Page 1

Package leaflet: Information for the patient Ibandronic Acid Hexal 3 mg / 3 ml solution for injection

ibandronic acid

Read all of this leaflet carefully before you start using 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.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet:

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

2.    What you need to know before you use Ibandronic Acid

3.    How to use Ibandronic Acid

4.    Possible side effects

5.    How to store Ibandronic Acid

6.    Contents of the pack and other information

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

Ibandronic Acid belongs to a group of medicines called bisphosphonates. . It contains ibandronic acid.

It does not contain hormones.

Ibandronic Acid may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Ibandronic Acid may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic Acid 3 mg/3ml solution for injection is a solution for intravenous injection by a health care professional. Do not inject Ibandronic Acid yourself.

Ibandronic Acid is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include:

•    not enough calcium and vitamin D in the diet

•    smoking cigarettes, or drinking too much alcohol

•    not enough walking or other weight-bearing exercise

•    a family history of osteoporosis

Many people with osteoporosis have no symptoms. If you have no symptoms you may not know if you have the condition. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.

Ibandronic Acid prevents loss of bone from osteoporosis, thus helping to rebuild lost bone. Therefore, Ibandronic Acid makes bones less likely to break.

A healthy lifestyle will also help you to get the most benefit from your treatment. This includes eating a balanced diet rich in calcium and vitamin D, walking or other weight-bearing exercise, not smoking and not drinking too much alcohol.

2.    What you need to know before you take Ibandronic Acid Do not recieve Ibandronic Acid

-    if you have, or had in the past, low blood calcium. Please consult your doctor

-    if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients in Ibandronic Acid injection

Warnings and precautions

Some patients need to be especially careful when using Ibandronic Acid. Talk to your doctor or nurse before receiving Ibandronic Acid

-    if you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys

-    if you have any disturbance of mineral metabolism (such as vitamin D deficiency)

You should take calcium and vitamin-D supplements while receiving Ibandronic Acid. If you are unable to do so, you should inform your doctor.

If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronic Acid.

Other medicines and Ibandronic Acid

Tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any other medicines. Mention to your doctor, nurse or pharmacist anything you are taking which you bought over the counter, without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

You should not be given Ibandronic Acid if you are pregnant, or if there is a possibility you may become pregnant. If you are breast-feeding, you will need to stop breast-feeding in order to receive Ibandronic Acid.

Driving and using machines

You can drive and use machines as it’s very unlikely that Ibandronic Acid will affect your ability to drive and use machines.

Important information about some of the ingredients of Ibandronic Acid

Ibandronic Acid contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially ‘sodium-free’.

3.    How to receive Ibandronic Acid

The recommended dose of Ibandronic Acid for the intravenous injection is:

3 mg (1 pre-filled syringe) once every 3 months

The injection should be given into the vein by a physician or qualified/trained health care worker. Do not administer the injection to yourself.

The solution for injection must be administered into a vein only, and not anywhere else in the body. Continuing to receive Ibandronic Acid

To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long as your doctor prescribes it for you. Ibandronic Acid can treat osteoporosis only for as long as you keep receiving the treatment, even though you will not be able to see or feel a difference.

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

If too much Ibandronic Acid is given

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

If a dose of Ibandronic Acid is missed

You should arrange an appointment to get the next injection as soon as possible. After that, go back to getting the injections every 3 months from the date of the most recent injection.

4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

•    rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an allergic reaction to the medicine.

•    severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting.

•    flu-like symptoms (if any effects become troublesome or last more than a couple of days).

•    pain or sore in your mouth or jaw

•    eye pain and inflammation (if prolonged)

Other possible side effects

Common (may affect up to 1 in 10 people):

•    headache

•    heartburn, stomach pain (such as “gastroenteritis” or “gastritis”), indigestion, nausea, having diarrhoea or constipation

•    rash

•    pain or stiffness in your muscles, joints, or back

•    flu-like symptoms (including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints)

•    fatigue

Uncommon (may affect up to 1 in 100 people):

•    bone pain

•    feeling weak

•    dizziness

•    flatulence

•    inflammation of a vein and pain or injury at the injection site

Rare (may affect up to 1 in 1,000 people):

•    hypersensitivity reaction; swelling of the face, lips and mouth (see allergy)

•    itching

•    eye pain or inflammation

•    unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

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

•    a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.

If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.

5. HOW TO STORE IBANDRONIC ACID

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

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”. The expiry date refers to the last day of that month.

The person giving the injection should throw away any unused solution and put the used syringe and injection needle into an appropriate disposal container.

6. Contents of the pack and other information

What Ibandronic Acid Hexal 3 mg/ 3ml solution for injection contains

•    The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).

•    The other ingredients are citric acid, monohydrate, sodium chloride, sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment, water for injections

What Ibandronic Acid Hexal 3 mg/ 3ml solution for injection looks like and contents of the pack

Ibandronic Acid Hexal 3 mg/ 3ml solution for injection is a clear colourless solution in a pre-filled syringe. Each pre-filled syringe contains 3 ml of solution. Ibandronic Acid is available in packs of 1, 2, 4 or 5 prefilled syringes with or without injection needles or with injection needles and alcohol swabs for skin cleansing.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HEXAL AG Industriestrasse 25, 83607 Holzkrichen Germany

Manufacturer

Sirton Pharmaceuticals S.P.A. Piazza XX Settembre, 2 22079 Villa Guardia (CO) Italy

or

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

or

LEK Pharmaceuticals d.d. Verovskova 57,

1526 Ljubljana Slovenia

or

Jenahexal Pharma GmbH Otto-Schott-Strasse 15 D-07745 Jena Germany

This information is intended for medical or healthcare professionals only.

INFORMATION FOR THE HEALTHCARE PROFESSIONALS Please see the Summary of Product Characteristics for more information.

Administration of Ibandronic Acid Hexal 3 mg/ 3ml solution for injection:

Ibandronic Acid Hexal 3 mg/ 3ml solution for injection should be injected intravenously over a period of 15 - 30 seconds.

The solution is irritant, therefore strict adherence to the intravenous route of administration is important. If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.

Ibandronic Acid Hexal 3 mg/ 3ml solution for injection must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products. Where Ibandronic Acid is administered via an existing intravenous infusion line, the intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.

Missed dose:

If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection.

Overdose:

No specific information is available on the treatment of overdosage with Ibandronic Acid.

Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia. In severe cases intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, may be needed.

General advice:

Ibandronic Acid Hexal 3 mg/ 3ml solution for injection like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.

Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting Ibandronic Acid injection therapy. Adequate intake of calcium and vitamin D is important in all patients. All patients must receive supplemental calcium and vitamin D.

Patients with concomitant diseases, or who use medicinal products which have a potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.

Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.