10 mg / ml injection solution
furosemide
1. What Furix is and what it is used for
Furosemide contained in Furix may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
Furix is a fast-acting diuretic that frees the body from excess fluid ( edema ). Furix solution for injection is used to treat fluid retention in the tissues ( edema ) and to treat acute and chronic renal impairment.
2. What you need to know before you use Furix
Do not use Furix
- if you are allergic to furosemide, sulfonamides (eg antidiabetic drugs), or any of the other ingredients of this medicine (listed in section 6)
- in the severe liver or kidney disease
- if you are at risk of dehydration
- if you suffer from almost eliminated urine excretion
- if you suffer from very low potassium and sodium levels in your blood
- if you are breast-feeding (the active substance passes into breast milk).
Warnings and cautions
Talk to your doctor or pharmacist before using Furix if:
- you are taking heart medication that contains digoxin
- you are on a strictly low-salt diet
- you have difficulty emptying your bladder or if you suspect that there may be an obstruction to your urine output
- you have low blood pressure
- you get sharp drops in blood pressure
- you have diabetes
- you have gout
- you have kidney failure due to severe liver disease or injury
- you have low egg white levels in the blood (if it occurs dose adjustment is required)
- you have systemic lupus erythematosus (a disease in which the body’s immune system attacks the body)
- you are older, taking other medicines that can lower your blood pressure, or have any other illness that carries a risk of low blood pressure.
If you suffer from vomiting, diarrhea, and heavy sweating, there may be an increased risk of disturbing the salt and electrolyte balance in the body. There may then be a need to take an extra blood sample. Contact your doctor if you feel unsure.
Other medicines and Furix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if this medicine and certain other medicines are taken at the same time, this also applies to over-the-counter medicines, herbal medicines, or other natural products. The treating physician, therefore, needs to be aware of such concomitant medication.
The following drugs should be avoided during concomitant treatment with Furix:
- gentamicin (used for infections )
- chloral hydrate (a kind of sleeping pill)
- risperidone (used in schizophrenia, among others)
- drugs are known to adversely affect hearing such as certain antibiotics ( aminoglycosides ) and diuretics (ethacrynic acid).
The following medicines may be taken with Furix but may need to be dose-adjusted:
- ACE inhibitors and angiotensin II receptor blockers (used for high blood pressure, among others )
- medicines for high blood pressure
- digitalis glycosides and other drugs that affect the rhythm of the heart
- lithium (used in manic depressive illness)
- NSAID- type anti-inflammatory and analgesic agents such as ibumetin and acetylsalicylic acid
- drugs are known to adversely affect the kidneys
- cephalosporins (used for infections )
- sotalol (used for high blood pressure, among other things )
- cisplatin (used in cancer)
- sucralfate (used for stomach ulcers )
- phenytoin (used in epilepsy )
- cyclosporin A (used in organ transplantation)
- methotrexate (used in cancers, among others)
- drugs against diabetes
- adrenaline (used in anesthetics and hypersensitivity reactions )
- norepinephrine (for low blood pressure )
- curare-like muscle relaxants
- theophylline (used in asthma )
- corticosteroids (used for inflammation, among other things )
- carbenoxolone (used for stomach ulcers )
- large amounts of licorice
- long-term use of laxatives.
Pregnancy and breastfeeding
Pregnancy
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Furix during pregnancy.
Breast-feeding
There is a risk that children who are breastfed may be affected. Therefore, do not use Furix while breastfeeding other than on a doctor’s prescription. Breastfeeding mothers should be aware that the amount of milk may decrease.
Driving and using machines
Due to certain side effects (eg a sharp drop in blood pressure), the degree of alertness and reaction time can change to such an extent that it is not possible to drive motor vehicles or safely operate 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.
3. How to use Furix
Furix solution for injection will be given to you by a healthcare professional, as an injection either into a vein, into a muscle,, or as a drip. Ask your doctor or pharmacist if you are unsure.
If you use more Furix than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital,, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Furix can in rare cases cause severe allergic reactions that can lead to allergic shock with symptoms such as rash, swelling, fever, difficulty breathing,, and drop in blood pressure (symptoms such as dizziness and fainting).
Furix can in very rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.
Contact a doctor as soon as possible if you experience unexplained muscle pain, muscle cramps,, or muscle weakness (occurs in an unknown number of users).
Very common (may affect more than 1 user in 10):
- Disorders in the body’s salt balance or dehydration, especially in the elderly. Detected using blood tests. May cause symptoms such as fatigue, headache, and dizziness.
- Decreased blood volume, especially in the elderly, is detected with the help of a blood test.
- Increased blood creatinine levels, which may be a sign of impaired kidney function. Detected using blood tests.
- Increased levels of triglycerides in the blood (blood fats) may increase the risk of atherosclerosis / increase the risk of cardiovascular disease. Detected using blood tests.
Common (may affect up to 1 in 10 people):
- Elevated uric acid levels in the blood, which can lead to gout Gout can be experienced as sore and swollen joints.
- Increased blood cholesterol (blood fats) can increase the risk of atherosclerosis / increase the risk of cardiovascular disease. Detected using blood tests.
- Increased urine volume.
- The concentration of the blood, ie reduced amount of fluid in the blood, gives the increased concentration of blood components and can increase the risk of blood clots. Detected via a blood test. May occur due to excessive diuretic effect.
- Brain effects in users with impaired liver function.
- Gout attacks.
Uncommon (may affect up to 1 in 100 people):
- Nausea.
- Hearing loss.
- Decreased platelet count ( platelets ), which can cause bruising and bleeding.
- Skin reactions such as itching, hives, blisters, flaking, redness, and inflammation of the skin, slight bleeding in the skin, and mucous membranes. Sensitivity to sunlight.
- Impaired glucose tolerance, which manifests itself as elevated blood sugar levels. Risk of developing diabetes (diabetes).
- Deafness (sometimes persistent).
Rare (may affect up to 1 in 1,000 people):
- Vomiting.
- Diarrhea.
- Inflammation of blood vessels. The symptoms depend on where the vessel/vessels are located.
- Kidney inflammation, which can cause symptoms in the form of fever and pain.
- Earwax.
- Abnormal sensations, such as ant crawling, tingling, and “sugar drinking feeling”.
- A low number of white blood cells, which increases the risk of infection.
- Fever.
Very rare (may affect up to 1 in 10,000 people):
- Acute inflammation of the pancreas, which, for example, can be experienced as pain to varying degrees in the upper abdomen or between the shoulder blades, vomiting,, and fever.
- High liver enzyme values were detected using blood tests.
- Bile duct obstruction, which can cause symptoms such as pain, nausea, and vomiting.
- Impact on the blood picture and anemia.
- Very slow heartbeat when Furix is given as a drip,
Has been reported (occurs in an unknown number of users):
- High pH in the blood, which can cause very serious conditions such as lack of oxygen in the blood.
- Lack of calcium or magnesium which is detected by blood tests. May increase the risk of osteoporosis.
- Increased level of urea in the blood, which is detected with the help of blood tests.
- Blood clot.
- Increased levels of sodium and chloride in the urine, which are detected with the help of blood tests.
- Difficulty urinating.
- Impaired renal function.
- Skin and mucous membrane changes (sometimes severe).
- Severe widespread skin damage (skin detachment).
- Lichenoid reactions, characterized by small, itchy, reddish-purple, angular rashes on the skin, genitals, or in the mouth.
- Pseudo-Bartter syndrome (unusual genetic kidney disease).
- Deterioration or activation of systemic lupus erythematosus (a disease in which the body’s immune system attacks the body).
- Acute generalized exanthematous pustulosis (AGEP) (sudden drug rash with fever).
- Dizziness, fainting, and unconsciousness (caused by low blood pressure ).
5. How to store Furix
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label 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 furosemid . One ml contains 10 mg of furosemid .
The other ingredients are sodium hydroxide, sodium chloride, and water for injections.
What the medicine looks like and the contents of the pack
Furix solution for injection is a clear solution that is colorless or slightly yellowish.
Pack sizes:
Ampoules are 5 x 2 ml and 50 x 2 ml, 5 x 4 ml and 50 x 4 ml, 5 x 25 ml and 50 x 25 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Takeda Pharma AB
Vasagatan 7, 6 tr
111 20 Stockholm