Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bracco UK, Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ-UK
Hypersensitivity to the active ingredient iopamidol or to any of the excipients.
Diagnostic procedures which involve the use of any radiopaque medium should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed.
Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast medium itself.
Disturbances in water or electrolyte balance must first be corrected. This product is formulated for gastro-intestinal use only and should not be used parenterally.
Care should also be exercised in patients with severe functional impairment of the liver, kidney or myocardium, severe systemic disease and in myelomatosis. In such patients adequate hydration should be maintained and parameters of hepatic and renal function, especially urinary output should be monitored after the procedure.
Patients with hepato-renal insufficiency should not be examined unless benefits clearly outweigh risks and re-examination should be delayed for 5-7 days.
The risk of severe hypersensitivity reactions may be increased in patients with history of known clinical hypersensitivity to any of the ingredients, other contrast media or history of asthma or other allergic disorders.
In case of suspected perforation of the gastrointestinal tract, use only when the benefit of the information outweighs the risk.
Concomitant administration of β-blockers can exacerbate severe hypersensitivity reactions as emergency medication which may be used to treat any side effects caused by Gastromiro may not be effective. X-ray examination of women should be conducted as far as possible during the pre-ovulation phase of the menstrual cycle. This product may interfere with tests of thyroid function.
Aspiration of orally administered contrast medium into the tracheobronchial tree can result in pulmonary complications. therefore avoid useof Iopamidol solution in patients with oesophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If the contrast medium is given by nasogastric tube, the position of the tube in the stomach must be verified before administration.
Alcohol: Iopamidol solution contains 2.4 mg of ethanol per mL which may be harmful for those suffering from alcoholism, and to be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Appropriate investigations and measures should be taken when exposing women of child-bearing potential to any X-ray examination, whether with or without contrast medium.
Infants (age<1year), and especially newborns are particularly susceptible to electrolyte imbalances and haemodynamic alterations. It is recommended that they are adequately hydrated prior to administration of Iopamidol solution.
Transient hypothyroidism may occur in neonates when the mother or the neonate has received an iodinated contrast agent. Thyroid function tests (usually TSH and T4) are recommended in neonates 7-10 days and 1 month after exposure to Gastromiro, especially in preterm neonates.
Concomitant administration of β-blockers can exacerbate severe hypersensitivity reactions.
No interaction studies have been performed. There are no known interactions.
There are no or a limited amount of data from the use of Iopamidol in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of Iopamidol solution during pregnancy.
It is unknown whether Iopamidol is excreted in human milk. A risk to newborns/infants cannot be excluded.
However, due to the low level of absorption of Iopamidol from the gastrointestinal tract, it is unlikely that a foetus could be exposed to significant levels. Stopping breastfeeding is unnecessary.
No effects on fertility are anticipated due to the low absorption of Iopamidol from the gastrointestinal tract following oral or rectal administration.
Reproduction studies performed in animals with Iopamidol administered parenterally revealed no evidence of impaired fertility. No studies have been performed in women.
Gastromiro has no or negligible influence on the ability to drive and use machines.
The undesirable effects reported with Gastromiro were, in general, non-serious, mild to moderate, transient and resolved spontaneously without residual effects.
Solutions of iodinated contrast media administered oral route or by enema can cause diarrhoea due to high osmolality of these solutions. Anaphylactoid reactions/hypersensitivity may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, pulmonary oedema, circulatory arrest, respiratory arrest, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock. Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access.
More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.
In clinical trials, the most commonly reported adverse reactions are vomiting in adult patients (1.8%) and diarrhoea in paediatric patients (5.7%). These reactions have been reported mostly after oral administration of the contrast agent.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Adverse reactions derived from clinical trials in 269 adult patients who received Iopamidol by either oral or rectal route of administration and from post-marketing spontaneous reporting are tabulated below.
Frequency not known: Anaphylactoid reaction
Uncommon: Hypotension
Frequency not known: Dyspnoea
Common: Vomiting
Uncommon: Diarrhoea, Abdominal discomfort
Frequency not known: Rash
The table below lists the adverse reactions derived from clinical trials conducted in 335 paediatric patients, who received Iopamidol by either oral or rectal route of administration.
Common: Diarrhoea
Uncommon: Nausea, Vomiting
No cases were received as post-marketing spontaneous reporting.
No anaphylactoid reaction has been reported in children after oral or rectal administration of iopamidol however they have been reports of such reactions after parenteral administration of iopamidol.
Following oral administration of Gastromiro, aspiration, manifested with coughing and possible pulmonary complications, has been reported (see section 4.4 Special warnings and precautions for use).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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