40 mg tablets
furosemide

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

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

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

2. What you need to know before you use Furosemide Orifarm

Do not take Furosemide Orifarm if you

  • is allergic to
    • furosemide
    • drugs with a chemical structure similar to furosemide , so-called sulfonamides , which are used against bacterial infections, diabetes , increased pressure in the eyes or to increase urinary excretion
    • any other ingredient of this medicine (listed in section 6).
  • 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 greatly reduced potassium or sodium levels in the blood
  • have decreased blood volume or are dehydrated
    If any of these two conditions occur during treatment, your doctor may stop treatment with Furosemide Orifarm and treat them.
  • ammar

Warnings and cautions

If any of the following apply to you, talk to your doctor, pharmacist or nurse before taking Furosemid Orifarm:

  • Problems with urine flow e.g. due to prostate enlargement, or decreased urine outputYour doctor will closely monitor your urine output
  • Low blood pressure
  • Risk of severe drop in blood pressure
  • DiabetesUndetected diabetes may become apparent, or you may need to use more insulin . Regular blood sugar checks are recommended.
  • GoutRegular checks of uric acid level are recommended
  • Renal impairment also applies to patients with liver disease, called hepatorenal syndromeYour doctor may need to change the dose of Furosemide Orifarm
  • Decreased protein level in the bloodYour doctor will prescribe dose one of Furosemide Orifarm carefully
  • Premature babiesYour doctor will check your kidney function. Specialist care is required during the first weeks of life in premature babies with certain breathing difficulties
  • Risk of low mineral levels, abnormal acid-base balance in the bloodIn 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 Orifarm.
  • Long-term treatment with Furosemide OrifarmPotassium-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 Orifarm with a suitable alternative.
  • You are older, you are taking other medicines that can lower your blood pressure , or you have another illness that carries a risk of lowering your blood pressure .

Other medicines and Furosemide Orifarm

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 Orifarm:

  • 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, a medicament against allergy s
    • 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 Orifarm at the same time . Dose of a Furosemide Orifarm should be reduced or treatment discontinued at least three days before using drugs whose active substance ends in “pril” or “sartan”.
  • Lithium, a drug for depression and mental illnessYour doctor will monitor your blood lithium levels carefully and adjust your lithium dose if necessary
  • Risperidone , a medicine for mental illnessYour doctor will make a very careful assessment of the risks and benefits of concomitant treatment with Furosemide Orifarm. This is especially true for elderly patients with dementia.
  • Levothyroxine, a drug used to treat low metabolism
  • Chloral hydrate, a drug for sleep disordersAvoid using Furosemide Orifarm if you are taking chloral hydrate
  • Sucralfate, a medicine for ulcers in the stomach and intestinesThere must be at least 2 hours between the intake of Furosemide Orifarm 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 name ends with “kuronium” or “kurium”
  • Cisplatin, an anti-cancer drugYour doctor will prescribe the lowest possible dose of Furosemide Orifarm 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 euphoria / depression
  • Aminoglutethimide, a medicine used to treat breast cancer and Cushing’s disease
  • Corticosteroids , medicines 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 medicine for preventing graft rejection and for treating severe skin diseases as well as severe eye and joint inflammation
  • Contrast agents, drugs used in X-rays of internal organs or blood vessels

Furosemide Orifarm with food, drink and alcohol

Take the tablets at least half an hour before a meal with a glass of water. Avoid eating large amounts of licorice while taking Furosemide Orifarm.

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 this medicine.

Pregnancy

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

While you are using Furosemide Orifarm, your doctor will closely monitor you

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

Breast-feeding

Do not use Furosemide Orifarm if you are breast-feeding

Driving and using machines

Furosemide Orifarm 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 Orifarm. 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 increased vigilance. 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 Orifarm 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.

How to take Furosemide Orifarm

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

Take the tablet at least half an hour before a meal, together with a glass of water. The tablet he is divided into two equal doses .

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:
    • ½ to 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. An extra dose of 4 tablets can be taken after another 6 hours, 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, your doctor may increase the dose by one to 1 tablet daily.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 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 Orifarm”, the third item on the list.

If you take more Furosemid Orifarm than you should

Contact a doctor or pharmacist immediately for appropriate treatment.

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

If you forget to take Furosemide Orifarm

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 Orifarm

Do not stop taking Furosemide Orifarm 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, pharmacist or nurse.

4. Possible side effects

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

Stop taking Furosemide Orifarm and contact  your doctor immediately if you get any of the following serious side effects , you may need urgent medical attention:


Common , may affect up to 1 in 10 users

  • confusion, severe headache, restlessness, impaired consciousness, coma caused by brain disorders when used in patients with severe hepatic impairment


Uncommon , may affect up to 1 in 100 people

  • bleeding in the skin and mucous membranes and bruising due to changes in the blood (reduced number of platelets )


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

  • severe allergic reactions such as life-threatening allergic shock
  • nephritis, affects the fluid surrounding the kidney ducts


Very rare , may affect up to 1 in 10,000 users

  • severe anemia with jaundice (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
  • severe abdominal pain and fever due to inflammation of the pancreas
  • jaundice (decreased bile flow due to decreased bile production)


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

  • rash on the face, inflammation of the kidneys, fever, joint and muscle pain due to a connective tissue disease (systemic lupus erythematosus)
  • Kidney Disease (Pseudo-Bartter’s Syndrome)
  • blood clot that can clog a blood vessel
  • severe skin reactions with signs such as blisters, dandruff and fever, which may be life-threatening ( Stevens-Johnson syndrome , toxic epidermal necrolysis , acute generalized exanthematous pustulosis (AGEP), (sudden rash with fever), rash with eosinophilia and systemic symptoms)
  • muscle aches, muscle weakness or dark brown urine due to muscle breakdown. May cause kidney failure
  • kidney failure


Other 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
  • circulation problems, especially when getting up.
    These circulatory problems can also mean circulatory collapse.
  • increased creatinine levels in the blood

Common , may affect up to 1 in 10 users

  • 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
  • increased urine output

Uncommon , may affect up to 1 in 100 people

  • allergic reactions in the skin and mucous membranes
  • higher blood sugar level
  • reduced glucose tolerance
  • hearing problems, usually temporary and mainly in patients with impaired renal function or low protein content in the blood, deafness (sometimes persistent)
  • nausea, itching , hives , rash
  • dermatitis
  • severe inflammation of the skin and mucous membranes, with signs such as blistering and fever (bullous erythema multiforme, pemphigoid , exfoliative 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
  • inflammation of the blood vessels
  • vomiting, diarrhea
  • fever

Very rare , may affect up to 1 in 10,000 users

  • ringing or wheezing in the ears
  • increase of some liver enzymes called transaminase s

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

  • lower calcium or magnesium levels in the blood
  • too high pH in the body (alkaline)
  • 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 bladder)
  • 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 is given to premature babies during the first weeks of life.
  • dizziness, fainting and unconsciousness (caused by low blood pressure )

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 Furosemid Orifarm

Store the blister in the outer carton. Sensitive to light.

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 carton after EXP. dat / 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 40 mg
  • The other ingredients are lactose monohydrate , magnesium stearate, corn starch, pregelatinized starch and sodium starch glycolate.

What the medicine looks like and contents of the pack

Furosemide Orifarm tablets are white, round, smooth on one side and marked with F 40 on the other side (F and 40 are separated by a notch).

Pack sizes

Blister packs containing 50, 56, 98, 100, 250 and 300 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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