Ibandronic acid Tarbis 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid Tarbis 150 mg film-coated tablets EFG

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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Ibandronic Acid Tarbis belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

Ibandronic acid 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 notice the difference. Ibandronic acid can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed Ibandronic Acid Tarbis to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in 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 greater her risk of fractures due to osteoporosis. 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 help you get the maximum benefit from 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 taking Ibandronic Acid Tarbis

Do not take Ibandronic Acid Tarbis:

• 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 passage (oesophagus), such as narrowing or difficulty swallowing.
• If you cannot remain upright, either standing or sitting, for at least one hour (60 minutes) continuously.
• If you have or have had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

Very rarely, a serious 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 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 mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction.
• You do not receive routine dental care or have not had a dental check-up for a long time.
• You are a smoker (as this may increase the risk of dental problems).
• You have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• You have cancer.

Your doctor may ask you to have 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 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 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 healing of 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 Ibandronic Acid Tarbis:

• If you have a mineral metabolism disorder (e.g. vitamin D deficiency).
• If you have kidney problems.
• If you have any difficulty swallowing or digestive problems.

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

Children and adolescents

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

Other medicines and Ibandronic Acid Tarbis

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

• Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of Ibandronic Acid Tarbis.
• 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 Ibandronic Acid Tarbis. Therefore, take great care when taking analgesics or anti-inflammatory medicines at the same time as Ibandronic Acid Tarbis.

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

Ibandronic Acid Tarbis with food and drink:

Do not take Ibandronic Acid Tarbis with food. Ibandronic Acid Tarbis becomes less effective 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 intended only for use in postmenopausal women and must not be taken by women of childbearing age.

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

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Ibandronic Acid Tarbis contains lactose monohydrate and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Ibandronic Acid Tarbis

Follow exactly the administration instructions for this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist.

The usual dose of ibandronic acid is one tablet per month.

How to take the monthly tablet

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

• Take one 150 mg ibandronic acid 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 (e.g., the first Sunday of each month). Choose whichever best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours without food or drink, except water.

• Take the ibandronic acid tablet

• immediately upon waking up, and

• before breakfast or drinking any liquids (on an empty stomach)

• Swallow the tablet with a full glass of water (at least 180 ml). Do not take the tablet with water high in calcium, 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 dissolve it in the mouth.

• During the following 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 medication

• After waiting 1 hour, you may have your first meal and drink of the day. Once you have eaten, you may lie down and take any other medicines you need.

Continuing treatment with ibandronic acid

It is important that you take ibandronic acid every month, as directed by your doctor.

After 5 years of taking ibandronic acid, consult your doctor about whether you should continue treatment.

If you take more ibandronic acid than you should

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

Do not induce vomiting or lie down, because ibandronic acid could irritate the esophagus.

In case of overdose, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91.562.04.20, stating the medicine and the amount taken.

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

If you forget to take ibandronic acid

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 determine when your next dose is due:

If you missed 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 missed your chosen day and your next dose is due in more than 7 days... Take one tablet 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 will experience them.

Tell your doctor or nurse 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 swelling, 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 sensation of pain in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone]
• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the ear bones
• severe allergic reaction which may be life-threatening
• serious skin 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, diarrhoea (loose bowel movements)
• muscle cramps, stiffness in joints and limbs
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any of these effects become troublesome or last more than a few days.
• skin rash.

Uncommon (may affect up to 1 in 100 people):

• dizziness
• flatulence (wind, bloated feeling)
• back pain
• feeling of fatigue and exhaustion
• 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 (urticaria).

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 through the national reporting system included in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Tarbis

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

No special storage conditions are required.

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 drains or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid Tarbis

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as sodium ibandronate hydrate).

• The other components are:

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

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

Appearance of the medicinal product and contents of the pack

The 150 mg film-coated tablets of Ibandronic Acid Tarbis are white, oblong-shaped, and marked with the inscription "LC" on one side.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Czech Republic: Licobondrat

Norway: Licobondrat 150 mg Tablett, filmdrasjert

Slovakia: Licobondrat 150 mg Filmdragerad tablett

Spain: Ácido Ibandrónico Tarbis 150 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this package leaflet: January 2023

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