Furosemide aurovitas

Package leaflet: Information for the patient

Furosemidum Aurovitas, 40 mg, tablets
Furosemidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Furosemidum Aurovitas is and what it is used for
2. Important information before taking Furosemidum Aurovitas
3. How to take Furosemidum Aurovitas
4. Possible side effects
5. How to store Furosemidum Aurovitas
6. Contents of the pack and other information

1. What Furosemidum Aurovitas is and what it is used for

Furosemid belongs to a group of medicines called diuretics, which increase the amount of urine
produced by the kidneys, helping to remove excess fluid from the body. Diuretics are also
known as water tablets.
Furosemid is used to treat oedema (fluid retention) caused by disorders of the
heart, kidneys or liver, either as a single treatment or in combination with other
antihypertensive medicines. It may also be used in the treatment of pulmonary oedema (fluid accumulation
in the lungs) and in mild to moderate arterial hypertension (high blood pressure).

2. Information before using Furosemidum Aurovitas

When not to use Furosemidum Aurovitas

• if the patient is allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swelling, or difficulty breathing, swelling of the lips, face, throat or tongue;
• if the patient is allergic to amiloride, sulfonamides or sulfonamide derivatives, such as sulfadiazine or co-trimoxazole;
• if the patient has reduced intravascular volume or is dehydrated (with or without accompanying low blood pressure);
• if the patient has kidney failure – in some types of kidney failure this medicine may still be used – the decision will be made by the doctor;
• if the patient has severe liver disease (cirrhosis);
• if the patient has severe liver disease with brain disorders (hepatic encephalopathy);
• if the patient has electrolyte imbalances (e.g. low potassium or sodium levels in the blood, confirmed by blood tests);
• if the patient is not passing urine;
• if the patient has Addison's disease, which may cause fatigue and weakness;
• if the patient is taking other medicines that affect potassium levels in the blood (see "Furosemidum Aurovitas and other medicines", below);
• if the patient is breastfeeding (see "Pregnancy, breastfeeding and fertility", below).

Warnings and precautions
Before starting treatment with Furosemidum Aurovitas, consult a doctor or
pharmacist if the patient:

• has low blood pressure, requires regular monitoring of electrolyte levels and appropriate dose adjustment, or experiences dizziness when standing up;
• has diabetes (high blood sugar levels);
• is 65 years of age or older;
• has difficulty passing urine;
• has gout, liver or kidney disorders;
• has low protein levels in the blood (hypoproteinaemia);
• has symptoms of acute porphyria, such as severe abdominal, back or leg pain, nausea, vomiting or constipation accompanied by weakness in the arms and legs;
• is elderly, has dementia and is taking risperidone;
• has prostate disorders;
• experiences dizziness or is dehydrated – these symptoms may occur if the patient has lost significant fluids due to vomiting, diarrhoea or frequent urination, or if the patient has difficulty drinking or eating;
• is scheduled for a glucose tolerance test;
• has systemic lupus erythematosus (an autoimmune disease affecting the skin, bones, joints and internal organs);
• is taking other diuretic medicines;
• intends to administer this medicine to a premature infant;
• is elderly, taking other medicines that may lower blood pressure, or has other conditions that may increase the risk of low blood pressure.

If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before using
Furosemidum Aurovitas.
Athletes
Be aware that this medicine contains furosemide, which may result in a positive doping test.
Furosemidum Aurovitas and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use. This includes over-the-counter medicines, including herbal remedies. Furosemidum Aurovitas may affect the action of other medicines, and other medicines may affect the action of Furosemidum Aurovitas.
The doctor may recommend adjusting the dose and/or taking additional precautions if the patient is taking
any of the following medicines:

• Aliskiren – used to treat high blood pressure.
  The following medicines may affect the action of Furosemidum Aurovitas and increase the risk of
  adverse effects:
• Medicines such as ramipril, enalapril, perindopril (known as ACE inhibitors) or losartan, candesartan, irbesartan (angiotensin II receptor antagonists). The doctor may adjust the dose or recommend discontinuation.
• Medicines used for high blood pressure or heart disorders. The doctor may adjust the dose.
• Medicines used to treat high blood pressure or prostate disorders, known as alpha-blockers, such as prazosin.
• Other medicines used to treat high blood pressure and other diuretics used to remove excess fluid from the body, such as amiloride, spironolactone, acetazolamide and metolazone.
• Medicines that affect potassium levels in the blood. These include potassium supplements such as potassium chloride or certain diuretics such as triamterene.
• Medicines used to treat heart rhythm disorders, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine.
• Sleeping or sedative medicines, e.g. chloral hydrate.
• Medicines used in general anaesthesia to relax muscles during surgery. If undergoing anaesthesia, ensure the doctor or nurse knows that the patient is taking furosemide.
• Antidiabetic medicines – their effect may be reduced during furosemide treatment.
• Theophylline – used for wheezing or breathing difficulties.
• Phenytoin – used to treat epilepsy – may reduce the effectiveness of furosemide.
• Medicines used to treat psychiatric disorders called psychoses, such as risperidone, amisulpride, sertindole, pimozide and chlorpromazine. Pimozide should not be used with furosemide.

The following medicines may increase the risk of adverse effects when used with furosemide:

• Lithium – used to treat psychiatric disorders. To prevent adverse effects, the doctor may adjust the lithium dose and recommend monitoring lithium blood levels.
• Platinum compounds.
• Cisplatin – used to treat certain cancers.
• Digoxin – used for heart conditions. The doctor may adjust the dose.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain relief and treating inflammatory conditions, such as aspirin, ibuprofen, ketoprofen or indomethacin.
• Carbamazepine – used to treat epilepsy.
• Aminoglutethimide – used to treat breast cancer.
• Cyclosporine, tacrolimus, aldesleukin – used to prevent rejection of transplanted organs.
• Moxisylyte – used to treat Raynaud's syndrome.
• Medicines used to treat angina pectoris in inhaled or sublingual tablet form, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate – used for skin, joint or intestinal disorders.
• Carbenoxolone and sucralfate – used to treat oesophageal and gastric ulcers.
• Reboxetine, amitriptyline and phenelzine – used for depression.
• Amphotericin – used for fungal infections, particularly with prolonged use.
• Corticosteroids – used for inflammatory conditions, such as prednisolone.
• Atomoxetine – used to treat attention deficit hyperactivity disorder (ADHD).
• Muscle relaxants such as baclofen and tizanidine.
• Antihistamines used to treat allergies, such as cetirizine.
• Alprostadil – used to treat erectile dysfunction in men.
• Estrogens and drospirenone – used as contraceptives or in hormone replacement therapy (HRT).
• Liquorice – often found in cough medicines, particularly when taken in large amounts.
• Probenecid (used with other medicines in HIV infection).
• Medicines used to treat infections, such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or cephalosporins in high doses.
• Substances used as intravenous contrast agents in radiological imaging.
• Laxatives (purgatives) used long-term, such as bisacodyl or senna.
• Anti-asthma medicines used in high doses, such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol.
• Medicines used for nasal congestion, such as ephedrine and xylometazoline.
• Potassium salts used for low potassium levels in the blood.
• Medicines used to treat Parkinson's disease, such as levodopa.
• Other diuretics (diuretics), such as bendroflumethiazide. The doctor may adjust the dose.

High doses of furosemide given with levothyroxine may initially lead to a transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.
Furosemidum Aurovitas with food, drink and alcohol
While taking furosemide, alcohol should be avoided, as it may further lower blood pressure.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

• Furosemidum Aurovitas should not be taken during pregnancy. Contact a doctor before using this medicine if the patient is pregnant, planning to become pregnant or suspects she may be pregnant.
• Breastfeeding should not be undertaken while taking Furosemidum Aurovitas, as small amounts may pass into breast milk. Contact a doctor before starting this medicine if the patient is breastfeeding or planning to breastfeed.

In case of pregnancy or breastfeeding, consult a doctor or pharmacist before using any medicine.
Driving and using machines
This medicine may cause dizziness or general discomfort. This may occur more frequently at the beginning of treatment, when changing doses, or when combined with alcohol. In such cases, driving or operating machinery should be avoided.
Furosemidum Aurovitas contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.
Furosemidum Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Furosemidum Aurovitas

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.

• The doctor will determine the number of tablets required depending on the patient's condition. Tablets should be swallowed whole with a glass of water.
• Tablets should be taken daily, approximately at the same time each day, before a meal or as directed by the doctor.

Adults and elderly patients:
The recommended dose is one or two tablets in the morning. Your doctor will inform you how many tablets you should take.
Children and adolescents (under 18 years of age):

• Initial dose: The doctor will determine the dose based on the child's body weight.
• Maximum dose: 1 tablet per day.

Patients taking sucralfate (a medicine used in peptic ulcer disease)
Sucralfate should not be taken at the same time as furosemide. The dose should be taken at least 2
hours before or after administration of furosemide, as sucralfate may affect the action of
furosemide.
Taking more Furosemidum Aurovitas than prescribed
If you accidentally take too much medicine or any amount is taken by a child, contact your doctor immediately or go to the nearest hospital emergency department, even if there are no symptoms. Bring the medicine packaging with you so the doctor knows which medicine has been taken. Taking too much furosemide may
cause confusion, difficulty concentrating, lack of emotion or interest in anything.
Dizziness, a feeling of "emptiness" in the head, fainting (due to low blood pressure), irregular heartbeat, weakness or muscle cramps, and blood clots (causing pain and swelling in the affected body part) may also occur. Kidney or blood disorders may also develop.
If a dose of Furosemidum Aurovitas is missed
Take the missed dose as soon as you remember, unless it is evening time, because taking the missed dose then may lead to the need to urinate during the night. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Furosemidum Aurovitas
Continue taking furosemide as long as your doctor has not advised you to stop.
Blood tests
Your doctor may perform blood tests to check whether the levels of certain electrolytes are within the normal range.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking the medicine immediately and consult a doctor straight away:

• allergic reactions such as itching, skin rash with severe itching and urticaria, fever, photosensitivity, severe allergic reaction with (high) fever, red skin spots, joint pain and (or) eye inflammation, severe acute (allergic) reaction with accompanying fever and blisters on the skin/skin peeling and petechiae due to bleeding into the skin.
• acute pancreatitis, accompanied by severe upper abdominal pain radiating to the back.

Other possible adverse reactions are listed below according to their frequency of occurrence, classified as follows:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data

Common
Furosemide may cause pronounced loss of fluids (e.g. increased urination) and electrolytes (sodium, potassium, magnesium, calcium). Symptoms may include: thirst, headache, confusion, muscle cramps, increased muscle irritability, muscle weakness, cardiac arrhythmias, and gastrointestinal disturbances such as stomach discomfort with nausea or diarrhoea.
Slight increase in uric acid levels (hyperuricaemia), potentially triggering an attack of gout.
Increased blood creatinine levels.

Symptoms of sodium deficiency:

• calf muscle cramps
• loss of appetite
• apathy
• feeling of weakness
• dizziness
• drowsiness
• confusion

Symptoms of potassium deficiency:

• muscle weakness and loss of contractility of one or more muscles (paralysis), increased urine output
• cardiac disturbances
• in case of significant potassium deficiency: effects on intestinal function or disorientation, which may lead to coma

Symptoms of magnesium and calcium deficiency:

• increased muscle irritability
• cardiac arrhythmias
• low blood pressure causing concentration and reaction disturbances, feeling of "emptiness" in the head, feeling of pressure in the head, headache, dizziness, drowsiness, feeling of weakness, visual disturbances, dryness of the oral mucosa, and inability to straighten up

Uncommon

• abnormal blood cell count accompanied by bruising and tendency to bleed
• reduced platelet count (thrombocytopenia)
• photosensitivity
• involuntary leakage of urine
• in elderly people - reduced intravascular volume, fluid deficiency and blood concentration, which may lead to thrombosis
• deafness (sometimes irreversible)
• formation of blisters on the skin or mucous membranes (pemphigoid)
• decreased glucose tolerance. May reveal latent diabetes.

Rare

• abnormal blood cell count (leucopenia), accompanied by increased susceptibility to infections
• increased number of certain blood cells (eosinophils) in the blood
• sensation of crawling, itching or tingling on the skin without cause
• life-threatening loss of consciousness
• hearing disturbances and tinnitus, which are usually transient
• vasculitis
• lichenoid reactions characterised by small, itchy, red-purple, polygonal skin lesions on the skin, genitals or in the oral cavity
• acute renal failure
• kidney inflammation with blood in the urine, fever and back pain – in case of urinary tract obstruction, urine retention may occur
• if the patient has bladder dysfunction, enlarged prostate or ureteral narrowing, sudden urine retention may occur
• shock (significant drop in blood pressure, extreme pallor, restlessness, weak rapid pulse, cold clammy skin, impaired consciousness) due to sudden, marked vasodilation caused by hypersensitivity to certain substances
• fever
• mild psychiatric disturbances

Very rare

• anaemia (condition characterised by deficiency of red blood cells)
• very severe blood disorders (leucopenia) with accompanying sudden high fever, severe sore throat and oral ulcers
• agranulocytosis
• some disorders of liver function
• brain function disorders (hepatic encephalopathy) may develop in patients with severe liver disease (liver failure)
• increased activity of certain liver enzymes

During treatment with furosemide, blood levels of certain lipids (cholesterol and triglycerides) may increase, but usually return to normal within 6 months.
Frequency not known

• acute generalised exanthematous pustulosis (acute drug eruption with fever)
• dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
• reduced blood calcium or magnesium levels
• metabolic alkalosis
• pseudo-Bartter syndrome in cases of improper and (or) prolonged use of furosemide
• exacerbation or onset of systemic lupus erythematosus
• cases of rhabdomyolysis have been reported, often in cases where significant decrease in blood potassium (hypokalaemia) occurs
• kidney stone formation (nephrocalcinosis/kidney stones) in premature infants.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Furosemidum Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister pack following “Expiry date (EXP):”/”EXP:”. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Furosemidum Aurovitas contains

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other ingredients are: monohydrate lactose, maize starch, sodium carboxymethyl starch (type A), magnesium stearate.

What Furosemidum Aurovitas looks like and contents of the pack
Tablet.
White, uncoated, round (8 mm in diameter), flat tablets with bevelled edges, printed with the code "F and 40" separated by a division line on one side and smooth on the other side.
The tablet can be divided into equal doses.
Furosemidum Aurovitas is packed in blisters and HDPE bottles, placed in a cardboard box.
Pack sizes:
Blister: 10, 20, 30, 50, 60, 90 and 100 tablets.
HDPE bottle: 30, 50, 60, 90, 100 and 500 (exclusively for hospital use or dose dispensing) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Furosemide Auro 20 mg, tabletten
Furosemide Aurobindo 40 mg, tabletten
Poland: Furosemidum Aurovitas
Portugal: Furosemida Generis
Spain: Furosemida Aurovitas 40 mg comprimidos EFG