Niopam 370, solution for injection – patient leaflet, side effects, dosage

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, kidney, urinary tract or bladder using X-rays.

This medicine is for diagnostic use only.

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

You should not be given Niopam if you:

• Are allergic to iopamidol or any other ingredients of this medicine (listed in 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
• 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 disease where the amino acid methionine cannot be broken down completely by the body)
• Multiple sclerosis (MS) ((a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and damages the nerve)
• Myelomatosis (a disease of the bone marrow)
• Poor general health
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Niopam or other iodinated contrast media

Take special care with Niopam:

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell’s syndrome or TEN) and acute generalised exanthematous pustulosis (AGEP), have been reported in association with the use of Niopam. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

During or shortly after the imaging procedure you may experience a short-term brain disorder called encephalopathy. Seek medical attention immediately if you notice any of the symptoms related to this condition described in Section 4. 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. Thyroid disorders may be observed after administration of iopamidol. Special care should be taken in newborns, including those whose mother received iopamidol during pregnancy and premature infants. Doctors may check the child’s thyroid gland function.

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.

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 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.

Niopam 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. If you have been given this medicine during your pregnancy or this medicine has been given to your newborn baby, your doctor will check the thyroid gland function of your baby as it may be temporarily underactive (hypothyroidism).

Driving and using machines

There is no known effect of Niopam on the ability to drive or operate machines. You should not drive or operate machinery for one hour after the injection because of possible reactions.

Niopam contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per bottle, that is to say essentially “sodium-free”.

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 an artery or a vein or into the heart.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Niopam 370 solution for injection

(Iopamidol)

FCI00VD13-PIL-NIO-370

Versione interna: 02

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy CROMinFOTO _^s.n.c.

GRAFICA - FOTOCOMPOSIZIONE

Via G. Tartini, 2 - 201 58 - MILANO

AZIENDA CERTIFICATA UNI EN ISO 9001:2015

21 MAR 2024

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 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 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, this medicine 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.

Seek medical attention immediately if you notice any of the following symptoms:

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).

The frequency of these side-effects is not known.

The following side effects have been reported following injection of Niopam in a blood vessel.

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

• headache
• feeling sick (nausea)
• feeling hot

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

• dizziness
• taste disturbance,
• abnormal or irregular heartbeat, uncoordinated twitching of heart muscle,
• low and high blood pressure
• redness of the skin
• vomiting, diarrhoea, abdominal pain, dry mouth
• skin rash, itchy rash, itching, reddening of the skin, increased sweating
• back pain
• inability of the kidneys to work properly
• chest pain, injection site pain, 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
• sensations like numbness, tingling, pins and needles or slow heart rates
• water in the lungs, asthma, excessive contraction of the airway muscles causing breathing difficulty
• muscle cramps
• swelling at the site of injection

Not known: (cannot be estimated).

• reduced blood platelet count (this can be detected by a test carried out by a doctor)
• sudden, severe allergic reaction
• coma
• mini- stroke, fainting, low level of consciousness, loss of consciousness, fits, inability to move one side of the body, brain disorder (encephalopathy) with symptoms including headache, difficulties with vision, loss of vision, confusion, seizures, loss of coordination, loss of movement in one side of the body, problems with speech and loss of consciousness
• temporary loss of vision, vision difficulties, redness and discomfort in the eye, abnormal sensitivity of the eyes to light
• heart attack, heart not pumping blood as well as it should, cessation of breathing and of heart beating, increased heart rate, heart attack caused by an allergic reaction
• failure of the blood circulation
• stopped breathing, inability of the lungs to work properly, acute respiratory distress syndrome (a severe lung disease), abnormal breathing, suspension of breathing, swelling of the throat, difficulty breathing
• increased salivation,swollen salivary glands
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis), severe disease of the skin, skin necrosis after product leakage out of the vessel, swelling of the face, A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis)
• muscle pain with abnormal sensations (compartment syndrome)
• pain in the bones, muscles, ligaments, tendons and/or nerves, weakness of the muscles
• shaking chills, pain, feeling generally unwell, redness, heat and pain at injection site
• abnormal electrocardiogram (this can be detected by a test carried out by a doctor)

Children

Thyroid disorders have been reported in newborns born prematurely.

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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 bottles containing: 50ml, 100ml and 200ml. Not all packs sizes may be marketed.

Marketing Authorisation Holder

Bracco UK Ltd, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, United Kingdom

Manufacturers

Patheon Italia S.p.A., 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR), Italy Bracco Imaging S.p.A., Bioindustry Park, Via Ribes 5, 10010 Colleretto Giacosa (TO), Italy

This leaflet was last revised in March 2024

CI00VD13 - 000000

FCI00VD13-PIL-NIO-370

Versione interna: 02

Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy CROMinFOTO _^s.n.c.

GRAFICA - FOTOCOMPOSIZIONE

Via G. Tartini, 2 - 201 58 - MILANO

AZIENDA CERTIFICATA UNI EN ISO 9001:2015

21 MAR 2024