Ibandronic acid PensA

PACKAGE LEAFLET: INFORMATION FOR THE USER

IBANDRONIC ACID PENSA

150 mg film-coated tablets
ibandronic acid
Equivalent medicine
Please read all of 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. WHAT IBANDRONIC ACID PENSA IS AND WHAT IT IS USED FOR
IBANDRONIC ACID PENSA belongs to a group of medicines called bisphosphonates.
It contains the active substance ibandronic acid.
IBANDRONIC ACID PENSA can reverse bone loss by preventing further bone breakdown and increasing bone mass in many women who take it, although they may not see or feel any difference.
IBANDRONIC ACID PENSA can help reduce the likelihood of bone fractures. This reduction in fractures has been demonstrated for the spine, but not for the hip.
IBANDRONIC ACID PENSA has been prescribed for you to treat post-menopausal osteoporosis because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a condition common in women after menopause.
At menopause, a woman's ovaries stop producing the female hormone estrogen, which helps maintain a healthy skeleton.
The earlier a woman reaches menopause, the higher 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
• insufficient weight-bearing activity such as walking
• family history of osteoporosis

A healthy lifestyle will also 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 SHOULD KNOW BEFORE TAKING ACIDO IBANDRONICO PENSA

Do not take ACIDO IBANDRONICO PENSA

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

Warnings and precautions
An adverse effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported very rarely in post-marketing experience in patients treated with ACIDO IBANDRONICO PENSA for osteoporosis. Osteonecrosis of the jaw may occur even after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw, 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 any mouth or dental problems such as poor dental hygiene, 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 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 ACIDO IBANDRONICO PENSA.
During treatment, you should maintain good oral hygiene (including regular tooth brushing) and receive routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or need dental surgery (e.g. tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with ACIDO IBANDRONICO PENSA.
Contact your doctor and dentist immediately if you experience any mouth or dental problems such as tooth loss, pain or swelling, or failure of wounds to heal or discharge, as these may be signs of osteonecrosis of the jaw.
Some people need to take particular care when taking ACIDO IBANDRONICO PENSA. Inform your doctor before taking ACIDO IBANDRONICO PENSA:

• 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 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 ACIDO IBANDRONICO PENSA. If you develop these symptoms, stop taking ACIDO IBANDRONICO PENSA and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer ACIDO IBANDRONICO PENSA to children or adolescents under 18 years of age.
Other medicines and ACIDO IBANDRONICO PENSA
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 PENSA.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen), which may irritate the stomach and intestines. ACIDO IBANDRONICO PENSA may have a similar effect. Be especially careful if you take painkillers or anti-inflammatory medicines at the same time as ACIDO IBANDRONICO PENSA. After taking the monthly tablet of ACIDO IBANDRONICO PENSA, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.

ACIDO IBANDRONICO PENSA with food and drinks:
Do not take ACIDO IBANDRONICO PENSA with food. ACIDO IBANDRONICO PENSA is less effective if taken with food.
You may drink plain water but no other beverages
After taking ACIDO IBANDRONICO PENSA, wait one hour before consuming food and other drinks (see section 3. “How to take ACIDO IBANDRONICO PENSA”).
Pregnancy and breastfeeding
ACIDO IBANDRONICO PENSA should only be used by postmenopausal women and must not be taken by women who could still have children.
Do not take ACIDO IBANDRONICO PENSA 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 PENSA is not expected to affect, or to affect only negligibly, the ability to drive and use machines.
ACIDO IBANDRONICO PENSA contains lactose.
If your doctor has told you that you have an intolerance or are unable to digest certain sugars (e.g. if you have galactose intolerance, Lapp lactase deficiency or other glucose-galactose malabsorption problems), consult your doctor before taking this medicine.

3. HOW TO TAKE IBANDRONIC ACID PENSA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose of IBANDRONIC ACID PENSA is one tablet per month.
Taking your monthly tablet
It is important to follow the instructions below carefully. These instructions are designed to help the IBANDRONIC ACID PENSA tablet reach your stomach quickly, minimizing the risk of irritation.

• Take one 150 mg tablet of IBANDRONIC ACID PENSA once a month.
• Choose a day each month that is easy to remember. For taking your IBANDRONIC ACID PENSA tablet, you may choose the same date (e.g., the 1st of each month) or the same day (e.g., the first Sunday of each month), whichever best fits your routine.
• Take the IBANDRONIC ACID PENSA tablet at least 6 hours after eating or drinking anything other than water.
• Take the IBANDRONIC ACID PENSA tablet:
• immediately after getting up in the morning and
• before consuming 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. If there is concern about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water with a low mineral content.

• Swallow the tablet whole – do not chew, crush, or let it dissolve in your mouth.
• During the hour (60 minutes) following tablet intake:
• do not lie down – if you do not remain in an upright position (standing or sitting), part of the medicine may reflux into the esophagus

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

Continuing treatment with IBANDRONIC ACID PENSA
It is important to continue taking IBANDRONIC ACID PENSA every month for as long as your doctor prescribes it.
After 5 years of treatment with IBANDRONIC ACID PENSA, consult your doctor to determine whether you should continue taking IBANDRONIC ACID PENSA.
If you take more IBANDRONIC ACID PENSA 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 – doing so may cause IBANDRONIC ACID PENSA to irritate your esophagus.
If you forget to take IBANDRONIC ACID PENSA

• 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 and see 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, do not take two tablets of IBANDRONIC ACID PENSA within the same week. Wait until the next scheduled dose and take the tablet as usual; then continue taking one tablet once a 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 the day you remember; 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 everyone experiences them.
Seek immediate medical attention from a nurse or doctor 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, severe pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. You may develop a serious inflammation of the throat/food passage, possibly 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 or throat, with breathing difficulties
• persistent eye pain and inflammation
• new pain, weakness or discomfort in the thigh, hip or groin. This may be an early sign of an unusual femur fracture.

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

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

Other possible side effects
Common (may affect up to 1 in 10 people)

• headache
• heartburn, discomfort when swallowing, stomach ache or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea
• muscle cramps, joint or limb stiffness
• flu-like symptoms (fever, restlessness and trembling, feeling unwell, bone pain, muscle and joint pain). Contact your nurse or doctor if any of these effects become bothersome or last more than two days
• skin rash

Uncommon (may affect up to 1 in 100 people)

• dizziness
• flatulence (intestinal gas, bloating sensation)
• 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
• hives (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 the following website:
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 PENSA

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ACIDO IBANDRONICO PENSA contains

• The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid.
• The excipients are: tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica

tablet coating: hydroxypropylcellulose, titanium dioxide, macrogol 6000
Description of the appearance of ACIDO IBANDRONICO PENSA and contents of the package
The 150 mg tablets of ACIDO IBANDRONICO PENSA are film-coated tablets, white in colour, elongated in shape, marked "LC" on one side.
The 150 mg tablets of ACIDO IBANDRONICO PENSA are available in packages containing 1 or 3 film-coated tablets. The tablets are supplied in blisters containing 1 or 3 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:
Italy: ACIDO IBANDRONICO PENSA 150 mg film-coated tablets
Norway: Vinodran 150 mg Tablett, filmdrasjert
United Kingdom: Ibandronic acid 150 mg film-coated tablets
Spain: Acido Ibandronico combix 150 mg comprimidos recubiertos con película EFG
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