IBANDRONIC ACID TECNIGEN 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid TecniGen 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

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

Ibandronic Acid TecniGen belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. This medicine 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 appreciate the difference. Ibandronic Acid TecniGen may help reduce the risk of broken bones (fractures). This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed Ibandronic Acid TecniGen to treat your postmenopausal osteoporosis because you are at high risk of fractures.Osteoporosis is a condition where bones become thinner and weaker, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone, estrogen, which helps to keep the skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of getting fractures due to osteoporosis.

Other factors that increase the risk of getting fractures are:

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

Healthy lifestyle habitsalso help 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 TecniGen

Do not take Ibandronic Acid TecniGen:

• 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 side effect 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 problems in your mouth 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 this medicine.

While you are being treated, you must maintain good oral hygiene (including regular toothbrushing) 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 have 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, pharmacist, or nurse before starting to take this medicine:

• 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.
• If you are undergoing dental treatment or have planned dental surgery, inform your dentist that you are being treated with ibandronic acid.

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 if they lie down before one hour has passed after taking ibandronic acid. If you develop these symptoms, stop taking the medicine and inform your doctor immediately (see section 3).

Children and adolescents

This medicine must not be used in children and adolescents under 18 years.

Other medicines and Ibandronic Acid TecniGen:

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

• Supplements containing calcium, magnesium, iron, or aluminumas they may affect the action of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen) that may irritate the stomach and intestines, as well as bisphosphonates (such as ibandronic acid). Therefore, be very careful when taking painkillers or anti-inflammatory drugs at the same time as this medicine.

After taking the monthly ibandronic acid tablet, wait 1 hour before taking any other medicine,including antacids, calcium supplements, and vitamins.

Ibandronic Acid TecniGen with food, drinks, and alcohol:

Do not take ibandronic acidwith food.This medicine loses its effectiveness if taken with food.

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

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop breastfeeding to take Ibandronic Acid TecniGen.

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.

Driving and using machines

You can drive and use machines as this medicine is not expected to affect your ability to drive or use machines. Inform your doctor first if you want to drive, use machines, or tools.

Ibandronic Acid TecniGen contains lactose.

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

3. How to take Ibandronic Acid TecniGen

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

The usual dose of Ibandronic Acid TecniGen is one tablet per month.

How to take the monthly tablet

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

• Take one ibandronic acid tablet once a month.
• Choose a day of the monththat you can easily 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). 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 takethe tablet with water that has a 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 a low mineral content.

• Swallow the tablet whole- do not chew, crush, or dissolve it in your mouth.

• During the next hour (60 minutes)after taking the tablet
• do not lie down; if you do not stay upright (standing or sitting), part of the medicine may come back up into your 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 lie down and take any other medicines you need.

Do not takethis medicine at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid TecniGen

It is essential that you take this medicine every month, until your doctor tells you to stop. Ibandronic acid only works to treat osteoporosis while you are taking it.

If you take more Ibandronic Acid TecniGen than you should

If you have taken more tablets than you should, drink a full glass of milk and contact your doctor immediatelyor call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

Do not induce vomiting and do not lie down- this can cause ibandronic acid to irritate your esophagus.

If you forget to take Ibandronic Acid TecniGen

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

Never take two Ibandronic Acid TecniGen tablets within the same week.

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:

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

• flu-like symptoms, including fever, chills, and flushing, 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. You may be having an allergic reaction to the medicine.

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 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 symptoms of an unusual fracture of the thigh bone.

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

• pain or sensation of pain in the mouth or jaw. These may be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jawbone].
• severe allergic reaction that can be life-threatening
• 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.

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 (loose stools)
• muscle cramps, stiffness of joints and limbs

Uncommon(may affect up to 1 in 100 people)

• dizziness
• flatulence (bloating, feeling bloated)
• back pain
• feeling tired and weak

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

• Inflammation of the duodenum (first part of the intestine) that causes stomach pain.
• Hives

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid TecniGen

Keep in the original packaging to protect from moisture

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 blister and carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid TecniGen

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as ibandronic acid monohydrate sodium).
• The other ingredients are: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and sodium stearyl fumarate, in the tablet core, and hypromellose, titanium dioxide (E 171), and macrogol 6000, in the tablet coating.

Appearance ofIbandronic Acid TecniGen and contents of the pack

White, oblong tablets. They are available in blister packs of 1 and 3 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Manufacturer

Atlantic Pharma – Produções Farmacêutica, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra

Portugal

Date of last revision of this leaflet:June 2022

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