Lasix: detailed information

Package leaflet: Information for the patient

LASIX 10 mg/ml oral solution

furosemide
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lasix is and what it is used for
What you need to know before taking Lasix
How to take Lasix
Possible side effects
How to store Lasix
Contents of the pack and other information

1. What Lasix is and what it is used for

Lasix contains furosemide, a substance that belongs to a group of medicines called diuretics, which
help increase urine production, thereby helping to relieve conditions caused by excessive accumulation of
fluid in the body ( edema ).
Lasix is used to treat edema caused by heart diseases (cardiac obstruction or heart failure), liver (hepatic ascites due to cirrhosis), kidneys (nephrotic syndrome; in this case, Lasix may also be used in combination with other medicines such as ACTH or corticosteroids), and peripheral edema (for example, in the ankles and legs).
Lasix is also used in cases of mild to moderate hypertension (high blood pressure).
If you do not feel better or feel worse, talk to your doctor.

2. What you need to know before taking Lasix

Do not take Lasix

if you are allergic to the active substance, to any of the antibiotics belonging to the sulfonamide class (or sulfonylureas: you may also be allergic to these substances), or to any of the other ingredients of this medicine (listed in section 6);
if you are dehydrated;
if you are not passing urine or your urine output is significantly reduced (renal insufficiency with oliguria or anuria) and does not respond to treatment with medicines containing a substance called furosemide;
if your blood potassium levels are lower than normal (hypokalaemia);
if your blood sodium levels are lower than normal (hyponatraemia);
if your body is unable to produce adequate amounts of adrenal hormones (Addison's disease);
if you are in the first trimester of pregnancy or if you are breastfeeding;
if you have taken an excessive amount (overdose) of digitalis.

Lasix must not be used also in the following conditions:

in case of precoma (a condition characterized by mental confusion, apathy, and muscle weakness);
in case of coma due to impaired liver function (hepatic encephalopathy);
in case of hypovolemia (a significant decrease in your blood volume).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasix.
Your doctor will perform a series of clinical checks before prescribing Lasix to you if:

you are a patient with urinary tract obstruction (for example, if you have difficulty emptying your bladder due to an enlarged prostate or urethral strictures); since Lasix is a medicine that increases diuresis, adequate urine outflow must be ensured;
you suffer from low blood pressure (hypotension);
you experience sudden drops in blood pressure, particularly if you are a patient with narrowing (stenosis) of the coronary arteries or blood vessels supplying the brain;
you are elderly, are taking other medicines that may lower blood pressure, or suffer from other conditions that increase the risk of low blood pressure;
you have diabetes;
you have gout;
you have severe liver and kidney problems (hepatorenal syndrome);
you have a disease of the adrenal glands (see section 2 “What you need to know before taking Lasix”);
your blood protein levels are low (hypoproteinaemia).

Your doctor may also periodically prescribe tests to monitor blood and urine sugar levels, blood creatinine or uric acid levels, and to check the levels of certain electrolytes such as potassium and sodium, which are particularly important if you have disorders affecting electrolyte balance or following episodes of vomiting, diarrhoea, or excessive sweating.
Your doctor must also correct any reduction in circulating blood volume, dehydration, and any significant disturbances in electrolyte balance and blood acidity or alkalinity.
This may require a temporary interruption of the medicine.
Depending on the results of clinical monitoring, your doctor may decide to adjust your Lasix dosage.
If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body, called systemic lupus erythematosus, taking this medicine could worsen your condition. The use of this medicine may also trigger the onset of this disease in individuals in whom it has not yet manifested (see section 4 “Possible side effects”).

Children
Administration in premature infants should be accompanied by appropriate medical monitoring to prevent the development of kidney complications (nephrolithiasis or nephrocalcinosis).

Other medicines and Lasix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Particular caution is necessary if Lasix is taken together with:

Chloral hydrate (a sedative medicine): skin flushing, sudden sweating, agitation, nausea, increased blood pressure, and increased heart rate (tachycardia) may occur if furosemide is taken within 24 hours of chloral hydrate; concomitant use of furosemide and chloral hydrate is not recommended;
Aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin) and other medicines toxic to the ear (ototoxic), such as cisplatin (an anticancer medicine): furosemide may enhance the ototoxic effects, including irreversible damage, of these medicines on the ear (auditory system). The combination of these drugs should only be used when strictly necessary;
Sucralfate (a medicine used to treat stomach ulcers): this medicine should be taken at least 2 hours apart, as sucralfate may reduce the effect of furosemide;
Lithium salts (used to treat mental disorders): furosemide may enhance the toxic effects of lithium on the heart and nervous system;
ACE inhibitors and angiotensin II antagonists (medicines used to lower blood pressure): due to the risk of severe hypotension and impaired kidney function; if you are taking these medicines with furosemide, carefully follow your doctor’s instructions;
Risperidone (an antipsychotic medicine used to treat mental disorders): your doctor will evaluate the risks and benefits before prescribing furosemide together with this medicine due to an increased risk of mortality, especially in elderly patients with dementia;
Levothyroxine (a medicine used to stimulate the thyroid gland): high doses of furosemide may lead to an overall reduction in thyroid hormone levels;
Non-steroidal anti-inflammatory drugs (NSAIDs; including acetylsalicylic acid): they may reduce the effect of furosemide, and furosemide may increase the toxicity of salicylates;
Phenytoin (an antiepileptic medicine): may reduce the effect of furosemide;
Corticosteroids, carbenoxolone, liquorice, and prolonged use of laxatives: concurrent use with Lasix may increase the risk of excessively low blood potassium levels (hypokalaemia);
Diuretics: taking furosemide together with other medicines of the same class leads to a greater reduction in blood pressure;
Probenecid (a medicine used to treat gout) and methotrexate (a medicine used to treat certain types of cancer and some severe inflammatory diseases): may reduce the effects of furosemide and simultaneously increase its adverse effects;
Antidiabetic medicines (such as biguanides, sulfonylureas, and thiazolidinediones) and sympathomimetics (such as adrenaline and noradrenaline): furosemide may reduce their effectiveness;
Peripheral muscle relaxants (curare agents) and theophylline (a medicine used in certain respiratory diseases): furosemide may enhance their effects;
Antibiotics belonging to the cephalosporin class: simultaneous administration of these medicines and Lasix may cause impaired kidney function;
Cyclosporine A (used to prevent transplant rejection): concomitant use with furosemide increases the risk of developing gouty arthritis (a form of acute inflammatory arthritis);
Contrast media (substances used in certain radiological examinations): furosemide may increase the harmful effects of these substances on the kidneys;
Aliskiren (used to treat high blood pressure): may reduce blood concentrations of orally administered furosemide.

Lasix and food
Lasix may rarely cause a decrease in blood potassium; it is therefore important that you follow a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes, spinach, and dried fruits during treatment.
Moreover, the therapeutic effect of Lasix may be reduced if taken with food: always take the medicine on an empty stomach (see also section “How to take Lasix”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not take this medicine during the first three months of pregnancy, as furosemide crosses the placental barrier. You may take Lasix during the second and third trimesters of pregnancy only if strictly necessary, as determined by your doctor, who will monitor your baby’s growth regularly.

Breastfeeding
Do not take Lasix while breastfeeding, as furosemide passes into breast milk and may reduce milk production.

Driving and using machines
Lasix may impair your ability to drive or operate machinery.
Do not drive or operate machinery requiring special attention while taking this medicine, as it may cause low blood pressure, thereby reducing reflex speed and attention levels.

Lasix contains:

Sorbitol: this medicine contains 35 g of sorbitol per 100 ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine;
Methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions);
Ethanol: this medicine contains 10 g of alcohol (ethanol) in 100 ml of solution. A single dose equivalent to 20 mg of furosemide (2 ml of this medicine) contains 200 mg of ethanol, equivalent to 5 ml of beer and 2 ml of wine. A maximum dose of 250 mg of furosemide (25 ml of this medicine) contains 2.5 g of ethanol, equivalent to 62.5 ml of beer and 25 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.
Sodium: for a single dose of 20 mg furosemide (2 ml of Lasix), this medicine contains less than 1 mmol (23 mg) of sodium, i.e. essentially sodium-free. For a maximum daily dose of 250 mg furosemide (25 ml of Lasix), this medicine contains 26 mg of sodium (the main component of table salt). This corresponds to 1.3% of the maximum recommended daily dietary intake for an adult.
Sunset Yellow FCF (E110): may cause allergic reactions.

For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Lasix

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dose used should be the lowest sufficient to achieve the desired effect.
Your doctor will determine the dose and duration of treatment based on your health condition and your response to the medication.
Below are the usual recommended doses.

Treatment of edema (swelling due to fluid accumulation in the body) caused by heart, liver, or kidney disease
In adults, the recommended starting dose is 40 mg.
If the increase in urine output (diuretic effect) achieved is not sufficient, a second dose of 80 mg may be taken 6 hours later. If the dose is still not sufficient, after another 6 hours the dose may be further increased to 160 mg.
Depending on your health condition, your doctor may prescribe an initial treatment dose exceeding 200 mg.
The daily maintenance dose is approximately 40–80 mg.
Please note that weight loss due to the marked increase in urine elimination (diuresis) should not exceed 1 kg per day; inform your doctor if you experience excessive weight loss.
In children, the recommended dose is 1–2 mg/kg per day, and the maximum dose must not exceed 40 mg per day.

Treatment of edema (swelling due to fluid accumulation in the body) due to burns
The recommended dose ranges between 40 mg and 100 mg per day.
However, if your kidney function is severely reduced, your doctor may prescribe an initial dose of Lasix higher than usual (up to 250 mg).

Treatment of high blood pressure (hypertension):
Lasix may be used alone or in combination with other antihypertensive medicines. The maintenance dose is 20 mg to 40 mg per day. In cases of hypertension associated with chronic kidney failure, your doctor may prescribe higher doses.
If you are taking other medicines for high blood pressure, your doctor will carefully adjust your furosemide dose to avoid excessive lowering of your blood pressure.

Patients with kidney or liver disorders
In case of kidney disease (low glomerular filtration rate), liver disease (hepatic cirrhosis), or impaired function of both kidneys and liver, your doctor may adjust the dose.

Method of administration
Lasix should be taken on an empty stomach.
If you are an adult, always use the graduated dosing spoon to measure the exact volume of the dose to be taken.

Graduated dosing spoon:
20 mg of furosemide corresponds to 2 ml of oral solution
40 mg of furosemide corresponds to 4 ml of oral solution
60 mg of furosemide corresponds to 6 ml of oral solution
80 mg of furosemide corresponds to 8 ml of oral solution

If, instead, you need to administer the medicine to your child, use the graduated dropper to measure the exact volume of the dose to be given. For doses below 4 mg, you must fill the dropper beyond this mark, then let the excess Lasix drip out until the required dose is reached.
Once screwed onto the bottle, the dropper acts as a closure.

Graduated dropper:
4 mg of furosemide corresponds to 0.4 ml of oral solution
5 mg of furosemide corresponds to 0.5 ml of oral solution
6 mg of furosemide corresponds to 0.6 ml of oral solution
7 mg of furosemide corresponds to 0.7 ml of oral solution
8 mg of furosemide corresponds to 0.8 ml of oral solution
9 mg of furosemide corresponds to 0.9 ml of oral solution
10 mg of furosemide corresponds to 1.0 ml of oral solution

If you take more Lasix than you should
If you take more than the prescribed dose, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose are due to excessive fluid loss through urine, such as dehydration, excessive blood concentration, disturbances in heart rhythm (A-V block and ventricular fibrillation), decreased blood pressure, even severely (severe hypotension up to shock), kidney problems (acute renal failure), formation of blood clots in blood vessels (thrombosis), delirium, muscle paralysis, apathy, and confusion.

If you forget to take Lasix
Do not take a double dose to make up for the missed dose.

If you stop taking Lasix
Consult your doctor before stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking this medicine immediately and contact your doctor or nurse if you experience any of the following symptoms:
difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue, skin irritation: these may be symptoms of a severe allergic reaction (anaphylactic shock), which occurs rarely.

The side effects that may occur with furosemide are listed below.

Very common (may affect more than 1 in 10 people)

electrolyte disturbances (imbalance of salts in the blood);
dehydration; reduction in blood volume (hypovolaemia), especially in elderly patients;
increased levels in certain blood tests (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

increased concentration of blood (haemoconcentration);
reduced sodium levels in the blood (hyponatraemia);
reduced chloride levels in the blood (hypochloraemia);
reduced potassium levels in the blood (hypokalaemia);
increased cholesterol levels in blood tests;
increased levels of uric acid in the blood (hyperuricaemia);
gout (inflammation of the joints causing pain and swelling);
brain disturbances as a consequence of liver disorders (hepatic encephalopathy);
production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

reduced number of blood cells called platelets (thrombocytopenia);
diabetes and worsening of pre-existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
drowsiness;
headache;
dizziness;
confusion;
visual disturbances;
hearing disorders, sometimes irreversible (deafness);
changes in heart rhythm (cardiac arrhythmias);
dry mouth;
nausea;
intestinal motility disorders;
itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
appearance of small red or purplish spots spread across the skin, with or without joint pain, muscle pain, weakness and fever (may be symptoms of inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight, presenting as skin irritation accompanied by itching (photosensitivity reaction);
sudden, severe muscle pain caused by involuntary contraction of one or more muscles (cramps);
muscle weakness (myasthenia);
cramps, muscle spasms, involuntary muscle contractions and tremors (symptoms of a condition known as tetany);
fatigue.

Rare (may affect up to 1 in 1,000 people)

reduced white blood cells in the blood (leucopenia);
increased white blood cells in the blood (eosinophilia);
altered sensation in limbs or other parts of the body (paraesthesia);
inflammation of blood vessels (vasculitis);
vomiting and diarrhoea;
a kidney disease called interstitial nephritis;
fever.

Very rare (may affect up to 1 in 10,000 people)

inadequate production in the bone marrow of all types of blood cells (aplastic anaemia);
severe reduction in the number of white blood cells called granulocytes (agranulocytosis);
excessive reduction in haemoglobin concentration in the blood due to abnormal destruction of red blood cells (haemolytic anaemia);
ringing in the ears (tinnitus);
severe inflammation of the pancreas (acute pancreatitis);
impairment of normal bile flow (cholestasis);
increased levels of certain liver enzymes in the blood (transaminases).

Not known (frequency cannot be estimated from available data)

decreased calcium levels in the blood (hypocalcaemia);
decreased magnesium levels in the blood (hypomagnesaemia);
disturbance in blood acidity (metabolic alkalosis);
increased urea levels in blood tests;
Bartter syndrome (a rare kidney disease) in cases of abuse or prolonged use of furosemide;
formation of blood clots within blood vessels (thrombosis);
skin diseases such as hives, development of red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, sometimes accompanied by fever. These may be symptoms of serious skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP) or DRESS syndrome;
lichenoid reactions, characterised by small itchy, reddish-purple, polygon-shaped lesions on the skin, genitals or inside the mouth;
increased sodium levels in urine tests;
increased chloride levels in urine tests;
difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other bladder emptying difficulties);
impaired kidney function (renal failure);
onset or worsening of a chronic autoimmune disease affecting multiple organs and tissues known as systemic lupus erythematosus;
dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
severe damage to skeletal muscle and release into the blood of substances contained in muscle cells (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood.

Additional side effects in children

kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis) in preterm neonates;
increased risk of heart abnormalities (patent ductus arteriosus) in premature infants receiving furosemide during the first weeks of life.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lasix

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light.
This medicine must NOT be used more than 60 days after first opening.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lasix contains

The active substance is furosemide. 1 ml of solution contains 10 mg of furosemide.
The other components are sodium hydroxide, non-crystallizable liquid sorbitol, glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, quinoline yellow (E104), sunset yellow FCF (E110), orange flavour, 96 per cent ethanol and purified water.

Description of the appearance of Lasix and contents of the pack
Lasix 10 mg/ml oral solution is supplied in a carton containing a 100 ml glass bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan
Manufacturer
A. Nattermann & CIE GmbH, Nattermannallee, 1 - 50829 Cologne (Germany)

Patient Information Leaflet

LASIX 25 mg tablets

furosemide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lasix is and what it is used for
What you need to know before taking Lasix
How to take Lasix
Possible side effects
How to store Lasix
Contents of the pack and other information

1. What Lasix is and what it is used for

Lasix contains furosemide, a substance that belongs to a group of medicines called diuretics, which
help increase urine production, thereby helping to relieve disorders caused by excessive accumulation of
fluid in the body ( edema ).
Lasix is used to treat edema caused by heart diseases (obstruction or heart failure), liver diseases (hepatic ascites due to cirrhosis), kidney diseases (nephrotic syndrome; in this case, Lasix may also be used in combination with other medicines, such as ACTH or corticosteroids), and peripheral edema (for example, in the ankles and legs).
Lasix is also used in cases of mild to moderate hypertension (high blood pressure).
If you do not feel better or feel worse, consult your doctor.

2. What you should know before taking Lasix

Do not take Lasix

if you are allergic to the active substance, to any of the antibiotics belonging to the sulfonamide class (or sulfonylureas: you might also be allergic to these substances), or to any of the other components of this medicine (listed in section 6);
if you are dehydrated;
if you are not urinating or your urine output is significantly reduced (renal failure with oliguria or anuria) and does not respond to treatment with medicines containing a substance called furosemide;
if your blood potassium levels are lower than normal (hypokalaemia);
if your blood sodium levels are lower than normal (hyponatraemia);
if your body is unable to produce adequate amounts of adrenal hormones (Addison's disease);
if you are in the first trimester of pregnancy or are breastfeeding;
if you have taken too much digitalis (digitalis overdose).

Lasix must not be used also in the following conditions:

in case of precoma (a condition characterised by mental confusion, apathy, muscle weakness);
in case of coma due to impaired liver function (hepatic encephalopathy);
in case of hypovolaemia (a significant decrease in your blood volume).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasix.
Your doctor will carry out a series of clinical checks before prescribing Lasix to you if:

you are a patient with urinary tract obstruction (for example, if you have difficulty emptying your bladder due to an enlarged prostate or urethral narrowing); since Lasix is a drug that increases diuresis, urine outflow must be ensured;
you suffer from low blood pressure (hypotension);
you suffer from sudden drops in blood pressure, particularly if you have narrowing (stenosis) of the heart arteries (coronary arteries) or blood vessels supplying the brain;
you are elderly, are taking other medicines that may cause a drop in blood pressure, or suffer from other diseases that carry a risk of low blood pressure;
you have diabetes;
you have gout;
you have severe liver and kidney problems (hepatorenal syndrome);
you have a disease of the adrenal glands (see section 2 "What you should know before taking Lasix");
your blood protein levels are low (hypoproteinaemia). Your doctor may also regularly prescribe tests to monitor blood and urine sugar levels, blood creatinine or uric acid levels, and to check levels of certain electrolytes such as potassium and sodium, which are particularly important especially if you suffer from conditions affecting electrolyte balance or following vomiting, diarrhoea, or excessive sweating. Your doctor will also need to correct any possible reduction in circulating blood volume, dehydration, and any significant disturbances in the balance of minerals and in the blood's acid-base equilibrium. This may require a temporary interruption of the medicine. Depending on the results of clinical monitoring, your doctor may decide to adjust your Lasix dosage.

If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body, called systemic lupus erythematosus, taking this medicine could worsen your condition. The use of this drug may also trigger the onset of this disease in individuals in whom it has not yet been diagnosed (see section 4 "Possible side effects").

Children
Administration in premature infants should be accompanied by appropriate medical monitoring to prevent the development of kidney complications (nephrolithiasis or nephrocalcinosis).

Other medicines and Lasix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you need to be cautious if Lasix is to be taken together with:

chloral hydrate (a drug with sedative properties): skin flushing, sudden sweating, agitation, nausea, increased blood pressure, and increased heart rate (tachycardia) may occur if furosemide is taken less than 24 hours after chloral hydrate; concomitant use of furosemide and chloral hydrate is not recommended;
aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin) and other medicines toxic to the ear (ototoxic), such as cisplatin (an anticancer drug): furosemide may enhance the toxic effects, even irreversible ones, that all these medicines exert on the ear (auditory system). The combination of these drugs should only occur if strictly necessary;
sucralfate (a medicine used to treat stomach ulcers): this medicine should be taken at least 2 hours apart, as sucralfate may reduce the effect of furosemide;
lithium salts (used to treat mental disorders): furosemide may enhance the toxic effects of lithium on the heart and nervous system;
ACE inhibitors and angiotensin II antagonists (medicines used to lower blood pressure): due to the risk of developing severe hypotension and impaired kidney function; if you take these medicines with furosemide, carefully follow your doctor's instructions;
risperidone (an antipsychotic medicine used to treat mental disorders): your doctor will consider the risks and benefits before prescribing furosemide together with this medicine due to an increased risk of death, especially in elderly patients with dementia;
levotiroxine (a medicine used to stimulate the thyroid gland): high doses of furosemide may lead to an overall reduction in thyroid hormone levels;
non-steroidal anti-inflammatory drugs (NSAIDs; including acetylsalicylic acid): they may reduce the effect of furosemide and furosemide may increase salicylate toxicity;
phenytoin (an antiepileptic drug): may reduce the effect of furosemide;
corticosteroids, carbenoxolone, liquorice, and prolonged use of laxatives: concomitant use with Lasix may increase the risk of excessively reducing blood potassium levels (hypokalaemia);
diuretics: taking furosemide together with other drugs in the same category leads to a greater reduction in blood pressure;
probenecid (a medicine used to treat gout) and methotrexate (a medicine used to treat certain types of cancer and some severe inflammatory diseases): they may reduce the effects of furosemide and simultaneously increase its side effects;
antidiabetic medicines (such as biguanides, sulfonylureas, and thiazolidinediones) and sympathomimetics (such as adrenaline and noradrenaline): furosemide may reduce their action;
peripheral muscle relaxants (curares) and theophylline (a medicine used in certain respiratory diseases): furosemide may enhance their action;
antibiotics belonging to the cephalosporin class: concomitant administration of these drugs and Lasix may cause impaired kidney function;
ciclosporin A (used to prevent transplant rejection): taking it with furosemide increases the risk of developing gouty arthritis (a form of acute inflammatory arthritis);
contrast media (substances used in certain radiological examinations): furosemide may increase the harmful effects these substances exert on the kidneys;
aliskiren (used in the treatment of high blood pressure): may reduce blood concentrations of orally administered furosemide.

Lasix and food
Lasix may rarely lead to a decrease in blood potassium; it is therefore important that you follow a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes, spinach, and dried fruit during treatment with this medicine.
Moreover, the therapeutic effect of Lasix may be reduced if taken during meals: always take the medicine on an empty stomach (see also section "How to take Lasix").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are in the first three months of pregnancy, you must not take this medicine, as furosemide crosses the placental barrier. You may take Lasix during the second and third trimesters of pregnancy only if your doctor considers it strictly necessary, and your doctor will periodically monitor your baby's growth.
Breastfeeding
If you are breastfeeding, you must not take Lasix, as furosemide passes into breast milk and may reduce milk production.

Driving and using machines
Lasix may impair your ability to drive or use machinery.
Do not drive or operate machinery requiring particular attention while taking this medicine, as it may cause low blood pressure, thereby reducing reflex responsiveness and attention levels.

Lasix contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Lasix

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine must always be taken under medical supervision.

Treatment of oedema (swelling due to fluid accumulation in the body)
The recommended dose is 1–3 tablets of 25 mg once daily, preferably in the morning or at the time of day when you wish the effect to occur.
Depending on the effect achieved, a second dose may be taken 4 hours after the first.
However, if this dose is still not sufficient, the dose may be increased to 1–2 tablets every 4 hours until the desired therapeutic effect is obtained. If necessary, the dose may be further increased at the discretion of the doctor.

Treatment of hypertension (high blood pressure):
The recommended dose is 1–3 tablets of 25 mg to be taken during the day.
If you are taking other medicines for high blood pressure, your doctor will carefully determine the dose of furosemide you should take in order to avoid excessive lowering of your blood pressure.

Patients with kidney or liver disorders
In case of kidney disease (low glomerular filtration), liver disease (hepatic cirrhosis), or impaired function of both kidneys and liver, your doctor may adjust the dose.
In more severe cases, your doctor may decide to start treatment in hospital in order to adequately monitor for possible adverse effects (hepatic coma).

Instructions for administration
Lasix should be taken on an empty stomach.

If you take more Lasix than you should
If you take more than the prescribed dose, inform your doctor immediately or go to the nearest hospital. Overdose symptoms are related to excessive fluid loss through urine, such as dehydration, excessive concentration of the blood, disturbances in heart rhythm (A-V block and ventricular fibrillation), a drop in blood pressure, even severe (severe hypotension up to shock), kidney problems (acute renal failure), formation of blood clots in blood vessels (thrombosis), delirium, muscle paralysis, apathy, and confusion.

If you forget to take Lasix
Do not take a double dose to make up for the forgotten dose.

If you stop taking Lasix
Consult your doctor before stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine immediately and contact your doctor or nurse if you experience any of the
following symptoms:
difficulty breathing or swallowing, swelling of the face, eyes, lips and/or tongue, skin irritation: these may be
signs of a severe allergic reaction (anaphylactic shock), which is rare.

The side effects that may occur with furosemide are listed below.

Very common (may affect more than 1 in 10 people)

electrolyte disturbances (imbalance of salts in the blood);
dehydration; reduction in blood volume (hypovolemia), especially in elderly patients;
increased levels of certain blood tests (creatinine and triglycerides).

Common (may affect up to 1 in 10 people)

increased concentration of blood (haemoconcentration);
low sodium levels in the blood (hyponatremia);
low chloride levels in the blood (hypochloremia);
low potassium levels in the blood (hypokalemia);
increased cholesterol levels in blood tests;
increased levels of uric acid in the blood (hyperuricemia);
gout (joint inflammation causing pain and swelling);
brain disturbances as a consequence of liver problems (hepatic encephalopathy);
production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

reduced number of blood cells called platelets (thrombocytopenia);
diabetes and worsening of pre-existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
drowsiness;
headache;
dizziness;
confusion;
vision disturbances;
hearing disorders, sometimes irreversible (deafness);
changes in heart rhythm (cardiac arrhythmias);
dry mouth;
nausea;
intestinal motility disorders;
itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
appearance of small red or purple spots on the skin, with or without joint pain, muscle pain, weakness and fever (may be symptoms of inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight, manifesting as skin irritation with itching (photosensitivity reaction);
sudden, severe muscle pain caused by involuntary contraction of one or more muscles (cramps);
muscle weakness (myasthenia);
cramps, muscle spasms, involuntary muscle contractions and tremors (symptoms of a condition known as tetany);
fatigue.

Rare (may affect up to 1 in 1,000 people)

reduced number of white blood cells in the blood (leukopenia);
increased number of white blood cells in the blood (eosinophilia);
altered sensation in limbs or other parts of the body (paresthesia);
inflammation of blood vessels (vasculitis);
vomiting and diarrhea;
kidney disease called interstitial nephritis;
fever.

Very rare (may affect up to 1 in 10,000 people)

inadequate production in the bone marrow of all types of blood cells (aplastic anemia);
severe reduction in the number of white blood cells called granulocytes (agranulocytosis);
excessive reduction in hemoglobin levels in the blood due to abnormal destruction of red blood cells (hemolytic anemia);
ringing in the ears (tinnitus);
severe inflammation of the pancreas (acute pancreatitis);
impairment of normal bile flow (cholestasis);
increased levels of certain liver enzymes in the blood (transaminases).

Not known (frequency cannot be estimated from available data)

decreased calcium levels in the blood (hypocalcemia);
decreased magnesium levels in the blood (hypomagnesemia);
disturbance in blood acidity (metabolic alkalosis);
increased urea levels in blood tests;
Bartter syndrome (a rare kidney disease) in cases of furosemide abuse or prolonged use;
formation of blood clots within blood vessels (thrombosis);
skin disorders such as hives, red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, sometimes accompanied by fever. These may be symptoms of serious skin conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), or DRESS syndrome;
lichenoid reactions, characterized by small itchy, reddish-purple, polygonal lesions on the skin, genitals or in the mouth;
increased sodium levels in urine tests;
increased chloride levels in urine tests;
difficulty emptying the bladder (urinary retention, in patients with prostate enlargement, urethral stenosis or other bladder emptying difficulties);
impaired kidney function (renal failure);
onset or worsening of a chronic autoimmune disease affecting various organs and tissues called systemic lupus erythematosus;
dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
severe damage to skeletal muscle and release into the blood of substances contained in muscle cells (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood.

Additional side effects in children

kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis) in preterm infants;
increased risk of heart abnormalities (patent ductus arteriosus) in premature infants receiving furosemide during the first weeks of life.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Lasix

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lasix contains

The active substance is furosemide. Each tablet contains 25 mg of furosemide.
The other components are corn starch, pregelatinized starch, monohydrate lactose, talc, anhydrous colloidal silica, and magnesium stearate.

Description of the appearance of Lasix and contents of the pack
Lasix 25 mg tablets are supplied in a box containing a blister pack of 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan
Manufacturer
Sanofi S.r.l. - S.S. n. 17, Km 22 – 67019 - Scoppito (AQ)

Patient Information Leaflet

LASIX 250 mg/25 ml infusion solution

sodium furosemide
LASIX 500 mg tablets
furosemide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lasix is and what it is used for
What you need to know before taking Lasix
How to take Lasix
Possible side effects
How to store Lasix
Contents of the pack and other information

1. What Lasix is and what it is used for

Lasix contains furosemide, a substance that belongs to a group of medicines called diuretics, which help the body produce more urine, thereby helping to relieve conditions caused by excessive accumulation of fluid in the body ( edema ).
Lasix 250 mg/25 ml solution for infusion and Lasix 500 mg tablets are used in patients with the following kidney diseases:

poor urine output (severely impaired glomerular filtration);
acute renal failure (oliguria), for example in the postoperative phase of severe infectious diseases;
chronic renal failure (in the stage preceding dialysis or during dialysis with fluid retention), particularly when there is also frequent accumulation of fluid in the lungs (chronic pulmonary edema);
nephrotic syndrome associated with severely impaired kidney function (i.e. patients affected by various diseases such as chronic glomerulonephritis, lupus erythematosus, kidney disease in diabetics (Kimmelstiel-Wilson syndrome), with excessive fluid retention in the body (uncontrolled edema), who do not respond to or cannot take corticosteroid medicines);
chronic renal failure without fluid retention;
shock state (a syndrome due to reduced blood flow to tissues).
Lasix 500 mg tablets may also be used as maintenance therapy in patients who have responded positively to treatment with high doses of furosemide administered by infusion.

2. What you need to know before taking Lasix

Do not take Lasix

if you are allergic to the active substance, to any of the antibiotics belonging to the sulfonamide class (or sulfonylureas: you may also be allergic to these substances), or to any of the other ingredients of this medicine (listed in section 6);
if you are dehydrated;
if you are not passing urine or your urine output is significantly reduced (renal insufficiency with oliguria or anuria) and does not respond to treatment with medicines containing a substance called furosemide;
if your blood potassium levels are lower than normal (hypokalaemia);
if your blood sodium levels are lower than normal (hyponatraemia);
if your body is unable to produce adequate amounts of adrenal hormones (Addison's disease);
if you are in the first trimester of pregnancy or if you are breastfeeding;
if you have taken an excessive amount (overdose) of digitalis.

Lasix must not be used also under the following conditions:

in case of precoma (a state characterized by mental confusion, apathy, muscle weakness);
in case of coma due to impaired liver function (hepatic encephalopathy);
in case of hypovolemia (severe reduction in your blood volume).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasix.
Your doctor will carry out a series of clinical checks before prescribing Lasix to you if:

you are a patient with urinary tract obstruction (for example, if you have difficulty emptying your bladder due to an enlarged prostate or urethral narrowing); since Lasix is a drug that increases diuresis, adequate urine excretion must be ensured;
if you suffer from low blood pressure (hypotension);
if you experience sudden drops in blood pressure, particularly if you have narrowing (stenosis) of the heart arteries (coronary arteries) or of blood vessels supplying the brain;
if you are elderly, if you are taking other medicines that may cause a drop in blood pressure, or if you suffer from other diseases that pose a risk of low blood pressure;
if you have diabetes;
if you have gout;
if you have severe liver and kidney problems (hepatorenal syndrome);
if you have a disease of the adrenal glands (see section 2 "What you need to know before taking Lasix");
if your blood protein levels are low (hypoproteinaemia).

Additionally, your doctor may regularly prescribe tests to monitor blood and urine sugar levels, blood creatinine or uric acid levels, as well as to check levels of certain electrolytes such as potassium and sodium, particularly important if you have disorders affecting electrolyte balance or following episodes of vomiting, diarrhoea, or profuse sweating.
Your doctor must correct any possible reduction in circulating blood volume, dehydration, and any significant imbalance in mineral salts and in the blood's acid-base equilibrium.
This may require a temporary interruption of the treatment.
Depending on the results of clinical monitoring, your doctor may decide to adjust the dose of Lasix you need to take.
If you suffer from a chronic autoimmune disease that can affect various organs and tissues of the body, called systemic lupus erythematosus, taking this medicine could worsen your condition. The use of this drug may also trigger the onset of this disease in individuals in whom it has not yet been diagnosed (see section 4 "Possible side effects").

Children
Administration in preterm neonates should be accompanied by appropriate medical monitoring to prevent the development of kidney complications (nephrolithiasis or nephrocalcinosis).

Other medicines and Lasix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, caution is required if Lasix is taken together with:

chloral hydrate (a sedative drug): skin flushing, sudden sweating, restlessness, nausea, increased blood pressure, and increased heart rate (tachycardia) may occur if furosemide is taken less than 24 hours after chloral hydrate; concomitant use of furosemide and chloral hydrate is not recommended;
aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin) and other medicines toxic to the ear (ototoxic), such as cisplatin (an anticancer drug): furosemide may enhance the toxic effects, even irreversible ones, that all these medicines exert on the ear (auditory system). The combination of these drugs should therefore occur only if strictly necessary;
sucralfate (a drug used to treat stomach ulcers): administration of this medicine should be spaced at least 2 hours apart, as sucralfate may reduce the effect of furosemide;
lithium salts (used to treat mental disorders): furosemide may enhance the toxic effects of lithium on the heart and nervous system;
ACE inhibitors and angiotensin II antagonists (drugs used to lower blood pressure): due to the risk of developing severe hypotension and impaired kidney function; if you take these drugs with furosemide, carefully follow your doctor's instructions;
risperidone (an antipsychotic drug used to treat mental disorders): your doctor will consider the risks and benefits before prescribing furosemide together with this medicine due to increased mortality, especially in elderly patients with dementia;
levotiroxine (a medicine used to stimulate the thyroid gland): high doses of furosemide may lead to an overall reduction in thyroid hormone levels;
non-steroidal anti-inflammatory drugs (NSAIDs; including acetylsalicylic acid): they may reduce the effect of furosemide, and furosemide may increase the toxicity of salicylates;
phenytoin (an antiepileptic drug): may reduce the effect of furosemide;
corticosteroids, carbenoxolone, liquorice, and prolonged use of laxatives: concomitant use with Lasix may increase the risk of excessively low blood potassium levels (hypokalaemia);
diuretics: taking furosemide together with other drugs of the same class leads to a greater reduction in blood pressure;
probenecid (a drug used to treat gout) and methotrexate (a drug used to treat certain types of cancer and some severe inflammatory diseases): they may reduce the effects of furosemide and simultaneously increase its side effects;
antidiabetic agents (such as biguanides, sulfonylureas, and thiazolidinediones) and sympathomimetics (such as adrenaline and noradrenaline): furosemide may reduce their effectiveness;
peripheral muscle relaxants (curares) and theophylline (a drug used in certain respiratory diseases): furosemide may enhance their effects;
antibiotics belonging to the cephalosporin class: concomitant administration of these drugs and Lasix may cause impaired kidney function;
ciclosporin A (used to prevent transplant rejection): co-administration with furosemide increases the risk of developing gouty arthritis (a form of acute inflammatory arthritis);
contrast media (substances used in certain radiological examinations): furosemide may increase the harmful effects of these substances on the kidneys;
aliskiren (used in the treatment of high blood pressure): may reduce blood concentrations of orally administered furosemide. The effects of aliskiren on intravenous furosemide solution have not been studied.

Lasix and food
Lasix may rarely cause a decrease in blood potassium levels; it is therefore important that you follow a diet rich in this mineral by consuming potatoes, bananas, oranges, tomatoes, spinach, and dried fruit during treatment with this medicine.
Moreover, the therapeutic effect of Lasix may be reduced if the drug is taken with food; always take the medicine on an empty stomach (see also section "How to take Lasix").

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Breastfeeding
You must not take Lasix while breastfeeding, as furosemide passes into breast milk and may reduce milk production.

Driving and using machines
Lasix may impair your ability to drive or operate machinery.
Do not drive or use machines requiring particular attention while taking this medicine, as it may cause low blood pressure, thereby reducing reflex response and level of alertness.

Lasix 250 mg/25 ml contains sodium: one vial contains 19.1 mg of sodium (the main component of table salt). A maximum daily dose (7 vials) contains 133.6 mg of sodium, equivalent to 6.7% of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

Lasix 500 mg tablets contain sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially sodium-free.

Lasix 500 mg contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

For those engaged in sports activities: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Lasix

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Lasix 250 mg/25 ml infusion solution
The dose used should be the lowest sufficient to achieve the desired effect.
Your doctor will determine the most appropriate dose for you based on your response to treatment.
Below are the doses usually prescribed.
The recommended initial dose is 1 vial appropriately diluted in 250 ml of infusion solution. An increase in urine output (diuresis) should already occur during the infusion, lasting approximately 1 hour.
If a satisfactory increase in diuresis is not achieved, one hour after completion of the first administration, a second infusion may be given with 2 vials of Lasix appropriately diluted in infusion solution. The duration of this administration will be determined by healthcare personnel according to your condition.
If the desired effect is still not achieved after the second administration, one hour after completion of the second infusion, a third infusion may be performed using 4 vials of Lasix appropriately diluted in infusion solution.
If the desired effects are not obtained even after the third administration, your doctor will consider whether dialysis is necessary.
If you are a patient with hypervolemia (excess blood volume), Lasix 250 mg/25 ml infusion solution may be administered without prior dilution in infusion solution to avoid administering an excessive amount of fluid (hyperhydration). The duration of this administration must be carefully regulated by healthcare personnel.
Patients with renal impairment
In case of kidney disease, your doctor may adjust the dose.
Method of administration
Lasix 250 mg/25 ml infusion solution is administered intravenously (into a vein) as a slow infusion only by healthcare professionals, who will regulate the infusion rate and dilute the vial contents in an appropriate infusion solution. No other medications should be added to this solution.
Lasix infusion solutions must be used immediately after dilution.
Lasix 500 mg tablets
The dose used should be the lowest sufficient to achieve the desired effect.
Treatment in chronic renal failure
Your doctor will determine the most appropriate dose for you based on your response to treatment (the effective dose will allow urine output of approximately 2.5 liters).
The recommended initial dose at the beginning of treatment is ½ tablet of 500 mg.
If a satisfactory increase in urine production (diuresis) does not occur within 4–6 hours, your doctor will increase the initial dose by ½ tablet to be taken every 4–6 hours until the desired effect is achieved.
The maximum dose, which will be determined by your doctor, may range from 250 mg to 2 g (from ½ tablet to 4 tablets).
Maintenance therapy
The recommended dose for maintenance therapy in patients who have responded positively to high-dose furosemide administered parenterally (by intravenous infusion) is equal to the effective dose previously administered by infusion.
If a satisfactory increase in diuresis does not occur within 4–6 hours, your doctor will increase the dose by ½–1 tablet.
Method of administration
Lasix 500 mg tablets should be taken with some water in the morning during breakfast.
If you take more Lasix than you should
If you take more than the prescribed dose, contact your doctor immediately or go to the nearest hospital. Overdose symptoms are due to excessive fluid loss in the urine, such as dehydration, excessive concentration of the blood, disturbances in heart rhythm (A-V block and ventricular fibrillation), a marked decrease in blood pressure (severe hypotension up to shock), kidney problems (acute renal failure), formation of blood clots in blood vessels (thrombosis), delirium, muscle paralysis, apathy, and confusion.
If you forget to take Lasix
Do not take a double dose to make up for a missed dose.
If you stop taking Lasix
Consult your doctor before stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with this medicine and contact your doctor or nurse immediately
if you experience the following symptoms: difficulty breathing or swallowing, swelling of the face,
eyes, lips and/or tongue, skin irritation: these may be symptoms of a severe allergic reaction (anaphylactic shock), which is rare.

The side effects that may occur with furosemide are listed below.

Very common (may affect more than 1 in 10 people)

electrolyte disturbances (imbalance of salts in the blood);
dehydration; reduction in blood volume (hypovolaemia), especially in elderly patients;
increased levels in certain blood tests (creatinine and triglycerides);
reduction in blood pressure (including orthostatic hypotension) following intravenous infusion.

Common (may affect up to 1 in 10 people)

increased concentration of blood (haemoconcentration);
reduced sodium levels in the blood (hyponatraemia);
reduced chloride levels in the blood (hypochloraemia);
reduced potassium levels in the blood (hypokalaemia);
increased cholesterol levels in blood tests;
increased levels of uric acid in the blood (hyperuricaemia);
gout (joint inflammation causing pain and swelling);
brain disturbances as a consequence of liver disorders (hepatic encephalopathy);
production of a large amount of urine (polyuria).

Uncommon (may affect up to 1 in 100 people)

reduced number of blood cells called platelets (thrombocytopenia);
diabetes and worsening of pre-existing diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
drowsiness;
headache;
dizziness;
confusion;
vision disturbances;
hearing disorders, sometimes irreversible (deafness);
changes in heart rhythm (cardiac arrhythmias);
dry mouth;
nausea;
intestinal motility disorders;
itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
appearance of small red or purple spots spread across the skin, with or without joint pain, muscle pain, weakness and fever (may be symptoms of inflammation of blood vessel walls, known as purpura);
allergic reaction to sunlight, presenting as skin irritation accompanied by itching (photosensitivity reaction);
sudden, severe muscle pain caused by involuntary contraction of one or more muscles (cramps);
muscle weakness (myasthenia);
cramps, muscle spasms, involuntary muscle contractions and tremors (symptoms of a condition known as tetany);
fatigue.

Rare (may affect up to 1 in 1,000 people)

reduced white blood cells in the blood (leucopenia);
increased white blood cells in the blood (eosinophilia);
altered sensation in limbs or other body parts (paraesthesia);
inflammation of blood vessels (vasculitis);
vomiting and diarrhoea;
a kidney disease called interstitial nephritis;
fever.

Very rare (may affect up to 1 in 10,000 people)

inadequate production in the bone marrow of all types of blood cells (aplastic anaemia);
severe reduction in white blood cells called granulocytes (agranulocytosis);
excessive reduction in haemoglobin concentration in the blood due to abnormal destruction of red blood cells (haemolytic anaemia);
ringing in the ears (tinnitus);
severe inflammation of the pancreas (acute pancreatitis);
impairment of normal bile flow (cholestasis);
increased levels of certain liver enzymes in the blood (transaminases).

Not known (frequency cannot be estimated from available data)

decreased calcium levels in the blood (hypocalcaemia);
decreased magnesium levels in the blood (hypomagnesaemia);
disturbance in blood acidity (metabolic alkalosis);
increased urea levels in blood tests;
Bartter syndrome (a rare kidney disease) in cases of abuse or prolonged use of furosemide;
formation of blood clots within blood vessels (thrombosis);
skin disorders such as hives, red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever. These may be symptoms of serious skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP), or DRESS syndrome;
lichenoid reactions, characterised by small itchy, reddish-purple, polygon-shaped lesions on the skin, genitals or in the mouth;
increased sodium levels in urine tests;
increased chloride levels in urine tests;
difficulty emptying the bladder (urinary retention, in patients with prostatic hypertrophy, urethral stenosis or other bladder emptying difficulties);
impaired kidney function (renal failure);
pain at the injection site if the medicine is administered intravenously;
onset or worsening of a chronic autoimmune disease affecting various organs and tissues of the body, known as systemic lupus erythematosus;
dizziness, fainting and loss of consciousness (due to symptomatic hypotension or other causes);
severe damage to skeletal muscle cells and release into the blood of substances contained in muscles (rhabdomyolysis), usually in the context of severe potassium deficiency in the blood.

Additional side effects in children

kidney stones (nephrolithiasis) or kidney calcifications (nephrocalcinosis) in preterm neonates;
increased risk of heart abnormalities (patent ductus arteriosus) in premature infants receiving furosemide during the first weeks of life.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lasix

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lasix contains
Lasix 250 mg/25 ml infusion solution

The active substance is furosemide. Each vial contains 250 mg of furosemide (equivalent to 266.6 mg of sodium furosemide) in 25 ml.
The other ingredients are mannitol and water for injections.

Lasix 500 mg tablets

The active substance is furosemide. Each tablet contains 500 mg of furosemide.
The other ingredients are maize starch, monohydrate lactose, powdered cellulose, sodium carboxymethylstarch (Type C), talc, anhydrous colloidal silica, magnesium stearate and quinoline yellow (E104).

Description of the appearance of Lasix and contents of the pack
Lasix 250 mg/25 ml infusion solution is supplied in a carton containing 5 glass vials.
Lasix 500 mg tablets is supplied in a carton containing a blister pack of 20 divisible tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan
Lasix 250 mg/25 ml infusion solution
Manufacturer
Sanofi-Aventis Deutschland GmbH - Industriepark Höchst - 65926 Frankfurt am Main - Germany
Delpharm Dijon - 6, Boulevard de l’Europe - 21800 Quétigny (France)
Lasix 500 mg tablets
Manufacturer
Sanofi S.r.l. - S.S. n. 17, Km 22 - 67019 - Scoppito (AQ)
Opella Healthcare International SAS - 56, Route de Choisy – 60200 Compiegne - France

The following information is intended exclusively for healthcare professionals:

Therapeutic indications:
The use of Lasix formulations containing 250 mg/25 ml infusion solution and 500 mg tablets is indicated exclusively in patients with:

Severely impaired glomerular filtration (GFR < 0.33 ml/s = 20 ml/min);
Acute renal failure (oliguria/anuria), e.g., in the postoperative phase or in septic conditions;
Chronic renal insufficiency in the pre-dialysis and dialysis stages with fluid retention, particularly in chronic pulmonary edema;
Nephrotic syndrome with severely impaired renal function, e.g., in chronic glomerulonephritis and systemic lupus erythematosus; Kimmelstiel-Wilson syndrome. In nephrotic syndrome, corticosteroid therapy is of primary importance. However, Lasix is indicated when edema is inadequately controlled, in patients refractory to corticosteroid therapy, or when corticosteroids are contraindicated;
Chronic renal insufficiency without fluid retention. In these patients, a therapeutic trial with Lasix may be attempted; if diuresis remains insufficient (less than 2.5 l/day), the patient should be considered for dialysis;
Shock state; prior to initiating saluretic therapy, hypovolemia and hypotension must be corrected with appropriate measures. Severe electrolyte imbalances and acid-base disturbances should also be corrected beforehand. Due to its high therapeutic reserve, furosemide may induce a significant increase in saluresis even in clinical situations where other diuretic measures are ineffective (marked renal impairment, hypoalbuminemia, metabolic acidosis).

Special warnings and precautions for use
Lasix 250 mg/25 ml infusion solution must not be used for intravenous bolus injection, but only for slow intravenous infusion using volumetric or rate-controlled infusion pumps to reduce the risk of accidental overdose.
Lasix 500 mg tablets should be used only in patients with markedly reduced glomerular filtration; otherwise, there is a risk of excessive fluid and electrolyte loss.

Dosage and administration
Lasix 250 mg/25 ml infusion solution
The infusion rate must always be adjusted so that no more than 4 mg of furosemide per minute are administered. In patients with severe renal impairment (serum creatinine > 5 mg/dL), an infusion rate exceeding 2.5 mg per minute is not recommended.
The pH of the ready-to-use infusion solution must not be less than 7, as furosemide may precipitate in acidic solutions.
Furosemide solution must not be infused together with other drugs.
If a test dose of 40–80 mg furosemide, administered slowly intravenously (over 2–5 minutes), does not produce a significant increase in diuresis within 30 minutes, infusion therapy with Lasix 250 mg may be initiated.
The contents of one vial of Lasix 250 mg/25 ml infusion solution should be diluted in 250 ml of isotonic Ringer's solution or another isotonic neutral or alkaline solution.
Considering the recommended infusion rate, the duration of infusion (250 mg in 275 ml total volume) is approximately 1 hour. If the patient responds to this dose, an increase in diuresis should be observed during the infusion. Therapeutically, the goal is to achieve an increase in diuresis of at least 40–50 ml/hour.
If an adequate increase in diuresis is not achieved with the first dose, a second infusion should be administered one hour after completion of the first, using two vials of Lasix 250 mg/25 ml infusion solution (500 mg in 50 ml), diluted in an appropriate infusion solution, with the total volume adjusted according to the patient's hydration status. The infusion duration must always be adjusted to ensure a maximum infusion rate of 4 mg/min of active substance.
If the desired diuretic effect is still not achieved, a third infusion may be administered one hour after completion of the second infusion, using four vials of Lasix 250 mg/25 ml infusion solution (1000 mg in 100 ml). The same guidelines apply regarding total infusion volume and infusion rate. If no satisfactory diuretic effect is obtained even with this dose, transition to dialysis should be considered.
In hypervolemic patients, if the intravenous test dose of 40–80 mg is ineffective, it is preferable to administer Lasix 250 mg/25 ml infusion solution undiluted or added to a volume of compatible infusion solution adjusted to the patient's hydration status, to avoid hyperhydration. Direct infusion of the vial contents is permissible only if the administration rate does not exceed 4 mg furosemide/min (= 0.4 ml/min).
Infusion solutions containing furosemide must be used immediately after preparation.

Fluid retention associated with chronic renal insufficiency
The natriuretic response to furosemide depends on several factors, including the severity of renal impairment and sodium balance; therefore, the effect of a given dose cannot be precisely predicted. In patients with chronic renal insufficiency, the dose must be carefully titrated to ensure that initial fluid loss occurs gradually.

Maintenance of fluid excretion in acute renal failure
Hypovolemia, hypotension, and significant electrolyte and acid-base imbalances must be corrected before initiating furosemide therapy. It is recommended that transition from intravenous to oral administration be performed as soon as possible.

Lasix 250 mg/25 ml infusion solution
Vials are equipped with a pre-scored break ring.

Incompatibilities
Lasix 250 mg/25 ml infusion solution
Furosemide, as an anthranilic acid derivative, is soluble in alkaline environments. The Lasix 250 mg/25 ml infusion solution contains the sodium salt of furosemide; this solution has a pH of approximately 9 and has no buffering effect.
At pH values below 7, the active substance may precipitate. Therefore, for infusion administration, Lasix 250 mg/25 ml infusion solution may only be mixed with weakly alkaline or neutral solutions with modest buffering capacity, e.g., isotonic sodium chloride solution or Ringer's solution.
Acidic solutions, particularly those with high buffering capacity, must not be mixed with Lasix.
Lasix must not be mixed with other drugs in the same syringe.
Once diluted, the solution should be used as soon as possible.

Lasix 500 mg tablets
The dose used should be the lowest sufficient to achieve the desired effect.

Treatment in chronic renal insufficiency
Your physician will determine the most appropriate dose based on your response to treatment (the effective dose will allow urine output of approximately 2.5 liters).
The recommended initial dose is ½ tablet of 500 mg.
If a satisfactory increase in urine output (diuresis) is not achieved within 4–6 hours, your physician will increase the initial dose by ½ tablet every 4–6 hours until the desired effect is obtained.
The maximum dose, to be determined by your physician, may range from 250 mg to 2 g (½ to 4 tablets).

Maintenance therapy
The recommended maintenance dose in patients who have responded positively to high-dose furosemide administered parenterally (by intravenous infusion) is equal to the effective dose previously administered by infusion.
If a satisfactory increase in diuresis is not achieved within 4–6 hours, your physician will increase the dose by ½ to 1 tablet.