FUROSEMIDE 25 mg Coated Tablets

Зміст інструкції

1. Furosemide Aurobindo 25 mg tablets
   1. What is Furosemide Aurobindo 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

Furosemide Aurobindo 25 mg tablets

Generic 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Furosemide Aurobindo 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, promoting the elimination of excess fluids from the body. Diuretics are also known as “water pills”.
Furosemide tablets are used in the treatment of edema (fluid retention), caused by
heart, kidney or liver disorders, alone or in combination with other antihypertensive agents. The
tablets can also be used to treat pulmonary edema (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 sulfonamide derivatives, such as sulfadiazine or co-trimoxazole;
• you have been told that you have a reduced blood volume in your body or are dehydrated (with or without low blood pressure);
• you have been told by your doctor that you have kidney failure. In some types of kidney failure, you may be able to 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 do not produce urine;
• you have a disease called “Addison’s disease”, which can make you feel tired and weak;
• you are taking other medicines that change the amount of potassium in the blood (see “Other medicines and Furosemide Aurobindo”);
• you are a child or adolescent under the age of 18. 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 needs to be monitored regularly and the dose needs to be adjusted accordingly, or if you feel dizzy when you stand up;
• you have diabetes (high blood sugar);
• you are 65 years of age or older;
• you have difficulty urinating;
• you have gout, liver or kidney problems;
• you have low levels of protein in your blood (hypoproteinaemia);
• you suffer from symptoms of acute porphyria, which can include stomach, back or thigh pain. You may also experience nausea, vomiting or constipation with weakness in your arms and legs;
• you are an elderly patient with dementia and are taking risperidone;
• you have problems with your prostate;
• you feel dizzy or are dehydrated. This can happen if you have lost a lot of fluids because you have been vomiting, had diarrhoea or been urinating frequently. It can also happen if you have difficulty eating or drinking;
• you need to undergo a test for glucose;
• you are taking any other diuretic;
• you are about to give this medicine to a premature baby;
• you are an elderly person, if you are taking other medicines that can cause a drop in blood pressure and if you have other medical conditions that present a risk of low blood pressure.

If you are not sure if any of these apply to you, talk 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 can affect how other medicines
work. Also, some medicines can affect how furosemide tablets work.

The following medicines can affect how Furosemide Aurobindo works and
increase the possibility of you having 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 for removing water from the body, known as diuretics, such as amiloride, spironolactone, acetazolamide and metolazone.
• Medicines that change the amount of potassium in the blood, including potassium supplements such as potassium chloride or some diuretics.
• Medicines used to treat irregular heartbeat, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine.
• Medicines that help you sleep and relax, such as chloral hydrate.
• Medicines used as a general anaesthetic to relax muscles during surgery. If you are about to receive an anaesthetic, make sure the doctor or nurse knows that you are taking furosemide.
• Medicines for diabetes. These may not work as well when you are taking furosemide.
• Theophylline - used for breathlessness or difficulty breathing.
• Phenytoin - used for epilepsy. This can reduce the effect of furosemide.
• Medicines used for mental health problems called “psychoses”, such as risperidone, amisulpride, sertindole, pimozide and chlorpromazine. Avoid the simultaneous use of pimozide and furosemide.

The following medicines can increase the possibility of experiencing unwanted effects
when taken with furosemide:

• Lithium - used for mental illnesses. To help prevent unwanted effects, your doctor may need to adjust the dose of lithium and check the amount of lithium in your blood.
• Platinum compounds.
• Cisplatin - used for some 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, alemtuzumab - used to prevent organ rejection after transplantation.
• Moxisylyte used to treat Raynaud’s syndrome.
• Medicines used to treat angina that are sprayed or dissolved under the tongue, such as glyceryl nitrate or isosorbide dinitrate.
• Methotrexate - used for skin, joint or bowel cancers.
• Carbenoxolone and sucralfate - used for ulcers in the esophagus.
• Reboxetine, amitriptyline and phenelzine - used for depression.
• Amphotericin - used for fungal infections if taken for a long period.
• Corticosteroids - used for inflammation such as prednisolone.
• Atomoxetine used to treat attention deficit hyperactivity disorder (ADHD).
• Medicines to relax muscles such as baclofen and tizanidine.
• Antihistamines, used to treat allergies such as cetirizine.
• Alprostadil, used to treat male impotence.
• Oestrogens and drospirenone, used as contraceptives or in hormone replacement therapy (HRT).
• Liquorice - often used in cough medicines, if taken in large amounts.
• Probenecid (used with another medicine for HIV).
• Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or high doses of cephalosporins.
• Medicines used by injection before X-ray examinations (radiocontrast agent).
• Medicines used for constipation (laxatives) if used for a long period such as bisacodyl or senna.
• Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol.
• Medicines used to treat a blocked nose, 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 this can further
lower your blood pressure.

Pregnancy, breastfeeding and fertility
If you are pregnant, trying 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, might become pregnant or are trying to become pregnant.
• Do not breastfeed if you are taking furosemide tablets. Small amounts can 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 can cause dizziness or feeling unwell. Do not drive or use machines if this happens.

Furosemide Aurobindo contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact 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, which is
essentially ‘sodium-free’.

For athletes:the use of the drug without therapeutic need constitutes doping and
may still result in positive doping tests.

3. How to take Furosemide Aurobindo

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

• The number of tablets you need will depend on your condition. The tablets must be swallowed whole with a glass of water.
• You should take the tablets at about the same time each day before a meal or as prescribed by your doctor.

Adults and the elderly
The recommended dose is one or two tablets 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 emergency room of the nearest hospital even if there are no signs of discomfort. Bring the
medicine in its original packaging to allow the doctor to easily identify your
medicine. Taking too many Furosemide tablets can make you feel confused, unable to
concentrate, without emotions or interest in things.
You may also experience dizziness, lightheadedness, fainting (due to low blood pressure),
irregular heartbeat, muscle weakness or cramps, and blood clots (the signs include pain and
swelling in the affected part of the body). You may also have 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 which case if you take
the missed dose you may need to get up during the night to urinate. Take the next dose
as usual.
Do not take a double dose to make up for a missed dose.

If you stop taking Furosemide Aurobindo
Continue taking Furosemide tablets until your doctor tells you to stop taking them.

Blood tests
Your doctor may perform blood tests to check that the levels of certain salts are correct.

If you have any further questions on 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 everyone will experience them.

If you experience any of the following side effects while taking the medicine, inform your doctor immediately or go to hospital straight away:

• Severe allergic reaction which can include a skin rash, itching, dermatitis, skin peeling, sensitivity to sunlight or sunlamps, or 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 may be symptoms of a condition called Stevens-Johnson syndrome.
• Inflammation of blood vessels (vasculitis which can cause skin rash, fever and joint or muscle pain) or inflammation of the kidneys, this can change the number of times you urinate or you may see blood in your urine. You may have a fever, feel sleepy or notice swelling, for example in your 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, altered fluid and electrolyte balance (e.g. sodium, potassium, chlorine, calcium and magnesium) causing dry mouth, weakness, fatigue or drowsiness, restlessness, seizures, muscle pain, fatigue or cramps, low blood pressure causing loss of concentration and slowed reactions, difficulty passing urine, fast or irregular heartbeat, nausea and vomiting.

Common: may affect up to 1 in 10 people

• Low blood volume (hypovolemia).
• Increased creatinine and blood urea (observed in blood tests).

Uncommon: may affect up to 1 in 100 people

• Anemia causing fatigue, shortness of breath, unusual bleeding or bruising.
• Changes in the body observed in tests, such as cholesterol, glucose, uric acid levels.
• Gout.
• Changes in vision including blurred vision or yellow vision.
• Dizziness, feeling of pressure in the head, headache, drowsiness, weakness, impaired vision, dry mouth, lightheadedness when standing up.
• Irregular heartbeat.
• Muscle cramps or weakness.
• Changes in the amount or need to urinate.
• Fatigue.
• Dry mouth, thirst, nausea or vomiting, changes in bowel movements including diarrhea and constipation.
• Hearing loss (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, fatigue and weight loss. Your doctor will regularly perform blood tests to ensure that no changes have occurred.
• Psychiatric disorders NCA causing delirium, hallucinations, disorganized speech.
• Feeling of tingling.
• Confusion, headache, fatigue, 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 abdominal or back pain and nausea.
• Changes in the liver 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.
• Inflammation or kidney failure which can cause back pain or changes in the amount of urine or the need to urinate.

Not known: frequency cannot be estimated from available data

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

Additional side effects in children

• Increased or persistent risk of patent ductus arteriosus in premature infants.
• Kidney stones in children.

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 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 Aurobindo

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 package or blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Furosemide Aurobindo contains

• The active ingredient is furosemide. Each tablet contains 25 mg of furosemide.
• The other ingredients are: Lactose monohydrate, corn starch, sodium starch glycolate (type A), magnesium stearate.

Description of the appearance of Furosemide Aurobindo and contents of the pack
Tablet.
Tablets from white to almost white, uncoated, circular, with flat and chamfered edges imprinted with
“F” and “25” separated by a score line on one side and smooth on the other side. The tablet can be
divided into two equal doses.
Furosemide Aurobindo tablets is available in blister packs.
Packs: 30 tablets.
Not all pack sizes may be 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 Member States of the European Economic Area under the
following denominations:
Italy: Furosemide Aurobindo