3 mg solution for injection in a pre-filled syringe of
ibandronic acid

1. What Ibandronic Acid Accord is and what it is used for

Ibandronic Acid Accord belongs to a class of preparations called bisphosphonates. It contains the active substance inbandronic acid.

Ibandronic Acid Accords can reverse the breakdown of bone tissue by stopping further loss of bone tissue and increasing bone mass in most women taking Ibandronic Acid Accord, even if they do not see or feel any difference.

Ibandronic Acid Accord can help reduce the risk of bone fractures ( fractures ). This reduction in fractures has been shown for vertebral fractures but not for hip fractures.

Ibandronic Acid Accord has been prescribed for you to treat postmenopausal osteoporosis (osteoporosis) as you have an increased risk of fractures. Osteoporosis involves thinning and weakening of the skeleton, which is common in postmenopausal women. After menopause, a woman’s ovaries stop producing the female sex hormone, estrogen, which helps keep the skeleton healthy.

The earlier a woman reaches menopause, the greater the risk of her getting a fracture in osteoporosis.

Other factors that may increase the risk of fracture include the following:

  • not enough calcium and vitamin D in the diet
  • cigarette smoking or consuming too much alcohol
  • not enough walking or other exercise where the skeleton is loaded
  • a medical history of familial osteoporosis

A healthy lifestyle will also help you achieve the best results from the treatment. This means:

  • to keep a balanced diet rich in calcium and vitamin D.
  • to take walks or to perform other exercise where the skeleton is loaded
  • not to smoke and not to drink too much alcohol.

2. What you need to know before using Ibandronic Acid Accord

Do not use Ibandronic Acid Accord

  • if you have or have had a low calcium level in your blood. Consult your doctor.
  • if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

A side effect called osteonecrosis of the jaw (skeletal damage to the jaw) has in very rare cases been reported after the drug has been approved for sale in patients receiving ibandronic acid for osteoporosis. Osteonecrosis of the jaw can also occur after the end of treatment.

It is important to try to prevent the development of osteonecrosis of the jaw as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before you receive treatment, tell your doctor/nurse (healthcare professional) about:

  • you have any problems with your mouth or teeth, e.g. poor dental health, gum disease or a planned tooth extraction
  • you do not regularly go to dental checkups or have not been to any checkups in a long time
  • you smoke (because it can increase the risk of dental problems)
  • you have previously received treatment with a bisphosphonate (used to treat or prevent skeletal diseases)
  • you are taking medicines called corticosteroids (eg prednisolone or dexamethasone)
  • you have cancer.

Your doctor may ask you to have a dental check-up before starting treatment with ibandronic acid.

During the time you receive treatment, you should maintain good oral hygiene (including regular toothbrushing) and go to the dentist regularly. If you have prostheses, make sure that they fit properly. If you are receiving dental treatment or are about to undergo dental surgery (eg tooth extraction), tell your doctor that you are receiving dental treatment and tell your dentist that you are receiving treatment with ibandronic acid.

Contact a doctor or dentist immediately if you have problems with your mouth or teeth, e.g. loose teeth, pain or swelling, non-healing wounds, or discharge, as these may be signs of osteonecrosis of the jaw.

Talk to your doctor, pharmacist, or nurse before using Ibandronic Acid Accord.

Some patients should be especially careful when using Ibandronic Acid Accord. Tell your doctor before using Ibandronic Acid Accord:

  • If you have or have ever had kidney problems, kidney failure or needed dialysis , or if you have any other disease that may affect your kidneys
  • If you have any disorders in the metabolism of minerals (such as vitamin D deficiency )
  • You should take calcium and vitamin D supplements during treatment with Ibandronic Acid Accord. If you can not take this, you should inform your doctor
  • If you have heart problems and your doctor has advised you to limit your daily intake of fluids.

Cases of severe allergic reactions, sometimes fatal, have been reported in patients treated with ibandronic acid intravenously.

If you experience any of the following symptoms such as shortness of breath/difficulty breathing, that it feels stuffy in the throat, swelling of the tongue, dizziness, feeling of losing consciousness, redness or swelling of the face, rash on the body, nausea, and vomiting, you should immediately inform your doctor or nurse (see section 4).

Children and young people

Ibandronic Acid Accord should not be used in children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid Accord

Tell your doctor, nurse, or pharmacist if you have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Ibandronic Acid Accord is only for postmenopausal women and should not be taken by women who are still able to have children.

Do not take Ibandronic Acid Accord if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it is expected that Ibandronic Acid Accord has no or negligible effect on your ability to drive and use machines.

Ibandronic Acid Accord contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose (3 ml), ie essentially ‘sodium-free.

3. How to use Ibandronic Acid Accord

The recommended dose for intravenous injection of Ibandronic Acid Accord is 3 mg (1 pre-filled syringe ) once every 3 months.

Injection should be given into a vein by a doctor or qualified/trained healthcare professional. Do not administer injection one yourself.

The solution for injection should only be given in the vein and not elsewhere in the body.

Continue to use Ibandronic Acid Accord

To get the most benefit from the treatment, it is important to continue getting the injections every three months for as long as your doctor has prescribed them. Ibandronic Acid Accord can only treat osteoporosis as long as you continue to receive the treatment, even if you cannot see or feel any difference. After 5 years of using Ibandronic Acid Accord, talk to your doctor about continuing to take Ibandronic Acid Accord.

You should also take calcium and vitamin D supplements, as recommended by your doctor.

If you take more Ibandronic Acid Accord than you should

You may have low levels of calcium, phosphorus, or magnesium in your blood. Your doctor may take steps to correct such changes and may give you an injection that contains these minerals.

If you forget to take Ibandronic Acid Accord

You should make an appointment to get the next injection as soon as possible. Then return to receive the injections every 3 months from the date of the last injection.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to a nurse or doctor immediately if you notice any of the following serious side effects – you may need immediate medical attention:

Rare (affects less than 1 user in 1,000):

  • itching , swelling of the face, lips, tongue and throat, difficulty breathing
  • persistent eye pain and inflammation (if prolonged)
  • new pain, weakness or discomfort in the thigh, hip or groin. You may have early signs of an unusual fracture of the femur.

Very rare (affects less than 1 user in 10,000):

  • pain or soreness in the mouth or jaw. You may have early signs of severe jaw problems ( necrosis (dead bone tissue) in the jawbone).
  • talk to a doctor if you have pain in the ears, discharge from the ear and / or ear infection. These may be signs of skeletal damage to the ear.
  • severe allergic reaction which may be life threatening (see section 2)
  • severe skin reactions.

Other possible side effects are

Common (affects less than 1 user in 10):

  • headache
  • stomach pain or stomach pain, indigestion, nausea, diarrhea (loose stomach) or constipation
  • pain in muscles, joints or back
  • feeling tired and exhausted
  • flu-like symptoms , including fever, tremors and chills, discomfort, fatigue, skeletal pain and aching muscles and joints. Talk to a nurse or doctor if any side effects are bothersome or last for more than a few days
  • rash.

Uncommon (affects less than 1 user in 100):

  • inflammation in a friend
  • pain or injury at the injection site
  • skeletal pain
  • feeling weak
  • asthma attacks.

Rare (affects less than 1 user in 1,000):

  • hives.

5. How to store Ibandronic Acid Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “Ed. dat ”and on the syringe after“ EXP ”. The expiration date is the last day of the specified month.

No special storage instructions.

The person giving the injection should discard any unused solution and throw the used syringe and injection needle into a suitable container for disposal.

6. Contents of the packaging and other information

Content declaration

  • A pre-filled syringe with 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate). Each ml of solution contains 1 mg of ibandronic acid.
  • The other ingredients are sodium chloride, concentrated acetic acid, sodium acetate trihydrate and water for injections.

What the medicine looks like and contents of the pack

Ibandronic Acid Accord 3 mg solution for injection in pre-filled syringes is a clear, colorless solution. Each pre-filled syringe contains 3 ml of solution. Ibandronic Acid Accord is supplied in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare SLU

World Trade Center, Moll de Barcelona, ​​s / n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4HF

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Muhammad Nadeem

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