PATIENT INFORMATION LEAFLET

Ibandronic Acid Tarbis 150 mg Film-Coated Tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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.

Ibandronic Acid Tarbis belongs to a group of medications calledbisphosphonates.It contains the active ingredient ibandronic acid.

Ibandronic acid 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. Ibandronic acid can 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 Ibandronic Acid Tarbis to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures.Osteoporosis is a condition characterized by the thinning and weakening of 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 calcium and vitamin D intake in the diet
• smoking or excessive alcohol consumption
• limited walking or other weight-bearing exercise
• family history of osteoporosis

Healthy lifestyle habitsalso help maximize the benefits 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 Tarbis:

• If you are allergic to ibandronic acid 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 straight (60 minutes).

-If you have or have had low calcium levels 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 Tarbis for osteoporosis. ONJ may 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 may 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 corticosteroid medications (such as prednisolone or dexamethasone)

• If you have cancer

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

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) 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 Tarbis.

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 Tarbis. Consult your doctor before starting to take Ibandronic Acid Tarbis:

• 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.

Irritation, inflammation, or ulceration of the throat/food pipe (esophagus) 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 Tarbis. If you develop these symptoms, stop taking Ibandronic Acid Tarbis and inform your doctor immediately (see section 3).

Children and adolescents

Do not administer Ibandronic Acid Tarbis to children or adolescents under 18 years old.

Other medications and Ibandronic Acid Tarbis

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 aluminum,as they may influence the effects of Ibandronic Acid Tarbis.

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; similarly, Ibandronic Acid Tarbis. Therefore, be careful when takinganalgesics or anti-inflammatory medicationsat the same time as Ibandronic Acid Tarbis.

After taking the monthly Ibandronic Acid Tarbis tablet,wait 1 hour before taking any other medication,including antacids, calcium supplements, and vitamins.

Ibandronic Acid Tarbis with food and drinks:

Do not take Ibandronic Acid Tarbis with food.Ibandronic Acid Tarbis loses effectiveness if taken with food.

You may drink water but not other liquids.

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

Pregnancy and breastfeeding

Ibandronic Acid Tarbis is only for use in postmenopausal women, and they should not take it if they are fertile.

Do not take Ibandronic Acid Tarbis if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking this medication.

Driving and operating machines

You may drive and operate machines as it is expected that Ibandronic Acid Tarbis will have no effect or a negligible effect on your ability to drive and operate machines.

Ibandronic Acid Tarbis contains lactose monohydrate and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

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Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult with your doctor or pharmacist.

The usual dose of ibandronate 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 ibandronate reaches the stomach quickly and causes less irritation.

• Take one ibandronate 150 mg tablet once a month.

• Choose the day of the month that 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 fits your routine.

• Take the ibandronate tabletafter a minimum of 6 hours from the last meal or drink, except for water.

• Take the ibandronate tablet
• nothing more than upon waking,and
• before breakfast or consuming 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 a high calcium concentration, 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 dissolve it in your mouth.

• During the hour following (60 minutes)after taking 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 your first meal and drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medications you need.

Continuation of ibandronate treatment

It is essential to take ibandronate every month until your doctor tells you to stop.

After 5 years of takingibandronateconsult with your doctor if you should continue taking ibandronate.

If you take more ibandronate than you should

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

Do not induce vomiting or lie downbecauseibandronatecould irritate the esophagus.

In case of overdose, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take ibandronate

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

Like all medications, this medication 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:

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/food pipe.
• 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 serious jaw problems [jaw necrosis (bone tissue death) 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)
• Muscle cramps, joint stiffness and extremities
• Flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone and muscle pain, and joint pain. Consult your nurse or doctor if any side effect becomes bothersome or lasts more than a couple of days.
• Skin rash.

Rare(may affect up to 1 in 100 people)

• Dizziness
• Flatulence (gas, feeling bloated)
• Back pain
• Sensation of fatigue and exhaustion
• 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 national notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medicationafter 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 the packaging and medications you no longer need at the SIGRE collection pointof 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 Tarbis

• The active ingredient is ibandronic acid. Each tablet contains 150mg of ibandronic acid (in the form of ibandronate sodium hydrate).

• The other components are:

tablet core:monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose, magnesium stearate (E470b), anhydrous colloidal silica

tablet coating:hydroxypropylcellulose (E463), titanium dioxide (E171), macrogol 6000

Appearance of the product and contents of the packaging

Ibandronic Acid Tarbis 150 mg film-coated tablets are white, oblong in shape, and have the inscription "LC" on one face.

Ibandronic Acid Tarbis 150 mg film-coated tablets EFG are supplied in packs of 1 or 3 tablets. The tablets are supplied in blisters of 1 or 3 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for Manufacturing

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Republic of Czech: Licobondrat

Norway: Licobondrat 150 mg Tablet, film-coated

Slovakia: Licobondrat 150 mg Film-coated tablet

Spain: Ibandronic Acid Tarbis 150 mg film-coated tablets EFG

Last review date of thisleaflet: January 2023

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/