Prospect: information for the user

Ibandronic Acid TecniGen 150 mg film-coated tabletsEFG

Read this prospect carefully before starting to take the medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult yourdoctor, pharmacist, or nurse even if they do not appear in this prospect. See section4.

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

2.What you need to know before starting to take Ibandronic Acid TecniGen

3.How to take Ibandronic Acid TecniGen

4.Possible adverse effects

5.Storage of Ibandronic Acid TecniGen

6.Contents of the package and additional information

TecniGen Ibandronic Acid belongs to a group of medications called bisphosphonates. It contains the active ingredient ibandronic acid. This medication 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. TecniGen Ibandronic Acid may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed TecniGen Ibandronic Acid 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, estrogen, which 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 suffering 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

Healthy lifestyle habits also facilitate 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 moderate alcohol consumption.

Do not take Ácido Ibandrónico TecniGen:

• If you are allergic to ibandronate or any of the other components of this medication (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 (60 minutes) in a row.
• If you have or have had low calcium levels in your blood. Please consult your doctor.

Warnings and precautions

Rarely, a side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with ibandronate 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) 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 regular 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 medication.

While on treatment, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo regular 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 ibandronate.

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 ibandronate. Consult your doctor, pharmacist, or nurse before starting to take this medication:

• 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 ibandronate.

It may cause irritation, inflammation, or ulceration of the throat/food pipe (esophagus), 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 glass of water and/or if they lie down before an hour has passed after taking ibandronate. If you develop these symptoms, stop taking the medication and inform your doctor immediately (see section 3).

Children and adolescents

This medication should not be used in children and adolescents under 18 years old.

Other medications and Ácido Ibandrónico TecniGen:

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

• Supplements containing calcium, magnesium, iron, or aluminumas they may influence the effects of ibandronate.
• 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 ibandronate). Be careful when taking pain relievers or anti-inflammatory medications at the same time as this medication.

After taking the monthly ibandronate tablet,wait 1 hour to take any other medication,including antacids, calcium supplements, and vitamins.

Ácido Ibandrónico TecniGen with food, drinks, and alcohol:

Do not take ibandronatewith food.This medication loses its effectiveness if taken with food.

You may drink water but not other liquids(see point 3 How to take Ácido Ibandrónico TecniGen).

Pregnancy, breastfeeding, and fertility

Do not take this medicationif you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop it to take Ácido Ibandrónico TecniGen.

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

Driving and operating machinery

You may drive and operate machinery as it is expected that this medicationwill have no effect or a negligible effect on your ability to drive and operate machinery. Inform your doctor first if you want to drive, operate machinery, or use tools.

Ácido Ibandrónico TecniGen contains lactose.

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

This medication contains less than 1 mmol of sodium (23 mg)per tablet; this 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 usual dose of Ibandronic Acid TecniGen is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to ensure that ibandronic acid reaches the stomach quickly and causes less irritation.

• Take one ibandronic acid 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). Choose what best suits your routine.
• Take the ibandronic acid tabletat least 6 hours after the last meal or drink, except for water
• Take the ibandronic acid tablet

• nothing more than upon waking, and
• before breakfast or consuming liquids(with an empty stomach)

• Swallow the tablet with a glass of water(at least 180 ml).

Do not takethe tablet with water with a high concentration of calcium, fruit juice, or other beverages.

If you have any doubts about the potentially 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 dissolve it in your mouth.

• For 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 medication may 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.

Do not takethis medication at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid TecniGen

It is essential to take this medication every month until your doctor tells you to stop. Ibandronic acid is only effective for treating osteoporosis while you are taking this medication.

If you take more Ibandronic Acid TecniGen 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 immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Do not induce vomiting or lie down-this may cause ibandronic acid to irritate your esophagus.

If you forget to take Ibandronic Acid TecniGen

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

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

Wait until it is time to take your next dose and take it as usual, then go back to taking one tablet per month according to the days marked on your calendar.

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

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

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

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

Inform your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

• flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone pain, and muscle and joint pain. Consult your nurse or doctor if any side effect becomes bothersome or lasts more than a couple of days.
• skin rash. You may be having an allergic reaction to the medicine.

Infrequent(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.

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 [jaw necrosis (death of bone tissue) of the jawbone].
• severe allergic reaction that may pose a life-threatening risk
• Consult your doctor if you have ear pain, your ear is discharging, or you have an ear infection. These may be symptoms of damage to the ear bones.

Other possible side effects

Frequent(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)
• muscle cramps, joint stiffness, and limb stiffness

Infrequent(may affect up to 1 in 100 people)

• dizziness
• flatulence (gas, feeling bloated)
• back pain
• sensation of fatigue and exhaustion

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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. Website: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store in the original packaging to protect it from moisture

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

Do not use this medication after the expiration date that appears on the blister pack and 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibandronic Acid TecniGen

•The active ingredient is ibandronic acid. Each coated tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).

•The other components are: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and sodium stearate fumarate, in the tablet core, as well as hypromellose, titanium dioxide (E 171), and macrogol 6000, in the tablet coating.

Appearance ofIbandronic Acid TecniGen and contents of the packaging

White, oblong-shaped tablets. They are presented in blister packaging of 1 and 3 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) Spain

Responsible for Manufacturing

Atlantic Pharma – Produções Farmacêutica, S.A.

Rua da Tapada Grande nº 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet:June 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es