28 NOV 2014

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--------PACKAGE LEAFLET: INFORMATION FOR THE USER

Niopam 300 solution for injection

(lopamidol)

The name of your medicine is Niopam 300 solution for injection, which will be called Niopam throughout this leaflet.

Read all of this leaflet carefully before you start 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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

-    lf you get any the side effects talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Niopam is and what it is used for

2.    What you need to know before you are given Niopam

3.    How you are given Niopam

4.    Possible side effects

5.    How to store Niopam

6.    Content of the pack and other information

1. What is Niopam and what it is used for

Niopam is a special dye (or contrast agent) which blocks X-rays because it contains iodine. Niopam works by helping your doctor to see the internal body structures on an X-ray picture. Your doctor has prescribed Niopam to help view the blood vessels, joint and spine or brain using X-rays.

This medicine is for diagnostic use only.

2. What you need to know before you are given Niopam

i

You should not be given Niopam if you:

• Are allergic to iopamidol or any other ingredients of this medicine (listed ir section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you are given Niopam if you have any of the following conditions:

•    A history of allergy or asthma

•    Blood clots, circulation problems, inflammations of the veins

•    An infection

•    Diabetes

•    Sickle cell disease (your body produces abnormally shaped red blood cells, which leads to aneamia)

•    Heart problems

•    High blood pressure in the lungs

•    Kidney or liver problems

•    Over-active thyroid gland (this is particularly important in newborn babies)

•    Myasthenia gravis (a disease causing weak muscles)

•    Brain tumour or other brain diseases

•    A history of epilepsy

•    Alcoholism

•    Phaeochromocytoma (a tumor of the adrenal gland)

•    Homocystinuria (an inherited condition affecting the muscles, nervous system and heart)

•    Multiple sclerosis (MS) (a neivous system disease)

•    Myelomatosis (a disease of the bone marrow)

•    Poor general health

•    High blood pressure

Particular care should be taken in children under 1 year of age and in the elderly. These groups might be susceptible to adverse reactions.

Tell your doctor if you have had thyroid function tests performed in the past.

Other medicines and Niopam

Tell your doctor if you have been given recently a cholecystographic agent, a special dye to help check for problems of the gallbladder and the biliary tract, as side effects risks may be increased.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines n. Especially tell your doctor if you are taking the following medicines, as they may react with Niopam:

•    painkillers

•    neuroleptics (treatments for mental illness)

•    antiemetics (treatments that prevent vomiting)

•    metformin (a treatment for diabetes)

•    antihistamines (treatments for allergies)

•    sedatives

•    anti-epileptics (treatment for epileptic fits)

•    vasopressors such as papaverine (used to treat impotence)

•    Beta blockers (drugs to be used to treat heart or blood pressure)

•    Interleukin-2 (treatment for cancer)

Niopam should not be injected in your spine if you are receiving corticosteroid in the same way.

Niopam may affect the results of laboratory tests such as thyroid function test, bilirubin, proteins or other substances. Always tell your doctor or laboratory staff that you have been given Niopam.

It may still be all right for you to be given Niopam and your doctor will be able to decide what is suitable for you.

Using with food and drink

If you have a disorder of your body water or body salts balance this will be corrected before the examination this will be corrected before the examination.

Do not reduce the amount you normally drink before the investigation especially if you have any of the following:

•    Severe kidney problems

•    Severe liver problems

•    Severe cardiac problems

•    Multiple myeloma (disease of the bone marrow)

•    Diabetes

•    Blood disease

•    Abnormal production of urine (large or small amounts)

•    Poor general health

If the examination is for your baby or young child do not reduce the fluid intake.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, you should only be given Niopam if your doctor believes it is clearly necessary. Tell your doctor if you are or believe you might be pregnant.

Stopping breastfeeding is not necessary.

Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines

There is no known effect of Niopam on the ability to drive or operate machines.

However if you receive Niopam in the spine you should not drive or operate machinery for 6 hours because of delayed side effects.

3. How you are given Niopam

Niopam will be given to you by a doctor or a nurse in hospital or clinic. It wi be injected into an artery or a vein or in the spine or in a joint

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Dosage

The recommended dose depends on which part of the body is being X-rayed and is usually in the range 5-250 ml. Your doctor may decide to vary this dose or to repeat the dose if required.

The dose for children depends also on the age and the body size.

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

If you are given more Niopam than you should:

You should know that the hospital area or clinic where Niopam is given to you is well equipped to treat any effects of overdose.

4. Possible side effects

Like all medicines, this medicine c everybody gets them.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). These are signs of an allergic reaction which can be serious and might require medical treatment.

The following side effects have been reported following injection of Niopam

Very common (more than 1 out of 10 persons) • headache

Common: (more than 1 out of 100 persons and less than 1 out of 10 persons)

•    feeling sick (nausea)

•    feeling hot

•    flushing

•    vomiting

•    pain in the back, neck or in the arms or legs

•    sensation of heaviness

Uncommon: (more than 1 out 1,000 persons and less than 1 out of 100 persons)

•    dizziness

•    problems with sense of taste

•    changes in heart rhythm

•    low and high blood pressure

•    diarrhoea

•    dry mouth

•    itching, skin rash, urge to itch, redness of the skin

•    chest pain, abdominal pain, injection site pain

•    kidney failure

•    increased sweating

•    feeling cold

•    abnormal laboratory test results for creatinine (this can be detected by a test carried out by a doctor)

Rare: (more than 1 out 10,000 persons and less than1 out of 1,000 persons)

•    confusion

•    sensation of tingling, pricking or numbness

•    slow heart beat

•    water in the lungs

•    asthma

•    difficulty in breathing

•    muscle cramps

Not known: (cannot be estimated)

•    reduced blood platelet count (this can be detected by a test carried out by a doctor)

•    allergic reaction

•    meningitis

•    mini- stroke

•    fainting low level of consciousness, loss of consciousness, fits

•    temporary loss of vision, vision difficulties, inflamed eyes, excessive sensitivity to light

•    heart attack, heart failure, the cessation of normal circulation of the blood due to failure of the heart to contract effectively, increased heart rate

•    failure of the blood circulation

•    stopped breathing, respiratory failure, acute respiratory distress syndrome (a severe lung disease), abnormal breathing, suspension of breathing, shortness of breath

•    swelling of the throat, swelling of the face, swollen salivary glands

•    increased salivation

•    severe disease of the skin

•    pain in the bones, muscles, ligaments, tendons and/or neives

•    shaking due to high fever

•    pain, feeling of general discomfort or uneasiness

•    abnormal electrocardiogram (this can be detected by a test carried ou by a doctor)

•    neck stiffness with intolerance of bright light and headache

•    reduced sense of touch or sensation

If you think you notice any side effects after receiving an injection of Niopam immediately tell the medical staff.

Reporting side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

If you have any other questions not answered in this leaflet please ask the medical staff.

5. How to store Niopam

You will not be required to store the medicine yourself. Your doctor or hospital pharmacist will know how to store Niopam.

Keep this medicine out of the sight and reach of children. Store below 30 °C and protected from light.

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.

Niopam should be given to you immediately once drawn up into the syringe.

Do not throw away any medicine via wastewater or household waste These measures will help protect the environment.

6. Content of the pack and other information

What Niopam contains

The active substance is iopamidol.

The other ingredients are trometamol, hydrochloric acid, edetate calcium disodium and water.

What Niopam looks like and contents of the pack

Niopam is supplied in glass ampoules and bottles containing: 10, 20, 30, 50, 70, 100, 200 and 250 ml.

Not all packs sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bracco U.K. Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire HP10 OHH, United Kingdom

Manufacturer

Patheon Italia S.p.A., 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR), Italy

^{This leaflet was last revised in December} 2014    CI00VB04 - 000000