Ibandronat Polpharma

Package Leaflet: Information for the User

Ibandronat Polpharma, 150 mg, Film-Coated Tablets

Ibandronic Acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ibandronat Polpharma and what is it used for
• 2. Important information before taking Ibandronat Polpharma
• 3. How to take Ibandronat Polpharma
• 4. Possible side effects
• 5. How to store Ibandronat Polpharma
• 6. Contents of the pack and other information

1. What is Ibandronat Polpharma and what is it used for

Ibandronat Polpharma belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Ibandronat Polpharma can reverse the process of bone loss by inhibiting bone loss and increasing bone mass in most women who take this medicine, even if they do not notice or feel the difference. Ibandronat Polpharma may reduce the risk of bone fractures. A reduction in the number of fractures has been demonstrated in the case of vertebral fractures, but not in the case of hip fractures.

Ibandronat Polpharma has been prescribed to treat postmenopausal osteoporosis due to an increased risk of bone fractures.

Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones, which often occurs in women after menopause. During menopause, the female ovaries stop producing the female hormone - estrogen, which helps maintain normal bone structure.
The earlier menopause occurs in a woman, the greater her risk of osteoporotic fractures.
Other factors that may increase the risk of fractures include:

• insufficient calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• insufficient walking or other weight-bearing exercises
• a family history of osteoporosis.

A healthy lifestylewill also help achieve the greatest benefits from treatment. This means:

• following a balanced diet rich in calcium and vitamin D
• walking or other weight-bearing exercises
• not smoking and limiting excessive alcohol consumption.

2. Important information before taking Ibandronat Polpharma

When not to take Ibandronat Polpharma

• If the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If the patient has problems with the esophagus (the tube through which food passes), such as narrowing or difficulty swallowing.
• If the patient is unable to stand or sit upright for at least 1 hour (60 minutes).
• If the patient has or has had a decrease in calcium levels in the blood.Consult a doctor.

Warnings and precautions

A side effect called jaw necrosis (damage to the jawbone) has been very rarely reported after the introduction of ibandronic acid in patients being treated for osteoporosis. Jaw necrosis may also occur after treatment has ended.
It is essential to take preventive measures to avoid the development of jaw necrosis, as it can be a painful and difficult condition to treat. To reduce the risk of jaw necrosis, the following precautions should be taken:
Before starting treatment, the patient should inform the doctor/nurse (healthcare professional):

• if they have any oral or dental problems, such as poor dental condition, gum disease, or planned tooth extraction
• if they do not receive regular dental care or have not had dental check-ups for a long time
• if they smoke (which may increase the risk of dental problems)
• if they have been previously treated with bisphosphonates (used to treat or prevent bone diseases)
• if they are taking corticosteroids (e.g., prednisolone or dexamethasone)
• if they have been diagnosed with cancer.

The doctor may recommend that the patient undergo a dental examination before starting ibandronic acid treatment.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend regular dental check-ups. If the patient wears dentures, they should ensure a proper fit. Patients undergoing dental treatment or procedures (e.g., tooth extraction) should inform their doctor and dentist that they are taking ibandronic acid.
If the patient experiences any oral or dental problems, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, they should immediately contact their doctor and dentist, as these may be symptoms of jaw necrosis.
In some individuals, extra caution is required when taking Ibandronat Polpharma.
Therefore, before taking Ibandronat Polpharma, consult your doctor:

• if you have any mineral metabolism disorders (such as vitamin D deficiency).
• if your kidneys do not work properly or you have kidney disease.
• if you have any swallowing or digestive problems.

Irritation, inflammation, or ulceration of the esophagus may occur, often with symptoms of severe chest pain after swallowing food or drink, severe nausea, or vomiting may occur, especially if the patient does not drink a full glass of water or lies down after taking ibandronic acid. If such symptoms occur, stop taking ibandronic acid and consult a doctor immediately (see section 3).

Children and adolescents

Ibandronic acid should not be used in children and adolescents under 18 years of age.

Ibandronat Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and any medicines you plan to take, especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the efficacy of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium, naproxen) may irritate the stomach and intestines. Ibandronic acid may have a similar effect. Therefore, be cautious when taking painkillers or anti-inflammatory drugs during ibandronic acid treatment.

After taking the monthly tablet of Ibandronat Polpharma, wait for 1 hourbefore taking any other medicines, including antacids or calcium supplements.

Ibandronat Polpharma with food and drink

Do not take Ibandronat Polpharma with food.Ibandronic acid taken with food is less effective.

You can drink water, but do not drink any other beverages.

After taking Ibandronat Polpharma, wait for 1 hour before taking any food or other beverages (see section 3: "How to take Ibandronat Polpharma").

Pregnancy and breastfeeding

Ibandronat Polpharma should only be taken during menopause and should not be taken by women who may still become pregnant.
Do not take ibandronic acid during pregnancy or breastfeeding.
Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

The patient can drive and use machines, as ibandronic acid has no or negligible influence on the ability to drive and use machines.

Ibandronat Polpharma contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ibandronat Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual dose of Ibandronat Polpharma is one tablet once a month.

Taking the tablet once a month

It is essential to carefully follow the instructions below. These instructions have been developed to ensure that the Ibandronat Polpharma tablet reaches the stomach quickly, reducing the risk of irritation.

• The 150 mg Ibandronat Polpharma tablet should be taken once a month.
• Choose a specific day of the monththat is easy to remember. To take the Ibandronat Polpharma tablet, you can choose the same date (e.g., the first day of each month) or the same day (e.g., the first Sunday of each month). Choose a time that best suits your habits.
• Ibandronat Polpharma should be taken at least 6 hours after eatingany food or drink, except water.
• Take the Ibandronat Polpharma tablet:
• in the morning after getting upand
• before eating or drinking anything("on an empty stomach").
• Swallow the tablet with a full glass of water(at least 180 ml). Do notswallow the tablet with water that has a high calcium content, fruit juice, or any other beverage. If you are concerned that the tap water has a high calcium content (so-called hard water), it is recommended to use water with low mineral content.
• Swallow the tablet whole- do not chew, crush, or let it dissolve in your mouth.
• For the next hour (60 minutes)after taking the tablet:
• -do not lie down; if you do not maintain an upright position (standing or sitting), part of the medicine may flow back into the esophagus,

• do not eat anything,

• do not drink anything(except water, if necessary),
• do not take any other medicines.
• After 1 hour, you can take your first meal and drink of the day. After eating, you can lie down and take other medicines if necessary.

Continuing treatment with Ibandronat Polpharma

It is essential to take Ibandronat Polpharma every month, as long as your doctor recommends. After 5 years of taking Ibandronat Polpharma, consult your doctor to determine if you should continue taking Ibandronat Polpharma.

Taking more than the recommended dose of Ibandronat Polpharma

If you accidentally take more than one tablet, drink a full glass of milkand immediately contact your doctor.
Do not induce vomiting and do not lie down- this may cause irritation of the esophagus by Ibandronat Polpharma.

Missing a dose of Ibandronat Polpharma

If you forget to take a tablet in the morning on the planned day, do not take the tablet later that day. Check when the next planned dose is due:

• If you forget to take a tablet on the planned day, and the next planned dose is due in 1 to 7 days…

Never take two Ibandronat Polpharma tablets in the same week.

Wait until the next planned dose.Take the tablet according to the established schedule, and then continue taking one tablet per month on the planned days marked in the calendar.

• If you forget to take a tablet on the planned day, and the next planned dose is due in more than 7 days…Take one tablet the next morning after the day you remembered the missed dose, and then continue taking one tablet per month on the planned days marked in the calendar.

4. Possible side effects

Like all medicines, Ibandronat Polpharma can cause side effects, although not everybody gets them.

Immediately inform your nurse or doctor if you experience any of the following serious side effects, as you may need urgent medical attention:

Uncommon(may affect less than 1 in 100 people)

• Severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting. Severe esophagitis, as well as esophageal ulcers or narrowing, may occur.

Rare(may affect less than 1 in 1,000 people)

• Itching, swelling of the face, lips, tongue, and throat, with difficulty breathing
• Chronic eye pain and inflammation
• New pain, weakness, or discomfort in the thigh, hip, or groin area. These may be early signs of atypical femoral fractures.

Very rare(may affect less than 1 in 10,000 people)

• Pain or ulcers in the mouth or jaw. These may be early signs of serious jaw problems (necrosis of the jawbone).
• If you experience ear pain, discharge from the ear, and/or ear infection, tell your doctor. These may be symptoms of bone damage in the ear.
• Severe, potentially life-threatening allergic reactions.
• Severe skin reactions.

Other possible side effects

Common(may affect less than 1 in 10 people)

• Headache
• Heartburn, unpleasant sensations when swallowing, stomach or abdominal pain (may be related to gastritis), indigestion, nausea, diarrhea (loose stools)
• Muscle cramps, stiffness of the joints and limbs
• Flu-like symptoms, including fever, chills, and shivering, discomfort, fatigue, bone pain, and muscle pain. Talk to your nurse or doctor if any of these symptoms become troublesome or last more than a few days.
• Rash.

Uncommon(may affect less than 1 in 100 people)

• Dizziness
• Bloating with gas (feeling bloated)
• Back pain
• Feeling tired and weak
• Asthma attacks.

Rare(may affect less than 1 in 1,000 people)

• Duodenitis (inflammation of the duodenum), causing abdominal pain
• Hives.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronat Polpharma

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibandronat Polpharma contains

• The active substance of Ibandronat Polpharma is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).
• The other ingredients are: lactose monohydrate, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate (core of the tablet); polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171) (tablet coating).

What Ibandronat Polpharma looks like and contents of the pack

Ibandronat Polpharma film-coated tablets are white or almost white, oblong with "I9BE" embossed on one side and "150" on the other side.
1 tablet (1 blister x 1 tablet)
3 tablets (1 blister x 3 tablets)
Blister OPA/Aluminum/PVC/Aluminum or PVC/PVDC/Aluminum in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Manufacturer:
Synthon BV
Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Polpharma Commercial Office Ltd.
Bobrowiecka 6
00-728 Warsaw
phone: 22 364 61 01
Date of last revision of the leaflet:October 2020