FUROSEMIDE 25 mg Tabletka

Treść ulotki

1. Furosemide L.F.M. 25 mg tablets
   1. What is Furosemide L.F.M. and what is it used for
   2. What you need to know before taking Furosemide L.F.M.
   3. How to take Furosemide L.F.M.
   4. Possible side effects
   5. How to store Furosemide L.F.M.
   6. Contents of the pack and other information

Furosemide L.F.M. 25 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking this medicine as 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 they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Furosemide L.F.M. is and what it is used for
• 2. What you need to know before you take Furosemide L.F.M.
• 3. How to take Furosemide L.F.M.
• 4. Possible side effects
• 5. How to store Furosemide L.F.M.
• 6. Contents of the pack and other information

1. What is Furosemide L.F.M. and what is it used for

Furosemide L.F.M. contains furosemide, a substance that belongs to a group of drugs called

diuretics, which help to produce more urine thus contributing to relieve the disorders caused by an excessive accumulation
of fluids in the body (edema).
Furosemide L.F.M. is indicated for treating edema caused by heart diseases (obstruction or heart failure), liver (hepatic ascites caused by cirrhosis), kidneys (nephrotic syndrome, in this case
Furosemide L.F.M. can also be used in association with other medicines such as ACTH or corticosteroids)
and peripheral edema (for example in the ankles and legs).
Furosemide L.F.M. is also used in case of hypertension (high blood pressure) of mild or moderate type.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Furosemide L.F.M.

Do not take Furosemide L.F.M.:

• if you are allergic to the active ingredient, to any of the antibiotics belonging to the class of sulfonamides(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 do not urinate or your urine output is significantly reduced (kidney failure with oliguria or anuria) and do not respond to treatment with medicines containing a substance called furosemide;
• if your potassium levels in the blood are lower than normal (hypokalemia);
• if your sodium levels in the blood are lower than normal (hyponatremia);
• if your body is unable to produce an adequate amount of adrenal hormones (Addison's disease) if you are in the first trimester of pregnancy or breastfeeding;
• if you have taken too much (overdose) of digitalis.

Furosemide L.F.M. must not beused also in the following conditions:

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

Warnings and precautions
Consult your doctor or pharmacist before taking Furosemide L.F.M.
The doctor will subject you to a series of clinical tests before prescribing Furosemide L.F.M., if:

• you are a patient with problems of obstruction of the urinary tract (for example if you have problems emptying the bladder due to enlarged prostate or narrowing of the urethra); being Furosemide L.F.M. a drug that increases diuresis, the outflow of urine must be ensured;
• if you suffer from low blood pressure (hypotension);
• if you suffer from sudden drops in blood pressure, especially if you are a patient with narrowing (stenosis) of the heart (coronary) arteries or blood vessels that irrigate the brain);
• if you are elderly, if you are taking other medicines that can cause a lowering of blood pressure and if you suffer from other diseases that involve risks of lowering 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 Furosemide L.F.M.”);
• if your blood protein levels are low (hypoproteinemia).

The doctor may also prescribe you regular tests to check the amount of sugar in your
blood and urine, creatinine or uric acid in the blood, as well as to control the levels of certain
salts, such as potassium and sodium, which are particularly important especially if you suffer from disorders that
regulate salts in your body or following vomiting, diarrhea or heavy sweating.
The doctor will also correct any decrease in circulating blood volume, dehydration
and any significant alteration of the balance of mineral salts and the degree of acidity and basicity of the blood.
This may require a temporary suspension of the administration of the medicine.
It is possible that, following the results of clinical tests, the doctor decides to change the dose of
Furosemide L.F.M. that you must 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 may worsen the condition of your
disease, worsening it. Following the use of the drug, this disease may begin in subjects in whom
it is not yet established (see section 4 “Possible side effects”).

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

Other medicines and Furosemide L.F.M.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, you need to be careful if Furosemide L.F.M. is to be taken 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 taking chloral hydrate; the combination of furosemide with chloral hydrate is not recommended;
• aminoglycoside antibiotics(e.g. gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin) and other ototoxic medicines (toxic to the ear), such as cisplatin(an anticancer drug): furosemide may potentiate the toxic effects, even irreversible, that all these medicines exert on the ear (auditory apparatus). The association of these drugs should therefore only occur if absolutely necessary;
• sucralfate (a drug used to treat stomach ulcers): The administration of this medicine should be spaced at least 2 hours apart, as it may reduce the effect of furosemide;
• lithium salts (used to treat mental disorders): furosemide may potentiate the onset of toxic effects of lithium on the heart and nervous system;
• ACE inhibitors and angiotensin II receptor blockers (drugs used to lower blood pressure): due to the risk of developing severe low blood pressure and impairing kidney function; if you are taking these medicines with furosemide, carefully follow your doctor's instructions;
• risperidone (an antipsychotic drug, to treat mental disorders): the doctor will consider the risks and benefits before having you take furosemide together with this medicine due to the increased risk of death that can occur, especially in elderly patients with dementia;
• levothyroxine(a medicine used to stimulate the thyroid): high doses of furosemide can lead to an overall decrease in thyroid hormone;
• non-steroidal anti-inflammatory drugs (NSAIDs, including acetylsalicylic acid): 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, licorice and prolonged use of laxatives: concomitant intake with Furosemide L.F.M. may increase the risk of reducing potassium levels in the blood (hypokalemia);
• diuretics:taking furosemide together with other drugs belonging to the same category induces a greater reduction in blood pressure;
• probenecid (a drug used to treat gout)and methotrexate (a drug used to treatsome types of cancer and some severe inflammatory diseases):may reduce the effects of furosemide and at the same time increase its side effects;
• antidiabetics(such as biguanides, sulfonylureas and thiazolidinediones) and sympathomimetics (such asadrenaline and noradrenaline): furosemide may reduce their action;
• peripheral muscle relaxants (curare) and theophylline (a drug used in some respiratory diseases): furosemide may increase their action;
• antibiotics belonging to the cephalosporin class: concomitant administration of these drugs and Furosemide L.F.M. may cause impaired kidney function;
• cyclosporine A (used to prevent transplant rejection): taking it with furosemide increases the risk of developing gouty arthritis (an acute inflammatory form of arthritis);
• contrast agents (substances used in some radiological examinations): furosemide may increase the harmful effects exerted by these substances on the kidneys;
• aliskiren (used in the treatment of high blood pressure): may reduce blood concentrations of furosemide, administered orally.

Furosemide L.F.M. with food
Furosemide L.F.M. can rarely lead to a decrease in potassium in the blood; it is however
important that you follow a diet rich in this mineral by taking potatoes, bananas, oranges, tomatoes,
spinach and dried fruit, during the intake of the medicine.
Furthermore, the therapeutic action of Furosemide L.F.M. may decrease if the drug is taken during
meals: always take the medicine on an empty stomach (see also section “How to take Furosemide
L.F.M.”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are in the first three months of pregnancy, you must absolutely not take this medicine as
furosemide crosses the placental barrier. You can take Furosemide L.F.M. in the second and third
trimesters of pregnancy only if deemed strictly necessary by your doctor, who will periodically monitor
the growth of your baby.
Breastfeeding
If you are breastfeeding, you must not take Furosemide L.F.M., as furosemide passes into breast
milk and may decrease milk production.

Driving and using machines
Furosemide L.F.M. may alter your ability to drive and use machines.
Do not drive and do not use machinery that requires particular attention while taking this
medicine, as it may cause a decrease in blood pressure and therefore decrease the promptness
of reflexes and the degree of attention.

Furosemide L.F.M. contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

For athletes: the use of the drug without therapeutic need constitutes doping and may
anyway determine positivity to anti-doping tests.

3. How to take Furosemide L.F.M.

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
This medicine must always be taken under the control of your doctor.

Treatment of edema (swelling due to fluid retention in the body):
The recommended dose is 1-3 tablets of 25 mg once a day, preferably in the morning or
choosing the most suitable time when you want to obtain the effect.
Depending on the effect obtained, a second dose can be taken after 4 hours. However, if the dose
is still not sufficient, it is possible to increase the dose by 1-2 tablets to be taken every 4 hours until
the desired therapeutic effect is achieved. If necessary, the dose may be further
increased at the doctor's discretion.

Treatment of hypertension (high blood pressure):
The recommended dose is 1-3 tablets of 25mg to be taken throughout the day.
If you are taking other medications for high blood pressure, your doctor will carefully define the dose of
furosemide you need to take in order to avoid an excessive drop in your blood pressure.

Use in patients with kidney or liver disorders:
In case of kidney disease (low glomerular filtration rate) or liver (hepatic cirrhosis) or in case of insufficient
functioning of the kidneys and liver simultaneously, the doctor may modify the dose.
In the most severe situations, the doctor may decide to start treatment in hospital to adequately control
any undesirable effects (hepatic coma).

Method of administration
Furosemide L.F.M. should be taken on an empty stomach.

If you take more Furosemide L.F.M. than you should
In case of taking a dose greater than that prescribed, immediately inform your doctor or go to the
nearest hospital.The disorders of overdose depend on excessive fluid loss with
urine such as dehydration, excessive blood concentration, heart rhythm disturbances (A-V block and
ventricular fibrillation), decrease in blood pressure even severe (severe hypotension up to
shock), kidney disorders (acute renal failure), formation of blood clots in blood vessels (thrombosis),
states of delirium, paralysis of muscles, apathy and confused state.

If you forget to take Furosemide L.F.M.
Do not take a double dose to make up for a missed dose.

If you stop taking Furosemide L.F.M.
Ask your doctor for advice if you intend to stop treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stop treatment with this medicine and contact your doctor or
nurse immediatelyif 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
rarely occurs.
The side effects that may occur with furosemide are as follows.

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

• electrolyte disturbances (alteration of the balance of salts in the blood);
• dehydration;
• decreased blood volume (hypovolemia), especially in elderly patients;
• increased values of some blood tests (creatinine and triglycerides).

Common(may affect up to 1 in 10 people)

• increased blood concentration (hemoconcentration);
• reduced sodium in the blood (hyponatremia);
• reduced chlorine in the blood (hypochloremia);
• reduced potassium in the blood (hypokalemia);
• increased cholesterol value in the blood test;
• increased uric acid levels in the blood (hyperuricemia);
• gout (inflammation of the joints causing pain and swelling);
• brain changes as a result of liver disorders (hepatic encephalopathy);
• production of a large amount of urine (polyuria).

Uncommon(may affect up to 1 in 100 people):

• reduction in the number of blood cells called platelets (thrombocytopenia);
• diabetes and worsening of initial diabetes (impaired glucose tolerance, clinical manifestation of latent diabetes mellitus);
• drowsiness;
• headache;
• dizziness;
• confusional state;
• visual impairment;
• hearing disorders, sometimes irreversible (deafness);
• irregular heartbeat (cardiac arrhythmias);
• dry mouth;
• nausea;
• bowel motility disorders;
• itching, hives, skin irritation, formation of blisters on the skin and mucous membranes (these are the symptoms of skin diseases such as bullous dermatitis, exfoliative dermatitis, erythema multiforme or pemphigoid);
• appearance of small red or purple spots spread over the skin, associated or not with joint, muscle pain, weakness and fever (these may be symptoms of inflammation of the blood vessel walls, called purpura);
• allergic reaction to sunlight which manifests as skin irritation accompanied by itching (photosensitivity reaction);
• severe sudden muscle pain, caused by the involuntary contraction of one or more muscles (cramps);
• muscle weakness (myasthenia);
• cramps, muscle spasms, involuntary muscle contraction and tremors (these are the symptoms of a disease known as tetany);
• fatigue.

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

• reduction of white blood cells in the blood (leukopenia);
• increased white blood cells in the blood (eosinophilia);
• alteration of the sensitivity of the limbs or other parts of the body (paresthesia);
• inflammation of the blood vessels (vasculitis);
• vomiting and diarrhea;
• kidney disease called interstitial nephritis;
• fever.

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

• insufficient 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 of hemoglobin concentration in the blood caused by abnormal destruction of red blood cells (hemolytic anemia);
• ringing in the ears (tinnitus);
• severe inflammation of the pancreas (acute pancreatitis);
• impaired correct flow of bile (cholestasis);
• increased values of some liver enzymes in the blood (transaminases).

Not known(frequency cannot be estimated from available data)

• decreased levels of calcium in the blood (hypocalcemia);
• decreased levels of magnesium in the blood (hypomagnesemia);
• alteration of blood acidity (metabolic alkalosis);
• increased urea value in the blood test;
• Bartter's syndrome (a rare disease affecting the kidneys) in case of abuse or prolonged use of furosemide;
• formation of blood clots inside the blood vessels (thrombosis);
• skin diseases, such as hives, formation of red or blistered papules spread and desquamation in particular on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever. These may be symptoms of severe diseases 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 value in the urine test;
• increased chlorine value in the urine test;
• difficulty emptying the bladder (urinary retention in patients with prostatic hypertrophy, urethral stenosis or other difficulty emptying the bladder);
• impaired kidney function (renal failure);
• onset or worsening of a chronic autoimmune disease, which can affect various organs and tissues of the body 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 the muscles (rhabdomyolysis), generally in the context of severe potassium deficiency in the blood.

Additional side effects in children

• kidney stones (nephrolithiasis) or calcifications at the level of the kidneys (nephrocalcinosis) in preterm infants;
• increased risk of heart alterations (patent ductus arteriosus) in premature infants to whom furosemide is administered during the first weeks of life.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 Furosemide L.F.M.

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

6. Contents of the pack and other information

What Furosemide L.F.M. contains

• The active ingredient is furosemide. One tablet contains 25 mg of furosemide.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, talc, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Furosemide L.F.M. and contents of the pack
Furosemide L.F.M. is presented in the form of 25 mg tablets in packs of 30 and 60 tablets in aluminum / PVC blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Laboratorio Farmacologico Milanese S.r.l. – Via Monterosso, 273 -21042 Caronno Pertusella (VA) – Italy.