NIOPAM 200 SOLUTION FOR INJECTION

Active substance: IOPAMIDOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Niopam 200 solution for injection
(Iopamidol)

The name of your medicine is Niopam 200 solution for injection, which will be
called Niopam throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
- 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.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Niopam is and what it is used for
2. Before you are given Niopam
3. How you are given Niopam
4. Possible side effects
5. How to store Niopam
6. Further information

1. WHAT NIOPAM IS 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, spine or brain using X-rays.
This medicine is for diagnostic use only.

2. BEFORE YOU ARE GIVEN NIOPAM
You should not be given Niopam if you:
• Are allergic (hypersensitive) to Niopam, or other contrast media that
contain iodine
• Are allergic to any other ingredients of Niopam (see list of ingredients in
Section 6)
• Are currently receiving corticosteroids injection into your spine
Take special care with Niopam and tell your doctor 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 nervous 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 side effects.
Tell your doctor if you have had thyroid function tests performed in the past.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You should not drive or operate machinery for one hour after the last injection
into a vein or artery or a joint because of possible side effects.
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 will
be injected into a vein or into the spine.

Dosage
The actual 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 doctor
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, Niopam can cause side effects, although not 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
• fever
• 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
• coma
• 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 nerves
• shaking due to high fever
• pain, feeling of general discomfort or uneasiness
• abnormal electrocardiogram (this can be detected by a test carried out
by a doctor)
• neck stiffness with intolerance of bright light and headache
• reduced sense of touch or sensation
If you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
If you think you notice any side effects after receiving an injection of Niopam,
immediately tell the medical staff.
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.
Niopam should be kept out of the reach and sight of children, stored below
30 °C and protected from light.
Niopam should not be used after the expiry date stated on the label.
Niopam should be given to you immediately once drawn up into the syringe.
Medicine should not be disposed of in waste-water or with household
garbage. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Niopam contains
One ml of Niopam 200 contains 408.2 mg of the active substance iopamidol,
equivalent to 200 mg iodine.
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
Bracco U.K. Ltd, Bracco House, Mercury Park, Wycombe Lane, Wooburn
Green, Buckinghamshire HP10 OHH, United Kingdom

This leaflet was last revised in
February 2013

CI0000 - 000000

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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