It is used to treat edema associated with heart, lung, liver, and kidney diseases.
What is Furosemide Sofarma and what is it used for?
Active substance: Furosemide 20 mg per 2 ml ampoule.
Other ingredients: Sodium chloride, sodium hydroxide (1 mol/L), water for injections
Furosemide Sofarma is a medicinal product from the group of diuretics (a drug that increases urine excretion, eliminates water from the body, and prevents water retention).
It is used to treat edema associated with heart, lung, liver, and kidney diseases; in hypertensive crisis (in combination with other therapeutic measures).
Furosemide Sofarma injection solution is used when a rapid effect is required, in emergency situations, or when oral tablet administration is complicated or impossible.
Do not take Furosemide Sofarma:
If you are allergic (hypersensitive) to the active substance of the drug or any other component (see section 6);
If you are allergic (hypersensitive) to sulfonamides;
In hypovolemia (reduced blood volume) or dehydration;
In renal insufficiency or anuria (production of very little or no urine);
In renal failure due to nephrotoxic or hepatotoxic substances;
In renal failure associated with hepatic coma (severe liver disease);
If potassium or sodium levels in the blood are low;
If the patient is in a pre-comatose or comatose state due to severe liver damage;
During breastfeeding.
Warnings and precautions:
Consult a doctor or pharmacist before using Furosemide Sofarma if:
You are elderly, taking other blood pressure-lowering drugs, or have other diseases that also reduce blood pressure;
You have prostate problems or difficulty urinating;
You have diabetes or gout;
You have hepatorenal syndrome (severe liver damage with progressive kidney dysfunction);
You are known to have low protein levels in the blood;
In newborn infants;
You have porphyria (a hereditary liver disease causing insufficient hemoglobin production);
When taken with risperidone (used to treat mental disorders).
Regular monitoring of sodium, potassium, calcium, chloride, magnesium, and creatinine levels in serum is necessary.
Other medicines and Furosemide Sofarma:
Inform your doctor or pharmacist if you are taking or have recently taken other medicines, including over-the-counter drugs.
Inform your doctor if you are taking antihypertensive drugs, including metolazone; antineuralgic and sleep medications (carbamazepine, phenobarbital); antiepileptic drugs (phenytoin); antidepressants (reboxetine); anti-inflammatory and antirheumatic drugs (indomethacin, aspirin); corticosteroids; immunosuppressants (methotrexate, cyclosporine); treatments for gout, diabetes, heart failure (digoxin), asthma (theophylline); antibiotics (cephalosporins or aminoglycosides); lithium products; cisplatin; carbenoxolone and sucralfate (for ulcer treatment); corticotropin; antifungal drugs (amphotericin B); laxatives; licorice (for cough); cholesterol-lowering drugs (cholestyramine).
After administration of contrast agents during radiological examinations, some patients may experience impaired kidney function.
Furosemide Sofarma may reduce the therapeutic effect of adrenaline and noradrenaline.
Pregnancy, breastfeeding, and fertility:
If you are pregnant, suspect pregnancy, or plan pregnancy, consult your doctor or pharmacist before starting this medicine.
Pregnancy:
Furosemide crosses the placenta. Do not take during pregnancy except in special cases, and only if the benefit to the mother outweighs the risk to the fetus. Fetal monitoring may be required.
Breastfeeding:
Furosemide may pass into breast milk and suppress lactation. If treatment is necessary during lactation, breastfeeding should be discontinued.
Driving and operating machinery:
Avoid driving or operating machinery while taking Furosemide, as it may cause lowered blood pressure and reduced attention, impairing your ability to drive or operate machinery.
Important information about Furosemide Sofarma ingredients:
One dose of this medicine contains less than 1 mmol of sodium (23 mg), i.e., practically sodium-free.
How to use Furosemide Sofarma:
Always take Furosemide Sofarma exactly as prescribed by your doctor. If in doubt, ask your doctor or pharmacist.
The medicine is usually administered intravenously and rarely intramuscularly. After injection, treatment may be continued with Furosemide tablets.
The dosage and duration of treatment are determined by the attending physician.
If you take more Furosemide Sofarma than prescribed: Overdose may cause arrhythmia, fluid loss, severe hypotension (low blood pressure), shock, acute renal failure, vascular obstruction (thrombosis), delirium, apathy, and confusion.
Treatment of these symptoms should be performed by a doctor in a medical facility.
If you miss a dose of Furosemide Sofarma: Do not take a double dose to compensate for a missed dose.
If you have additional questions regarding this medicine, consult your doctor or pharmacist.
Possible side effects:
Very common:
Reduction of various salts in the body (may cause increased thirst, headache, blood pressure drop, confusion, involuntary muscle contractions, muscle weakness, altered heart rhythm, digestive disturbances), decreased total blood volume and body fluids, especially in elderly patients. Increase in blood creatinine and triglycerides, drop in blood pressure to very low levels.
Common:
Decreased sodium, chloride, and potassium in the blood, increased cholesterol, elevated plasma creatinine and uric acid with gout attacks, hepatic encephalopathy (serious condition in patients with liver disease), blood thickening.
Uncommon:
Reduced blood sugar control, nausea, decreased hearing, deafness (sometimes irreversible), itching, hives, rash or inflammation with blisters, multiform erythema, pemphigoid, exfoliative dermatitis, purpura, increased sensitivity to light, decreased platelet count (increasing risk of bruising or bleeding).
Rare:
Vasculitis, nephritis, diarrhea, vomiting, severe allergic reactions including anaphylactic shock, tingling in limbs, leukopenia (reduced total white blood cells), eosinophilia (increase in certain white blood cells), fever.
Very rare:
Acute pancreatitis (severe abdominal or back pain), cholestasis (bile secretion disorder), increased liver transaminases, tinnitus, decreased red blood cells, changes in white blood cell count.
Frequency unknown:
Low calcium and magnesium levels in blood, increasing plasma urea, metabolic alkalosis, tendency to thrombosis, urine retention (narrowed pelvic bones), calcium salt deposition and kidney stone formation in newborns, renal failure, severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP) (serious condition with fever), dizziness, fainting, loss of consciousness (due to symptomatic hypotension), increased risk of congenital heart defects when used in newborns in the first week of life, local reactions such as pain after intramuscular injection.
Storage:
This medicine does not require special storage conditions.
Store ampoules in the original cardboard packaging to protect from light.
Keep out of reach of children.
Do not use Furosemide Sofarma after the expiry date indicated on the packaging and ampoule. The expiry date refers to the last day of the indicated month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to safely dispose of unwanted medicines. This helps protect the environment.
Marketing authorization holder and manufacturer:
Sofarma AD
16 Ilienskoe Shose Blvd, 1220 Sofia, Bulgaria
