Prospect: Patient Information

Genta Gobens 80 mg/ml injectable solution and for perfusion

gentamicin (sulfate)

Read this prospect carefully before starting to use this medication because it contains important information for you.

–Keep this prospect as you may need to read it again.

–If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you alone, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Genta Gobens and how it is used

2.What you need to know before starting to use Genta Gobens

3.How to use Genta Gobens

4.Adverse effects

5Storage ofGenta Gobens

6.Contents of the package and additional information

Genta Gobens belongs to a group of medications called antibiotics, meaning they are used to treat severe infections caused by bacteria that can be eliminated by the active ingredient gentamicin.

Antibiotics are used to treat bacterial infections and are not effective for treating viral infections such as the flu or a cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Genta Gobens should only be used in combination with other antibiotics for the treatment of the following diseases, except for complicated kidney, urinary tract, and bladder infections.

You may receive Genta Gobens to treat the following diseases:

–Complicated and recurrent kidney, urinary tract, and bladder infections.

–Pneumonia and respiratory tract infections that occur during hospital treatment.

–Abdominal infections, such as peritonitis.

–Skin and soft tissue infections, such as severe burns.

–Sepsis (body-wide infection), bacteria in the blood.

–Endocarditis (inflammation of the heart's inner lining) for treating infections.

–Post-surgical infections.

No use Genta Gobens

• If you are allergic to gentamicin or any of the other components of this medication (listed in section6).

• If you havemyasthenia gravis.

Warnings and precautions

Consult your doctor or pharmacist before using Genta Gobens if:

• You are pregnant or breastfeeding.
• You have impaired renal function or inner ear deafness.
• If you have, or have had a maternal history of mitochondrial disease (a genetic disorder), or hearing loss due to antibiotic medication, it is recommended that you inform your doctor or pharmacist before taking an aminoglycoside; certain mitochondrial mutations may increase the risk of hearing loss with this medication. Your doctor may recommend a genetic test before administering Genta Gobens.

Then, you will only receive gentamicin if your doctor considers it essential for the treatment of your disease. Your doctor will be especially careful when adjusting your gentamicin dose correctly.

Your doctor will be especially careful if you have any disease that affects nerve and muscle function, such as Parkinson's disease, or if you receive a muscle relaxant during surgery, because gentamicin may have a blocking effect on nerve and muscle function.

You must inform your doctor immediately if you experience intense diarrhea.

Your infection may not respond to gentamicin if it did not respond to other aminoglycosides, and you may show an allergic reaction to gentamicin if you are already allergic to another aminoglycoside.

The experience with once-daily gentamicin administration in elderly patients is limited.

To reduce the risk of nerve damage to the ear and kidneys, your doctor will be especially careful when evaluating the following:

–Auditory, balance, and renal function monitoring before, during, and after treatment.

–Strict dosing according to renal function.

–If you have impaired renal function, the total dose will be taken into account for additional antibiotics administered directly to the site of infection.

–Auditory and renal function monitoring during treatment if your case requires it.

–If you already have nerve damage in the ear (auditory or balance dysfunction), or if treatment is long-term, additional monitoring of balance and auditory function is required.

–You will receive gentamicin treatment for no more than 10-14days (usually 7-10days).

–Sufficient time, 7-14days, should elapse between individual gentamicin treatments and other closely related antibiotics.

–Avoid administering other substances that may be harmful to the auditory nerve or kidneys in combination with gentamicin. If this is unavoidable, close monitoring of renal function is required.

–Your fluid levels and urine production should be within the normal range.

Other medications and Genta Gobens

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pay special attention to the following medications:

Ether, muscle relaxants

The blockade of nerve and muscle function by aminoglycosides is reinforced by ether and muscle relaxants. Therefore, you will be closely monitored while receiving these substances.

Metoxiflurane anesthesia

The anesthetist should be aware if you have received or are receiving aminoglycosides before performing metoxiflurane anesthesia (a gas anesthetic) and avoid using this agent if possible, due to an increased risk of renal damage.

Other medications with potential harm to the auditory nerve and kidneys

You will be closely monitored if you receive gentamicin before, during, or after treatment with medications containing the following substances:

• amphotericin B (for fungal infections),
• colistin (for intestinal decontamination),
• ciclosporin (for suppressing unwanted immune reactions),
• cisplatin (anticancer agent),
• vancomycin, streptomycin, viomicin, carbenicillin, other aminoglycosides, cephalosporins (antibiotics).

You will also be closely monitored if you receive medications to increase urine flow that contain, for example, etacrynic acid and furosemide.

Pregnancy and lactation

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication. This medication should not be used during pregnancy unless absolutely necessary.

Lactation

Inform your doctor if you are breastfeeding. Your doctor will carefully evaluate whether you should stop breastfeeding or discontinue gentamicin treatment.

Driving and operating machinery

Caution is advised when driving and operating machinery due to possible adverse effects such as dizziness and vertigo.

Genta Gobens may causeallergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) because it containsparahydroxybenzoate of methyl (E-218) and parahydroxybenzoate of propyl (E-216).

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it containssodium metabisulfite (E-223).

This medication contains less than 23 mg of sodium (1 mmol) per vial, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult again with your doctor or pharmacist.

Genta Gobens is presented in the form of a ready-to-use solution for intramuscular administration, or intravenous administration after its dilution.

Dosage for patients with normal renal function

The recommended daily dose in adolescents and adults with normal renal function is 3 to 6 mg/kg of body weight per day, in 1 (preferably) or up to 2 single doses.

Generally, you will receive gentamicin treatment for no more than 7 to 10 days; treatment may exceed 10 days only in cases of severe and complicated infections.

Your gentamicin blood levels will be closely monitored by examining blood samples taken at the end of a dosing interval and immediately after the end of the infusion, mainly to control renal function. Your dose will be carefully adjusted to avoid renal damage.

Use in children

The daily dose in newborns is 4 to 7 mg/kg of body weight per day. Newborns are administered the daily dose needed in a single dose.

The recommended daily dose in lactating infants after the first month of life is 4.5 to 7.5 mg/kg of body weight per day in 1 (preferably) or up to 2 single doses.

The recommended daily dose in older children (2 to 12 years) with normal renal function is 3 to 6 mg/kg of body weight per day, in 1 (preferably) or up to 2 single doses.

Dosage in patients with renal insufficiency

If you have renal insufficiency, your gentamicin blood levels will be closely monitored to adjust the dose appropriately, either by reducing the dose or extending the time between individual doses. Your doctor knows how to adjust the dosing regimen in this case.

Dosage in patients undergoing renal dialysis

In this case, the dose will be carefully adjusted according to your gentamicin blood level.

Older patients may require lower maintenance doses than young adults to achieve sufficient gentamicin blood levels.

In obese patients, the initial dose should be based on the ideal body weight plus 40% of the excess weight.

In patients with liver insufficiency, no dose adjustment is required.

If you receive more Genta Gobens than you should

In case of accumulation (e.g., due to renal insufficiency), more renal damage and auditory nerve damage may occur.

Treatment in case of overdose

First, treatment will be interrupted. There is no specific antidote. Gentamicin can be removed from the blood by renal dialysis. For the treatment of nerve and muscle blockade, calcium chloride and artificial respiration may be administered if necessary.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

If you forgot to useGenta Gobens:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Genta Gobens:

If you have any questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In certain conditions, gentamicin shows toxic effects on the auditory nerve and kidneys. Renal insufficiency is commonly observed in patients treated with gentamicin, and it generally resolves after the drug is discontinued. In most cases, renal toxicity is associated with an excessively high dose or prolonged treatment, pre-existing renal abnormalities, or other substances that also have a toxic effect on the kidneys. Additional risk factors for renal toxicity are advanced age, low blood pressure, decreased blood volume or shock, or existing liver disease. The risk factors for toxic effects on the auditory nerve are existing liver or hearing insufficiency, bacteria in the blood, and fever.

The following side effects, which may occur very rarely, that is, in less than 1 in 10,000 patients treated, may be severe and require immediate treatment:

• Acute and severe allergic reactions.
• Acute renal insufficiency.

Itching, skin rash, and difficulty breathing may be signs of acute hypersensitivity.

Decreased urine output or complete interruption of urination (oliguria, anuria), excessive nighttime urination, and generalized swelling (fluid retention) are signs of acute renal insufficiency.

The following side effects have also been reported, although their frequency is unknown: The frequencies cannot be estimated from the available data:

• Irreversible hearing loss, deafness.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Genta Gobens 80 mg/ml injectable solution:

• The active ingredient is gentamicin (sulfate). Each vial contains 240 mg of gentamicin (sulfate).
• The other components (excipients) are sodium metabisulfite (E-223), methylparaben (E-218), propylparaben (E-216), EDTA (ethylenediaminetetraacetic acid), sodium hydroxide (E-524) and water for injectable preparations.

Appearance of the product and contents of the packaging

The solution contained in the vials of Genta Gobens 80 mg/ml injectable solution is transparent, colorless or slightly yellow. Each package contains 1 vial. Each 3 ml vial contains 240 mg of gentamicin (as sulfate).

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations:

Genta Gobens 20 mg/ml injectable solution and for perfusion.

Genta Gobens 40 mg/ml injectable solution and for perfusion.

Date of the last review of this leaflet:March 2024.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.