Prospect: information for the user

Tobramycin Normon 100 mg/2 ml injectable solution EFG

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

1. What is Tobramycin Normon and how it is used

2. Before using Tobramycin Normon

3. How to use Tobramycin Normon

4. Possible adverse effects

5. Storage of Tobramycin Normon

6. Contents of the package and additional information

Tobramicina is an antibiotic that belongs to the group of aminoglycosides (it is used to combat infections produced by bacteria).

Tobramicina Normon may be used to treat:

• Treatment of central nervous system infections such as meningitis, septicemia, and neonatal sepsis.
• Treatment of gastrointestinal infections such as peritonitis.
• Treatment of complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.
• Treatment of lower respiratory tract infections such as pneumonia, bronchopneumonia, and acute bronchitis, including patients with cystic fibrosis.
• Treatment of skin, bone, and soft tissue infections such as burns.

Tobramycin should not be administered intrathecally (into the spinal column) under any circumstances.

Do not use Tobramycin Normon

• If you are allergic to tobramycin, other aminoglycoside antibiotics, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are taking potent diuretics (urine tablets) such as furosemide or etacrynic acid.

If any of these cases apply to you, inform your doctor before using this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tobramycin Normon

• If you or your maternal family members have a mitochondrial disease (a genetic disorder) or hearing loss due to antibiotics, it is recommended that you inform your doctor or pharmacist before taking this medication. Certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of tobramycin.
• If you have severe muscle disorders, such as myasthenia gravis (a disease in which muscles weaken and fatigue easily) or Parkinson's disease (a brain disorder that affects mobility).
• If you have kidney problems.
• If you have severe burns.
• If you have endocarditis (inflammation within the heart).
• If you have neutropenia (low white blood cell count).
• If you are an elderly person.
• If you are dehydrated.

Special care is also required if this medication is to be administered to infants or young children under 6 weeks of age, or if you have received a large volume blood transfusion or have cystic fibrosis.

Use of Tobramycin Normon with other medications

Special care is required if you are to take or use other medications, as they may interact with Tobramycin Normon, for example:

• Aminoglycosides (e.g., amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromycin).
• Anfotericin B (a medication used to treat fungal infections), clindamycin, and vancomycin, immunosuppressants, and cytotoxic agents (such as cyclosporine, cisplatin) increase the risk of renal toxicity. Cefalosporins (e.g., cephalothin), aspirin, and methoxyflurane may also increase the risk of renal toxicity.
• Magnesium salts, medications for treating myasthenia gravis, pancuronium, and tubocurarine, some inhalation anesthetics, massive citrated blood transfusions, as they may increase neuromuscular blockade.
• Some potent diuretics, such as etacrynic acid and furosemide, increase auditory toxicity.
• General anesthetics, as they may increase respiratory depression.
• Muscle relaxants used during general anesthesia.
• Antihistamines, buclizine, cyclizine, loxapine, meclozine, phenothiazines, thioantens, or trimethobenzamide.
• Neostigmine and pyridostigmine (medications used to treat muscle weakness).
• Indomethacin, as it may decrease the elimination of the antibiotic, increasing the risk of toxicity.
• Betalactam antibiotics, as they produce inactivation of the effects of both tobramycin and betalactams.
• Malation.
• Other medications (e.g., warfarin and phenindione).

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

There may be a risk of congenital defects if this medication is used during pregnancy, and some children whose mothers took a similar medication (streptomycin) were born deaf. It will only be used if the potential benefits clearly outweigh the risks.

Driving and operating machinery

Do not drive or operate machinery if you experience any adverse reaction (e.g., dizziness or drowsiness), which may reduce your ability to do so.

Tobramycin Normon contains sodium and sodium metabisulfite

Tobramycin Normon may cause severe allergic reactions and bronchospasm (sudden sensation of choking) due to the presence of sodium metabisulfite (E-223).

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

This medication is administered by injection (using a syringe) intramuscularly or intravenously, or by infusion (drip) into a vein.

It is administered as an infusion, and it must be diluted before use. It is infused over a period of 20 to 60 minutes.

Dose

Your doctor will determine the most suitable dose of tobramycin for you and how often you should take it.

The dose will depend on your overall health, weight, the severity of the infection, your age, and the functioning of your kidneys. Your doctor will inform you of the kidney function using urine and blood samples.

The treatment usually lasts between 7 and 10 days. If you take tobramycin for more than 10 days or exceed the recommended dose, you may experience more severe side effects, including life-threatening respiratory difficulty, which could also occur if you do not drink enough liquid, have impaired kidney function, or are taking other medications that can affect your hearing.

Your doctor will take blood samples periodically to ensure you are receiving the correct dose.

Patients with normal kidney function:

• Use in adults: the recommended dose in adults is 3 mg/kg per day in three equal doses every 8 hours.

In cases of very severe infections, it may be administered up to 5 mg/kg per day in 3 or 4 equal doses. Your doctor may reduce this dose when deemed necessary.

• Use in children:The recommended dose is 6 to 7.5 mg/kg per day in 3 or 4 doses.
• Use in premature or newborn infants less than one week old: a dose of up to a maximum of 4 mg/kg per day every 12 hours is recommended.

The usual duration of treatment is 7 to 10 days, although sometimes a longer treatment is necessary. In these cases, kidney, auditory, and vestibular (balance) functions should be closely monitored, as the risk of toxicity increases when the treatment duration exceeds 10 days.

Patients with altered kidney function:If you experience any alteration in kidney function, inform your doctor, as they will need to adjust the dose.

Use in the elderly:They may require lower maintenance doses than younger individuals.

Obese patients:Your doctor will adjust the dose based on your body weight.

Patients with burns and patients with severe infections: they may require higher doses or more frequent administrations.

If you use more Tobramycin Normon than you should

In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount administered.

Information for the doctor:In case of overdose or toxic reactions, symptomatic treatment should be administered. Hemodialysis or peritoneal dialysis can help eliminate aminoglycosides from the blood in patients with renal dysfunction, but not in patients with normal renal function. Respiratory and renal functions should be closely monitored. When two or more aminoglycosides are administered simultaneously, neuromuscular blockade may occur, leading to skeletal muscle weakness and prolonged respiratory depression or paralysis. Anticholinesterases or calcium salts may be used to help reverse the blockade, and mechanical respiratory assistance may be necessary.

If you forgot to use Tobramycin Normon

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

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

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

If you experience any of the following symptoms, inform your doctor immediately:

• Severe allergic reaction: you may experience sudden hives (urticaria), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and may feel like you are going to faint.
• Loss of hearing.
• Ringing, buzzing, or roaring in the ears.
• Dizziness.
• Vertigo (feeling like you or your surroundings are spinning).

These side effects are serious. You may need urgent medical attention.

If you experience any of the following symptoms, inform your doctor as soon as possible:

Frequent: may affect up to 1 in 10 people

• Pain or reaction at the injection site.
• Swelling, redness, and sensitivity along a vein.
• Change in white blood cell levels.
• Changes in urinary function, urinating more than usual.

Rare: may affect up to 1 in 100 people

• Increased white blood cell levels.
• Headache.
• Cough.
• Hoarseness or difficulty speaking.
• Sore throat.
• Difficulty breathing.
• Respiratory noise.
• Nausea and vomiting.
• Rash or development of raised colored patches.
• Itching.

Very rare: may affect up to 1 in 1000 people

• Confusion and disorientation.
• Increased sputum or coughing up blood.
• Diarrhea.
• Fever.
• Sensation of fatigue or drowsiness.
• Palpitations.
• Blurred vision.
• Paresthesia in arms or legs, "tingling".
• Anemia (decrease in red blood cells that may cause pale skin).
• Decrease in white blood cells (which may make you more prone to infections).
• Decrease in platelet count, increasing the risk of bleeding or hematomas.

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

• Seizures or muscle spasms.
• Loss of strength.

Frequency unknown: cannot be estimated from available data

• Oral or genital infections caused by fungi.
• State of near unconsciousness.

Tobramycin Normon may cause kidney damage (damage may vary from mild renal insufficiency to acute renal failure). Your doctor may perform blood tests to monitor this.

Tobramycin Normon may lead to changes in blood cells. Your doctor may perform blood tests to check the number of cells and blood electrolyte levels, which may decrease.

Furthermore, your doctor will check if you experience hearing problems. Hearing loss is usually irreversible.

Some patients who have received an injection of tobramycin in the eye have experienced severe vision problems. This is not a recommended use for this medication.

Reporting of side effects

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

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

No special storage conditions are required. The solution may occasionally appear pale yellow in color, which does not indicate any alteration in the potency of the drug.

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

Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Tobramycin Normon Composition

• The active ingredient is tobramycin. Each vial contains 100 mg of tobramycin (sulfate).
• The excipients are: sodium metabisulfite (E-223), phenol, disodium edetate, sulfuric acid (E-513) and water for injectable preparations.

Appearance of the product and content of the packaging

Tobramycin Normon 100 mg/2 ml is a colorless or slightly yellowish, transparent, clear injectable solution, containing 100 mg of tobramycin per 2 ml of solution. It is presented in a glass vial packaging. Each vial contains 2 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Other presentations

Tobramycin Normon 50 mg/2 ml injectable solution EFG

Last revision date of this leaflet: October 2023

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

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This information is intended solely for healthcare professionals:

Intravenous administration: Dilute with sodium chloride 0.9% or with dextrose 5%. The normal amount of diluent is 50 to 100 ml for adult doses. In pediatric doses, the volume of diluent should be proportionally smaller than for adults. The diluted solution is usually administered directly over a period of 20 to 60 minutes. Periods less than 20 minutes are not recommended to avoid exceeding serum levels of 10 µg/ml.

Mixtures of extemporaneous antibacterial beta-lactams and aminoglycosides may lead to mutual inactivation. Tobramycin is incompatible with amphotericin B, cephalothin sodium, nitrofurantoin sodium, sulfadiazine sodium, and tetracyclines. Additionally, incompatibilities should be checked if any other medication is added to the solution. Handle under standard aseptic conditions when using intravenous infusion solutions.