Ibandronic acid Alter

Patient Information Leaflet: Information for the User

IBANDRONIC ACID ALTER

150 mg film-coated tablets
ibandronic acid
Generic medicine
Please read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Acido Ibandronico Alter and what is it used for?

Acido Ibandronico Alter belongs to a group of medicines called bisphosphonates. It contains the
active substance ibandronic acid.
Acido Ibandronico Alter 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 Alter 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 Alter 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 common condition in women after menopause. After
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
• lack of physical activity (such as walking or other weight-bearing exercise)
• 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 Alter

Do not take Acido Ibandronico Alter

• 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 in an upright position (standing or sitting) for at least one hour continuously
• if you have, or have previously had, low levels of calcium in your blood. In this case, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Ibandronico Alter.
A side effect called osteonecrosis of the jaw/mandible (bone damage in the jaw/mandible) has been reported very rarely after marketing in patients treated with ibandronic acid. 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, certain 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 (as this may increase the risk of dental problems);
• you have previously been treated with a bisphosphonate (used to treat or prevent bone diseases);
• 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 Acido Ibandronico Alter.
During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and have routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing dental treatment or need 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 Alter.
Contact your doctor and dentist immediately if you experience any mouth or dental problems such as tooth loss, pain or swelling, or non-healing sores or discharge, as these may be signs of osteonecrosis of the jaw/mandible.
Some people need to take special care when taking Acido Ibandronico Alter. Consult your doctor before taking Acido Ibandronico Alter:

• if you have any mineral metabolism disorders (such as vitamin D deficiency)
• if your kidneys do not function normally
• if you have swallowing or digestive problems

Irritation, inflammation or ulceration of the throat/food passage (oesophagus) may occur, often accompanied by 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 Alter. If you develop these symptoms, stop taking Acido Ibandronico Alter and inform your doctor immediately (see section 3).
Children and adolescents
Do not give Acido Ibandronico Alter to children or adolescents under 18 years of age.
Other medicines and Acido Ibandronico Alter
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 Alter.
• 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 Alter may have the same effect. Be especially careful if you are taking painkillers or anti-inflammatory medicines at the same time as Acido Ibandronico Alter.

After swallowing the monthly Acido Ibandronico Alter tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.
Acido Ibandronico Alter with food and drinks
Do not take Acido Ibandronico Alter with food. Acido Ibandronico Alter is less effective if taken with food.
You may drink water but no other beverages
After taking Acido Ibandronico Alter, wait 1 hour before consuming food and other drinks (see section 3 “How to take Acido Ibandronico Alter”).
Pregnancy and breastfeeding
Acido Ibandronico Alter may only be used by post-menopausal women and must not be taken by women who are still able to have children.
Do not take Acido Ibandronico Alter if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and operate machinery, as Acido Ibandronico Alter is expected to have no or negligible effect on the ability to drive and use machines.
Acido Ibandronico Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Acido Ibandronico Alter contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Ibandronic Acid Alter

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Ibandronic Acid Alter is one tablet per month.
Taking your monthly tablet
It is important to follow the instructions below carefully. They are designed to help the Ibandronic Acid Alter tablet reach your stomach quickly, reducing the likelihood of irritation.

• Take one 150 mg Ibandronic Acid Alter tablet once a month.
• Choose a day of the month that is easy to remember. For taking Ibandronic Acid Alter, you may choose 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 every month), depending on what best suits your routine.
• Take the Ibandronic Acid Alter tablet at least 6 hours after eating or drinking anything other than water.
• Take the Ibandronic Acid Alter tablet either immediately after getting up 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 that has a high calcium content, fruit juice, or any other beverage. It is recommended to use bottled water with 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 allow it to dissolve in your 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.

• 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 eat and drink for your morning meal. After eating, you may lie down if desired and take other medicines as needed.

Continuing treatment with Ibandronic Acid Alter
It is important to continue taking Ibandronic Acid Alter every month as long as your doctor prescribes it. After taking Ibandronic Acid Alter for 5 years, consult your doctor to determine whether you should continue treatment.
If you take more Ibandronic Acid Alter 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 Alter to irritate your oesophagus.
If you forget to take Ibandronic Acid Alter

• If you forget to take the tablet in 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 you forget to take the tablet on your scheduled day and there are only 1 to 7 days remaining until your next scheduled dose…

Never take two Ibandronic Acid Alter tablets within the same week. Wait until your next scheduled dose, take the tablet as usual, and continue taking one tablet per month on the dates marked on your calendar.

• If you forget to take the tablet on your scheduled day and there are more than 7 days until your next scheduled dose… take one tablet the morning after you remember; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact a nurse or doctor immediately if you notice any of the following serious side
effects – urgent medical treatment may be required:
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
• persistent eye pain and 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)

• mouth pain or sores, or jaw pain. These may be early signs of serious jaw problems (osteonecrosis – death of bone tissue – of the jaw)
• contact your doctor if you have ear pain, ear discharge and/or ear infection. These may be signs of bone damage in the ear
• severe, potentially 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 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, shivering and chills, feeling unwell, bone, muscle and joint pain. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days
• skin rash.

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

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

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 suspected adverse reactions
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Alter contains

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as monosodium monohydrate).
• The other components are: Tablet core: povidone, microcrystalline cellulose, pregelatinized corn starch, crospovidone, anhydrous colloidal silica, glyceryl dibehenate. Tablet coating: Opadry OY-LS-28908 (White II) containing: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Description of the appearance of Acido Ibandronico Alter and the contents of the pack
The Acido Ibandronico Alter 150 mg film-coated tablets are white, round and biconvex.
Acido Ibandronico Alter 150 mg film-coated tablets are packed in cardboard boxes containing an appropriate number of blisters made of PA/Aluminum/PVC-Aluminum (aluminum-aluminum blister) containing 1 or 3 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 - Milan, Italy

Manufacturer and responsible for batch release:
Pharmathen S.A.
6 Dervenakion Str.
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5, 693 00 Rodopi
Greece
Laboratorios Alter S.A
C/ Mateo Inurria, 30
28036 Madrid – Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic Gerousia
Italy Acido Ibandronico Alter
Portugal Ácido Ibandrónico Alter
Slovakia Gerousia 150 mg
Spain Ácido Ibandrónico Alter 150 mg
film-coated tablets EFG
United Kingdom Gerousia 150 mg film-coated tablets