Ibandronic acid Zentiva: detailed information

Package leaflet: Information for the patient

Ibandronic Acid Zentiva 150 mg film-coated tablets

Generic medicine
Please read all of 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet

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

1. What Acido Ibandronico Zentiva is and what it is used for

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

inadequate dietary intake of calcium and vitamin D;
smoking or excessive alcohol consumption;
lack of physical activity (such as walking or other weight-bearing exercise);
a family history of osteoporosis.

In addition, 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 engaging in other weight-bearing activities;
not smoking and avoiding excessive alcohol consumption.

2. What you need to know before taking Acido Ibandronico Zentiva

Do not take Acido Ibandronico Zentiva:

if you are allergic to ibandronic acid or to 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 in a sitting or standing position for at least one hour (60 minutes) continuously;
if you have, or have previously had, low levels of calcium in your blood. Consult your doctor.

Warnings and precautions
An adverse effect called osteonecrosis of the jaw/mandible (severe deterioration of the bone tissue of the jaw and mandible) has been reported very rarely after marketing in patients taking Acido Ibandronico Zentiva for osteoporosis. Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, several precautions should be taken.
Before starting treatment, inform your doctor or nurse (healthcare professional) if:

you have any problems with your mouth or teeth, such as poor dental health, gum disease, or if you are scheduled for a 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 (this may increase the risk of dental problems);
you have previously been treated with bisphosphonates (used to treat or prevent bone problems);
you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with Acido Ibandronico Zentiva.
During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and attend routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing dental treatments or are scheduled for dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Acido Ibandronico Zentiva.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or non-healing lesions or discharge, as these could be signs of osteonecrosis of the jaw/mandible.
Some people need to take special care while taking Acido Ibandronico Zentiva. Consult your doctor before taking Acido Ibandronico Zentiva:

if you have any mineral metabolism disorders (such as vitamin D deficiency);
if your kidneys are not functioning normally;
if you have 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 eating 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 Acido Ibandronico Zentiva. If you develop these symptoms, stop taking Acido Ibandronico Zentiva and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer Acido Ibandronico Zentiva to children or adolescents under 18 years of age.
Other medicines and Acido Ibandronico Zentiva
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 Acido Ibandronico Zentiva;
Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen), which can irritate the stomach and intestines. Acido Ibandronico Zentiva may have a similar effect. Pay particular attention if you are taking painkillers or anti-inflammatory medicines at the same time as Acido Ibandronico Zentiva.

After taking the monthly Acido Ibandronico Zentiva tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.
Acido Ibandronico Zentiva with food and drink
Do not take Acido Ibandronico Zentiva with food. Acido Ibandronico Zentiva is less effective if taken with food.
You may drink water but no other beverages.
After taking Acido Ibandronico Zentiva, wait 1 hour before taking your first meal and other beverages (see section 3 “How to take Acido Ibandronico Zentiva”).
Pregnancy, breast-feeding and fertility
Acido Ibandronico Zentiva is intended exclusively for use in post-menopausal women and must not be taken by women who could still become pregnant.
Do not take Acido Ibandronico Zentiva if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and operate machinery, as Acido Ibandronico Zentiva is expected to have no or negligible effect on the ability to drive and operate machinery.
Acido Ibandronico Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Ibandronic Acid Zentiva

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

Take one 150 mg tablet of Ibandronic Acid Zentiva once a month.
Choose a day each month that is easy to remember. You may choose a specific date (e.g. the 1st of each month) or the same day of the week (e.g. the first Sunday of each month) to take your Ibandronic Acid Zentiva tablet. Choose the date that best fits your routine.
Take the Ibandronic Acid Zentiva tablet at least 6 hours after eating or drinking anything other than water.
Take the Ibandronic Acid Zentiva tablet
immediately after getting up in the morning and
before taking any food or drink (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 content, fruit juice, or any other beverage. It is recommended to use bottled water with a low mineral content if there is a concern about potentially high calcium levels in tap water (hard water).
Swallow the tablet whole – do not chew, crush, or let it dissolve in your mouth.
During the hour following (60 minutes) tablet intake
do not lie down; if you do not remain upright (standing or sitting), part of the medicine may reflux into the oesophagus.
do not eat anything.
do not drink anything (except water if needed).
do not take any other medicines.
After waiting for one hour, you may have your first food or drink of the day. After eating, you may lie down if desired and take other medicines as needed.

Continuing treatment with Ibandronic Acid Zentiva
It is important to continue taking Ibandronic Acid Zentiva every month for as long as your doctor prescribes it.
After 5 years of taking Ibandronic Acid Zentiva, consult your doctor to determine whether you should continue treatment.

If you take more Ibandronic Acid Zentiva than you should
If you have taken more than one tablet by mistake, 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 Zentiva to irritate your oesophagus.

If you forget to take Ibandronic Acid Zentiva
If you forget to take the tablet on the scheduled morning, do not take the tablet later during the day. Instead, check your calendar and determine when your next scheduled dose is due.

If you forgot to take a tablet on the scheduled day and there are only 1 to 7 days left until your next scheduled dose…

Never take two tablets of Ibandronic Acid Zentiva within the same week. You must wait until the day of your 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 you forgot to take a tablet on the scheduled day and 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult a nurse or doctor immediately if you notice any of the following serious side effects –
you may need urgent medical treatment:
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 severe inflammation of the throat/food passage, sometimes with sores or narrowing of the throat/food passage.

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

itching, swelling of the face, lips, tongue and throat, with breathing difficulties. You may have an allergic reaction to this medicine.
persistent eye pain and inflammation.
new pain, weakness or discomfort in the thigh, hip or groin. You may be experiencing early signs of an atypical femoral fracture.

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

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

Other possible side effects
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, stiffness of joints and limbs.
flu-like symptoms, including fever, trembling and chills, feeling unwell, bone pain, and muscle and joint pain. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days.
rash.

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

dizziness.
flatulence (intestinal gas, bloating sensation).
back pain.
feeling tired and exhausted.
asthma attacks.
- 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):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Ibandronico Zentiva contains

The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
The other components are: Tablet core: Ludipress (lactose, povidone, crospovidone), magnesium stearate. Tablet coating: Opadry II 85F18422 White (a mixture of polyethylene glycol, titanium dioxide, talc, and polyvinyl alcohol).

Description of the appearance of Acido Ibandronico Zentiva and contents of the pack
Acido Ibandronico Zentiva are white, oblong, biconvex film-coated tablets.
Pack sizes:
1, 3 or 6 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa 7, 20121 Milano
Manufacturer
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague (Czech Republic)

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
United Kingdom (Northern Ireland) Ibandronic Acid 150mg Film Coated Tablets
Italy Acido Ibandronico Zentiva