IBANDRONIC ACID DOC GENERICI

Package Leaflet: Information for the User

IBANDRONIC ACID DOC Generici 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 or pharmacist.
• 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACIDO IBANDRONICO DOC Generici is and what it is used for

ACIDO IBANDRONICO DOC Generici belongs to a group of medicines called bisphosphonates. It contains the
active substance ibandronic acid.
ACIDO IBANDRONICO DOC Generici can reverse bone loss by preventing further bone loss and increasing bone mass in many women who take it, although you may not see or feel any difference. ACIDO IBANDRONICO DOC Generici 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 DOC Generici has been prescribed to you for the treatment of postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in women after menopause. At menopause, a woman's ovaries stop producing a female hormone, estrogen, 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 intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• lack of walking or other weight-bearing exercises
• family history of osteoporosis.

A healthy lifestyle will also help you achieve the maximum benefit from 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 should know before taking ACIDO IBANDRONICO DOC Generici

Do not take ACIDO IBANDRONICO DOC Generici

• 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 (60 minutes) continuously
• if you have, or have previously had, low levels of calcium in the blood. In this case, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACIDO IBANDRONICO DOC Generici.
A side effect called osteonecrosis of the jaw/mandible (degeneration of the bone tissue in the jaw and mandible) has been reported very rarely after marketing authorization in patients taking ibandronic acid for osteoporosis. Osteonecrosis of the jaw/mandible may also occur after the end 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. Several precautions should be taken to reduce the risk of developing osteonecrosis of the jaw/mandible.
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 have a dental examination before starting treatment with ACIDO IBANDRONICO DOC Generici.
During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and have routine dental check-ups. If you wear dentures, make sure they fit properly in your mouth. If you are undergoing dental treatments or need to undergo 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 DOC Generici.
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 when taking ACIDO IBANDRONICO DOC Generici. Talk to your doctor before taking ACIDO IBANDRONICO DOC Generici:

• if you have any disorders of mineral metabolism (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 DOC Generici. If you develop these symptoms, stop taking ACIDO IBANDRONICO DOC Generici and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer ACIDO IBANDRONICO DOC Generici to children or adolescents under 18 years of age.
Other medicines and ACIDO IBANDRONICO DOC Generici
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 DOC Generici.
• 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 DOC Generici may have the same effect. Be particularly careful if you are taking painkillers or anti-inflammatory drugs together with ACIDO IBANDRONICO DOC Generici. After taking the monthly tablet of ACIDO IBANDRONICO DOC Generici, wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.

ACIDO IBANDRONICO DOC Generici with food and drink
Do not take ACIDO IBANDRONICO DOC Generici with food. ACIDO IBANDRONICO DOC Generici is less effective when taken with food.
You may drink water but no other beverages.
After taking ACIDO IBANDRONICO DOC Generici, wait 1 hour before eating your first meal of the day and before drinking other beverages (see section 3 “How to take ACIDO IBANDRONICO DOC Generici”).
Pregnancy and breastfeeding
ACIDO IBANDRONICO DOC Generici can 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 DOC Generici 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 use machinery, as ACIDO IBANDRONICO DOC Generici is expected to have no or negligible effect on the ability to drive and use machines.
ACIDO IBANDRONICO DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
ACIDO IBANDRONICO DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take ACIDO IBANDRONICO DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of ACIDO IBANDRONICO DOC Generici is one tablet per month.
Taking your monthly tablet
It is important to follow the instructions below carefully. They are designed to help the ACIDO IBANDRONICO DOC Generici tablet reach your stomach quickly, reducing the likelihood of irritation.

• Take one 150 mg ACIDO IBANDRONICO DOC Generici tablet once a month.
• Choose a day each month that is easy to remember. For taking your ACIDO IBANDRONICO DOC Generici tablet, you may choose a specific date each month (e.g. the 1st of every month) or a specific day of the week (e.g. the first Sunday of each month), depending on what best fits your routine.
• Take the ACIDO IBANDRONICO DOC Generici tablet at least 6 hours after eating or drinking anything other than water.
• Take the ACIDO IBANDRONICO DOC Generici tablet
• immediately after getting up in the morning, and
• before eating or drinking anything else (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 in an upright position (standing or sitting), part of the medicine may flow back into the oesophagus.

Do not eat anything

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 first meal of the day. After eating, you may lie down if desired and take other medicines if needed.

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

• If you forget to take the tablet in the morning on your scheduled day, do not take it later during the day. Instead, check your calendar to see when your next dose is due:
• If you forgot to take the tablet on your chosen day and there are only 1 to 7 days until your next scheduled dose… Never take two ACIDO IBANDRONICO DOC Generici tablets within the same week. Wait until the next scheduled dose, take the tablet as usual, and continue taking one tablet per month on the scheduled dates marked on your calendar.
• If you forgot to take the tablet on your chosen day and there are more than 7 days until your next scheduled dose… Take one tablet the morning after the day you remembered; then continue taking one tablet per month on the scheduled dates marked on your calendar. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a nurse or doctor immediately if you notice any of the following serious side effects – you may
need urgent medical treatment:
Uncommon (occur in 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 (occur in 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. You may experience early signs of a possible atypical fracture of the femur.

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

• mouth pain or soreness, or jaw pain. You may experience early signs of serious jaw problems (necrosis, i.e. death of jawbone tissue)
• contact your doctor if you have ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear
• severe, potentially life-threatening allergic reaction
• severe skin reactions.

Other possible side effects
Common (occur in up to 1 in 10 people):

• headache
• heartburn, difficulty swallowing, stomach or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea
• muscle cramps, joint and limb stiffness
• flu-like symptoms, including fever, shivering and chills, feeling unwell, bone and muscle pain, and painful joints. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days
• skin rash.

Uncommon (occur in 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 (occur in up to 1 in 1,000 people):

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

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 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 ACIDO IBANDRONICO DOC Generici

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 after "Exp.".
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What ACIDO IBANDRONICO DOC Generici contains

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as sodium 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 DOC Generici and package contents
ACIDO IBANDRONICO DOC Generici 150 mg film-coated tablets are white, round and biconvex.
ACIDO IBANDRONICO DOC Generici 150 mg film-coated tablets are packaged in cardboard boxes containing a blister made of PA/Aluminum/PVC-Aluminum (alu-alu blister) with 1 or 3 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers:
Pharmathen S.A.
6 Dervenakion Str.
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Sapes Industrial Park, Block 5
693 00 Rodopi
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: ACIDO IBANDRONICO DOC Generici
United Kingdom: Ibandronic acid Pharmathen
Iceland: Ibandronic acid Alvogen
Cyprus: Ibandronic acid Pharmathen