Ibandronic acid Tecnigen: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid TecniGen 150 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Ibandronic Acid TecniGen is and what it is used for
What you need to know before taking Ibandronic Acid TecniGen
How to take Ibandronic Acid TecniGen
Possible side effects
How to store Ibandronic Acid TecniGen
Contents of the pack and other information

1. WHAT ACIDO IBANDRONICO TECNIGEN IS AND WHAT IT IS USED FOR

Acido Ibandronico TecniGen belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Acido Ibandronico TecniGen can reverse bone loss by preventing further bone loss and increasing bone mass in many women who take it, although they may not see or feel any difference. Acido Ibandronico TecniGen can help reduce the likelihood of bone breaks (fractures). This reduction in fractures has been demonstrated for the spine, but not for the hip.
Acido Ibandronico TecniGen has been prescribed to you for the treatment of post-menopausal osteoporosis
because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a phenomenon common in women after menopause. At menopause, a woman's ovaries stop producing a female hormone, oestrogen, which helps maintain a healthy skeleton.
The earlier a woman reaches menopause, the higher the risk of fractures in osteoporosis.
Other factors that may increase the risk of fractures include:

inadequate intake of calcium and vitamin D through diet
smoking or excessive alcohol consumption
insufficient physical activity (such as walking or other weight-bearing exercise)
family history of osteoporosis

A healthy lifestyle will help you get the maximum benefit from your treatment.
This includes:

following a balanced diet rich in calcium and vitamin D
walking or performing other weight-bearing activities
not smoking and avoiding excessive alcohol consumption.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IBANDRONIC ACID TECNIGEN

Do not take Ibandronic Acid TecniGen

if you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6)
if you have problems with the passage through which food travels (esophagus), such as narrowing or difficulty swallowing
if you are unable to remain in an upright position (standing or sitting) for at least one hour (60 minutes) continuously
if you have, or have previously had, low levels of calcium in your blood. In such cases, consult your doctor.

Warnings and precautions
Some people should take special care when taking Ibandronic Acid TecniGen. Talk to your doctor, pharmacist, or nurse before taking Ibandronic Acid TecniGen:

if you have any disorders of mineral metabolism (such as vitamin D deficiency)
if your kidneys do not function normally
if you have swallowing or digestive problems
if you are undergoing or are scheduled for dental treatment or dental surgery, inform your dentist that you are being treated with Ibandronic Acid TecniGen

Irritation, inflammation, or ulceration of the esophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as severe chest pain, severe pain after eating food and/or drinking, severe nausea, or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour after taking Ibandronic Acid TecniGen. If you develop these symptoms, stop taking Ibandronic Acid TecniGen and contact your doctor immediately (see section 3).
Children and adolescents
Ibandronic Acid TecniGen must not be used in children and adolescents under 18 years of age.
Other medicines and Ibandronic Acid TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially:

calcium, magnesium, iron, or aluminium-containing supplements, as they may affect the effects of Ibandronic Acid TecniGen
acetylsalicylic acid and other non-steroidal anti-inflammatory drugs known as "NSAIDs" (including ibuprofen, sodium diclofenac, or naproxen) which may cause stomach and intestinal irritation. Bisphosphonates (such as Ibandronic Acid TecniGen) may have the same effect. Be particularly cautious if you are taking painkillers or anti-inflammatory drugs together with Ibandronic Acid TecniGen.

After taking the monthly tablet of Ibandronic Acid TecniGen, wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.
Ibandronic Acid TecniGen with food and drinks
Do not take Ibandronic Acid TecniGen with food. Ibandronic Acid TecniGen is less effective when taken with food.
You may drink water but not other beverages (see section 3. How to take Ibandronic Acid TecniGen).
Pregnancy and breastfeeding
Do not take Ibandronic Acid TecniGen if you are pregnant. If you are breastfeeding, you may need to stop breastfeeding while taking Ibandronic Acid TecniGen.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may drive and operate machinery, as no effects or only negligible effects of Ibandronic Acid TecniGen on the ability to drive and use machines are expected. However, consult your doctor before driving, operating machinery, or using equipment.
Ibandronic Acid TecniGen contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE IBANDRONIC ACID TECNIGEN

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose of Ibandronic Acid TecniGen is one tablet once a month.
Taking your monthly tablet
It is important to follow the instructions below carefully. They are designed to help the
Ibandronic Acid TecniGen tablet reach the stomach quickly, reducing the likelihood of irritation.

Take one 150 mg Ibandronic Acid TecniGen tablet once a month.
Choose a day of the month that is easy to remember. For taking the Ibandronic Acid TecniGen tablet, you may select a specific date each month (e.g., the 1st of every month) or a particular day of the week (e.g., the first Sunday of each month), depending on what best fits your routine.
Take the Ibandronic Acid TecniGen tablet at least 6 hours after eating or drinking anything other than water.
Take the Ibandronic Acid TecniGen tablet either immediately upon rising or before consuming food or drinks (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 any other beverage. If there is any concern 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, suck, or allow it to dissolve in the mouth.
During the hour following tablet intake (60 minutes), do not lie down; if you do not remain upright (standing or sitting), part of the medicine may reflux into the oesophagus.

Green circular prohibition symbol with a diagonal bar crossing through it

Do not eat anything

Green circular prohibition symbol with a diagonal bar over a white plate accompanied by black fork and knife

Do not drink anything (except water, if needed)
Do not take any other medicines
After waiting one hour, you may eat and drink for your morning meal. After eating, you may lie down if desired and take other medicines as needed.

Do not take the tablet just before going to bed or just before getting up.
Continuing treatment with Ibandronic Acid TecniGen
It is important to continue taking Ibandronic Acid TecniGen every month for as long as your doctor prescribes it. Ibandronic Acid TecniGen can treat osteoporosis only as long as you continue taking it.
If you take more Ibandronic Acid TecniGen than you should
If you accidentally take too many tablets, drink a full glass of milk and contact your doctor
immediately.
Do not induce vomiting and do not lie down – this could cause Ibandronic Acid TecniGen to irritate your oesophagus.
If you forget to take Ibandronic Acid TecniGen
If you forget to take the tablet on the morning of your scheduled day, do not take it later during the
day. Instead, check your calendar and determine when your next scheduled dose is due:
If there are only 1 to 7 days until your next scheduled dose…
You should wait until the next scheduled dose and take the tablet as usual; then continue taking one tablet once a month on the scheduled dates marked on your calendar.
If there are more than 7 days until your next scheduled dose…
You should take one tablet on the morning after the day you remembered; then continue taking one tablet once a month on the scheduled dates marked on your calendar.
Never take two Ibandronic Acid TecniGen tablets within the same week.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact a nurse or doctor immediately if you notice any of the following serious adverse reactions.
Urgent medical treatment may be required:

Common (may affect up to 1 in 10 people)

flu-like symptoms including fever, restlessness and tremor, feeling unwell, fatigue, bone pain, and muscle and joint pain. Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
skin rash. This could be an allergic reaction to the medicine.

Uncommon (may affect up to 1 in 100 people)

severe chest pain, intense pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. There may be a serious inflammation of the food passage (oesophagus), possibly with sores or narrowing of the oesophagus.
symptoms of low calcium levels in the blood (hypocalcaemia), 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 breathing difficulties
persistent eye pain or inflammation
new pain, weakness or discomfort in the thigh, hip or groin, as this could be an early sign of a possible femur fracture.

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

pain or ulceration in the mouth or jaw. You may be experiencing early signs of serious jaw problems (osteonecrosis (bone tissue death) of the jawbone).
severe, potentially life-threatening allergic reaction
contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.

Other possible adverse reactions

Common (may affect up to 1 in 10 people)

headache
heartburn, difficulty swallowing, stomach or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
muscle cramps, joint and limb stiffness

Uncommon (may affect up to 1 in 100 people)

dizziness
flatulence (intestinal gas, bloating sensation)
back pain
feeling tired and exhausted

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

inflammation of the duodenum (the first part of the intestine), causing stomach pain
urticaria (hives)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IBANDRONIC ACID TECNIGEN

Keep in the original packaging to protect the medicine 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 carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Acido Ibandronico TecniGen contains

The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).
The other ingredients are: monohydrate lactose, povidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silicon dioxide and sodium stearate fumarate in the tablet core; hypromellose, titanium dioxide (E171) and macrogol 6000 in the tablet coating.

Description of the appearance of Acido Ibandronico TecniGen and packaging contents
Acido Ibandronico TecniGen 150 mg film-coated tablets are white, oval-shaped tablets.
The tablets are packed in blisters. Packaging containing 1 tablet is available.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This leaflet was last updated on

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid TecniGen 50 mg film-coated tablets

Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ibandronic Acid TecniGen is and what it is used for
What you need to know before taking Ibandronic Acid TecniGen
How to take Ibandronic Acid TecniGen
Possible side effects
How to store Ibandronic Acid TecniGen
Contents of the pack and other information

1. WHAT ACIDO IBANDRONICO TECNIGEN IS AND WHAT IT IS USED FOR

Acido Ibandronico TecniGen contains the active substance ibandronic acid. This belongs to a group of medicines known as bisphosphonates.
Acido Ibandronico TecniGen is indicated for adults and is prescribed to you if you have breast cancer that has spread to the bones (bone metastases).

Helps prevent bone fractures.
Helps prevent other bone complications that might require surgery or radiotherapy.

Acido Ibandronico TecniGen works by reducing the loss of calcium from the bones. This helps to prevent bone weakening.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IBANDRONIC ACID TECNIGEN

It is important that you take Ibandronic Acid TecniGen at the correct time and in the correct manner, as it may cause irritation, inflammation, or ulcers in the passage through which food travels (esophagus), that is, the tube connecting the mouth to the stomach.
Discontinue treatment with Ibandronic Acid TecniGen and contact your doctor immediately if you experience severe chest pain, severe pain after swallowing food or drinks, or severe nausea or vomiting.
Do not take Ibandronic Acid TecniGen

if you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6)
if you have problems with the food passage (esophagus), such as narrowing or difficulty swallowing
if you are unable to remain in an upright position (standing or sitting) for at least one hour (60 minutes) continuously
if you have, or have previously had, low levels of calcium in the blood.

If any of these conditions apply to you, do not take Ibandronic Acid TecniGen.
If you are unsure, consult your doctor or pharmacist before taking Ibandronic Acid TecniGen.
Ibandronic Acid TecniGen must not be used in children and adolescents.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Ibandronic Acid TecniGen:

if you are allergic to any other bisphosphonate
if you have swallowing or digestive problems
if you have high or low levels of vitamin D or any other mineral in the blood
if you have kidney problems

If any of these conditions apply to you (or if you are uncertain), consult your doctor or pharmacist before taking Ibandronic Acid TecniGen.
If you are undergoing dental treatment or are scheduled to have dental surgery, or know you will need it in the future, inform your dentist that you are being treated with Ibandronic Acid TecniGen.
Children and adolescents
Ibandronic Acid TecniGen must not be used in children and adolescents under 18 years of age.
Other medicines and Ibandronic Acid TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Ibandronic Acid TecniGen may affect the action of other medicines. Other medicines may also affect the action of Ibandronic Acid TecniGen.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

supplements containing calcium, magnesium, iron, or aluminum
non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, or naproxen, since both NSAIDs and Ibandronic Acid TecniGen may cause irritating gastrointestinal disturbances
if you are taking a type of injectable antibiotic known as an “aminoglycoside,” such as gentamicin, since both aminoglycosides and Ibandronic Acid TecniGen may reduce the amount of calcium in the blood.

Taking medicines that reduce gastric acidity, such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid TecniGen.
Ibandronic Acid TecniGen with food and drinks
Do not take Ibandronic Acid TecniGen with food or other types of drinks except water, as Ibandronic Acid TecniGen is less effective when taken with food or drinks (see section 3).
Take Ibandronic Acid TecniGen at least 6 hours after the last intake of food, drinks, or any other medicine or supplements (for example, products containing calcium (milk), aluminum, magnesium, and iron) except water. After taking the tablet, wait at least 30 minutes before consuming the first food and drinks of the day, and other medicines or supplements (see section 3).
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, planning to become pregnant, or breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may drive and operate machinery, as no effects or only negligible effects of Ibandronic Acid TecniGen on the ability to drive and use machines are expected. However, consult your doctor before driving or operating machinery or equipment.
Ibandronic Acid TecniGen contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE IBANDRONIC ACID TECNIGEN

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the tablet at least 6 hours after the last intake of food, drinks, or any other
medicines or supplements, except water. Water with a high calcium concentration must not be used. If there is no concern about calcium levels in tap water (hard water), it is recommended to use bottled water with a low mineral content.
Your doctor may periodically request blood tests while you are taking Ibandronic Acid TecniGen to ensure you are receiving the correct dose of the medicine.
Taking the medicine
It is important that you take Ibandronic Acid TecniGen at the correct time and in the correct manner, as it may cause irritation, inflammation, or ulcers in the passage through which food travels (oesophagus).
To prevent this from happening, follow the instructions below:

take the tablet as soon as you wake up, before taking food, drinks, or any other medicines or supplements.
take the tablet with a full glass of water only (approximately 200 ml). Do not take the tablet with any other beverage except water.
swallow the tablet whole; do not chew, suck, or crush it. Do not allow the tablet to dissolve in the mouth.
after taking the tablet, wait at least 30 minutes before taking any food, drinks, or other medicines or supplements.
remain in an upright position (sitting or standing) while taking the tablet and for one hour afterwards (60 minutes), otherwise part of the medicine could flow back into the passage through which food travels (oesophagus).

How much medicine to take
The recommended dose of Ibandronic Acid TecniGen is one tablet per day. If you have mild kidney problems, your doctor may reduce the dose to one tablet taken on alternate days. If you have severe kidney problems, your doctor may reduce the dose to one tablet per week.
If you take more Ibandronic Acid TecniGen than you should
If you take too many tablets, contact your doctor immediately or go to hospital.
Before going, drink a full glass of milk. Do not induce vomiting and do not lie down.
If you forget to take Ibandronic Acid TecniGen
Do not take a double dose to make up for the forgotten dose. If you take one tablet daily, completely skip the missed dose and continue as usual the next day. If you take the tablet on alternate days or once a week, consult your doctor or pharmacist for advice.
If you stop taking Ibandronic Acid TecniGen
Continue taking Ibandronic Acid TecniGen for as long as your doctor tells you, because this medicine is effective only if taken continuously for the prescribed duration.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

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

persistent eye pain or inflammation
new pain, weakness, or discomfort in the thigh, hip, or groin. These may be early signs of an atypical femoral fracture.

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

pain or ulceration in the mouth or jaw. These may be early signs of serious jaw problems (osteonecrosis (bone tissue death) of the jawbone)
itching, swelling of the face, lips, tongue, and throat, with breathing difficulties. This may be a severe, potentially life-threatening allergic reaction.
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be signs of bone damage in the ear.

Other possible adverse reactions

Common adverse reactions (may affect up to 1 in 10 people)

stomach pain, abdominal pain, indigestion
nausea, heartburn, and difficulty swallowing (inflammation of the food passage tube/oesophagus)
low levels of calcium in the blood
feeling of weakness

Uncommon adverse reactions (may affect less than 1 in 100 people)

chest pain
skin itching or numbness (paresthesia)
flu-like symptoms, general feeling of illness or pain
severe stomach pain. This may be a sign of a bleeding ulcer in the first part of the intestine (duodenum) or inflammation of the stomach lining (gastritis)
dry mouth, unusual taste in the mouth, or difficulty swallowing
anemia
elevated levels of urea or parathyroid hormone in the blood

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the website: www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IBANDRONIC ACID TECNIGEN

Keep in the original packaging to protect the medicine 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 carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Acido Ibandronico TecniGen contains

The active substance is ibandronic acid. Each film-coated tablet contains 50 mg of ibandronic acid (as sodium ibandronate monohydrate).
The other ingredients are: monohydrate lactose, povidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silica and sodium stearil fumarate in the tablet core; hypromellose, titanium dioxide (E171) and macrogol 6000 in the tablet coating.

Description of the appearance of Acido Ibandronico TecniGen and packaging contents
Acido Ibandronico TecniGen 50 mg film-coated tablets are white, oval-shaped tablets.
The tablets are packaged in blisters. Packs containing 28 tablets are available.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This leaflet was last updated on