IBANDRONIC ACID TARBIS 150 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid Tarbis 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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Ibandronic Acid Tarbis and what is it used for
2. What you need to know before you take Ibandronic Acid Tarbis
3. How to take Ibandronic Acid Tarbis
4. Possible side effects
5. Storage of Ibandronic Acid Tarbis
6. Contents of the pack and further 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, 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 may help reduce the number of bone fractures. This reduction has been shown in spinal fractures but not in 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 where bones become thinner and weaker, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone - oestrogen - which helps to keep the skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures due to osteoporosis. Other factors that increase the risk of fractures include:

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

Healthy lifestyle habitsalso help to get the maximum benefit from treatment. These include a balanced diet rich in calcium and vitamin D; weight-bearing exercise; not smoking and not drinking too much alcohol.

2. What you need to know before you take 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 gullet (oesophagus), 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 levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

A rare side effect has been reported with Ibandronic Acid Tarbis called osteonecrosis of the jaw (ONJ) (bone damage in the jaw). This has been reported mostly in patients being treated with bisphosphonates for osteoporosis who have had dental procedures such as tooth extraction or who have poor dental health.

It is important to try to prevent ONJ as it can be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should:

Before starting treatment, tell your doctor or nurse (healthcare provider) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned tooth extraction
• you are not receiving 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 been treated with a bisphosphonate (used to treat or prevent bone disorders) in the past
• you are taking corticosteroids (such as prednisolone or dexamethasone)
• you have cancer

Your doctor may ask you to have a dental check-up before starting treatment with Ibandronic Acid Tarbis.

While being treated with Ibandronic Acid Tarbis, you should:

Maintain good oral hygiene (including regular brushing of the teeth) and have regular dental check-ups.

If you wear dentures, you should make sure they fit properly.

If you are having dental treatment or are about to have a dental procedure, tell your doctor and dentist that you are being treated with Ibandronic Acid Tarbis.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or difficulty healing after dental procedures, as these could be signs of osteonecrosis of the jaw.

Some people need special care when taking Ibandronic Acid Tarbis. Tell your doctor:

• If you have any mineral metabolism disorders (such as vitamin D deficiency).
• If you have kidney problems.
• If you have any swallowing or digestive problems.

Irritation, inflammation or ulceration of the gullet (oesophagus) may occur, often with symptoms of severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, especially if you do not drink a full glass of water and/or if you lie down less than 60 minutes after taking Ibandronic Acid Tarbis. If you develop these symptoms, stop taking Ibandronic Acid Tarbis and tell your doctor immediately (see section 3).

Children and adolescents

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

Other medicines and Ibandronic Acid Tarbis

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 aluminium, as they may affect the action of Ibandronic Acid Tarbis.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium and naproxen) which may irritate the stomach and intestines, as does Ibandronic Acid Tarbis. Therefore, be careful when taking analgesics or anti-inflammatory drugsat the same time as Ibandronic Acid Tarbis.

After taking the monthly tablet of Ibandronic Acid Tarbis, wait 1 hour before taking any other medicine, 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 its effect if taken with food.

You can drink water but not other liquids.

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

Pregnancy and breast-feeding

Ibandronic Acid Tarbis is only for use in postmenopausal women and must not be taken by women of childbearing potential.

Do not take Ibandronic Acid Tarbis if you are pregnant or breast-feeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines as Ibandronic Acid Tarbis is not expected to affect your ability to drive or use machines.

Ibandronic Acid Tarbis contains lactose monohydrate and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

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3. How to take Ibandronic Acid Tarbis

Follow the instructions for administration of this medicine exactly as your doctor has told you.

If you are unsure, ask your doctor or pharmacist.

The usual dose of ibandronic acid is one tablet once a month.

How to take the monthly tablet

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

• Take one 150 mg 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 the one that best fits your routine.

• Take the ibandronic acid tablet after an interval of at least 6 hours from the last food or drink, except water.

• Take the ibandronic acid tablet
• immediately after waking up, and
• before breakfast or drinking (on 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 concentration of calcium, fruit juice or other drinks. If you are unsure about the potentially high levels of calcium 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 remain upright (standing or sitting), part of the medicine could come back up into the gullet

• do not eat anything

• do not drink anything(except water, if needed)
• do not take any other medicine

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

Continuation of treatment with ibandronic acid

It is important that you take ibandronic acid every month, until your doctor tells you to stop.

After 5 years of taking ibandronic acid, consult your doctor to see if you should continue taking ibandronic acid.

If you take more Ibandronic Acid Tarbis than you should

If you have taken too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting or lie downbecause ibandronic acidcould irritate the gullet.

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

It is recommended to take the packaging and the leaflet of the medicine to the healthcare provider.

If you forget to take Ibandronic Acid Tarbis

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 you forget to take the tablet on your chosen day and your next dose is due within 1 to 7 days...Never take two Ibandronic Acid Tarbis 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 days marked on your calendar.

If you forget to take the tablet on your chosen day and your next dose is due in more than 7 days...Take a tablet on the 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.

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:

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 gullet.
• symptoms of low levels of calcium in the blood (hypocalcaemia), including muscle cramps or spasms and/or a feeling of tingling 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 could be early signs of a possible unusual fracture of the thigh bone.

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

• pain or feeling of pain in the mouth or jaw. These could be early signs of serious jaw problems [necrosis (death of bone tissue) of the jawbone]
• consult your doctor if you have ear pain, discharge from the ear or an ear infection. These could be signs of damage to the bones of the ear
• life-threatening allergic reaction
• severe skin reactions.

Other possible side effects

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

• headache
• heartburn, difficulty swallowing, stomach pain or discomfort (due to inflammation of the stomach), indigestion, nausea, diarrhoea
• muscle cramps, stiffness in joints and limbs
• flu-like symptoms, including fever, chills and shivering, feeling unwell, pain in bones, muscles and joints. Consult your nurse or doctor if any effect becomes troublesome or lasts more than a couple of days.
• skin rash.

Uncommon(may affect up to 1 in 100 people)

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side 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 which is stated on the 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibandronic Acid Tarbis

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

• The other components are:

tablet core:lactose monohydrate, 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 Package Contents

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

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

Only some package sizes may be marketed.

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 Member States of the European Economic Area under the following names:

Czech Republic: 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

Date of the Last Revision of thisLeaflet: January 2023

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