Furosemide L.F.M.

Patient Information Leaflet

Furosemide L.F.M. 25 mg tablets

Generic Medicine
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, 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 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

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

Furosemide L.F.M. contains furosemide, a substance that belongs to a group of medicines called diuretics, which help increase urine production and thus relieve disorders caused by excessive fluid accumulation in the body ( edema ).
Furosemide L.F.M. is indicated for the treatment of edema caused by heart diseases (obstruction or heart failure), liver diseases (hepatic ascites due to cirrhosis), kidney diseases (nephrotic syndrome; in this case, Furosemide L.F.M. may also be used in combination 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 cases of mild to moderate hypertension (high blood pressure).
If you do not feel better or feel worse, consult your doctor.

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 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 are breastfeeding;
• if you have taken an excessive amount (overdose) of digitalis.

Furosemide L.F.M. 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 (a significant decrease in blood volume).

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

• you are a patient with urinary tract obstruction problems (for example, if you have difficulty emptying your bladder due to an enlarged prostate or urethral strictures); since Furosemide L.F.M. is a drug that increases diuresis, adequate urine outflow must be ensured;
• if you suffer from low blood pressure (hypotension);
• if you experience sudden drops in blood pressure, particularly if you are a patient with narrowing (stenosis) of the heart arteries (coronary arteries) or of the 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 carry 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 Furosemide L.F.M.”);
• if 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, as well as to check levels of certain electrolytes such as potassium and sodium, which are particularly important especially if you suffer from disorders affecting electrolyte balance or following episodes of vomiting, diarrhoea, or heavy sweating.
Your doctor must also correct any possible reduction in circulating blood volume, dehydration, and any significant disturbances in the balance of mineral salts 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 the dose of Furosemide L.F.M. you should 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 premature infants should be accompanied by appropriate medical monitoring to prevent the development of kidney complications (nephrolithiasis or nephrocalcinosis).

Other medicines and Furosemide L.F.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Particular caution is required if Furosemide L.F.M. is taken together with:

• Chloral hydrate (a sedative drug): 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 it 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 evaluate the risks and benefits before prescribing furosemide together with this medicine due to an increased risk of death, 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 drug): may reduce the effect of furosemide;
• Corticosteroids, carbenoxolone, liquorice, and prolonged use of laxatives: simultaneous use with Furosemide L.F.M. may increase the risk of excessively lowering 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): 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 effectiveness;
• Peripheral muscle relaxants (curare-type agents) and theophylline (a medicine used in certain respiratory diseases): furosemide may enhance their effects;
• 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 (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.

Furosemide L.F.M. and food
Furosemide L.F.M. 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 Furosemide L.F.M. may be reduced if 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 may be pregnant, are planning a pregnancy, or are 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 Furosemide L.F.M. during the second and third trimesters of pregnancy only if strictly deemed necessary by your doctor, who will periodically monitor your baby’s growth.

Breastfeeding
You must not take Furosemide L.F.M. while breastfeeding, as furosemide passes into breast milk and may reduce milk production.

Driving and using machines
Furosemide L.F.M. may affect your ability to drive and use machinery.
Do not drive or operate machinery requiring special attention while taking this medicine, as it may cause low blood pressure, thereby reducing reflex responsiveness and level of alertness.

Furosemide L.F.M. 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 Furosemide L.F.M.

Take this medicine exactly as your doctor has told you. If you are unsure, 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 most suitable time when you wish to achieve the desired effect.
Depending on the effect achieved, a second dose may be taken 4 hours after the first. If the dose is still not sufficient, it may be increased by 1–2 tablets every 4 hours until the desired therapeutic effect is obtained. 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 25 mg to be taken during the day.
If you are taking other medicines for high blood pressure, your doctor will carefully determine the appropriate dose of furosemide to avoid excessive lowering of your blood pressure.

Use in patients with kidney or liver disorders:
In case of kidney disease (reduced 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 to adequately monitor for any adverse effects (e.g. 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
If you take more than the prescribed dose, contact your doctor immediately or go to the nearest hospital. Overdose symptoms depend on excessive fluid loss through urine, leading to dehydration, increased blood concentration, disturbances in heart rhythm (A-V block and ventricular fibrillation), severe drop 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 Furosemide L.F.M.
Do not take a double dose to make up for the missed dose.

If you stop taking Furosemide L.F.M.
Consult your doctor before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with 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 and 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 cell count (leucopenia);
• increased white blood cell count (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 the number of white blood cells called granulocytes (agranulocytosis);
• excessive reduction in haemoglobin levels 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);
• impaired bile flow (cholestasis);
• increased levels of certain liver enzymes in the blood (transaminases).

Not known (frequency cannot be determined from available data):

• decreased calcium levels in the blood (hypocalcaemia);
• decreased magnesium levels in the blood (hypomagnesaemia);
• disturbance in blood acidity (metabolic alkalosis);
• increased blood urea levels;
• Bartter syndrome (a rare kidney disorder) 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 conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP), or DRESS syndrome;
• lichenoid reactions, characterised 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 that can affect 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, please inform your doctor or pharmacist.
You may also report side effects directly via 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 stated on the packaging after "Exp".
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 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 Furosemide L.F.M. contains

• The active substance 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 available as 25 mg tablets, in boxes containing 30 and 60 tablets in aluminum / PVC blisters.
Not all pack sizes may be marketed.

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