Ibandronate polpharma

Package leaflet: Information for the user

Ibandronat Polpharma, 150 mg, film-coated tablets
Acidum ibandronicum
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ibandronat Polpharma is and what it is used for
2. What you need to know before you take 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 Ibandronat Polpharma is and what it is used for

Ibandronat Polpharma belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Ibandronat Polpharma can reverse bone tissue loss by slowing down bone loss and increasing bone mass in most women taking this medicine, even if they cannot feel or notice the difference themselves. Ibandronat Polpharma may reduce the likelihood of bone fractures. A reduction in fractures has been demonstrated for vertebral fractures, but not for fractures of the femoral neck.
Ibandronat Polpharma has been prescribed for the treatment of postmenopausal osteoporosis associated with an increased risk of bone fractures.
Osteoporosis is a disease characterised by reduced bone density and weakened bones, which commonly occurs in women after menopause. During menopause, the 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 fractures related 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 exercise
• family history of osteoporosis.

A healthy lifestyle will also help you achieve the greatest benefits from treatment. This means:

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

2. Important information before using Ibandronat Polpharma

When not to use 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 oesophagus (the tube through which food passes), such as narrowing or difficulty swallowing.
• If the patient is unable to remain in an upright position (standing or sitting) continuously for at least one hour (60 minutes).
• If the patient has or has previously had low levels of calcium in the blood. Consult a doctor.

Warnings and precautions

A rare side effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bones) has been reported after marketing of ibandronic acid in patients treated for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after stopping treatment.
It is important to take preventive measures against developing osteonecrosis of the jaw and (or) mandible, as it may be a painful and difficult-to-treat condition. To reduce the risk of osteonecrosis of the jaw and (or) mandible, appropriate precautions should be taken.
Before starting treatment, the patient should inform the doctor/nurse (healthcare professional):

• if she has any diseases affecting the mouth or teeth, such as poor dental condition, gum disease, or planned tooth extraction
• if she does not receive routine dental care or has not had regular dental check-ups for a long time
• if she smokes (this may increase the risk of dental problems)
• if she has previously been treated with a bisphosphonate (used in the treatment or prevention of bone diseases)
• if she is taking corticosteroids (e.g. prednisolone or dexamethasone)
• if she has been diagnosed with cancer.

The doctor may recommend that the patient undergo a dental examination before starting treatment with ibandronic acid.
During treatment, proper oral hygiene (including regular tooth brushing) should be maintained, and routine dental check-ups should be attended. If the patient wears dentures, they should be properly fitted. Patients undergoing dental treatment or prior to dental procedures (e.g. tooth extraction) should inform their physician and tell the dentist that they are taking ibandronic acid.
If the patient experiences any symptoms in the mouth or teeth, such as loose teeth, pain or swelling, non-healing ulcers or presence of discharge, she should contact her physician and dentist immediately, as these may be symptoms of osteonecrosis of the jaw and (or) mandible.
Particular caution should be taken when using Ibandronat Polpharma in certain individuals.
Therefore, before taking Ibandronat Polpharma, consult your doctor:

• if there are any disturbances in mineral metabolism (e.g. vitamin D deficiency).
• if the kidneys are not functioning properly or if there are kidney diseases.
• if there are any problems with swallowing or digestion.

Irritation, inflammation or ulceration of the oesophagus may occur, often with symptoms of acute chest pain after swallowing food and (or) drink, and acute nausea or vomiting may appear, especially if the patient did not drink a full glass of water and (or) lies down after taking ibandronic acid. If such symptoms occur, the patient should stop taking ibandronic acid and contact 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take, especially:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may affect the effectiveness of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac, naproxen) may irritate the stomach and intestines. Ibandronic acid may have a similar effect. Therefore, particular caution should be exercised when taking painkillers or anti-inflammatory drugs during treatment with ibandronic acid.

After swallowing the monthly tablet of Ibandronat Polpharma, do not take any other medicines for 1 hour, including antacids, calcium supplements or vitamins.
Ibandronat Polpharma with food and drink
Do not take Ibandronat Polpharma with food. Ibandronic acid taken with food is less effective.
Water may be consumed, but no other drinks should be consumed.
After taking Ibandronat Polpharma, wait 1 hour before consuming any food or other drinks (see section 3: "How to use Ibandronat Polpharma").
Pregnancy and breastfeeding
Ibandronat Polpharma should only be used during postmenopause and must not be used in women who may still bear children.
Do not use ibandronic acid in pregnant or breastfeeding women.
Consult a doctor or pharmacist before using this medicine.
Driving and using machines
The patient may drive and operate machinery, as ibandronic acid has no effect or negligible effect on the ability to drive and operate machinery.
Ibandronat Polpharma contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Ibandronat Polpharma

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

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

Taking the tablet once a month

It is important to carefully follow the instructions below. These instructions are designed to ensure that the Ibandronat Polpharma tablet reaches the stomach quickly, thereby reducing the risk of irritation.

• The 150 mg Ibandronat Polpharma tablet should be taken once a month.
• Choose a specific day of the month that will be easy to remember. For taking the Ibandronat Polpharma tablet, you may choose the same date (e.g., the first of each month) or the same day of the week (e.g., the first Sunday of each month). Choose a schedule that best fits your routine.
• Ibandronat Polpharma should be taken after at least 6 hours have passed since consuming any food or drink, except water.
• The Ibandronat Polpharma tablet should be taken:
  • in the morning after getting up from bed and
  • before eating or drinking anything ("on an empty stomach").
• Swallow the tablet whole with a full glass of water (at least 180 ml). Do not take the tablet with calcium-rich water, fruit juice, or any other beverage. If there is concern that tap water may have high calcium content (so-called hard water), it is recommended to use water low in minerals.
• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in the mouth.
• For the next hour (60 minutes) after taking the tablet:
  • do not lie down – if an upright position (standing or sitting) is not maintained, some of the medicine may flow back into the oesophagus,

• do not eat,

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

Continuation of treatment with Ibandronat Polpharma

It is important to take Ibandronat Polpharma every month for as long as your doctor recommends. After 5 years of taking Ibandronat Polpharma, you should consult your doctor to determine whether continued treatment with Ibandronat Polpharma is necessary.

Taking more than the recommended dose of Ibandronat Polpharma

If you accidentally take more than one tablet, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting or lie down – this may cause irritation of the oesophagus by Ibandronat Polpharma.

Missing a dose of Ibandronat Polpharma

If you forget to take the tablet in the morning on the scheduled day, do not take the tablet later on the same day. In this case, check when the next scheduled dose is due:

• If you forget to take the tablet on the scheduled day, and the next scheduled dose is only 1 to 7 days away…

Never take two Ibandronat Polpharma tablets within the same week. Wait until the next scheduled dose day, take the tablet according to your regular schedule, and then continue taking one tablet per month on the previously planned dates marked on your calendar.

• If you forget to take the tablet on the scheduled day, and the next scheduled dose is more than 7 days away… Take one tablet in the morning on the day after you remember the missed dose, then continue taking one tablet per month on the previously planned dates marked on your calendar.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your nurse or doctor if any of the following serious adverse events occur,
as immediate medical assistance may be required:
Uncommon (may affect less than 1 in 100 people)

• Severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, difficulty swallowing. A severe inflammation of the oesophagus may occur, as well as ulceration or narrowing of the oesophagus.

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 groin, hip or thigh area. These may be early signs indicating the possibility of atypical fractures of the femur.

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

• Pain or ulceration in the mouth, jaw and/or lower jaw. Early signs of serious jaw problems may occur (necrosis (dead bone tissue) in the jaw and/or lower jaw).
• If a patient experiences ear pain, ear discharge and/or ear infection, this should be reported to the doctor. These may be symptoms of bone tissue damage in the ear.
• Serious, potentially life-threatening allergic reactions.
• Severe skin adverse reactions.

Other possible adverse reactions
Common (may affect less than 1 in 10 people)

• Headache
• Heartburn, unpleasant sensations during swallowing, stomach or abdominal pain (may be related to gastritis), indigestion, nausea, diarrhoea (loose stools)
• Muscle cramps, stiffness of joints and limbs
• Influenza-like symptoms including fever, chills and shivering, feeling unwell, fatigue, bone pain and muscle and joint aches. You should talk to your nurse or doctor if any of these symptoms become troublesome or last longer than a few days.
• Rash.

Uncommon (may affect less than 1 in 100 people)

• Dizziness
• Bloating with gas (feeling of bloating)
• Back pain
• Feeling of tiredness and exhaustion
• Asthma attacks.

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

• Duodenitis (inflammation of the duodenum, the initial part of the small intestine), causing abdominal pain
• Urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibandronat Polpharma

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must 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 is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other components are: monohydrate lactose, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate (forming the tablet core); polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171) (forming the tablet coating).

What Ibandronat Polpharma looks like and contents of the pack
Ibandronat Polpharma coated tablets are white or almost white, oblong-shaped, with
“I9BE” embossed on one side and “150” on the other.
1 tablet (1 blister x 1 tablet)
3 tablets (1 blister x 3 tablets)
Blister OPA/Aluminium/PVC/Aluminium or PVC/PVDC/Aluminium in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

Manufacturers:
Synthon BV
Microweg 22, 6545 CM Nijmegen, The Netherlands
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain

For further information, please contact the local representative of the Marketing Authorisation Holder:
Commercial Office POLPHARMA Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw, Poland
Tel: +48 22 364 61 01