PACKAGE LEAFLET: INFORMATION FOR THE USER

Etanorden 3 mg solution for injection in pre-filled syringe

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, pharmacist or nurse.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Etanorden is and what it is used for

2.    What you need to know before you receive Etanorden

3.    How to receive Etanorden

4.    Possible side effects

5.    How to store Etanorden

6.    Content of the pack and other information

1. What Etanorden is and what it is used for

Etanorden belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

Etanorden 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. Etanorden may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Etanorden 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

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 receive Etanorden Do not receive Etanorden

-    if you have, or had in the past , low blood calcium. Please 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 precautions

Some patients need to be especially careful when using Etanorden. Talk to your doctor before receiving Etanorden:

-    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 Etanorden. 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 Etanorden. When you have cancer, tell your dentist as well.

-    If you have heart problems and the doctor recommended to limit your daily fluid intake.

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid. If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).

Children and adolescents

Etanorden must not be used in children or adolescents below 18 years.

Other medicines and Etanorden

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

Pregnancy and breast-feeding

Etanorden is for use only by postmenopausal women and must not be taken by women who could still have a baby.

Do not take Etanorden if you are pregnant or breast-feeding.

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

Driving and using machines

You can drive and use machines as it’s expected that Etanorden has no or negligible effect on your ability to drive and use machines.

Etanorden contains sodium

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

3. How to receive Etanorden

The recommended dose of Etanorden 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 Etanorden

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. Etanorden 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. After 5 years of receiving Etanorden, please consult with your doctor whether you should continue to receive Etanorden.

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

If too much Etanorden 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 Etanorden 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:

Rare (may affect up to 1 in 1000 people):

-    itching, swelling of your face, lips, tongue and throat, with difficulty breathing.

-    persistent eye pain and inflammation (if prolonged)

-    new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10000 people):

-    pain or sore in your mouth or jaw .You may have early signs of severe jaw problems ( necrosis (dead bone tissue) in the jaw bone).

-    serious, potentially life-threatening allergic reaction (see section 2).

Other possible side effects

Common (may affect up to 1 in 10 people)

-    headache

-    stomach pain (such as gastritis), or tummy pain, indigestion, nausea, having diarrhoea (loose bowels) or constipation

-    pain in your muscles, joints, or back

-    feeling tired and exhausted

-    flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days

-    rash

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

-    inflammation of a vein

-    pain or injury at the injection site

-    bone pain

-    feeling weak

-    asthma attacks

Rare (may affect up to 1 in 1000 people):

- hives

Reporting of side effects

If you get any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Etanorden

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

Store in the original package in order to protect from light. This medicinal product does not require any special temperature storage conditions.

Do not use this medicine after the expiry date which is stated on the carton 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Etanorden 3 mg solution for injection in pre-filled syringes 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 ibandronate sodium monohydrate). 1ml of solution for injection contains 1mg of ibandronic acid.

-    The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections. Sodium hydroxide and hydrochloric acid (for pH adjustment).

What Etanorden 3 mg solution for injection in pre-filled syringes looks like and contents of the pack

Etanorden 3 mg solution for injection in pre-filled syringes is a clear colourless solution practically free from particles, pH 3.5 - 4.5. Each pre-filled syringe contains 3 ml of solution. Etanorden is available 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 Authorisation Holder

Gedeon Richter Plc.

1103 Budapest Gyomroi ut 19-21.

Hungary

Manufacturer

Gedeon Richter Plc.

1103 Budapest Gyomroi ut 19-21.

Hungary

This leaflet was last approved in June 2014

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 Etanorden 3 mg solution for injection in pre-filled syringe:

Etanorden 3 mg solution for injection in pre-filled syringe 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.

Etanorden 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products. Where Etanorden 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 Etanorden.

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:

Etanorden 3 mg solution for injection in pre-filled syringe 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 Etanorden 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.

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