1. Name of the medicinal product

Furosemide Oral Solution USP 10mg/ml Taj Pharma
Furosemide Oral Solution USP 40mg/5ml Taj Pharma

  1. Qualitative and quantitative composition

a) Furosemide Oral Solution USP 10mg/ml Taj Pharma
Each ml contains:
Furosemide USP 10mg
Excipients: Q.S.

b) Furosemide Oral Solution USP 40mg/5ml Taj Pharma
Each 5ml contains:
Furosemide USP 40mg
Excipients: Q.S.

Excipient(s) with known effect:

Each 5ml Oral Solution contains 0.5ml ethanol and 2.5g liquid maltitol.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

A clear, colourless to straw coloured liquid (Oral Solution)

  1. Clinical particulars
    • Therapeutic indications

Furosemide Taj Pharma is indicated in all conditions requiring prompt diuresis, including cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension.

It is also indicated for the maintenance therapy of mild oedema of any origin.

  • Posology and method of administration

Posology

Adults

The usual initial daily dose is 40mg. This may be adjusted until an effective dose is achieved.

Paediatric population

1 to 3mg/Kg body weight daily up to a maximum total dose of 40mg/day.

Elderly

In the elderly, Furosemide Taj Pharma is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Method of administration

For oral use.

Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. For further instructions see section 6.6.

The medication should be administered in the morning to avoid nocturnal diuresis.

  • Contraindications
Contra-indicated conditionsSee also
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides, sulphonamide derivatives.
Hypovolaemia and dehydration (with or without accompanying hypotension)Section 4.4
Severe hypokalaemia: severe hyponatraemiaSection 4.4
Comatose or pre-comatose states associated with hepatic cirrhosis or encephalopathySection 4.4
Anuria or renal failure with anuria not responding to Furosemide Taj Pharma, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents
Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m2 body surface areaSection 4.4
Addison’s diseaseSection 4.4
Digitalis intoxicationSection 4.5
Concomitant potassium supplements or potassium sparing diureticsSection 4.5
Breast-feeding womenSection 4.6
  • Special warnings and precautions for use

Conditions requiring correction before Furosemide Taj Pharma is started (see also section 4.3)

  • Hypotension
  • Hypovolaemia
  • Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base disturbances

Furosemide Taj Pharma is not recommended

  • In patients at high risk for radiocontrast nephropathy – it should not be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.
  • In elderly patients with dementia taking risperidone – Increased mortality (see below and section 4.5)

Particular caution and/or dose reduction required:

  • elderly patients (lower initial dose as particularly susceptible to side-effects – see section 4.2).
  • difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). Closely monitor patients with partial occlusion of the urinary tract
  • in moderate liver congestion dosage adjustment may be needed
  • diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase: stop Furosemide Taj Pharma before a glucose tolerance test)
  • pregnancy (see section 4.6)
  • gout (Furosemide Taj Pharma may raise uric acid levels/precipitate gout)
  • impaired hepatic function – hepatic failure and alcoholic cirrhosis particularly predispose to hypokalaemia and hypomagnesaemia (see section 4.3 and below – monitoring required)
  • impaired renal function and hepato-renal syndrome (see section 4.3 and below – monitoring required)
  • adrenal disease (see section 4.3 – contraindication in Addison’s disease)
  • hypoproteinemia e.g. nephrotic syndrome (effect of Furosemide Taj Pharma may be impaired and its ototoxicity potentiated – cautious dose titration required).
  • acute hypercalcaemia (dehydration results from vomiting and diuresis – correct before giving Furosemide Taj Pharma). Treatment of hypercalcaemia with a high dose of Furosemide Taj Pharma results in fluid and electrolyte depletion – meticulous fluid replacement and correction of electrolyte required
  • premature infants – possible development of nephrocalcinosis/ nephrolithiasis (see below – monitoring of renal function required)
  • some diuretics have been considered unsafe in acute porphyria
  • symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with Furosemide Taj Pharma, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

Avoidance with other medicines (see also section 4.5 for other interactions)

  • concurrent NSAIDs should be avoided – if not possible diuretic effect of Furosemide Taj Pharma may be attenuated
  • ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur – dose of Furosemide Taj Pharma should be reduced/stopped (3 days) before starting or increasing the dose of these
  • concurrent risperidone in elderly patients with dementia has resulted in increased mortality – no mechanism for and no consistent pattern of deaths identified (see section 4.5)

Laboratory and other monitoring requirements:

  • Serum sodium

Particularly in the elderly or in patients liable to electrolyte deficiency

  • Serum potassium

The possibility of hypokalaemia should be taken into account, in particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives. Regular monitoring of the potassium, and if necessary treatment with a potassium supplement, is recommended in all cases, but is essential at higher doses and in patients with impaired renal function. It is especially important in the event of concomitant treatment with digoxin, as potassium deficiency can trigger or exacerbate the symptoms of digitalis intoxication (see section 4.5). A potassium-rich diet is recommended during long-term use.

Frequent checks of the serum potassium are necessary in patients with impaired renal function and creatinine clearance below 60ml/min per 1.73m2 body surface area as well as in cases where Furosemide Taj Pharma is taken in combination with certain other drugs which may lead to an increase in potassium levels (see section 4.5 & refer to section 4.8 for details of electrolyte and metabolic abnormalities)

  • Renal function

Frequent BUN in first few months of treatment, periodically thereafter. Long-term/high-dose BUN should regularly be measured. Marked diuresis can cause reversible impairment of kidney function in patients with renal dysfunction. Adequate fluid intake is necessary in such patients. Serum creatinine and urea levels tend to rise during treatment. If used in premature infants there is a risk of nephrocalcinosis/nephrolithiasis so renal function must be monitored and renal ultrasonography performed

  • Glucose

Adverse effect on carbohydrate metabolism – exacerbation of existing carbohydrate intolerance or diabetes mellitus. Regular monitoring of blood glucose levels is desirable.

  • Other electrolytes

Patients with hepatic failure/alcoholic cirrhosis are particularly at risk of hypomagnesemia (as well as hypokalaemia). During long-term therapy (especially at high doses) magnesium, calcium, chloride, bicarbonate and uric acid should be regularly measured.

Clinical monitoring requirements (see also section 4.8):

Regular monitoring for

  • blood dyscrasias. If these occur, stop Furosemide Taj Pharma immediately
  • liver damage
  • idiosyncratic reactions

Excipient Warnings

  • Ethanol (Alcohol) – This medicinal product contains 10% v/v ethanol (alcohol), i.e. up to 0.4g per 5ml of dose.
  • It is harmful for those suffering from alcoholism.
  • It should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
  • Liquid maltitol – This medicinal product also contains liquid maltitol. Patients with a rare hereditary problem of fructose intolerance should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Antihypertensives – enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors or Angiotensin II receptor antagonists can result in marked falls in blood pressure, Furosemide Taj Pharma should be stopped or the dose reduced before starting an ACE-inhibitor or Angiotensin II receptor antagonists (see section 4.4). Increased risk of first dose hypotension with post-synaptic alpha-blockers (eg prazosin). Furosemide Taj Pharma may interact with ACE inhibitors causing impaired renal function.

Antipsychotics – Furosemide Taj Pharma-induced hypokalaemia increases the risk of cardiac toxicity. Avoid concurrent use with pimozide. Increased risk of ventricular arrhythmias with pimozide (avoid concurrent use), amisulpride or sertindole. Enhanced hypotensive effect with phenothiazines.

In placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with Furosemide Taj Pharma plus risperidone. No consistent pattern for cause of death was observed but caution should be exercised and the risks and benefits of this combination considered prior to the decision to use.

Anti-arrhythmics (including amiodarone, disopyramide, flecainide and sotalol) – risk of cardiac toxicity (because of Furosemide Taj Pharma-induced hypokalaemia). The effects of lidocaine, tocainide or mexiletine may be antagonised by Furosemide Taj Pharma.

Cardiac glycosides – hypokalaemia and electrolyte disturbances (including hypomagnesemia) increase the risk of cardiac toxicity.

Drugs that prolong Q-T interval – increased risk of toxicity with Furosemide Taj Pharma induced electrolyte disturbances.

Vasodilators – enhanced hypotensive effect with moxisylyte (thymoxamine) or hydralazine.

Other diuretics – profound diuresis possible when Furosemide Taj Pharma given with metolazone. Increased risk of hypokalaemia with thiazides. Contraindicated with potassium sparing diuretics (eg amiloride spironolactone) – increased risk of hyperkalaemia (see section 4.3). Concurrent use with tetracyclines may increase the risk of rising BUN (see section 4.4 – monitoring).

Renin inhibitors – aliskiren reduces plasma concentrations of Furosemide Taj Pharma.

Nitrates – enhanced hypotensive effect.

Lithium – Furosemide Taj Pharma reduces lithium excretion with increased plasma lithium concentrations (risk of cardio- and/or neuro-toxicity). Avoid concomitant administration unless plasma levels are monitored.

Chelating agents – sucralfate may decrease the gastro-intestinal absorption of Furosemide Taj Pharma – the 2 drugs should be taken at least 2 hours apart.

Lipid regulating drugs – Bile acid sequestrants (eg colestyramine: colestipol) – reduced absorption of Furosemide Taj Pharma – administer 2 to 3 hours apart.

NSAIDs – increased risk of nephrotoxicity (especially with pre-existing hypovolaemia/dehydration. Indometacin and ketorolac may antagonise the effects of Furosemide Taj Pharma (avoid if possible see section 4.4). In patients with dehydration or hypovolaemia, NSAIDs may cause acute renal insufficiency.

Salicylates – effects may be potentiated by Furosemide Taj Pharma. Salicylic toxicity may be increased by Furosemide Taj Pharma.

Antibiotics – increased risk of ototoxicity with aminoglycosides, polymixins or vancomycin – only use concurrently if compelling reasons. Increased risk of nephrotoxicity with aminoglycosides or cefaloridine. Furosemide Taj Pharma can decrease vancomycin serum levels after cardiac surgery. Increased risk of hyponatraemia with trimethoprim.

Antiviral – plasma concentrations of diuretics may be increased by nelfinavir, ritonavir or saquinavir.

Antidepressants – enhanced hypotensive effect with MAOIs. Increased risk of postural hypotension with TCAs (tricyclic antidepressants). Increased risk of hypokalaemia with reboxetine.

Antidiabetics – hypoglycaemic effects antagonised by Furosemide Taj Pharma.

Antiepileptics – increased risk of hyponatraemia with carbamazepine. Diuretic effect reduced by phenytoin.

Antihistamines – hypokalaemia with increased risk of cardiac toxicity.

Antifungals – increased risk of hypokalaemia and nephrotoxicity with amphotericin.

Anxiolytics and hypnotics – enhanced hypotensive effect. Chloral hydrate or triclofos may displace thyroid hormone from binding site.

CNS stimulants (drugs used for ADHD) – hypokalaemia increases the risk of ventricular arrhythmias.

Corticosteroids – diuretic effect anatgonised (sodium retention) and increased risk of hypokalaemia.

Cytotoxics – increased risk of nephrotoxicity and ototoxicity with platinum compounds/cisplatin.

Anti-metabolites – effects of Furosemide Taj Pharma may be reduced by methotrexate and Furosemide Taj Pharma may reduce renal clearance of methotrexate.

Potassium salts – contraindicated – increased risk of hyperkalaemia (see section 4.3).

Dopaminergics – enhanced hypotensive effect with levodopa.

Immunomodulators – enhanced hypotensive effect with aldesleukin. Increased

risk of hyperkalaemia with ciclosprin and tacrolimus. Increased risk of gouty arthritis with ciclosporin.

Muscle relaxants – enhanced hypotensive effect with baclofen or tizanidine. Increased effect of curare-like muscle relaxants.

Oestrogens – diuretic effect antagonised.

Progestogens (drospirenone) – increased risk of hyperkalaemia and diuretic effect antagonised.

Prostaglandins – enhanced hypotensive effect with alprostadil.

Sympathomimetics – increased risk of hypokalaemia with high doses of beta2 sympathomimetics.

Theophylline – enhanced hypotensive effect.

Probenecid –effects of Furosemide Taj Pharma may be reduced by probenecid and Furosemide Taj Pharma may reduce renal clearance of probenecid.

Anaesthetic agents – general anaesthetic agents may enhance the hypotensive effects of Furosemide Taj Pharma. The effects of curare may be enhanced by Furosemide Taj Pharma.

Warfarin and clofibrate – compete with Furosemide Taj Pharma in binding to serum albumin – possibly significant if this is low (eg nephrotic syndrome).

Aminoglutethimide – concomitant use may increase the risk of hyponatraemia.

Alcohol – enhanced hypotensive effect.

Laxative abuse – increases the risk of potassium loss.

Liquorice – excess intake may increase the risk of hypokalaemia

  • Fertility, pregnancy and lactation

Pregnancy

Furosemide Taj Pharma must not be given during pregnancy unless there are compelling medical reasons.

Breast-feeding

Furosemide Taj Pharma may inhibit lactation and may pass into breast milk. Women must not breastfeed if they are treated with Furosemide Taj Pharma.

  • Effects on ability to drive and use machines

Mental alertness may be reduced and the ability to drive or operate machinery may be impaired.

  • Undesirable effects

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:Uncommon:aplastic anaemia
Rare:bone marrow depression (necessitates withdrawal of treatment), eosinophilia, leucopenia.
Very rare:haemolytic anaemia, agranulocytosis, thrombocytopenia
Metabolism and nutritional disorders:Very common:dehydration, hyponatraemia, hypochloremic metabolic alkalosis, hypocalcaemia, hypomagnesemia (incidences of the last three are reduced by triamterene)
Common:Hypovolaemia, hypochloraemia
Uncommon:impaired glucose tolerance (by hypokalaemia) hyperuricaemia, gout, reduction of serum HDL-cholesterol, elevation of serum LDL-cholesterol, elevation of serum triglycerides, hyperglycaemia.
Very rare:tetany
Frequency not known:aggravated pre-existing metabolic alkalosis (in decompensated cirrhosis of the liver), fluid and electrolyte disturbances, excretion of potassium increased* In patients with diabetes mellitus this may lead to deterioration of metabolic control; latent diabetes mellitus may become manifest
Psychiatric disorder:Rare:psychiatric disorder NOC
Nervous system disorders:Rare:paraesthesia, confusion, headache
Not known:dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
Eye disorders:Uncommon:visual disturbance, blurred vision, yellow vision.
Ear and labyrinth disorders:Uncommon:deafness (sometimes irreversible)
Rare:tinnitus and reversible or irreversible loss of hearing (although usually transitory, particularly in patients with renal failure, hypoproteinaemia (e.g. in nephritic syndrome)
Cardiac disorders:Uncommon:orthostatic intolerance, cardiac arrhythmias, increased risk or persistence of patent ductus arteriosus in premature infants.
Vascular disorders:Very common:hypotension, (which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, light-headedness, sensations of pressure in the head, headache, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance).
Rare:vasculitis, thrombosis, shock
Gastrointestinal disorders:Uncommon:dry mouth, thirst, nausea, bowel motility disturbances, vomiting, diarrhoea, constipation
Rare:acute pancreatitis (in long-term diuretic treatment, including Furosemide Taj Pharma).
Hepatobiliary disorders:Rare:pure intrahepatic cholestasis (jaundice), hepatic function abnormal.
Skin and subcutaneous tissue disorders:Rare:rash, pruritus, photosensitivity, toxic epidermal necrolysis.
Frequency not known:urticaria, erythema multiforme, purpura, exfoliative dermatitis, itching, allergic reactions, such as skin rashes, various forms of dermatitis including urticaria, bullous lesions, acute generalised exanthematous pustulosis (AGEP). When these occur treatment should be withdrawn. Steven-Johnson’s syndrome
Musculoskeletal and connective tissue disorders:Uncommon:muscle cramps, muscle weakness.
Renal and urinary disorders:Very common:nephrocalcinosis in infants
Uncommon:reduced diuresis, urinary incontinence, urinary obstruction (in patients with hyperplasia of the prostate, bladder inability to empty, urethral stricture unspecified).
Rare:acute renal failure.
Frequency not known:Hepatic encephalopathy in patients with hepatocellular insufficiency may occur.
Congenital, familial and genetic disorders:Rare:patent ductus arteriosus
General disorders and administration site conditions:Uncommon:Fatigue
Rare:malaise, fever, severe anaphylactoid or anaphylactic reactions (e.g. with shock).
Investigations:Common:creatinine increased, blood urea increased
Rare:Transaminases increased, blood

*Potassium deficiency manifests itself in neuromuscular symptoms (muscular weakness, paralysis), intestinal symptoms (vomiting, constipation meterorism), renal symptoms (polyuria) or cardiac symptoms. Severe potassium depletion can result in paralytic ileus or confusion, which can result in coma.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

  • Overdose

Symptoms

Overdosing may lead to dehydration and electrolyte depletion through excessive diuresis. Severe potassium loss may lead to serious cardiac arrhythmias.

Management

Treatment of overdose consists of fluid replacement and electrolyte imbalance correction.

  1. Pharmacological properties
    • Pharmacodynamic properties

Pharmacotherapeutic group: High-Ceiling Diuretic Sulfonamide –

Furosemide Taj Pharma is a potent loop diuretic which inhibits sodium and chloride reabsorption at the Loop of Henlé. The drug eliminates both positive and negative free water production. Furosemide Taj Pharma acts at the luminal face of the epithelial cells by inhibiting co-transport mechanisms for the entry of sodium and chloride. Furosemide Taj Pharma gains access to its site of action by being transported through the secretory pathway for organic acids in the proximal tubule. It reduces the renal excretion of uric acid. Furosemide Taj Pharma causes an increased loss of potassium in the urine and also increases the excretion of ammonia by the kidney.

  • Pharmacokinetic properties

When oral doses of Furosemide Taj Pharma are given to normal subjects the mean bioavailability of the drug is approximately 52% but the range is wide. In plasma, Furosemide Taj Pharma is extensively bound to proteins mainly to albumin. The unbound fraction in plasma averages 2 – 4% at therapeutic concentrations. The volume of distribution ranges between 170 – 270ml/Kg. The half life of the ß phase ranges from 45 – 60 min. The total plasma clearance is about 200ml/min. Renal excretion of unchanged drug and elimination by metabolism plus faecal excretion contribute almost equally to the total plasma clearance. Furosemide Taj Pharma is in part cleared by the kidneys in the form of the glucuronide conjugate.

  • Preclinical safety data

Furosemide Taj Pharma is a widely used diuretic which has been available for over thirty years and its safety profile in man is well established.

  1. Pharmaceutical particulars
    • List of excipients

Ethanol, Sodium Hydroxide, Cherry flavour (Containing Ethanol and Propylene Glycol), Liquid Maltitol, Disodium Hydrogen Phosphate, Citric Acid Monohydrate and Purified Water.

  • Incompatibilities

None known

  • Shelf life

24 months

3 months after first opening

  • Special precautions for storage

Store at or below 25°C.

  • Nature and contents of container
Bottles:Amber (Type III) glass
Closures:HDPE, EPE wadded, tamper evident, child resistant
Capacity:150ml
  • Special precautions for disposal and other handling

Keep out of the sight and reach of children.

Instruction for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes:

Ensure that the enteral feeding tube is free from obstruction before administration.

  1. Flush the enteral tube with water, a minimum flush volume of 5mL is required.
  2. Administer the required dose of Furosemide Taj Pharma Oral Solution gently and slowly into enteral tube, with a suitable measuring device.
  3. Flush the enteral tube with water again. A minimum flush volume of 5mL is required. However, for large bore size tubes (18 Fr) a minimum flush volume of 10mL should be used.

This product has not been tested with latex NG or PEG tubes and therefore should not be used with tubes made from latex.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Pack Size:

Each pack contains 10mg/ml and 40mg/ml

Volume of per container is 100ml bottle, 360ml bottle and 450ml bottle or 1000ml bottle.

Not all pack size may be marketed to another country.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Furosemide Oral Solution USP 40mg/5ml Taj Pharma

Furosemide Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Furosemide Taj Pharma is and what is it used for

The name of your medicine is Furosemide Taj Pharma 50mg/5ml Oral Solution (called Furosemide Taj Pharma in this leaflet). It contains Furosemide Taj Pharma. This belongs to a group of medicines called diuretics, or water tablets.

Furosemide Taj Pharma can be used to remove the levels of excess water in the body caused by heart, lung, kidney, liver or blood vessel problems.

  1. What you need to know before you take Furosemide Taj Pharma

Do not take Furosemide Taj Pharma and tell your doctor if:

  • you are allergic (hypersensitive) to Furosemide Taj Pharma, sulphonamides or any other ingredients in this liquid (listed in Section 6). The signs of an allergic reaction include a rash, itching or shortness of breath
  • you have symptoms of weakness, difficulty in breathing and light-headedness. This could be a sign of having too little water in the body
  • you are dehydrated
  • you are not passing water (urine) at all or only a small amount each day
  • you have kidney failure or liver problems, including cirrhosis or liver encephalopathy (confusion, altered levels of consciousness and coma as a result of liver failure)
  • you have a severe change in blood salts, such as high potassium or calcium levels or low sodium or magnesium levels. You may notice signs of this such as muscle cramps, weakness and tiredness. You must nottake other medicines or supplements that contain potassium
  • you have low blood pressure. The signs of this include dizziness, feeling less alert than usual, fainting and general weakness
  • you have an illness called ‘Addison’s disease’. This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure
  • you are taking digoxin, used to treat heart problems
  • you are breast-feeding.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Furosemide Taj Pharma.

Warnings and precautions

Talk to your doctor before taking Furosemide Taj Pharma, if:

  • you have difficulty in passing water (urine), particularly if you have an enlarged prostate gland
  • you have gout
  • you have low levels of protein in the blood. The signs of this may include swelling, feeling sick (nausea) or being sick (vomiting), diarrhoea and stomach pain
  • you have liver congestion (slowed blood flow through the vessels) or other liver problems
  • you have kidney problems
  • you have brain disorders affecting your nervous system, or a condition called porphyria. This is a disorder that can cause skin blisters, pain in and around the stomach area (abdomen)
  • you have diabetes
  • you are going to give this medicine to a baby that was born too early
  • you have an abnormal heart rhythm or have a history of heart problems
  • you are elderly (above 65), especially if you are taking risperidone for dementia
  • you are pregnant
  • if you are elderly, if you are taking any other medication that can cause a drop in blood pressure or if you have any medical conditions that can cause a drop in blood pressure.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Furosemide Taj Pharma.

Having operations and tests whilst on Furosemide Taj Pharma

Tell your doctor, dentist or nurse you are taking this medicine if

  • you are going to have an anaesthetic
  • you are going to have an X-ray examination that involves taking medicines before the procedure.

While you are taking this medicine, your doctor may give you regular blood tests. Your doctor will do this to monitor levels of salts, minerals and glucose in your blood and to check that your kidneys are working properly.

Other Medicines and Furosemide Taj Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Furosemide Taj Pharma, the main ingredient of this medicine, can affect the way some other medicines work. Also some medicines can affect the way Furosemide Taj Pharma works.

Tell your doctor if you are taking any of these medicines:

  • medicines used to treat high blood pressure known as ACE-inhibitors or Angiotensin-II receptor antagonists, such as captopril and losartan or aliskiren or hydralazine
  • medicines used to treat high blood pressure or prostate problems known as alpha-blockers, such as prazosin
  • 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 used to treat unusual heart beats, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine
  • medicines used to treat angina that you spray or dissolve under your tongue such as glyceryl trinitrate or isosorbide dinitrate
  • warfarin, used to prevent atrial fibrillation, unwanted clotting and stroke
  • medicines used to treat high cholesterol, such as clofibrate, colestyramine or colestipol
  • moxisylyte used to treat Raynaud’s syndrome
  • medicines used to treat pain and inflammation known as NSAIDs, such as indometacin or salicylates such as aspirin
  • medicines used to treat inflammation known as corticosteroids, such as prednisolone and dexamethasone
  • medicines used to treat infections caused by bacteria, such as lymecycline, vancomycin, gentamicin, trimethoprim, cephaloridine, ceftriaxone and colistin
  • medicines used to treat infections caused by fungus, such as amphotericin
  • medicines used to treat infections caused by a virus, such as nelfinavir, ritonavir and saquinavir
  • drugs used after transplants, such as tacrolimus, ciclosporin, aldesleukin
  • medicines used for depression, such as reboxetine, amitriptyline and phenelzine
  • medicines used for mental problems called ‘psychoses’, such as risperidone (see section ‘Do not take Furosemide Taj Pharma’), amisulpride, sertindole, pimozide and chlorpromazine. Avoid using pimozide at the same time as Furosemide Taj Pharma
  • lithium, used to treat extreme mood swings
  • medicines used to help you sleep, such as chloral hydrate and triclofos
  • atomoxetine used to treat Attention Deficit Hyperactivity Disorder (ADHD)
  • medicines used to treat epilepsy, such as carbamazepine, phenobarbital and phenytoin
  • medicines used to treat Parkinson’s disease such as levodopa
  • medicines used to treat diabetes
  • medicines to treat asthma, such as salmeterol, salbutamol and theophylline. These medicines also treat chronic obstructive pulmonary disease
  • medicines used to treat blocked noses, such as ephedrine and xylometazoline
  • medicines used to treat cancer such as cisplatin, methotrexate and aminoglutethimide
  • medicines to relax muscles such as baclofen and tizanidine
  • laxatives that help you go to the toilet
  • alprostadil, used to treat male impotence
  • oestrogen and drospirenone, used as contraceptives or in hormone replacement therapy (HRT)
  • probenecid, used to treat gout
  • potassium salts used to treat low potassium in the blood
  • sucralfate, used to treat stomach ulcers. Do not take sucralfate within two hours of taking Furosemide Taj Pharma. This is because the sucralfate can stop the Furosemide Taj Pharma from working properly
  • antihistamines, used to treat allergies such as cetirizine
  • medicines or food containing liquorice.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Furosemide Taj Pharma.

Furosemide Taj Pharma with food, drink and alcohol

You should avoid drinking alcohol while taking Furosemide Taj Pharma as this may lower your blood pressure further.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine if you are breast-feeding.

Driving and using machines

While taking this medicine you may feel less alert than normal. If this happens, do not drive a car or use any tools or machines.

Furosemide Taj Pharma contains ethanol (10%v/v) and liquid maltitol:

  • Ethanol (Alcohol) – This medicinal product contains 10% v/v ethanol (alcohol), i.e. up to 0.4g per 5ml of dose, which is equivalent to 10ml beer or 4ml wine per 5ml dose. This is harmful to those suffering from alcoholism. This should also be taken into account in pregnant or breast feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
  • Liquid maltitol – This medicine also contains liquid maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
  1. How to take Furosemide Taj Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. Look on the label and check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • this medicine contains 50mg of Furosemide Taj Pharma in each 5ml
  • take this medicine by mouth
  • this medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes:
  1. ensure the tube is clear before taking the medicine
  2. flush the tube with a minimum of 5mL of water
  3. administer the medicine gently and slowly into the tube, with a suitable measuring device
  4. flush the tube again with a minimum of 5mL of water. A 10mL flush volume should be used for large bore size tubes (18 Fr).
  • it is best to take your dose in the morning
  • plan your doses so that they do not affect your personal activities and sleep
  • ask your doctor or pharmacist to help you plan the best time to take this medicine.

Adults

The usual dose for adults is:

  • 40mg each day
  • take the dose prescribed by your doctor.

Use in children

The usual dose for children is:

  • 1mg to 3mg for each kilogram of the child’s body weight
  • the correct dose will be worked out by the doctor
  • children should not take more than 40mg each day.

Older People

If you are an older person, your doctor may start you on a lower dose and gradually raise this dose.

If you take more Furosemide Taj Pharma than you should

If you take more of the medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Furosemide Taj Pharma

  • If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
  • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

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

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

  • severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight or sun lamps or fever, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing
  • inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have a fever, feel drowsy, or notice swelling e.g. of the ankles
  • blood clot (causing pain, swelling or tenderness in the legs).

If you get any of the following side effects, see your doctor as soon as possible:

Very common: may affect more than 1 in 10 people

  • dehydration
  • altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low pressure causing loss of concentration and slowed reactions, difficulty passing water, fast or irregular heart rate and feeling and being sick.

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 or yellow vision
  • light-headedness, 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 the amount or need to urinate
  • tiredness
  • dry mouth, thirst
  • feeling or being sick
  • 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 amount of white blood cells, reduction of platelets causing a rash fever, sweating, tiredness, and weight loss. Your doctor will perform regular blood tests to ensure no changes have occurred
  • psychiatric disorder NOC causing delusions, hallucinations, disorganized speech
  • feeling ‘pins and needles’ or tingling sensation
  • confusion
  • headache
  • ‘ringing’ in the ears, loss of hearing usually reversible
  • symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin
  • inflammation of the pancreas causing pains in your abdomen or back and nausea
  • changes in the liver causing yellowing of the skin or whites of the eyes
  • skin rashes
  • tiredness, generally feeling unwell
  • fever
  • acute kidney failure.

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

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

Not known: frequency cannot be estimated from the available data

  • worsening of conditions where there is already balances of fluid or chemicals in the body
  • acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)
  • dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
  • decreased levels of potassium in the body.

This medicine may raise cholesterol and lipid (fat) levels in the blood.

If this medicine is used in babies born too soon (prematurely), this medicine can cause:

  • persistence of a blood channel that normally closes at or around birth. This may cause heart failure, failure to grow, shortness of breath and rapid pulse
  • kidney stones and/or calcium deposits in the body.

Tell your doctor if you get any of these side effects:

  • feeling sick (nausea) or being sick (vomiting)
  • generally feeling unwell.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Furosemide Taj Pharma
  • Keep this medicine out of the sight and reach of children.
  • Do not store above 25°C.
  • After you open the bottle, this medicine expires after 3 months. Take this medicine back to the pharmacy three months after you first open it.
  • Do not use this medicine after the expiry date which is stated on the label and carton (exp: month, year). The expiry date refers to the last day of that month.
  • Do not use Furosemide Taj Pharma if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
  1. Contents of the pack and other information

What Furosemide Taj Pharma contains

  • The active substance is Furosemide Taj Pharma.
  • The other ingredients are Ethanol, Sodium Hydroxide, Cherry flavour (Containing Ethanol and Propylene Glycol), Liquid Maltitol, Disodium Hydrogen Phosphate, Citric Acid Monohydrate, And Purified Water.

What Furosemide Taj Pharma looks like and contents of the pack

A clear colourless to straw coloured liquid that smells like cherry.

Pack Size:

Each pack contains 10mg/ml and 40mg/ml

Volume of per container is 100ml bottle, 150ml Bottle, 360ml bottle and 450ml bottle or 1000ml bottle.

Not all pack size may be marketed to another country.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com