40 mg tablets
furosemide

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

Furosemide Teva is used to treat:

  • swelling caused by fluid accumulation in tissue are , in patients with
    • heart disease
    • liver disease
    • kidney disease.This also includes a kidney disease with extensive protein loss, elevated fat levels and swelling due to fluid retention. If you have this specific kidney disease, it should be treated in the first place.
  • swelling of the lungs due to fluid retention
  • high blood pressure .

Furosemide Teva is a diuretic , ie. a drug that increases urinary excretion.

Furosemide contained in Furosemide Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Furosemide Teva

Do not take Furosemide Teva

if you

  • is allergic to furosemide or any of the other ingredients of this medicine (listed in section 6).
  • is allergic to drugs with similar chemical structure as furosemide , so-called sulfonamides , which are used against bacterial infections, diabetes , increased pressure in the eyes or to increase urine excretion
  • have renal failure with insufficient urine production, which does not respond to treatment with furosemide .
  • have a severe liver disease with episodes of unconsciousness, associated with brain damage.
  • has significantly reduced potassium – or sodium levels in the blood.
  • has decreased blood volume or is dehydrated . If either of these conditions occurs during treatment, your doctor may stop treatment with Furosemide Teva and treat you.
  • ammar .

Warnings and cautions

Talk to your doctor or pharmacist before taking Furosemide Teva if any of the following apply to you:

  • Problems with urine flow e.g. due to prostate enlargement, or decreased urine output. Your doctor will closely monitor your urine output.
  • Low blood pressure .
  • Risk of severe drop in blood pressure.
  • Diabetes .
  • Undetected diabetes may become apparent, or you may need to use more insulin . Regular blood sugar checks are recommended.
  • Gout .Regular checks of uric acid level are recommended.
  • Renal impairment also applies to patients with liver disease, called hepatorenal syndrome.Your doctor may need to change the dose of Furosemide Teva.
  • Decreased protein level in the blood.Your doctor will set the dose of Furosemide Teva carefully.
  • Premature babies.Your doctor will check your kidney function. Specialist care is required during the first weeks of life for premature babies with certain breathing difficulties.
  • Risk of low mineral levels, abnormal acid-base balance in the blood.In general, your doctor will regularly check your blood for minerals, uric acid , glucose and creatinine , and especially for high-risk patients. Disorders in the amount of minerals and acid-base balance must be corrected. Your doctor may temporarily stop treatment with Furosemide Teva.
  • Long-term treatment with Furosemide Teva.Potassium-rich diets are recommended, e.g. potatoes, bananas, tomatoes, spinach and dried fruit. Sometimes your doctor may recommend that you also take potassium-containing medicines, or replace Furosemide Teva with a suitable alternative.
  • Use of other medicines.See section 2 “Other medicines and Furosemide Teva”.
  • If you are older, if you are taking other medicines that can lower your blood pressure , or if you have any other illness that carries a risk of lowering your blood pressure .

Other medicines and Furosemide Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines may affect or be affected by Furosemide Teva:

  • Medicines for inflammation and pain , e.g. acetylsalicylic acid and indomethacin.
  • Drugs to strengthen the heart’s pumping ability,e.g. digitoxin, digoxin and methyldigoxin.
  • Drugs that can cause a certain type of abnormal heartbeat, so-called QT prolongation, e.g.
    • terfenadine,
    • some medicines for irregular heartbeat .
  • Medicines for infection , e.g.
    • drugs with an active substance whose name begins with “cef”
    • kanamycin, gentamycin, tobramycin
    • polymyxin.
  • Other medicines that can damage your hearing .
  • Medicines for high blood pressure , e.g.
    • other drugs that increase urine output
    • drugs with an active substance whose name ends with “pril”
    • drugs with an active substance whose name ends with “sartan”.Your doctor may need to adjust the dose of one of your blood pressure lowering medicines while you are taking Furosemide Teva at the same time . Dose an Furosemide Teva should be reduced or discontinued at least three days before using the drug whose active ingredient ending in “pril” or “sartan”.
  • Lithium, a drug for depression and mental illness.Your doctor will monitor your blood lithium levels carefully and adjust your lithium dose if necessary.
  • Risperidone , a medicine for mental illness.Your doctor will make a very careful assessment of the risks and benefits of concomitant treatment with Furosemide Teva. This is especially true for elderly patients with dementia.
  • Chloral hydrate, a drug for sleep disorders.Avoid taking Furosemide Teva if you are taking chloral hydrate.
  • Sucralfate, a medicine for ulcers in the stomach and intestines.There must be at least 2 hours between the intake of Furosemide Teva and sucralfate.
  • Medicines for diabetes
  • Medicines to raise blood pressure and increase heart rate in certain shock conditions, e.g. adrenaline and noradrenaline .
  • Theophylline, a drug for asthma and other respiratory problems.
  • Some muscle relaxants with active substances whose names end in “curonium” or “curium”.
  • Cisplatin, an anti-cancer drug.Your doctor will prescribe the lowest possible dose of Furosemide Teva and a positive fluid balance is recommended.
  • Phenytoin , a drug for epilepsy and certain pain conditions.
  • Carbamazepine , a medicine for epilepsy , certain pain conditions and stages of elation / depression.
  • Aminoglutethimide , a drug for breast cancer and Cushing’s syndrome, which manifests itself as a round, moon-shaped face.
  • Corticosteroid s , drugs for inflammation or to prevent rejection of transplanted organs, such as cortisone .
  • Carbenoxolone , a drug for ulcers and inflammation of the esophagus.
  • Drugs that are inhaled or injected to dilate the airways, e.g. salbutamol , terbutaline , sameterol, formoterol and bambuterol.
  • Medicines for constipation
  • Reboxetine, an antidepressant.
  • Amphotericin, a drug for fungal infections.
  • Probenecid, a medicine for gout .
  • Methotrexate , a medicine for severe joint inflammation, cancer and psoriasis .
  • Ciclosporin, a drug to prevent graft rejection and to treat severe skin diseases and severe eye and joint inflammation.
  • Contrast agents, drugs used in X-rays of internal organs or blood vessels.

Furosemide Teva with food

Avoid eating large amounts of licorice while taking Furosemide Teva.

Pregnancy and breastfeeding

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

Pregnancy

Only take Furosemide Teva during pregnancy if your doctor thinks it is absolutely necessary. However, Furosemide Teva is not recommended if pregnancy is the cause of the swelling or high blood pressure .

While you are taking Furosemide Teva, your doctor will closely monitor you

  • mineral holder
  • the percentage of blood cells in the blood
  • the growth of your unborn child.

Driving and using machines

Furosemide Teva has minor or moderate influence on the ability to drive and use machines. However, it may happen that your mental alertness deteriorates if you take Furosemide Teva. If you feel that your attention span is impaired, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Furosemide Teva contains lactose and sodium

Furosemide Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Furosemide Teva contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Furosemide Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take the tablets at least half an hour before a meal, with a glass of water.

The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.

Your doctor will adjust the dose just for you until an effective dose is reached.

The recommended dose for adults and the elderly is:

Swelling due to fluid accumulation in tissue are

  • Starting dose:
    • 1 tablet for patients with heart or liver disease
    • 1 tablet for patients with kidney disease.
      If the treatment does not give satisfactory results, your doctor may recommend that you take up to 2 tablets after 6 hours. After a further 6 hours, an extra dose of 4 tablets can be taken if the result is still not satisfactory.Patients with renal impairment may need a higher dose .
  • Maintenance dose: 1 to 2 tablets daily.

High blood pressure

  • Usual dose :
  • 1 tablet once daily.In severe cases, the doctor may increase the dose one.Your doctor will prescribe additional medicines to lower your blood pressure if the treatment results are not satisfactory.

Use in children under 18 years

  • Starting dose: calculated by the doctor and based on the child’s body weight.When at least 6‑8 hours have passed, the doctor may increase the dose if the treatment with the previous dose has not given the desired result.
  • Max dose: 1 tablet daily.

Hepatic impairment

Your doctor may adjust your dose if your liver function is moderate or severely impaired. See also section 2, “Do not take Furosemide Teva”, the fourth item on the list.

Duration of treatment

Determined by the attending physician.

If you take more Furosemide Teva than you should

Contact a doctor or pharmacist immediately for appropriate treatment.

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Furosemide Teva

Take the tablet the same day as soon as you remember, or take the next dose as usual the next day. Do not take a double dose to make up for a forgotten dose .

If you stop taking Furosemide Teva

Do not stop taking Furosemide Teva without your doctor’s permission. It can seriously injure you and reduce the effect of the treatment.

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

4. Possible side effects

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

If you get any of the following side effects , talk to your doctor straight away or call the nearest emergency department:

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

  • severe allergic reaction which may include redness of the skin, itching , inflammation of the skin, blisters, dandruff, sensitivity to sunlight, fever, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing. This includes sudden drug rash with fever, so-called acute generalized exanthematous pustulosis (AGEP).
  • inflammation of the blood vessels ( vasculitis , which may include redness , fever, and joint or muscle pain).
  • Inflammation of the kidneys, this can change how often you need to urinate or you can see blood in the urine. You may have a fever, feel drowsy or swollen, e.g. around the ankles.

Has been reported (occurs in unknown number of users):

  • blood clot (causes pain, swelling or tenderness in the legs).

Furosemide Teva can also cause the following side effects:

Very common (may affect more than 1 user in 10):

  • disorders in the amount of minerals
  • dehydration and decreased blood volume
  • increased concentration of triglycerides (a fatty substance) in the blood
  • lower blood pressure than normal, especially when you get up.More severe circulatory problems can lead to a state of insufficient blood supply to the body’s organs in the event of very heavy urination. This mainly affects children and the elderly.
  • increased creatinine levels in the blood.

Common (may affect up to 1 in 10 people):

  • increased concentration of blood cells is due to fluid loss
  • decreased levels of potassium , sodium and chloride in the blood
  • increased level of uric acid in the blood, gout
  • increased concentration of cholesterol (a fatty substance) in the blood
  • brain damage in patients with previously severely impaired liver function
  • increased urine output.

Uncommon (may affect up to 1 in 100 people):

  • decreased platelet count
  • allergic reactions in the skin and mucous membranes
  • higher blood sugar level
  • hearing problems, usually temporary and mainly in patients with impaired renal function or low protein content in the blood
  • deafness (sometimes irreversible )
  • nausea
  • itching
  • hives , skin rash
  • dermatitis
  • red or purple spots on the skin
  • increased photosensitivity.

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

  • decreased white blood cell count
  • increased number of a certain type of white blood cell , called eosinophilic granulocyte s
  • emotional disorders such as ant crawling, tingling, burning sensation or numbness
  • vomiting, diarrhea
  • fever.

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

  • lack of red blood cells due to increased degradation
  • sharply reduced number of blood cells due to insufficient production
  • greatly reduced the number of a certain type of white blood cell , called granulocyte s
  • ringing or wheezing in the ears
  • inflammation of the pancreas
  • reduced bile flow due to reduced bile production
  • increase in certain liver enzymes, so-called transaminases .

Has been reported (occurs in unknown number of users):

  • lower calcium or magnesium levels in the blood
  • too high pH in the body (alkaline)
  • dizziness, fainting and unconsciousness (caused by low blood pressure )
  • increased sodium or chloride content in the urine
  • increased level of urea in the blood
  • urination problems, may develop into acute urinary retention (inability to empty the bladder completely)
  • storage of calcium salts in the vessels and tissues of the kidneys and / or urinary stones in the kidneys of premature babies
  • increased risk that the blood vessel connecting the pulmonary artery and aortic arch will not close if Furosemide Teva is given to premature babies during the first weeks of life.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Furosemide Teva

Keep this medicine out of the sight and reach of children.

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label, blister or carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is furosemide . One tablet contains 40 mg furosemide .
  • The other ingredients are lactose monohydrate 59.93 mg, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal anhydrous silica and magnesium stearate.

What the medicine looks like and contents of the pack

White, round, cupped tablet with partial notch. Diameter 7 mm.

Pressure packaging (PVC / aluminum) 100 and 100 x 1 tablets (single dose).

Plastic jar (HDPE) 500 tablets (for dose dispensing and hospital use only).

Marketing Authorisation Holder

Teva Sweden AB
Box 1070
251 10 Helsingborg

Muhammad Nadeem

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