Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use
It is necessary to ensure the free flow of urine. The increased production of urine may cause or exacerbate disorders in patients with urinary tract obstruction (e.g. in patients with impaired bladder emptying, prostatic hyperplasia or urethral stricture). Therefore, these patients require a particularly close monitoring, especially during the initial stages of treatment.
As with all diuretics, it is recommended to start the treatment of liver cirrhosis with ascites in the hospital, in order to appropriately intervene in case tendency to hepatic coma during diuresis.
Treatment with Furosemide 20mg/2ml requires regular medical tests. In particular, a careful monitoring is necessary in the following cases:
− patients with hypotension,
− patients who are particularly at risk following an excessive fall in blood pressure, e.g. patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain, − patients with latent or manifest diabetes mellitus,
− patients with gout,
− patients with hepatorenal syndrome, e.g. with functional renal failure associated with a severe liver disease,
− patients with hypoproteinemia, e.g. associated with nephrotic syndrome (the action of furosemide may thereby be weakened and its ototoxicity enhanced). Special caution is required in determining the dosage,
− premature babies (for the possible development of nephrocalcinosis/nephrolithiasis); it is necessary to perform renal ultrasonography and monitor the renal function.
In general, during a furosemide therapy a regular monitoring of serum sodium, potassium and creatinine is recommended; in particular, a strict monitoring is required for patients at high risk of electrolyte imbalance or when there is a further significant fluid removal (e.g. due to vomiting, diarrhea, or heavy sweating). Although the use of Furosemide 20mg/2ml only rarely leads to hypokalemia, a potassium-rich diet is recommended (potatoes, bananas, oranges, tomatoes, spinach and dried fruits). Sometimes an adequate pharmacological correction may also be necessary.
In particular, states predisposing to potassium deficiency, such as liver cirrhosis, chronic diarrhea, prolonged use of laxatives, low potassium diet, concomitant use of mineralocorticoid, require appropriate checks and additions. Hypovolaemia, dehydration, and any significant alteration of electrolyte and acid-base balance must be adjusted. This may require a temporary suspension of the administration of furosemide.
It is also advisable to carry out regular checks of blood glucose, urinary glucose and, where necessary, of uric acid metabolism.
Furosemide 20mg/2ml does not change pressure values in normotensive patients, while it is hypotensive in hypertensive patients; in severe forms of hypertension this treatment is recommended in combination with other medical devices.

Concomitant use with risperidone
In placebo-controlled studies on risperidone in elderly patients with dementia, there was a higher incidence of mortality in patients treated with furosemide plus risperidone (7.3%, mean age 89 years, range 75-97 years) than in patients treated with risperidone alone (3.1%, mean age 80 years, range 70-96 years) or furosemide alone (4.1%, mean age 80 years, range 67-90 years). A concomitant use of risperidone with other diuretics (mainly thiazide diuretics at low dosage) was not associated with such an event.
No patho-physiological mechanism has been identified to explain this finding and there was no pattern correlated to the cause of death. However, before deciding on the use of such a combination, caution should be used and the risks and benefits of this combination or co-administration with other strong diuretics should be taken into account. There was no increased incidence of mortality in patients taking other diuretics concomitantly with risperidone. Regardless of treatment, dehydration was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia (see section 4.5).

Special precautions and/or dose reduction
In patients treated with furosemide, particularly in the elderly, in patients treated with other medicines that may induce hypotension and in patients with other clinical disorders involving risks of hypotension, there may be cases of symptomatic hypotension resulting in dizziness, fainting or loss of consciousness.

Important information about some of the ingredients:
This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially 'sodium-free'.

Effects on Driving

4.7   Effects on ability to drive and use machines

Furosemide has a low effect on the ability to drive and to operate machinery. Even if administered correctly, this drug can impair responsiveness so that the ability to drive a vehicle, or operate machinery may be impaired. This effect is more pronounced at the beginning of treatment, if the dose is increased and in combination with alcohol.