Like all medicinal products, Optimark can cause side effects, although not everybody gets them. Most of the undesirable effects observed after the use of Optimark were of mild to moderate intensity and transient in nature. The most common undesirable effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Immediately tell the doctor or nurse/technologist who is giving you the injection, if you feel unwell, especially if you feel any tightness, pain or discomfort in your chest, face or throat, or you have difficulty breathing. Possible side effects are described in greater detail below.
The majority of adverse reactions observed after the use of Optimark were found to be adverse reactions of the nervous system, followed by general adverse reactions, digestive tract disorders/skin disorders.
The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:
very common In more than 1 of 10 treated patients common In less than 1 of 10, but more than 1 of 100 treated patients uncommon In less than 1 of 100, but more than 1 of 1,000 treated patients rare In less than 1 of 1,000, but more than 1 of 10,000 treated patients very rare In 1 case or less of 10,000 treated patients including isolated reports
Frequency Possible side effects common dizziness, headache, strange taste in the mouth, feeling hot uncommon allergichypersensitivity reaction, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, hives, itching, rash, chest discomfort, feeling cold, administration site reactions rare decreased appetite, feeling anxious, sleep disorder, fainting, shaking, drowsy feeling, burning sensation, ringing in the ears, eyelid redness, eye pain, vision blurred, fast heart beat, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, high blood pressure, shortness of breath, hoarseness, cough, runny nose, throat constriction, mouth watering, vomiting, abdominal pain, constipation, dry mouth, cold sweat, redness, sweating, higher blood level of a substance creatinine usually eliminated by the kidneys, blood in urine, chest pain, face swollen, fatigue,
fever, swelling in limbs, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, heart and muscle enzyme increased, decreased haemoglobin, changes in blood calcium levels very rare Feeling confused, convulsion, bloodshot eyes, heart beat irregularities, tightening of the airways, swollen throat or vocal cords, raw throat, itchy nose, sneezing, swelling around the eyes, flu-like symptoms, feeling unwell, problems with the electrical rhythm of the heart long QT
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
When Optimark was used in children aged 2 or older they had similar side effects as in adults.
You must report any of the following symptoms immediately to the doctor or nurse/technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).
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.