Furosemid Medreg

Package Leaflet: Information for the Patient

Furosemid Medreg, 40 mg, Tablets

Furosemide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Furosemid Medreg and what is it used for
• 2. Important information before taking Furosemid Medreg
• 3. How to take Furosemid Medreg
• 4. Possible side effects
• 5. How to store Furosemid Medreg
• 6. Contents of the pack and other information

1. What is Furosemid Medreg and what is it used for

Furosemid Medreg contains furosemide, which belongs to a group of medicines called loop diuretics. It reduces excess water (fluid retention) in the body by increasing urine production.
Furosemid Medreg is indicated in the following cases:

• edema associated with heart diseases
• edema associated with liver diseases
• edema associated with kidney diseases (in the case of nephrotic syndrome, treatment of the underlying disease is necessary)
• high blood pressure (hypertension).

2. Important information before taking Furosemid Medreg

When not to take Furosemid Medreg

• if you are allergic to furosemide, sulfonamides (possible cross-sensitivity with furosemide) or any of the other ingredients of this medicine (listed in section 6)
• if you have a severely reduced blood volume (hypovolemia) or dehydration
• if you have kidney failure with no urine production (anuria) that does not respond to furosemide treatment
• if you have a severe potassium deficiency (hypokalemia)
• if you have a severe sodium deficiency (hyponatremia)
• if you have lost consciousness due to liver failure (hepatic coma and pre-coma)
• if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Before starting treatment with Furosemid Medreg, discuss it with your doctor or pharmacist if you have:
difficulty urinating (e.g., prostate enlargement, urethral stricture)
low blood pressure or dizziness when changing body position from lying to standing
there is a risk of significant blood pressure drop, e.g., patients with cerebral or heart circulation problems
you are elderly, taking other medications that may cause blood pressure drop, and if you have other conditions that may cause blood pressure drop
you have diabetes
you have gout
you have low blood protein levels (hypoproteinemia), e.g., in nephrotic syndrome (kidney disease; protein loss, disturbed lipid metabolism, and fluid retention)
you have kidney disease associated with severe liver disease (hepato-renal syndrome)
there is excessive fluid loss (e.g., vomiting, diarrhea, or excessive sweating).
If you have an electrolyte deficiency, your doctor will need to regularly monitor your serum electrolyte levels (especially potassium, sodium, and creatinine) during treatment with Furosemid Medreg.
There is a possibility of exacerbating or activating systemic lupus erythematosus (a chronic autoimmune disease of connective tissue).
Concomitant use with risperidone:
In controlled placebo studies of risperidone in elderly patients with dementia, increased mortality was observed in patients treated with furosemide in combination with risperidone compared to patients treated with risperidone alone or furosemide alone.
Therefore, caution should be exercised, and before making a decision, the doctor should consider the risks and benefits associated with this combination or concomitant treatment with other potent diuretics. This should be avoided in case of dehydration.

Children

Premature infants treated with furosemide should be carefully monitored for kidney function due to the risk of kidney stones or calcifications.

Furosemid Medreg and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Furosemid Medreg may affect the action of some medicines. Similarly, other medicines may affect the action of Furosemid Medreg.
It is especially important to inform your doctor if you are taking:

• chloral hydrate (a sleeping pill)
• ototoxic drugs, e.g., aminoglycoside antibiotics (drugs used to treat bacterial infections) or cisplatin (a drug used to treat cancer)
• sucralfate (a drug used to treat stomach disorders)
• lithium (a drug used to treat mental illnesses)
• antihypertensive drugs, including other diuretics
• risperidone (a drug used to treat mental illnesses)
• thyroid hormones, e.g., levothyroxine
• aliskiren, used to treat hypertension
• non-steroidal anti-inflammatory drugs, e.g., indomethacin and acetylsalicylic acid
• phenytoin (a drug used to treat epilepsy)
• corticosteroids (drugs used to treat inflammatory and autoimmune diseases)
• carbenoxolone (a drug used to treat ulcers)
• laxatives (drugs used to treat constipation)
• cardiac glycosides, e.g., digoxin
• probenecid (a drug used to treat gout)
• methotrexate (a drug used to suppress the immune system and treat certain types of cancer)
• antidiabetic drugs (drugs that lower blood sugar levels)
• muscle relaxants (drugs that relax muscles and cause anesthesia)
• theophylline (a drug used to treat asthma)
• nephrotoxic drugs, e.g., aminoglycoside antibiotics, cephalosporins (drugs used to treat bacterial infections), or cisplatin
• cyclosporin A (a drug that suppresses the immune system)
• radioactive contrast agents (radioactive substances administered to the patient before a medical imaging procedure).

Furosemid Medreg with food and drink

It is recommended to take Furosemid Medreg on an empty stomach.
Combination of licorice and Furosemid Medreg may cause increased potassium loss.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Furosemid Medreg should not be given to pregnant women unless it is absolutely necessary. Furosemide treatment during pregnancy requires monitoring of fetal growth.
Breastfeeding
Furosemide passes into breast milk and reduces milk production. The use of Furosemid Medreg is contraindicated during breastfeeding.
Fertility
There are no data on the effect of furosemide on human fertility.

Driving and using machines

This medicine may cause dizziness or fainting. In this case, do not drive vehicles, operate tools, and machines.

Furosemid Medreg contains lactose

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

Furosemid Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Furosemid Medreg

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Recommended dose for adults is as follows:
Recommended maximum daily dose of furosemide is 1500 mg after oral administration.
Edema associated with heart diseases
Recommended initial dose is 20 mg (1/2 tablet) to 80 mg (2 tablets) per day. If necessary, the dose can be adjusted depending on the response. It is recommended to administer the daily dose in two or three divided doses.
Edema associated with liver diseases
Furosemid Medreg is used to treat edema associated with liver diseases in combination with other drugs called aldosterone antagonists when treatment with these drugs is not sufficient.
Recommended initial dose is 20 mg (1/2 tablet) to 80 mg (2 tablets) per day. If necessary, the dose can be adjusted depending on the response. This daily dose may be administered in a single dose or in several divided doses.
Edema associated with kidney diseases
Recommended initial dose is 40 mg (1 tablet) to 80 mg (2 tablets) per day. If necessary, the dose can be adjusted depending on the response. The total daily dose may be administered in a single dose or in two divided doses. In dialyzed patients, the usual maintenance dose is from 250 mg to 1500 mg per day.
High blood pressure (hypertension)
Usual maintenance dose is 20 mg (1/2 tablet) to 40 mg (1 tablet) per day.
Furosemid Medreg can be used alone or in combination with other antihypertensive drugs.

Use in children and adolescents

In children, the dose should be reduced depending on body weight. Recommended dose is from 2 mg/kg to a maximum of 6 mg/kg body weight. Do not exceed the dose of 40 mg per day.

Elderly

Initial dose is 20 mg (1/2 tablet) per day and is gradually increased to achieve the desired response.
Method of administration
Swallow the tablet with a glass of water and on an empty stomach.
The tablet can be divided into equal doses.
The duration of treatment is decided by your doctor.

Overdose of Furosemid Medreg

If you suspect that you have taken more than the recommended dose of Furosemid Medreg, contact your doctor immediately. The decision on how to proceed is made by the doctor based on the assessment of the severity of the overdose.
In case of overdose of Furosemid Medreg, symptoms such as excessive fluid loss (urine), low blood pressure, acute kidney failure, thrombosis, heart rhythm disturbances, hallucinations, muscle weakness, apathy, and confusion may occur.
These symptoms depend on the degree of electrolyte loss (potassium, sodium, and chloride levels) and fluid loss.
If ingestion has occurred recently, gastric lavage or activated charcoal may be used to reduce absorption.

Missed dose of Furosemid Medreg

Take the missed dose as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Furosemid Medreg can cause side effects, although not everybody gets them.
Classification of side effects is based on the following frequencies:
Very common(may affect more than 1 in 10 people):

• electrolyte imbalance disorders (including symptomatic), dehydration, and reduced blood volume (especially in elderly patients)
• increased levels of certain lipids in the blood (triglycerides)
• increased creatinine levels in the blood.

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

• blood concentration (hematocrit) in case of excessive urine production
• sodium and chloride deficiency in the blood
• potassium deficiency in the blood
• increased cholesterol and uric acid levels in the blood, and gout attacks
• hepatic encephalopathy (liver disease affecting the brain) in patients with advanced liver failure
• increased urine production.

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

• reduced platelet count (thrombocytopenia)
• increased blood sugar levels (impaired glucose tolerance and hyperglycemia). This may lead to worsening of metabolic conditions in patients with diabetes symptoms. Latent diabetes may be revealed.
• hearing disorders (mostly transient), especially in patients with kidney function disorders or reduced protein levels in the blood (e.g., in nephrotic syndrome)
• nausea
• itching, hives, skin and mucous membrane reactions with redness, blistering, or peeling (e.g., bullous eruption, erythema multiforme, pemphigoid, exfoliative dermatitis, lichenoid eruption)
• increased sensitivity to light (photosensitivity).

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

• increased count of certain white blood cells (eosinophilia)
• reduced count of white blood cells (leukopenia)
• severe allergic reactions (anaphylactic shock)
• tingling or numbness of limbs (paresthesia)
• vasculitis (inflammation of blood vessels)
• deafness (sometimes irreversible), ringing in the ears (tinnitus)
• gastrointestinal disorders (vomiting, diarrhea)
• kidney inflammation (interstitial nephritis)
• fever.

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

• anemia caused by excessive breakdown of red blood cells (hemolytic anemia)
• anemia caused by disorders of blood cell production in the bone marrow (aplastic anemia)
• significant reduction in the count of certain white blood cells, associated with increased risk of infection and severe general symptoms (agranulocytosis)
• acute pancreatitis
• bile flow disorders (cholestasis)
• increased activity of certain liver enzymes (transaminases).

Frequency not known(frequency cannot be estimated from the available data):

• exacerbation or activation of systemic lupus erythematosus (a disease in which the immune system is directed against the body itself)
• calcium deficiency in the blood
• magnesium deficiency in the blood
• metabolic alkalosis (elevated blood pH)
• kidney function disorders associated with abuse and/or long-term use of furosemide (pseudo-Bartter syndrome) (elevated blood pH, potassium loss, and low blood pressure)
• dizziness, fainting, and loss of consciousness, headaches
• thrombosis (blockage of a blood vessel by a clot)
• severe skin and mucous membrane reactions with blistering or peeling: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP, acute, febrile, pustular eruption), drug reaction with eosinophilia and systemic symptoms DRESS (increased count of certain white blood cells, systemic symptoms), lichenoid reactions
• cases of serious muscle problems (rhabdomyolysis), often associated with severe potassium deficiency (see section "When not to take Furosemid Medreg")
• increased sodium levels in urine, increased chloride levels in urine, increased urea levels in urine
• symptoms of urinary tract obstruction, urinary retention (in patients with partial urinary retention)
• kidney stones in premature infants (nephrolithiasis/calcification)
• kidney failure
• increased risk of persistent ductus arteriosus (a blood vessel connection bypassing pulmonary circulation before birth that does not close) in premature infants treated with furosemide in the first weeks of life.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Furosemid Medreg

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Furosemid Medreg contains

• The active substance is furosemide. Each tablet contains 40 mg of furosemide.
• The other ingredients are: lactose monohydrate, corn starch, corn starch pregelatinized, sodium carboxymethylcellulose (type A), magnesium stearate.

What Furosemid Medreg looks like and contents of the pack

Furosemid Medreg is a white or almost white, round tablet with a diameter of 8 mm (approximately), marked with "F 40" on one side ("F" and "40" separated by a dividing line) and smooth on the other side.
The tablet can be divided into equal doses.
Tablets are provided in PVC/PVDC/Aluminum blisters in a cardboard box.
Package sizes: 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Furosemid Medreg
Czech Republic:
Furosemid Medreg
Romania:
Furosemid Gemax Pharma 40 mg tablets
Slovakia:
Furosemid Medreg

Date of last revision of the package leaflet: