10 mg / ml solution for injection / infusion
furosemide

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

Furosemide Accord contains the active substance furosemide.

Furosemide belongs to a group of medicines called diuretics. Furosemide works by helping to produce more urine. This helps to reduce symptoms caused by the body containing too much fluid.

Furosemide Accord ges:

  • if fluid needs to be removed from the body quickly and efficiently
  • if you can not take this type of medicine by mouth or in an emergency
  • if you have too much fluid around your heart, lungs, liver, or kidneys
  • during periods of extremely high blood pressure that can lead to life-threatening conditions (hypertensive crisis)

Furosemide Accord should only be used under the supervision of healthcare professionals.

Furosemide contained in Furosemid Accord 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.

2. What you need to know before using Furosemid Accord

Do not use Furosemide Accord

  • if you are allergic (hypersensitive) to furosemide or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to sulfonamides
  • if you are severely dehydrated (you have lost a lot of body fluid after eg severe diarrhea or vomiting)
  • if you have kidney failure and do not produce urine, despite treatment with furosemide
  • if you have kidney failure as a result of poisoning with substances that are toxic to the kidneys and liver
  • if you have very low levels of potassium or sodium in your blood
  • if the patient is in a coma due to liver failure
  • if you are breast-feeding.

If you are not sure if you can take this medicine or not, talk to a doctor or pharmacist.

Warnings and cautions

Take special care with Furosemide Accord if:

  • you normally have trouble urinating due to an obstruction (eg enlarged prostate )
  • you have diabetes
  • you have low blood pressure or sometimes have sudden drops in blood pressure (the blood vessels in the heart or brain are too narrow).
  • you have liver disease (eg cirrhosis).
  • you have kidney problems (eg nephrotic syndrome )
  • you are dehydrated (you have lost body fluids after severe diarrhea or vomiting); this can lead to a collapse or a blood clot
  • you have gout (painful or inflamed joints) due to high levels of uric acid (a byproduct of the metabolism) in the blood
  • you have an inflammatory disease called “systemic lupus erythematosusSLE )”
  • you have hearing problems
  • you use sorbitol (sugar substitute for people with diabetes )
  • you have porphyria (a disease that means that the production of oxygen-binding molecules in red blood cells is stopped and the urine turns purple)
  • your skin has an increased sensitivity to sunlight (light hypersensitivity)
  • if you are elderly and receiving treatment with other medicines that can cause a drop in blood pressure and if you have other diseases that involve a risk of a drop in blood pressure.

If Furosemide Accord is given to premature babies, it can lead to kidney stones or calcification of the kidney tissue.

If any of these apply to you, your doctor may want to change your treatment or give you specific advice.

Your doctor may recommend regular tests of your blood sugar or blood uric acid levels. Also, the levels of important body salts in the blood, e.g. potassium and sodium, are especially important if you have vomiting or diarrhea.

Other medicines and Furosemide Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is important because some medicines should not be taken with Furosemide Accord. You must tell your doctor or pharmacist if you are taking:

  • Lithium is used for mental illness, as its effects and side effects can be exacerbated by furosemide. Your doctor will only prescribe this medicine if necessary and will then check your lithium levels and may change the dose one.
  • Cardiac drugs such as digoxin; your doctor may need to change your dose.
  • All medicines for high blood pressure , including thiazide diuretics (eg bendroflumethiazide or hydrochlorothiazide ), ACE inhibitors (eg lisinopril), angiotensin II antagonists (eg losartan ) as furosemide may cause your blood pressure to drop too much . Your doctor may need to change the dose of Furosemid Accord.
  • Cholesterol or lipid-lowering drugs such as cholestyramine, colestipol, and fibrates, e.g. clofibrate, as the effect of Furosemide Accord, may be impaired.
  • Diabetes drugs such as metformin and insulin as sugar levels may be elevated.
  • Anti-inflammatory drugs, including NSAIDs (such as acetylsalicylic acid or celecoxib) they may reduce the effects of Furosemide Accord; High doses of painkillers (salicylates) can increase the side effects of furosemide.
  • Anti-inflammatory or anti-allergic drugs such as corticosteroids, drugs used to treat stomach ulcers such as carbenoxolone, or laxatives, as they in combination with Furosemide Accord will affect sodium and potassium levels. Your doctor will check your potassium levels.
  • Injections are given during surgeries, including tubocurarine, curarine derivatives, and succinylcholine.
  • Chloral hydrate for sleep problems (in rare cases, intravenous administration [injection into a vein] of Furosemide Accord over a 24-hour period before the administration of chloral hydrate may lead to redness, increased sweating, anxiety, nausea, increased blood pressure, and faster heartbeat). Concomitant administration of Furosemide Accord and chloral hydrate is thus not recommended.
  • Phenytoin and phenobarbital for epilepsy as the effect of Furosemide Accord may be impaired.
  • Theophylline for asthma as its effect may be enhanced by Furosemide Accord.
  • Antibiotics such as cephalosporins, polymyxins, aminoglycosides or quinolones or other drugs that can affect the kidneys, e.g. immunosuppressants, iodine contrast agents, foscarnet, or pentamidine as Furosemide Accord may aggravate this.
  • Probenecid is used with some other medicines to protect the kidneys as it may reduce the effects of Furosemid Accord.
  • Organoplatins are used in certain cancers because Furosemide Accord may increase the side effects of this medicine.
  • Methotrexate is used in certain cancers and severe arthritis as it may reduce the effects of Furosemid Accord.
  • Medicines to increase blood pressure (pressor amines) as they may not work as well when you take them with Furosemide Accord.
  • Aminoglutethimide is used to inhibit corticoid production (Cushing’s syndrome) as it may increase the side effects of Furosemide Accord.
  • Carbamazepine is used to treat epilepsy or schizophrenia as it may increase the side effects of Furosemide Accord.
  • Sucralfate, a drug used to treat stomach ulcers. Do not take Furosemid Accord within two hours after taking sucralfate as the effect of Furosemid Accord is reduced.
  • Ciclosporin used to prevent organ transplant rejection because you are at risk for gouty arthritis (joint pain)
  • Drugs that change the heartbeat such as amiodarone, sotalol, dofetilide, and ibutilide as their effect may have been increased by Furosemide Accord.
  • Risperidone is used to treat mental illness.

Furosemide Accord with food, drink, and alcohol

Food is not expected to affect this medicine when given into a vein. Chronic moderate and heavy alcohol intake increases blood pressure and reduces the effect of antihypertensive drugs. Patients may experience dizziness and fainting shortly after consuming alcohol when receiving treatment.

Pregnancy and breastfeeding

Furosemide should not be used during pregnancy unless there are good medical reasons to use it. Furosemid Accord passes into breast milk and you must not breast-feed when you are being treated with Furosemid Accord.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking Furosemide Accord or other medicines.

Driving and using machines

Do not drive or use machines as Furosemid Accord may cause impaired attention.

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 Accord contains excipients

Furosemide 10 mg / ml solution for injection or infusion (2 ml, 4 ml and 5 ml)

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. This should be considered by patients prescribed a low-salt diet.

Furosemide Accord 10 mg / ml solution for injection / infusion (25 ml)

This medicine contains approximately 93 mg of sodium per vial. This should be considered by patients prescribed a low-salt diet.

3. How to use Furosemid Accord

Furosemide Accord ges:

  • as a slow injection into a vein ( intravenously )
  • in exceptional cases in a muscle ( intramuscularly ).

Your doctor will decide how much you need when you should receive it, and for how long you should be treated. This depends on age, weight, medical history, other medications, and the type and severity of the disease.

Generally:

  • Parenteral administration of furosemide is indicated if oral administration is not possible or not effective (eg in case of decreased intestinal absorption) or if the rapid effect is required.
  • If parenteral administration is used recommended a switch to oral administration as soon as possible.
  • For maximum efficacy and to inhibit counter-regulation, continuous injection of Furosemide Accord is generally preferred over repeated bolus injections.
  • If continuous injection of Furosemid Accord is not possible for follow-up treatment after one or more acute bolus doses, a low-dose follow-up treatment administered at short intervals (approximately 4 hours) is preferable to treatment with high bolus doses at long intervals.
  • Intravenous treatment with Furosemide Accord must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in the same syringe as other medicines.

Dosage regimen:

Adults:

  • In the absence of conditions requiring a reduced dose (see below), the recommended dose for adults and adolescents over 15 years of age is 20 mg to 40 mg Furosemide Accord (1 or 2 ampoules ) with intravenous (or in exceptional cases intramuscular ) administration. The maximum dose varies depending on the individual response.
  • If larger doses are required, they should be given as increments in increments of 20 mg and not given more frequently than every two hours.
  • In adults, the recommended maximum daily dose is a Furosemide Accord 1,500 mg.
  • Larger initial doses or maintenance doses may be required in some cases, depending on your medical condition. This is determined by the doctor. If such doses are needed, they can be given as a continuous infusion.

Children and adolescents (up to 18 years ):

  • The experience of children and young people is limited. Intravenous administration of Furosemide Accord to children and adolescents under 15 years of age is recommended only in exceptional cases.
  • Dose one should be adjusted to body weight and the recommended dose range is between 0.5 and 1 mg/kg body weight daily up to a maximum daily dose of 20 mg. Switch to oral treatment should be done as soon as possible.

Renal impairment:

  • In patients with severe renal impairment ( serum creatinine > 5 mg/dl), an infusion rate of 2.5 mg Furosemid Accord per minute should not be exceeded.

Older

  • The recommended initial dose is 20 mg/day, which is gradually increased until the required dose is reached.

If you use more Furosemide Accord then you should  

If you are concerned that you have received too much Furosemide Accord, talk to your doctor or another healthcare professional immediately. Signs that may occur if you have taken too much of this medicine are dry mouth, increased thirst, irregular heartbeat, mood swings, muscle cramps or pain, nausea or vomiting, unusual tiredness or weakness, weak heart rate, or decreased appetite.

If you forget to use Furosemide Accord

If you are worried that you have missed a dose, talk to your doctor or another healthcare professional immediately.

While you are receiving Furosemide Accord

If you experience severe allergic reactions, such as swelling of the face and/or throat, talk to your doctor or another healthcare professional immediately.

If you stop using Furosemide Accord

If you stop treatment earlier than recommended by your doctor, your heart, lungs, or kidneys may be severely affected by too much fluid.

If you have any further questions on the use of this product, ask your doctor or other healthcare professional

4. Possible side effects

Like all medicines, Furosemide Accord can cause side effects, although not everybody gets them. If you notice any of the following, contact your doctor immediately:

Uncommon (may affect up to 1 in 100 people)

  • Skin rash (including itching, redness, or scaling), a tendency to bruise, or skin sensitivity to sunlight
  • Blood cell changes that can lead to blood clotting (coagulating) (with increased risk of bleeding)
  • Deafness (sometimes persistent)

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

  • Nausea or vomiting, diarrhea, constipation, decreased appetite, discomfort in the mouth and stomach
  • Hearing problems (more common in kidney failure ) and tinnitus (ear ringing)
  • Anaphylaxis, a severe allergic reaction that can lead to skin rash, swelling, difficulty breathing, and unconsciousness. Seek medical attention immediately.
  • Kidney damage (interstitial nephritis)
  • Very low white blood cell count (which can lead to life-threatening infection ). Seek medical attention immediately.
  • Muscle problems, including leg cramps and muscle weakness
  • Pain or discomfort at the injection site (especially after muscle injection )
  • The inflammatory disease lupus erythematosus can occur or worsen.
  • Changes in blood test results (fat-like substances in the blood)
  • Numbness, tingling, or dizziness
  • High fever
  • Blurred vision, confusion, fatigue
  • Dry mouth

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

  • Severe muscle problems including twitching, spasms, cramps ( tetanus )
  • Blood cell changes that can lead to anemia, inability to fight infection.
  • Severe abdominal pain due to inflammation of the pancreas

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

  • Acute generalized exanthematous pustulosis (AGEP) (rare, acute rash with fever caused by medication)
  • Dizziness, fainting,g and unconsciousness (caused by low blood pressure )

The following may also occur:

  • Low blood pressure makes you feel weak or dizzy. You may also feel pressure in your head, joint pain, blood clots, or circulatory collapse ( shock )
  • Low levels of potassium in the blood. This can lead to muscle weakness, tingling and numbness, slight inability to move a body part, vomiting, constipation, increased gas formation in the intestine, increased urine production, increased thirst, or slow or irregular heartbeatThese problems are more likely if you have other diseases such as liver or heart problems or too little potassium in your diet or if you are taking other medicines (see “Taking other medicines”)
  • Low levels of sodium, calcium, and magnesium in the blood This can occur due to increased loss of sodium, calcium, and magnesium in the urine. Low sodium levels usually lead to lack of interest, calf cramps, decreased appetite, weakness, fatigue, nausea, and confusion. Seizures can also be associated with low calcium levels or low magnesium levels in the body.
  • Gout can occur or worsen.
  • Existing problems urinating can be exacerbated.
  • Diabetes can occur or worsen.
  • Liver problems or changes in the blood that can lead to jaundice (yellowish skin, dark urine, fatigue)
  • Decreased volume of body fluid especially in elderly patients. Severe fluid loss can lead to increased blood concentration with a tendency to develop blood clots.
  • Premature babies can get kidney stones and calcification of the kidney tissue. In premature infants, the canal between the pulmonary artery and the aorta, which is open in unborn infants, may remain open.

5. How to store Furosemid Accord

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

Do not store above 25 ° C.

Store in a cold place.

Store the ampoule/vial in the outer carton. Sensitive to light

For single use only. Used immediately after first opening. Do not use this medicine after the expiry date which is stated on the ampoule and carton after EXP and EXP. The expiration date is the last day of the specified month.

Storage of reconstituted / diluted medicinal products, see: The following information is only intended for healthcare professionals:

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 ml of solution contains 10 mg of the active substance furosemide.

2 ml sterile solution for injection contains 20 mg furosemide

4 ml sterile solution for injection contains 40 mg furosemide.

5 ml sterile solution for injection contains 50 mg furosemide .

25 ml sterile solution for injection contains 250 mg furosemide.

The other ingredients are sodium chloride, sodium hydroxide and water for injections.

What the medicine looks like and contents of the pack

Furosemide Accord is a colorless or almost colorless sterile solution for injection or infusion.

20 mg in 2 ml: amber ampoule with two white rings and a white OPC dot containing 2 ml solution.

40 mg in 4 ml: amber 5 ml ampoule with white refrain and a blue band containing 4 ml solution.

50 mg in 5 ml: amber 5 ml ampoule with white break and a white band containing 5 ml solution.

250 mg in 25 ml: Amber type I glass with a chlorobutyl rubber stopper and aluminum seal and a red snap cap containing 25 ml solution.

Pack sizes:

5, 10 x 2 ml ampoule is

1, 5.10 x 4 ml ampoule is

5, 10 x 5 ml ampoule is

1, 5, 10 x 25 ml vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

UK

Accord Healthcare Polska Sp.zoo,

ul. Lutomierska 50,95-200, Pabianice, Poland

Muhammad Nadeem

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