Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Severe orthostatic hypotension with supine hypertension

Regular monitoring of supine and standing blood pressure is necessary due to the risk of hypertension in the supine position, e.g. at night. Patients should be told to report symptoms of supine hypertension immediately such as chest pain, palpitations, shortness of breath, headache and blurred vision, and should be monitored for these side effects by the treating physician. Supine hypertension may often be controlled by an adjustment to the dose. If supine hypertension occurs, which is not overcome by reducing the dose, treatment with midodrine hydrochloride must be stopped.


The time of administration of the drug is important in this context. Avoid administration in the late evening. The last daily dose should be taken at least 4 hours before bedtime in order to prevent supine hypertension. The risk of supine hypertension occurring during the night can be reduced by elevating the head.


Severe disturbances of the autonomic nervous system
In patients suffering from a severe disturbance of the autonomic nervous system, administration of midodrine hydrochloride may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine hydrochloride should be stopped.


Atherosclerotic disease
Caution must be observed in patients with atherosclerotic disease especially with symptoms of intestinal angina or claudication of the legs.


Prostate disorders
Caution is advised in patients with prostate disorders. Use of the drug may cause urinary retention.


Renal and hepatic function
This medicinal product is contraindicated in patients with acute renal impairment or severe renal impairment (see Section 4.3). Treatment with midodrine hydrochloride has not been studied in patients with hepatic impairment. It is therefore recommended to evaluate the renal and hepatic parameters before starting treatment with midodrine hydrochloride and on a regular basis.



Heart rate
Slowing of the heart rate may occur after midodrine hydrochloride administration, due to vagal reflex. Caution is advised when midodrine hydrochloride is used concomitantly with cardiac glycosides (such as digitalis preparations) and other agents that directly or indirectly reduce heart rate. Patients should be monitored for signs or symptoms suggesting bradycardia.

Effects on Driving

4.7   Effects on ability to drive and use machines
Midodrine Hydrochloride Morningside 2.5 mg tablets have negligible influence on the ability to drive and use machines.


However patients who experience dizziness or light-headedness should refrain from driving or operating machinery.