Ibandronic acid Tecnigen 150 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you get any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ibandronic Acid TecniGen is and what it is used for
2. What you need to know before taking Ibandronic Acid TecniGen
3. How to take Ibandronic Acid TecniGen
4. Possible side effects
5. How to store 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 counteract bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they are unable to see or feel the difference. Ibandronic Acid TecniGen 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 TecniGen to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which commonly occurs in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which 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:

• insufficient 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 support 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 starting to 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 passage (oesophagus), such as narrowing or difficulty swallowing.
• If you are unable to remain upright, either standing or sitting, for at least one continuous hour (60 minutes).
• If you have or have had low levels of calcium in the blood. Please consult your doctor.

Warnings and precautions

Very rarely, an 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 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 problems with your mouth or teeth, such as poor dental health, gum disease, or a 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 this medicine.

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.

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

• If you have a mineral metabolism disorder (e.g. vitamin D deficiency).
• If you have kidney problems.
• If you have difficulty swallowing or any digestive problems.
• If you are undergoing dental treatment or have dental surgery planned, inform your dentist that you are being treated with ibandronic acid.

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. If you develop these symptoms, stop taking the medicine and inform your doctor immediately (see section 3).

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Other medicines and Ibandronic Acid TecniGen:

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

• Calcium, magnesium, iron, or aluminium-containing supplements, as they may interfere with the effects of ibandronic acid.
• 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 bisphosphonates (such as ibandronic acid). Therefore, be very careful when taking painkillers or anti-inflammatory medicines 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 acid with food. This medicine becomes less effective if taken with food.

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

Pregnancy, breast-feeding, and fertility

Do not take this medicine if you are pregnant or breast-feeding. If you are breast-feeding, you may need to stop breast-feeding in order to take Ibandronic Acid TecniGen.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and operate machinery, as this medicine is not expected to have any effect or its effect is negligible on your ability to drive and operate machinery. However, consult your doctor first if you plan to drive, operate machinery, or use tools.

Ibandronic Acid TecniGen contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Ibandronic Acid TecniGen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in 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 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 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 (such as the first day of each month) or the same day of the week (such as the first Sunday of each month). Choose whichever best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours since your last meal or drink, except water.

• Take the ibandronic acid tablet

• first thing in the morning, 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 that has a high calcium concentration, fruit juice, or other beverages.

If you are unsure about potentially high calcium levels in your 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 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 could return to the esophagus

• do not eat anything

• do not drink anything (except water, if needed)

• do not take any other medicines

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

Do not take this medicine at bedtime or just before getting up.

Continuation of treatment with Ibandronic Acid TecniGen

It is important that you take this medicine every month, as directed by your doctor. Ibandronic acid helps treat osteoporosis only while you are taking this medicine.

If you take more Ibandronic Acid TecniGen than you should

If you have accidentally taken extra tablets, drink a full glass of milk and contact your doctor immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 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 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 dates marked on your calendar.

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

Take one tablet on the morning after the day you remember missing the dose, then continue taking one tablet per month according to the dates marked on your calendar.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

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

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

• pseudo-flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any effect becomes bothersome 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 pain or tightness, in the throat/food pipe.
• symptoms of low calcium levels in the blood (hypocalcaemia), 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 swelling
• new pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an unusual femur (thigh bone) fracture.

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

• pain or aching sensation in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone].
• severe allergic reaction which may be life-threatening
• contact 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.

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 (bowel losses)
• muscle cramps, stiffness of joints and limbs

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

• dizziness
• flatulence (gas, bloated feeling)
• back pain
• feeling 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.
• hives

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

By reporting adverse 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 it from moisture.

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

Do not use this medicine after the expiry date stated on the blister and container following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 sodium ibandronate monohydrate).
• The other components are: monohydrate lactose, 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.

What Ibandronic Acid TecniGen looks like and contents of the pack

White, oblong-shaped tablets. They are supplied in blister packs containing 1 and 3 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. 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 the most recent revision of this leaflet: June 2022

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