MIDOTENSE

5 mg 3 times a day. Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day. This is the usual maintenance dosage. A careful evaluation of the response to treatment and of the overall balance of the expected benefits and risks needs to be undertaken before any dose increase and advice to continue therapy for long periods.

4). 2). Paediatric population The safety and efficacy of midodrine in children has not been established. No data are available. Elderly population There is limited data on dosing in the elderly and there are no specific studies which have focused on a possible dose reduction in the elderly population.

Cautious dose titration is recommended. Patients with renal impairment There are no specific studies that have been focused on a possible dose reduction in patients with renal impairment. 3). 4). Method of administration For oral use.

Summary of the safety profile The most frequent and very common adverse reactions related to midodrine therapy are piloerection, pruritus of the scalp and dysuria. Tabulated list of adverse reactions Organ Class Very Common (> 1/10) Common (> 1/100, < 1/10) Uncommon (> 1/1,000, < 1/100) Rare (> 1/10,000, < 1/1,000) Frequency not known (cannot be estimated from available data) Psychiatric disorders Sleep disorders Insomnia Anxiety Confusional state Nervous system disorders Paraesthesia Paraesthesia of the scalp Headache Restlessness Excitability Irritability Cardiac disorders Reflex bradycardia Tachycardia Palpitations Vascular disorders Supine hypertension (dose dependent effect) Gastrointestinal disorders Nausea Dyspepsia Stomatitis Abdominal pain Vomiting Diarrhoea Hepatobiliary disorders Abnormal hepatic function Raised liver enzymes Skin and subcutaneous tissue disorders Piloerection (goosebumps) Pruritus of the scalp Pruritus Chills Flushing Rash Renal and Urinary disorders Dysuria Urinary retention Urinary urgency Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 closely for these side effects by the treating doctor.

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 must be stopped. The time of administration of the drug is important.

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 may lead to a further reduction of blood pressure when standing. If this occurs, further treatment with midodrine 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. 3). Treatment with midodrine 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 and on a continuous basis.

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

• Hypertension. g. bradycardia, heart attack, congestive heart failure, cardiac conduction disturbances or aortic aneurysm). • Urinary retention. • Serious obliterative blood vessel disease, cerebrovascular occlusions and vessel spasms.

• Acute kidney disease. • Severe renal impairment (creatinine clearance of less than 30 ml/min). • Serious prostate disorder. • Proliferative diabetic retinopathy. • Pheochromocytoma. • Hyperthyroidism. • Narrow angle glaucoma. 1.