Special Warning : אזהרת שימוש

4.4       Special Warnings and precautions for use

Blood pressure should be monitored during treatment.
Phenylephrine Sintetica 0.1 mg/ml should be administered with caution in patients with: •   diabetes
•   arterial hypertension
•   aneurism
•   uncontrolled hyperthyroidism
•   myocardial pathology
•   coronary disease and chronic heart disease
•   bradycardia
•   partial heart block
•   tachycardia
•   arrhythmia
•   angina pectoris, (phenylephrine may precipitate or worsen angina in patients with coronary artery disease and a history of angina pectoris)
•   non-severe peripheral vascular insufficiency
•   serious arteriosclerosis
Phenylephrine Sintetica 0.1 mg/ml can induce decreased cardiac output. Therefore, it should be administered with extreme caution in patients with atherosclerosis, in the elderly and in patients with cerebral or coronary circulation dysfunction.
In patients with acute heart failure or cardiogenic shock, Phenylephrine Sintetica 0.1 mg/ml can aggravate the heart failure as a result of the induced vasoconstriction (increased afterload).
Frequent monitoring of vital body functions of patients with conditions such as decreased cardiac output or peripheral arterial disease should take place, and the systolic blood pressure lower limit should be considered as a criterion for dose reduction or discontinuation of Phenylephrine Sintetica 0.1 mg/ml.
Particular attention should be given to the injection of phenylephrine in order to avoid extravasation, as this could cause tissue necrosis.
Lower doses may be required in patients with renal failure.
Higher doses may be required in patients with cirrhosis of the liver.
Concomitant administration of Phenylephrine Sintetica 0.1 mg/ml and the following medicinal products is not recommended due to the risk of vasoconstriction and/or hypertensive crisis associated with its indirect sympathomimetic effect:
•   ergot alkaloid dopamine agonists (bromocriptine, cabergoline, lisuride, pergolide) or vasoconstrictors (dihydroergotamine, ergotamine or methysergide, methylergometrine) •   in combination with linezolid
To be taken into consideration in patients following a strict sodium diet.
In case of concomitant administration of Phenylephrine Sintetica 0.1 mg/ml and oxytocic drugs (oxytocin, neurohypophyseal extracts, rye ergot alkaloids, etc.), the effect of sympathomimetics is enhanced.


Phenylephrine Sintetica 0.1 mg/ml. contains less than 1 mmol (23 mg) of sodium per 5 ml ampoule, i.e., it is essentially “sodium free”.
Phenylephrine Sintetica 0.1 mg/ml contains 35.4 mg sodium per 10 ml ampoule, equivalent to 1.8% of the WHO recommended maximum daily dietary intake of 2 g of sodium per adult.
Phenylephrine Sintetica 0.1 mg/ml contains 177 mg sodium per 50 ml vial, equivalent to 8.9% of the WHO recommended maximum daily dietary intake of 2 g of sodium per adult.

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