Furosemide Aurobindo

Patient Information Leaflet

Furosemide Aurobindo 25 mg Tablets

Generic medicine
Please read all of 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, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Furosemide Aurobindo is and what it is used for

Furosemide Aurobindo belongs to a group of medicines called diuretics, which increase the amount of urine produced by the kidneys, thereby promoting the elimination of excess fluid from the body. Diuretics are also known as "water tablets".
Furosemide tablets are used in the treatment of oedema (fluid retention) caused by disorders of the heart, kidneys or liver, either alone or in combination with other antihypertensive agents. The tablets may also be used to treat pulmonary oedema (fluid accumulation in the lungs) and mild to moderate hypertension (high blood pressure).

2. What you need to know before taking Furosemide Aurobindo

Do not take Furosemide Aurobindo if:

• you are allergic to furosemide or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
• you are allergic to amiloride, sulfonamides, or sulfamide derivatives such as sulfadiazine or co-trimoxazole;
• you have been told you have low blood volume or are dehydrated (with or without low blood pressure);
• your doctor has told you that you have kidney failure. In some types of kidney failure, you may continue taking this medicine. This will be decided by your doctor;
• you have severe liver problems (cirrhosis);
• you have an electrolyte deficiency (e.g. low levels of potassium or sodium in the blood, as shown by blood tests);
• you are not producing urine;
• you have a condition called "Addison's disease", which may make you feel tired and weak;
• you are taking other medicines that affect potassium levels in the blood (see "Other medicines and Furosemide Aurobindo");
• you are a child or adolescent under 18 years of age. Furosemide tablets are not suitable for children;
• you are breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemide Aurobindo if:

• you have low blood pressure; your electrolyte balance must be monitored regularly and the dose adjusted accordingly, or if you experience dizziness when standing up;
• you have diabetes (high blood sugar);
• you are 65 years of age or older;
• you have difficulty urinating;
• you have gout, or liver or kidney problems;
• you have low protein levels in the blood (hypoproteinaemia);
• you suffer from symptoms of acute porphyria, which may include stomach, back or thigh pain. You may also experience nausea, vomiting or constipation, along with weakness in the arms and legs;
• you are an elderly patient with dementia and are taking risperidone;
• you have prostate problems;
• you feel dizzy or are dehydrated. This may occur if you have lost a lot of fluids due to vomiting, diarrhoea, or frequent urination. It may also happen if you have difficulty eating or drinking;
• you are due to undergo a glucose test;
• you are taking any other diuretic;
• you are about to give this medicine to a premature baby;
• you are elderly, taking other medicines that may cause low blood pressure, or have other medical conditions that increase the risk of low blood pressure.

If you are unsure whether any of these apply to you, speak to your doctor or pharmacist before taking furosemide tablets.

Other medicines and Furosemide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because furosemide tablets may affect how other medicines work. Likewise, some medicines may affect how furosemide tablets work.

The following medicines may affect how Furosemide Aurobindo works and increase the risk of
unwanted effects:

• Medicines such as ramipril, enalapril, perindopril (called "ACE inhibitors") or losartan, candesartan, irbesartan (called "angiotensin II receptor antagonists"). Your doctor may need to adjust the dose of your tablets or ask you to stop taking them.
• Medicines for high blood pressure or heart problems. Your doctor may need to adjust the dose of your medicine.
• Medicines used to treat high blood pressure or prostate problems, known as alpha-blockers, such as prazosin.
• Other medicines used to treat high blood pressure and other medicines used to remove water from the body, known as diuretics, such as amiloride, spironolactone, acetazolamide and metolazone.
• Medicines that affect potassium levels in the blood, including potassium supplements such as potassium chloride or certain diuretics.
• Medicines used to treat abnormal heart rhythm, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine.
• Medicines used to help sleep and relax, such as chloral hydrate.
• Medicines used as general anaesthetics to relax muscles during surgery. If you are due to receive an anaesthetic, ensure your doctor or nurse knows you are taking furosemide.
• Medicines for diabetes. These may not work as well when taking furosemide.
• Theophylline – used for breathlessness or difficulty breathing.
• Phenytoin – used for epilepsy. This may reduce the effect of furosemide.
• Medicines used for mental disorders called "psychoses", such as risperidone, amisulpride, sertindole, pimozide and chlorpromazine. Avoid concomitant use of pimozide and furosemide.

The following medicines may increase the risk of side effects when taken with furosemide:

• Lithium – used for mental illnesses. To help prevent unwanted effects, your doctor may need to adjust your lithium dose and monitor lithium levels in your blood.
• Platinum compounds.
• Cisplatin – used for certain types of cancer.
• Digoxin – used for heart problems. Your doctor may need to adjust the dose of the medicine.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, ketoprofen or indometacin.
• Carbamazepine – used for epilepsy.
• Aminoglutethimide – used for breast cancer.
• Cyclosporine, tacrolimus, aldesleukin – used to prevent organ rejection after transplantation.
• Moxisylyte – used to treat Raynaud's syndrome.
• Medicines used to treat angina, administered as sprays or sublingual tablets, such as glyceryl trinitrate or isosorbide dinitrate.
• Methotrexate – used for skin, joint or intestinal cancers.
• Carbenoxolone and sucralfate – used for oesophageal ulcers.
• Reboxetine, amitriptyline and phenelzine – used for depression.
• Amphotericin – used for fungal infections when taken for a long period.
• Corticosteroids – used for inflammation 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 male impotence.
• Estrogens and drospirenone – used as contraceptives or in hormone replacement therapy (HRT).
• Liquorice – often used in cough medicines, if taken in large quantities.
• Probenecid (used with another medicine for HIV).
• Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or high doses of cephalosporins.
• Medicines administered by injection before X-ray examinations (contrast agents).
• Laxatives used for constipation if taken for a long time, such as bisacodyl or senna.
• Medicines for asthma when administered in high doses, such as salbutamol, sulphate terbutaline, salmeterol, formoterol or bambuterol.
• Medicines used to treat nasal congestion, such as ephedrine and xylometazoline.
• Potassium salts used to treat low potassium in the blood.
• Medicines used to treat Parkinson's disease such as levodopa.
• Other diuretic medicines such as bendroflumethiazide. Your doctor may need to change the dose of your medicine.

Furosemide Aurobindo with food, drinks and alcohol
You should avoid drinking alcohol while taking Furosemide Aurobindo, as it may further lower your blood pressure.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• Do not take furosemide tablets if you are pregnant. Talk to your doctor before taking this medicine if you are pregnant, could become pregnant, or think you might be pregnant.
• Do not breastfeed if you are taking furosemide tablets. Small amounts may pass into breast milk. Talk to your doctor before taking this medicine if you are breastfeeding or planning to breastfeed.

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breastfeeding.

Driving and using machines
This medicine may cause dizziness or discomfort. Do not drive or operate machinery if this occurs.

Furosemide Aurobindo contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Furosemide Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 25 mg tablet, i.e. it is essentially 'sodium-free'.

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

3. How to take Furosemide Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.

• The number of tablets you need will depend on your condition. Swallow the tablets whole with a glass of water.
• Take the tablets at approximately the same time each day, before a meal, or as prescribed by your doctor.

Adults and elderly
The recommended dose is one or two tablets taken first thing in the morning. Your doctor will tell you how many
tablets you should take.
Children and adolescents (under 18 years of age)
Not recommended, as safety in this patient group has not yet been established.
If you are taking sucralfate (a medicine for stomach ulcers): Do not take sucralfate
at the same time as furosemide tablets. Take the dose at least 2 hours before or after the
furosemide tablets, as it may affect how your medicine works.
If you take more Furosemide Aurobindo than you should
If you or a child accidentally take too many tablets, inform your doctor immediately or
contact the nearest hospital emergency department, even if there are no signs of discomfort. Bring the
medicine in its original packaging so the doctor can easily identify it.
Taking too many furosemide tablets may make you feel confused, unable to concentrate, emotionally numb, or uninterested in things.
You may also experience dizziness, lightheadedness, fainting (due to low blood pressure), irregular heartbeat, muscle weakness or cramps, and blood clots (symptoms include pain and
swelling in the affected body part). You may also develop kidney or blood problems.
If you forget to take Furosemide Aurobindo
Take the missed dose as soon as you remember, unless it is evening. In that case, taking the missed dose may cause you to wake up during the night to urinate. Take the next dose at your usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Furosemide Aurobindo
Continue taking furosemide tablets until your doctor tells you to stop.
Blood tests
Your doctor may perform blood tests to monitor the levels of certain salts in your blood.
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 everyone gets them.
If you experience any of the following side effects while taking this medicine,
tell your doctor immediately or go to hospital straight away:

• Severe allergic reaction which may include a rash, itching, dermatitis, peeling of the skin, sensitivity to sunlight or sunbeds, fever, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• Blisters or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever which could be symptoms of a condition called Stevens-Johnson syndrome.
• Inflammation of blood vessels (vasculitis which may cause rash, fever and joint or muscle pain) or inflammation of the kidneys, which may change how often you urinate or you may see blood in your urine. You may have a fever, feel drowsy or notice swelling, for example in the ankles.
• Blood clots (causing pain, swelling or tenderness in the legs).

Tell your doctor or pharmacist if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people

• Dehydration, disturbed fluid and electrolyte balance (e.g. sodium, potassium, chloride, calcium and magnesium) causing dry mouth, weakness, tiredness or drowsiness, restlessness, seizures, muscle pain, fatigue or cramps, low blood pressure causing loss of concentration and slowed reactions, difficulty passing urine, rapid or irregular heartbeat, nausea and vomiting.

Common: may affect up to 1 in 10 people

• Low blood volume (hypovolaemia).
• Increased creatinine and blood urea (seen in blood tests).

Uncommon: may affect up to 1 in 100 people

• Anaemia causing tiredness, breathlessness, unusual bleeding or bruising.
• Changes in the body seen in tests, such as levels of cholesterol, glucose, uric acid.
• Gout.
• Changes in vision including blurred vision or yellow vision.
• Dizziness, sensations of pressure in the head, headache, drowsiness, weakness, changes in vision, dry mouth, dizziness when standing.
• Irregular heartbeat.
• Muscle cramps or weakness.
• Changes in amount or need to urinate.
• Tiredness.
• Dry mouth, thirst, nausea or vomiting, changes in bowel movements including diarrhoea and constipation.
• Deafness (sometimes irreversible).

Rare: may affect up to 1 in 1,000 people

• Changes in blood cells such as white blood cell count, reduced platelets causing a rash, fever, sweating, tiredness and weight loss. Your doctor will carry out regular blood tests to make sure there have been no changes.
• Unspecified psychiatric disorders causing delirium, hallucinations, disorganised speech.
• Tingling sensation.
• Confusion, headache, tiredness, general feeling of being unwell, fever.
• “Ringing” in the ears, hearing loss usually reversible.
• Symptoms of shock such as changes in heartbeat, shortness of breath, cold and clammy skin.
• Inflammation of the pancreas causing pain in the abdomen or back and nausea.
• Liver problems causing yellowing of the skin or whites of the eyes.
• Skin rashes.

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

• Involuntary muscle movements.
• Kidney inflammation or kidney failure which may cause back pain or changes in amount of urine or need to urinate.

Not known: frequency cannot be estimated from the available data

• Worsening of conditions where there is already a fluid and electrolyte imbalance in the body.
• Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption).
• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).
• Low levels of potassium in the body.

Additional side effects in children

• Increased risk or persistence of patent ductus arteriosus in premature newborns.
• Kidney stones in children.

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

5. How to store Furosemide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Furosemide Aurobindo contains

• The active substance is furosemide. Each tablet contains 25 mg of furosemide.
• The other components are: monohydrate lactose, maize starch, sodium starch glycolate (type A), magnesium stearate.

Description of the appearance of Furosemide Aurobindo and package contents
Tablet.
Tablets from white to almost white, uncoated, circular, with flat bevelled edges, marked with
“F” and “25” separated by a breakline on one side and smooth on the other side. The tablet may be
divided into two equal doses.
Furosemide Aurobindo tablets are available in blister packs.
Pack sizes: 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer
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
Amadora
2700-487 Portugal

This medicinal product is authorised in the European Economic Area countries under the
following names:
Italy: Furosemide Aurobindo