taking ibandronic acid cinfa with food and drinks

Do not take ibandronic acid cinfa with food.

Ibandronic acid becomes less effective 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 eating your first meal or drinking other beverages (see section 3 How to take ibandronic acid cinfa).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Ibandronic acid is intended for use only in postmenopausal women and should not be used by women of childbearing age. Do not take ibandronic acid if you are pregnant or breast-feeding.

Driving and using machines

You may drive and use machines, as ibandronic acid is not expected to have any effect or its effect is negligible on your ability to drive and use machines.

Ibandronic acid cinfa contains lactose.

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

Ibandronic acid cinfa contains sodium.

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

3. How to take ibandronic acid cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

How to take the monthly tablet

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

• Take one 150 mg ibandronic acid cinfa tablet once a month.
• Choose a 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 of the week (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 eating or drinking anything (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 tap water (hard water), it is recommended to use bottled water with low mineral content.
• Swallow the tablet whole; do not chew, crush, or allow it to dissolve 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 oesophagus.

• Do not eat anything

• Do not drink anything (except water, if needed)
• Do not take any other medicine
• After waiting one hour, you may eat your breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medicines you require.

Continuation of treatment with ibandronic acid cinfa

It is important that you take ibandronic acid every month for as long as your doctor prescribes it. After 5 years of taking ibandronic acid, consult your doctor whether you should continue taking ibandronic acid.

If you take more ibandronic acid cinfa than you should

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

Do not induce vomiting or lie down, as this could irritate the oesophagus.

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

If you forget to take ibandronic acid cinfa

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 see when your next dose is due.

If you forgot to take the tablet on your chosen day and your next dose is due in 1 to 7 days:

Never take two ibandronic acid 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 dates marked on your calendar.

If you forgot to take the tablet on your chosen day and your next dose is due in more than 7 days:

Take one tablet on the morning after you remember you missed the dose, then continue taking one tablet per month according to the dates marked on your calendar.

4. Possible adverse effects

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

Tell your doctor immediately if you notice any of the following serious adverse 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 pain or tightness, in the throat/food pipe.
• 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):

• 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 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 suffer from an ear infection. These could be symptoms of damage to the ear bones.
• Severe allergic reaction that may be life-threatening.
• Serious skin adverse 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, diarrhea (loose bowel movements).
• Skin rash.
• Muscle cramps, joint and limb stiffness.
• 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.

Uncommon (may affect up to 1 in 100 people)

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

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

• Inflammation of the duodenum (first section of the intestine) causing stomach pain.
• Hives.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Ibandronic acid cinfa storage instructions

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of ibandronic acid cinfa

• The active substance 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 contents of the pack

Ibandronic acid cinfa tablets are white or almost white, oblong-shaped, 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) containing 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

The Netherlands

Date of the most recent revision of this leaflet: June 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74407/P_74407.html

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